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02/08/2018 02:10 PM | Peter Pitts
The latest federal funding bill could issue a huge blow to beneficiaries of Medicare Part D, the government program that subsidizes the cost of prescription drugs for 42 million seniors.
The bill restructures how costs are divided between beneficiaries, insurers, and drug manufacturers once Medicare recipients' prescription costs hit a predetermined limit -- or what's known as the "donut hole." It's a terrible change, and it stands to raise costs for seniors, particularly those whose drug expenses already are through the roof.
Medicare Part D provides seniors with access to affordable prescription drug coverage offered by private insurers. There are more than 780 unique Part D plans available in the country, but each requires patients to follow the same payment plan.
First, patients must pay for their own medications until they meet a deductible -- $405 in 2018. Then, insurance kicks in and patients pay about 25 percent of their drug costs.
After patient's total drug spending hits $3,750, they enter the "donut hole," where they're responsible for 40 percent of brand-name drug costs.
Congress gets that the donut hole burdens patients. So they're trying to phase it out. Under current law, patients' cost-sharing would drop to 25 percent by 2020. Insurers would chip in the same percentage and manufacturers would cover the leftover 50 percent.
Now, Congress wants to shift the insurers' costs to drug makers. The new proposal would force manufacturers to front 75 percent of the cost of brand-name prescriptions in 2020, reducing insurers' cost-sharing to zero.
That change doesn't explicitly affect the percentage fronted by patients. But it will still affect the amount they pay for medications.
With their cost-sharing down to zero, insurers will have no reason to keep patients' drug costs low. Instead, they'll have an incentive to increase it -- and they'll put patients on the fast-track to the donut hole.
Proponents of the proposal say that it will save Medicare billions of dollars annually. But Part D already is economical. Its costs are 45 percent lower -- $349 billion less -- than initially projected for its first decade. And seniors like how Part D works. Nine in 10 report that they're satisfied with the program.
Part D is one of the highest-functioning branches of healthcare. Its performance and the care it secures for America's seniors should not be jeopardized because insurance companies want to shift some costs to drug makers. Read More & Comment...
The bill restructures how costs are divided between beneficiaries, insurers, and drug manufacturers once Medicare recipients' prescription costs hit a predetermined limit -- or what's known as the "donut hole." It's a terrible change, and it stands to raise costs for seniors, particularly those whose drug expenses already are through the roof.
Medicare Part D provides seniors with access to affordable prescription drug coverage offered by private insurers. There are more than 780 unique Part D plans available in the country, but each requires patients to follow the same payment plan.
First, patients must pay for their own medications until they meet a deductible -- $405 in 2018. Then, insurance kicks in and patients pay about 25 percent of their drug costs.
After patient's total drug spending hits $3,750, they enter the "donut hole," where they're responsible for 40 percent of brand-name drug costs.
Congress gets that the donut hole burdens patients. So they're trying to phase it out. Under current law, patients' cost-sharing would drop to 25 percent by 2020. Insurers would chip in the same percentage and manufacturers would cover the leftover 50 percent.
Now, Congress wants to shift the insurers' costs to drug makers. The new proposal would force manufacturers to front 75 percent of the cost of brand-name prescriptions in 2020, reducing insurers' cost-sharing to zero.
That change doesn't explicitly affect the percentage fronted by patients. But it will still affect the amount they pay for medications.
With their cost-sharing down to zero, insurers will have no reason to keep patients' drug costs low. Instead, they'll have an incentive to increase it -- and they'll put patients on the fast-track to the donut hole.
Proponents of the proposal say that it will save Medicare billions of dollars annually. But Part D already is economical. Its costs are 45 percent lower -- $349 billion less -- than initially projected for its first decade. And seniors like how Part D works. Nine in 10 report that they're satisfied with the program.
Part D is one of the highest-functioning branches of healthcare. Its performance and the care it secures for America's seniors should not be jeopardized because insurance companies want to shift some costs to drug makers. Read More & Comment...
01/31/2018 09:52 AM | Peter Pitts
The recent announcement by Bezos, Buffett and Dimon that they're teaming up to address health care costs is interesting. They certainly bring a lot to the table. But there seems to be some confusion.
USA Today reports that one of the things that Amazon can bring to the table is "shipping products to consumers." True. But there's a problem. According to the article, "Since drug companies rely heavily on mail orders, Amazon's long-rumored entry in the pharamcy world could introduce price-lowering competition."
Good idea -- except that drug companies don't send a single pill to patients. That's the job of PBMs and insurance companies.
Maybe the Big Three (and and the media covering this story) should get a 100 level course in the pharmaceutival supply chain.
Read More & Comment...
USA Today reports that one of the things that Amazon can bring to the table is "shipping products to consumers." True. But there's a problem. According to the article, "Since drug companies rely heavily on mail orders, Amazon's long-rumored entry in the pharamcy world could introduce price-lowering competition."
Good idea -- except that drug companies don't send a single pill to patients. That's the job of PBMs and insurance companies.
Maybe the Big Three (and and the media covering this story) should get a 100 level course in the pharmaceutival supply chain.
Read More & Comment...
01/25/2018 02:34 PM | Robert Goldberg
Despite receiving another $14 million from the Laura and John Arnold Foundation, ICER is turning into the walking dead.
The recent spate of ICER reports all come to the same premature and prejudged conclusion: that every new medicine that does not cure is not worth paying for at almost any price. Overextended and overexposed, ICER is slowly being destroyed by its ideological rigidity and analytic obsolescence. At a time when the use of data to match people to the right treatments over time and pay for performance at the patient level, ICER has doubled down on one size fits all reports that focus on saving insurers money by cutting drug prices. It roams the health care policy terrain in search of new targets to devour, guided by the same research methods and beliefs that shaped the eugenics movement. Like that movement, ICER is finding itself ridiculed and rejected by the same stakeholders that feared it just a year ago.
Of course, the unspoken but clear assumption behind ICER reports -- the same assumptions informing those who wanted to use eugenics to save society -- is another reason that Steve Pearson and company have jumped the shark: ICER assumes the use of new drugs siphons money from healthy people, wage increases, roads, potholes, etc. and that we need to put a limit on how much we pay and how much we spend for new medicines for people, most of whom, are not receiving many benefits from existing treatments.
These assumptions are laughable, and everyone knows it. Better medicines reduce the cost of treatment and staying healthy longer. Longer and better lives generate happiness and wealth, which in turn makes spending on everything -- including health care -- sustainable. ICER, now includes, but does not calculate, those goods, services, and actions we enjoy and product because we live longer and healthier. By listing those virtues but not measuring them, ICER has exposed how superficial and irrelevant it is.
Beyond that, ICER is unable to close the gap between a new generation of personalized medicines and finding a way to pay for them in order to "enhance health, prevent disease, track its development, intervene early, and manage disease most effectively if it occurs." Such treatments are based on a deep understanding of what causes disease as well as the individual differences in disease risk and response to medicine. As result, illnesses such as cancer, heart disease, and multiple sclerosis are being treated with greater effectiveness, while many rare or fatal diseases - such as cystic fibrosis, Hepatitis C, and HIV --now have treatments where none existed.
Simply put, personalized medicine is a powerful tool for extending life and making the delivery of great health, simple, convenient and more affordable. Yet ICER, captive of it paymasters and increasingly outdated approach, can't produce information to let consumers and everyone else determine which treatments work best for them to live healthier, longer. Rather, as the ability to deliver personalized medicine grows, ICER only proposes ways to reduce prices for PBMs and limit access. Meanwhile, PBMs are expanding step therapy, prior authorization and increasing cost sharing as more personalized or precision medicines become available. That means they are keeping people sick when they should be healthy and forcing them to spend more time and money on substandard care.
The rebate driven approach to drug benefits is under siege and intelligent stakeholders are seeking other ways to provide patient-centered coverage. That does not include ICER.
In addition to its need to carry out the societal rationing agenda of the Arnold Foundation, ICER lacks the bandwidth to help promote personalized medicine. The digitalization of medical data and the rapid increase in computing power now permits identifying what treatments work and measuring outcomes and analyzing such evidence to determine the links between the use of medicines and outcomes. Traditional analytical approaches employ manual, time-consuming, single hypothesis algorithms. As a result, ICER is limited in its ability to integrate multiple data types and are often limited to population averaged approaches.
For example, ICER makes all sorts of assumptions about the condition of patients and treatment patterns based on models it develops from clinical trial data. Such assumptions - including the selection of the treatment it uses to compare new medicines - are based on correlations that lack any basis in the reality of the life of every patient.
ICER will become increasingly irrelevant. Other stakeholders could accelerate that process by ignoring ICER's request for 'input' and invest the millions of dollars into creating models that capture personalized treatment response.
Such models would be based on the probabilistic and causal relationships between disease progression and treatment response (unbiased by methodological and data choices that characterize much of ICER's work) for each patient. They are less expensive to produce because the machine learning supporting it is automated. They are quicker to produce and more useful.
Indeed, personalized medicine models can be used to demonstrate and qualify an approach for using real-world evidence. The Food and Drug Administration is required to create a guidance and/or pathway for integrating real-world evidence into their approval processes. If the FDA encourages the use of real-world evidence to measure and predict clinical benefit at the individual level, it will force payors to rely more on such analyses and less on those developed by ICER and other groups. Speedily in our time. Read More & Comment...
01/16/2018 12:27 PM | Peter Pitts
Important advance at the FDA (courtesy of the Washington Post). WWPT? (What will Pharma think?)
FDA to release more clinical trial information for newly approved drugs
The Food and Drug Administration is taking steps to make it easier for doctors, patients and researchers to get access to clinical trial data amassed during the process of approving new drugs, Commissioner Scott Gottlieb said Tuesday.
Gottlieb announced the actions just before a speech on FDA transparency at a Washington forum. The meeting, attended by researchers and academics, focused on 18 recommendations for making the agency's decision-making less opaque. The suggestions were part of a report called Blueprint for Transparency.
The FDA has long said it is sharply limited in what information it can release because it often is dealing with drug companies' proprietary material.
Gottlieb, in his statement and in remarks to the forum, said the agency is starting a pilot program this month to release clinical study reports for recently approved drugs. These summaries, which are generated by drug-company sponsors of the treatments, spell out the methods and results of clinical trials. The data don't include patient-identifiable information.
The pilot is expected to ultimately include nine drugs volunteered by their sponsors for the effort, Gottlieb told Joshua Sharfstein, a Johns Hopkins Bloomberg School of Public Health professor, in a question-and-answer session at the forum.
The release of the study reports, which can run hundreds of pages, will allow researchers and others “to do more analysis around our decision-making,” especially on the safety and efficacy of new drugs, Gottlieb said. Some of the information is already released by the agency but in a format that is difficult for lay audiences to use, he said.
The commissioner also said the agency will make it easier to track clinical-research information by adding a study's identifier number from ClinicalTrials.gov to all FDA materials for a specific product. ClinicalTrials.gov is the database of studies maintained by the National Institutes of Health.
On another transparency issue, Gottlieb said the agency is exploring whether there is a “subset” of “complete response letters” that can be released. Such letters to drug companies detail why their drugs were not approved. He said the FDA is looking at possibly releasing information involving safety issues. Critics of the pharmaceutical industry have long complained that the companies don't always give the public accurate and comprehensive explanations of why their products were rejected. Read More & Comment...
FDA to release more clinical trial information for newly approved drugs
The Food and Drug Administration is taking steps to make it easier for doctors, patients and researchers to get access to clinical trial data amassed during the process of approving new drugs, Commissioner Scott Gottlieb said Tuesday.
Gottlieb announced the actions just before a speech on FDA transparency at a Washington forum. The meeting, attended by researchers and academics, focused on 18 recommendations for making the agency's decision-making less opaque. The suggestions were part of a report called Blueprint for Transparency.
The FDA has long said it is sharply limited in what information it can release because it often is dealing with drug companies' proprietary material.
Gottlieb, in his statement and in remarks to the forum, said the agency is starting a pilot program this month to release clinical study reports for recently approved drugs. These summaries, which are generated by drug-company sponsors of the treatments, spell out the methods and results of clinical trials. The data don't include patient-identifiable information.
The pilot is expected to ultimately include nine drugs volunteered by their sponsors for the effort, Gottlieb told Joshua Sharfstein, a Johns Hopkins Bloomberg School of Public Health professor, in a question-and-answer session at the forum.
The release of the study reports, which can run hundreds of pages, will allow researchers and others “to do more analysis around our decision-making,” especially on the safety and efficacy of new drugs, Gottlieb said. Some of the information is already released by the agency but in a format that is difficult for lay audiences to use, he said.
The commissioner also said the agency will make it easier to track clinical-research information by adding a study's identifier number from ClinicalTrials.gov to all FDA materials for a specific product. ClinicalTrials.gov is the database of studies maintained by the National Institutes of Health.
On another transparency issue, Gottlieb said the agency is exploring whether there is a “subset” of “complete response letters” that can be released. Such letters to drug companies detail why their drugs were not approved. He said the FDA is looking at possibly releasing information involving safety issues. Critics of the pharmaceutical industry have long complained that the companies don't always give the public accurate and comprehensive explanations of why their products were rejected. Read More & Comment...
01/11/2018 09:21 AM | Peter Pitts
Speaking of opioids and lawsuits, something very interesting just happened in the MDL (Multi-District Litigation) National Prescription Opiate Litigation case (MDL No. 2804, Case No. 1:17-CV-2804) – Presiding United States District Judge Dan A. Polster (United States District Court, Northern District of Ohio Eastern Division) made it clear to all parties that he intends to focus on fixing the problem, not the blame.
According to Judge Polster:
I don't think anyone in the country is interested in a whole lot of finger-pointing … People aren't interested in depositions, and discovery, and trials. People aren't interested in figuring out the answer to interesting legal questions like preemption and learned intermediary, or unraveling complicated conspiracy theories.
My objective is to do something meaningful to abate this crisis and to do it in 2018. … We've got all the lawyers. I can get the parties, and I can involve the states. So we'll have everyone who is in a position to do it. And with all of these smart people here and their clients, I'm confident we can do something to dramatically reduce the number of opioids that are being disseminated, manufactured, and distributed … and make sure that the pills that are manufactured and distributed go to the right people and no one else, and that there be an effective system in place to monitor the delivery and distribution, and if there's a problem, to immediately address it and to make sure that those pills are prescribed only when there's an appropriate diagnosis, and that we get some amount of money to the government agencies for treatment.
The full Transcript of Proceedings can be found here.
Stay tuned. Read More & Comment...
According to Judge Polster:
I don't think anyone in the country is interested in a whole lot of finger-pointing … People aren't interested in depositions, and discovery, and trials. People aren't interested in figuring out the answer to interesting legal questions like preemption and learned intermediary, or unraveling complicated conspiracy theories.
My objective is to do something meaningful to abate this crisis and to do it in 2018. … We've got all the lawyers. I can get the parties, and I can involve the states. So we'll have everyone who is in a position to do it. And with all of these smart people here and their clients, I'm confident we can do something to dramatically reduce the number of opioids that are being disseminated, manufactured, and distributed … and make sure that the pills that are manufactured and distributed go to the right people and no one else, and that there be an effective system in place to monitor the delivery and distribution, and if there's a problem, to immediately address it and to make sure that those pills are prescribed only when there's an appropriate diagnosis, and that we get some amount of money to the government agencies for treatment.
The full Transcript of Proceedings can be found here.
Stay tuned. Read More & Comment...
01/08/2018 06:34 AM | Peter Pitts
In a rush to find “pay fors” to balance the budget package that Congress is working to pass by January 19th, some lawmakers are pushing forward the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.
It’s a bad idea with dangerous unintended consequences. It’s time to take a breath – because the CREATES Act won’t speed a single drug to market or lower the cost of medicines for a single American. What it will most certainly provide is a windfall for the trial lawyers, raising legal costs for the pharmaceutical industry and threatening the incentives to invest in development programs for new medicines.
The CREATES Act aims to provide a series of new legal provisions that will make it easier for drug companies to introduce generic alternatives, thus spurring competition and bringing down prices. It’s well intentioned. Unfortunately, it’s worded poorly – and would lead to dangerous unintended consequences. Instead of bringing generics to market sooner, these bills could endanger patients’ lives and encourage costly, needless litigation.
CREATES strips the FDA of its watchdog role. Under its proposals, generic manufacturers won’t be required to outline testing and safety protocols for the FDA to approve. Even if a generic drug maker’s proposed risk evaluation and mitigation strategies are inadequate, the FDA has no authority to reject or halt the transfer of medicines to the generic company for testing. Whatever happened to “safety first?”
CREATES contains ambiguously worded liability provisions that subject innovators to unfair legal risk. Generic drug companies often obtain brand-name drug samples and ship them off to third-party research firms to perform clinical trials. If the third party is negligent with the samples, patients could get hurt. Under the bill’s terms, patients would be able to sue the brand-name drug company, even though it had no control over the testing or safety protocols. Higher legal fees for drug companies ultimately result in higher costs for everyone else.
CREATES would allow generic drug manufacturers to sue brand-name manufacturers if they fail to hand over their drug samples for testing within 31 days, or if the companies do not reach an agreement on shared risk evaluation and mitigation strategies for risky drugs. Such subjective wording is music to trial lawyers’ ears.
Congress deserve praise for trying to find pay-fors that bring generic medicines to market faster, relieving consumers from high drug prices. Yet good intentions don’t change the fact that the CREATES ACT, as currently constructed — is deeply flawed.
Congress could help consumers by reworking the legislative language to end bad behavior without gutting safeguards for patients or enabling unscrupulous trial lawyers to file costly, pointless suits. Whether it’s the practice of medicine or the development of public healthcare policy two rules apply – first, do no harm and, second, be wary of trial lawyers bearing gifts. The CREATES Act as a budget pay-for would be a Pyrrhic victory. Read More & Comment...
It’s a bad idea with dangerous unintended consequences. It’s time to take a breath – because the CREATES Act won’t speed a single drug to market or lower the cost of medicines for a single American. What it will most certainly provide is a windfall for the trial lawyers, raising legal costs for the pharmaceutical industry and threatening the incentives to invest in development programs for new medicines.
The CREATES Act aims to provide a series of new legal provisions that will make it easier for drug companies to introduce generic alternatives, thus spurring competition and bringing down prices. It’s well intentioned. Unfortunately, it’s worded poorly – and would lead to dangerous unintended consequences. Instead of bringing generics to market sooner, these bills could endanger patients’ lives and encourage costly, needless litigation.
CREATES strips the FDA of its watchdog role. Under its proposals, generic manufacturers won’t be required to outline testing and safety protocols for the FDA to approve. Even if a generic drug maker’s proposed risk evaluation and mitigation strategies are inadequate, the FDA has no authority to reject or halt the transfer of medicines to the generic company for testing. Whatever happened to “safety first?”
CREATES contains ambiguously worded liability provisions that subject innovators to unfair legal risk. Generic drug companies often obtain brand-name drug samples and ship them off to third-party research firms to perform clinical trials. If the third party is negligent with the samples, patients could get hurt. Under the bill’s terms, patients would be able to sue the brand-name drug company, even though it had no control over the testing or safety protocols. Higher legal fees for drug companies ultimately result in higher costs for everyone else.
CREATES would allow generic drug manufacturers to sue brand-name manufacturers if they fail to hand over their drug samples for testing within 31 days, or if the companies do not reach an agreement on shared risk evaluation and mitigation strategies for risky drugs. Such subjective wording is music to trial lawyers’ ears.
Congress deserve praise for trying to find pay-fors that bring generic medicines to market faster, relieving consumers from high drug prices. Yet good intentions don’t change the fact that the CREATES ACT, as currently constructed — is deeply flawed.
Congress could help consumers by reworking the legislative language to end bad behavior without gutting safeguards for patients or enabling unscrupulous trial lawyers to file costly, pointless suits. Whether it’s the practice of medicine or the development of public healthcare policy two rules apply – first, do no harm and, second, be wary of trial lawyers bearing gifts. The CREATES Act as a budget pay-for would be a Pyrrhic victory. Read More & Comment...
01/03/2018 06:25 PM | Robert Goldberg
Cary Gross and Abbe Gluck of Yale University get the Billy Madison award for the most incoherent and idiotic article about drug pricing. The piece: Soaring Cost of Cancer Treatment: Moving Beyond Sticker Shock published in the Journal of Clinical Oncology). There was a lot of competition but the authors managed to synthesize every pedestrian and inchoate assault on drug companies into an editorial that took the genre (if I can use this word without disparaging real scholarship) to a new level.
The failing heart of the article, entitled can be obtained by reading one paragraph: ( I am sparing you the painful waste of time required to slog through the entire article and endure the smell of decomposing bromides)
“We know that the cost of cancer drugs has increased dramatically, even though most drugs are brought into the market without compelling evidence that they prolong survival or improve quality of life. We know that these high costs render state-of-the-art cancer treatment unaffordable to patients without insurance and even to some patients with insurance. Furthermore, financial distress associated with paying for cancer treatment is common and is associated with stress, decreased adherence, bankruptcy, and worse outcomes. Finally, we know that the cost of new drugs is not well correlated with their effectiveness, nor with the presence of competing products.”
The authors then conclude that price controls and stricter formularies are the only way to control prices and help patients.
I won’t take on every citation Gross and Gluck (Gross-Gluck sounds like a Borscht Belt act) use to assert perfect knowledge about the havoc price increases have had on society. It is enough to say that once again, they all are written by people on the Arnold Foundation payroll. Or maybe not. As I and Peter Pitts pointed out, the most prolific of the paid hacks, Vinay Prasad, had an article published that was brazenly misleading and inaccurate. (Shame on the medical journals that continue to publish any anti-pharma crap if it fits the narrative.)
So here is my fact-based response to the fictional claims to support government regulation of access to new medicines.
1. As the number (and price) of targeted treatments have increased the percent of health care dollars devoted to cancer spending has remained at 4.6 percent. How? New cancer drugs reduce spending on more expensive medical services. In 2001, 64 percent of cancer care went to hospitals and only 3.6 percent to drugs. By 2016 drug spending ‘skyrocketed’ to about 25 percent of cancer costs but hospitalizations dropped to 38 percent of care. That’s why a government study concluded, “The net value of (cancer) treatment has grown substantially, consistent with medical technology improving over time and leading to better health outcomes at a lower cost per patient.” All these benefits have been generated by new medicines that are only .7 percent of health spending. This relationship – newer, initially expensive medicines (that go generic by the way) reducing the cost of care by letting people live longer and eliminating the need for other medicines -- has held up for nearly half a century.
2. GrossGluck enable the PBM payoff racket by remaining silent on the role PBMs and insurers play in setting cost-sharing levels.
As scientists find the shut-off switch for specific cancer-causing genes, they can make pills that go after cancer cells and block the specific biological mechanisms that produce them. These pills are not only less toxic than conventional IV chemotherapy; they've turned once-incurable cancers such a myeloma, breast cancer, and even pancreatic cancer into manageable diseases. They reduce the cost of cancer care over time but PBMs and insurers have responded by making these medicines more expensive and shifting patients to drugs that pay the most rebates.
Sadly, several studies show, 25 percent of patients don't even fill their initial prescriptions for cancer pills when the co-pays exceed $500. Even more will stop or interrupt treatment. Neither Medicare nor private health insurers are closing the gap between coverage and innovation. Instead, a survey of plans conducted by the Zitter Group found that insurers "recognize that oral therapy cost-sharing requirements actively encourage patients to use infusible products.
A Milliman study found that shifting to co-insurance would only add about $2 per member per month in private health plans. GrossGluck never discuss this solution. Instead, they remain true to the Arnold Foundation edict to give PBMs a pass. By the way, neither has advocated for co-pay reforms that could relieve the burden on patients.
3. They ignore the impact of government price controls on access and innovation. But then again, those with perfect knowledge trust themselves to makes decisions on behalf of everyone else. They don’t mention the National Institute for Health and Clinical Excellence or NICE but they see it as a model for how experts would set prices and determine access for everyone.
So, it is useful to know that NICE has turned down more new cancer drugs than other countries, even in Europe. Hence, 5-year survival rates for all cancers are lower in the UK than in any other European country. It’s mortality rates for many cancers, including breast, prostate, kidney, and others are higher. A study published in Lancet Oncology on cancer survival rates in Europe found.
“Cancer survival rates in Britain still lag well behind many other European countries, a study shows. Survival rates for nine out of ten common cancers are lower than the European average, despite improvements in diagnosis and treatment.
And the discrepancy is even worse among elderly sufferers. Patients with nearly all forms of the disease are more likely to die in Britain compared with patients in France, Germany, Spain, and Scandinavia.
For breast cancer, it found that British women have a 79 percent chance of surviving five years, compared with 86 percent in France, 87 percent in Finland, 85 percent in Norway and 82 percent on average.
Only 9 per cent of lung cancer patients in the UK live beyond five years, compared with the 13 per cent average, 17 per cent in Austria and 15 per cent in Sweden.
For prostate cancer, just under 81 percent of patients in Britain live beyond five years. The rate is 90 percent in Finland and 89 percent in France. Around 68 per cent of over-75s with breast cancer survive beyond five years, compared with 75 percent across Europe. About 45 percent of men over 85 with prostate cancer live for at least five years. The average is 58 percent.”
The only evidence they cite for the effectiveness of their approach is the now old case of Peter Bach claiming he saved patients money by refusing to add Zaltrap to the formulary.
(Indeed, it is ironic that Bach became crypto famous by getting Sanofi to cut the price of a cancer drug by 50 percent and writing about it in a New York Times op-ed piece. )
The duo asserted that they wouldn’t prescribe the drug because it cost twice as much as Genentech’s Avastin (bevacizumab), a competing biologic drug with similar expected clinical outcomes for colorectal cancer patients. In response, Sanofi said they would reduce the price of the drug by 50 percent. In fact, doctors and prescribing hospitals benefited hugely from Sanofi’s pricing move, while payers and patients did not. Zaltrap was sold in a dose twice as large as Avastin, thus the price discrepancy. Further, Sanofi didn’t cut the price of Zaltrap; it gave Memorial Sloan a 50 percent rebate. The price charged to patients remained the same. Which meant that MSKCC raked in even more dough. As an article in Health Affairs noted at the time, “Meanwhile, in the near term, physicians and hospitals will likely enjoy additional revenue opportunities from ziv-aflibercept use. the spread may be considerable: equal to $250 per treatment dose (insurer + patient reimbursement ($750) – discounted acquisition cost ($500)) and for 340B eligible purchases, $450 per treatment dose (insurer + patient reimbursement ($750) – discounted acquisition cost ($300)). Additional revenues may incentivize physicians and hospitals to favor ziv-aflibercept over bevacizumab to treat colorectal cancer among Medicare-eligible patients, despite the treatments having equivalent expected clinical outcomes. The strength of the incentive is based on comparing the magnitude of the spread obtained with the use of Zaltrap to that obtained with Avastin."
For this half-baked convoluted diatribe, GrossGluck get the Billy Madison award:
Principal: Mr. Madison, what you’ve just said is one of the most insanely idiotic things I have ever heard. At no point in your rambling, incoherent response were you even close to anything that could be considered a rational thought. Everyone in this room is now dumber for having listened to it. I award you no points and may G-d have mercy on your soul.
Read More & Comment...
12/13/2017 06:56 AM | Peter Pitts
Good news! The FDA is interested in using opioid labels to mandate packaging standards, as well as offer claims similar to those available for abuse deterrent products.
Per Commissioner Scott Gottlieb, labeling claims describing the benefits of packaging could be connected to agency efforts to work with medical societies to create better opioid prescribing guidelines.
Package design "opens up certain possibilities about how we drive more appropriate prescribing," Gottlieb said at the beginning of a two-day meeting on opioid packaging, storage and disposal options to enhance safety. "Could we, for example, require that the immediate-release drugs be packaged in units that comport with the majority of these consensus durations?"
Stand by. Read More & Comment...
Per Commissioner Scott Gottlieb, labeling claims describing the benefits of packaging could be connected to agency efforts to work with medical societies to create better opioid prescribing guidelines.
Package design "opens up certain possibilities about how we drive more appropriate prescribing," Gottlieb said at the beginning of a two-day meeting on opioid packaging, storage and disposal options to enhance safety. "Could we, for example, require that the immediate-release drugs be packaged in units that comport with the majority of these consensus durations?"
Stand by. Read More & Comment...
11/30/2017 05:47 PM | Peter Pitts
From the page of STAT News …
Gottlieb signals support for both ‘gold standard’ and expedited review for drug approvals
By Meghana Keshavan @megkesh
November 30, 2017
Regulatory standards for some clinical trials may soon slacken, per a new statement from Food and Drug Administration Commissioner Scott Gottlieb. And though his words are vague, they’ve been enough to raise red flags in some corners.
Testifying today before a Congressional committee on the 21st Century Cures Act, Gottlieb sent a mixed message: He wants the agency to “remain steadfast to our gold standard for safety and efficacy,” while making the development of breakthrough products “more scientifically modern and efficient, to meet the urgent needs of patients.”
Gottlieb said that in some cases, “when there’s a clear and outsized treatment effect,” a cancer drug might get expedited approval — and its efficacy will be evaluated only in postmarket studies.
The agency said it intends to release a document soon that will outline how it plans to expand on the Cures Act.
The term “gold standard” has historically referred to rigorous randomized controlled clinical trials. But this form of drug evaluation is onerous and costly — and many argue that it prevents promising experimental medicines from reaching patients quickly enough. The 21st Century Cures Act was devised, in part, to speed up that process — granting the agency $500 million over the course of a decade to work out the intricacies. And President Trump has spoken of hastening drug approvals.
Still, this gold standard is what keeps ineffective, or even dangerous, drugs away from patients. And there isn’t much evidence that speeding along approvals will bring better results to patients. A recent BMJ study, for instance, found that more than half of all new cancer drugs “show no benefits” for either survival or quality of life.
A big sticking point with Gottlieb’s apparent approach is that small clinical trials simply don’t offer enough meaningful data.
“Empirical evidence suggests that the findings from individual trials may be spurious,” said Joshua Wallach, a research fellow at Yale’s Collaboration for Research Integrity and Transparency. He added, as additional studies are performed, the effects observed in small, early stage trials often attenuate — and can even be invalidated.
“With cancer drugs, the patients in these small trials have been so carefully selected, they will do well whether you give them a good new drug or sugar water,” said Dr. Vinay Prasad, an oncologist at Oregon Health & Sciences University.
Meanwhile, the current system for monitoring postmarket drug efficacy remains highly flawed, according to a 2016 report from the Office of Inspector General. Since it’s harder to track a drug’s efficacy in the real world, which functions rather differently than a controlled trial, FDA already has issues with data management and workflow, the report concluded. As a result, many of these studies aren’t completed on time — or even at all, according to an August study in the New England Journal of Medicine.
The concern is that the agency is not equipped to handle a new influx of postmarket data — and much could slip through the cracks. It’ll take substantial investment to help plug those holes and create a smart system for postmarket analysis, Wallach said.
“FDA understands that different products need different regulatory pathways, from both a science and a patient-need perspective,” said Peter Pitts, president of the nonprofit Center for Medicine in the Public Interest. Read More & Comment...
Gottlieb signals support for both ‘gold standard’ and expedited review for drug approvals
By Meghana Keshavan @megkesh
November 30, 2017
Regulatory standards for some clinical trials may soon slacken, per a new statement from Food and Drug Administration Commissioner Scott Gottlieb. And though his words are vague, they’ve been enough to raise red flags in some corners.
Testifying today before a Congressional committee on the 21st Century Cures Act, Gottlieb sent a mixed message: He wants the agency to “remain steadfast to our gold standard for safety and efficacy,” while making the development of breakthrough products “more scientifically modern and efficient, to meet the urgent needs of patients.”
Gottlieb said that in some cases, “when there’s a clear and outsized treatment effect,” a cancer drug might get expedited approval — and its efficacy will be evaluated only in postmarket studies.
The agency said it intends to release a document soon that will outline how it plans to expand on the Cures Act.
The term “gold standard” has historically referred to rigorous randomized controlled clinical trials. But this form of drug evaluation is onerous and costly — and many argue that it prevents promising experimental medicines from reaching patients quickly enough. The 21st Century Cures Act was devised, in part, to speed up that process — granting the agency $500 million over the course of a decade to work out the intricacies. And President Trump has spoken of hastening drug approvals.
Still, this gold standard is what keeps ineffective, or even dangerous, drugs away from patients. And there isn’t much evidence that speeding along approvals will bring better results to patients. A recent BMJ study, for instance, found that more than half of all new cancer drugs “show no benefits” for either survival or quality of life.
A big sticking point with Gottlieb’s apparent approach is that small clinical trials simply don’t offer enough meaningful data.
“Empirical evidence suggests that the findings from individual trials may be spurious,” said Joshua Wallach, a research fellow at Yale’s Collaboration for Research Integrity and Transparency. He added, as additional studies are performed, the effects observed in small, early stage trials often attenuate — and can even be invalidated.
“With cancer drugs, the patients in these small trials have been so carefully selected, they will do well whether you give them a good new drug or sugar water,” said Dr. Vinay Prasad, an oncologist at Oregon Health & Sciences University.
Meanwhile, the current system for monitoring postmarket drug efficacy remains highly flawed, according to a 2016 report from the Office of Inspector General. Since it’s harder to track a drug’s efficacy in the real world, which functions rather differently than a controlled trial, FDA already has issues with data management and workflow, the report concluded. As a result, many of these studies aren’t completed on time — or even at all, according to an August study in the New England Journal of Medicine.
The concern is that the agency is not equipped to handle a new influx of postmarket data — and much could slip through the cracks. It’ll take substantial investment to help plug those holes and create a smart system for postmarket analysis, Wallach said.
“FDA understands that different products need different regulatory pathways, from both a science and a patient-need perspective,” said Peter Pitts, president of the nonprofit Center for Medicine in the Public Interest. Read More & Comment...
11/17/2017 02:19 PM | Peter Pitts
FDA unveiled a regenerative medicine framework aimed at speeding the development and review of cell and stem cell therapies and tissue-based products, while also cracking down on those that would game the system. The framework, which was outlined in two draft and two final guidances, builds on the agency's previous policy that took effect in 2005.
"Today we’re taking steps to advance an innovative framework for how we intend to apply the existing laws and regulations that govern these products," FDA Commissioner Scott Gottlieb said in a statement. "Our aim is to make sure we’re being nimble and creative when it comes to fostering innovation, while taking steps to protect the safety of patients."
The two final guidances aim to provide clarity on which products are exempt from FDA regulations, and how FDA defines "minimal manipulation" and "homologous use."
The first draft guidance clarifies regulatory pathways for devices used in the recovery, isolation, or delivery of Regenerative Medicine Advanced Therapies (RMAT). In the second draft guidance, FDA explains how it might consider regenerative medicine products for expedited review pathways, including Fast Track, breakthrough therapy and RMAT designations, as well as accelerated approval and Priority Review.
The RMAT designation, which was introduced in December as part of the 21st Century Care Act, applies the principles pioneered in FDA’s breakthrough designation to regenerative therapies including “cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products.” In August, Gottlieb announced that FDA will also make some gene therapies eligible for RMAT.
The second draft guidance also proposes the use of "innovative" trial designs, such as basket trials that compare multiple investigational products. Another example is a multi-center trial where individual academic centers use the same manufacturing protocols and share combined trial data to support BLAs from each individual center.
"Our goal is to achieve a risk-based and science-based approach to support innovative product development, while clarifying the FDA’s authorities and enforcement priorities and making sure we are protecting patients," Gottlieb said in his statement.
The second draft guidance also encourages companies to engage with Center for Biologics Evaluation and Research (CBER) review staff during product development. Several companies have voiced concern over the frequency of interaction with FDA, particularly regarding preclinical development of regenerative medicine therapies. In a media briefing Thursday, Peter Marks, director of CBER, said that the guidances aim to address this by providing clarity on “the agency’s interpretation of the regulations.”
FDA did not issue any new warning letters or enforcement actions with the guidances, but said it intends to focus enforcement actions for unlawfully marketed regenerative medicine products on those that pose a higher risk, considering factors such as whether it is for allogeneic use and the route and site of administration. Gottlieb said that providing a clear regulatory framework for developers "gives us the solid platform we need to continue to take enforcement action against a small number of clearly unscrupulous actors." Read More & Comment...
"Today we’re taking steps to advance an innovative framework for how we intend to apply the existing laws and regulations that govern these products," FDA Commissioner Scott Gottlieb said in a statement. "Our aim is to make sure we’re being nimble and creative when it comes to fostering innovation, while taking steps to protect the safety of patients."
The two final guidances aim to provide clarity on which products are exempt from FDA regulations, and how FDA defines "minimal manipulation" and "homologous use."
The first draft guidance clarifies regulatory pathways for devices used in the recovery, isolation, or delivery of Regenerative Medicine Advanced Therapies (RMAT). In the second draft guidance, FDA explains how it might consider regenerative medicine products for expedited review pathways, including Fast Track, breakthrough therapy and RMAT designations, as well as accelerated approval and Priority Review.
The RMAT designation, which was introduced in December as part of the 21st Century Care Act, applies the principles pioneered in FDA’s breakthrough designation to regenerative therapies including “cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products.” In August, Gottlieb announced that FDA will also make some gene therapies eligible for RMAT.
The second draft guidance also proposes the use of "innovative" trial designs, such as basket trials that compare multiple investigational products. Another example is a multi-center trial where individual academic centers use the same manufacturing protocols and share combined trial data to support BLAs from each individual center.
"Our goal is to achieve a risk-based and science-based approach to support innovative product development, while clarifying the FDA’s authorities and enforcement priorities and making sure we are protecting patients," Gottlieb said in his statement.
The second draft guidance also encourages companies to engage with Center for Biologics Evaluation and Research (CBER) review staff during product development. Several companies have voiced concern over the frequency of interaction with FDA, particularly regarding preclinical development of regenerative medicine therapies. In a media briefing Thursday, Peter Marks, director of CBER, said that the guidances aim to address this by providing clarity on “the agency’s interpretation of the regulations.”
FDA did not issue any new warning letters or enforcement actions with the guidances, but said it intends to focus enforcement actions for unlawfully marketed regenerative medicine products on those that pose a higher risk, considering factors such as whether it is for allogeneic use and the route and site of administration. Gottlieb said that providing a clear regulatory framework for developers "gives us the solid platform we need to continue to take enforcement action against a small number of clearly unscrupulous actors." Read More & Comment...
11/13/2017 10:08 AM | Robert Goldberg
The Trump administration has received kudos for the appointment (and performance of) CMS Administrator Seema Verna and FDA Commissioner Scott Gottlieb.
Nominating Alex Azar to by HHS Secretary is a trifecta for the agency. The media will make much of his Eli Lilly background. Here we focus on his stellar public service:
"From 2001 until February 3, 2007, Azar worked at the U.S. Department of Health and Human Services, first as the General Counsel of the Department (2001-2005), and then as the Deputy Secretary of Health and Human Services (2005-2007).[8][9] He was twice confirmed unanimously by the U.S. Senate. As Deputy Secretary, Azar worked closely with Secretary Mike Leavitt as the number two official and Chief Operating Officer of the largest civilian department in the federal government, with a budget of $698 billion and more than 66,000 employees reporting up to him.[10]
On behalf of Secretary Mike Leavitt, Azar supervised all operations of HHS, including the regulation of food and drugs, Medicare,Medicaid, medical research, public health, welfare, child and family services, disease prevention, Indian health, mental health services, emergency preparedness and response, and many other activities. Agencies that reported to him included, among others, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the National Institutes of Health and the Centers for Disease Control and prevention. Azar led the development and approval of all HHS regulations. He was a member of the Deputies Committees of the White House Homeland Security Council, National Economic Council, and Domestic Policy Council, and an ad hoc member of the Deputies Committee of the National Security Council. He also represented the Secretary on the Board of Governors of the American Red Cross and the Board of Trustees of the John F. Kennedy Center for the Performing Arts" Read More & Comment...
Nominating Alex Azar to by HHS Secretary is a trifecta for the agency. The media will make much of his Eli Lilly background. Here we focus on his stellar public service:
"From 2001 until February 3, 2007, Azar worked at the U.S. Department of Health and Human Services, first as the General Counsel of the Department (2001-2005), and then as the Deputy Secretary of Health and Human Services (2005-2007).[8][9] He was twice confirmed unanimously by the U.S. Senate. As Deputy Secretary, Azar worked closely with Secretary Mike Leavitt as the number two official and Chief Operating Officer of the largest civilian department in the federal government, with a budget of $698 billion and more than 66,000 employees reporting up to him.[10]
On behalf of Secretary Mike Leavitt, Azar supervised all operations of HHS, including the regulation of food and drugs, Medicare,Medicaid, medical research, public health, welfare, child and family services, disease prevention, Indian health, mental health services, emergency preparedness and response, and many other activities. Agencies that reported to him included, among others, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the National Institutes of Health and the Centers for Disease Control and prevention. Azar led the development and approval of all HHS regulations. He was a member of the Deputies Committees of the White House Homeland Security Council, National Economic Council, and Domestic Policy Council, and an ad hoc member of the Deputies Committee of the National Security Council. He also represented the Secretary on the Board of Governors of the American Red Cross and the Board of Trustees of the John F. Kennedy Center for the Performing Arts" Read More & Comment...
11/13/2017 09:01 AM | Robert Goldberg
As recent study by University of North Caroline researcher Stacey Dusetzina and her colleagues found that patients paying the most for their cancer pill prescriptions experienced increases in their monthly out-of-pocket costs. For those whose costs were more expensive than 95 percent of other patients, their out-of-pocket costs increased an estimated $143.25 per month. Those paying more than 90 percent of what other patients paid saw their costs increase by $37.19 per month.
The proportion of medication fills requiring patients to spend more than $100 per month out-of-pocket increased from 8.4 to 11 percent for plans subject to parity laws, while plans outside of the laws saw a slight decline.
Dusetzina said that one issue that may be impacting cost is that the parity laws do not address the affordability of cancer drugs.
Indeed, what good is parity if PBMs and health insurers continue to shift every patient who needs cancer drugs into the co-insurance or highest cost sharing tier?
Adam Fein's analysis of cost shifting underscores why oral parity is being undermined:
"In the charts below, I summarize employers’ 2017 pharmacy benefits by examining (1) cost sharing tier structures, (2) average copayments, by formulary tier, (3) type of cost sharing (coinsurance and copayment), and (4) coinsurance structures. I’ll investigate the growing role of deductibles in a follow-up article.
This year’s results show massive cost-shifting for specialty drugs. For the first time, a majority of plans have four tiers. Economically-debilitating coinsurance—in some cases with no limit on out-of-pocket expenses—is common.
When people complain about “drug costs,” they are actually thinking about the share of costs that they pay. Last week, I highlighted Prime Therapeutics’ data showing very slow growth in post-rebate drug spending. Given the new Kaiser/HRET survey, it looks like patients may not always be getting the benefit of lower costs."
The problem is that much of the price of drugs is being used to subsidize rebates and discounts for PBMs and insurers and the copay assistance required by higher cost sharing. Drug companies are paying rebates and then paying for the markup on the rebated prices at the backend. Where's the incentive to reduce patient costs? Consumerization requires a business model that rewards consumers, instead of exploiting them.
Read More & Comment...
The proportion of medication fills requiring patients to spend more than $100 per month out-of-pocket increased from 8.4 to 11 percent for plans subject to parity laws, while plans outside of the laws saw a slight decline.
Dusetzina said that one issue that may be impacting cost is that the parity laws do not address the affordability of cancer drugs.
Indeed, what good is parity if PBMs and health insurers continue to shift every patient who needs cancer drugs into the co-insurance or highest cost sharing tier?
Adam Fein's analysis of cost shifting underscores why oral parity is being undermined:
"In the charts below, I summarize employers’ 2017 pharmacy benefits by examining (1) cost sharing tier structures, (2) average copayments, by formulary tier, (3) type of cost sharing (coinsurance and copayment), and (4) coinsurance structures. I’ll investigate the growing role of deductibles in a follow-up article.
This year’s results show massive cost-shifting for specialty drugs. For the first time, a majority of plans have four tiers. Economically-debilitating coinsurance—in some cases with no limit on out-of-pocket expenses—is common.
When people complain about “drug costs,” they are actually thinking about the share of costs that they pay. Last week, I highlighted Prime Therapeutics’ data showing very slow growth in post-rebate drug spending. Given the new Kaiser/HRET survey, it looks like patients may not always be getting the benefit of lower costs."
The problem is that much of the price of drugs is being used to subsidize rebates and discounts for PBMs and insurers and the copay assistance required by higher cost sharing. Drug companies are paying rebates and then paying for the markup on the rebated prices at the backend. Where's the incentive to reduce patient costs? Consumerization requires a business model that rewards consumers, instead of exploiting them.
Read More & Comment...
11/13/2017 10:02 AM | Robert Goldberg
A recent study by University of North Carolina researcher "Stacey Dusetzina and her colleagues found that patients paying the most for their cancer pill prescriptions experienced increases in their monthly out-of-pocket costs. For those whose costs were more expensive than 95 percent of other patients, their out-of-pocket costs increased an estimated $143.25 per month. Those paying more than 90 percent of what other patients paid saw their costs increase by $37.19 per month.
The proportion of medication fills requiring patients to spend more than $100 per month out-of-pocket increased from 8.4 to 11 percent for plans subject to parity laws, while plans outside of the laws saw a slight decline.
Dusetzina said that one issue that may be impacting cost is that the parity laws do not address the affordability of cancer drugs."
Indeed, what good is parity if PBMs and health insurers continue to shift every patient who needs cancer drugs into the co-insurance or highest cost sharing tier?
Adam Fein's analysis of cost shifting underscores why oral parity is being undermined:
"In the charts below, I summarize employers’ 2017 pharmacy benefits by examining (1) cost sharing tier structures, (2) average copayments, by formulary tier, (3) type of cost sharing (coinsurance and copayment), and (4) coinsurance structures. I’ll investigate the growing role of deductibles in a follow-up article.
This year’s results show massive cost-shifting for specialty drugs. For the first time, a majority of plans have four tiers. Economically-debilitating coinsurance—in some cases with no limit on out-of-pocket expenses—is common.
When people complain about “drug costs,” they are actually thinking about the share of costs that they pay. Last week, I highlighted Prime Therapeutics’ data showing very slow growth in post-rebate drug spending. Given the new Kaiser/HRET survey, it looks like patients may not always be getting the benefit of lower costs."
In another blog Fein notes: "For 2017, about 8 out of 10 U.S. workers must meet a general annual deductible before their plan pays for most healthcare services. Prescriptions are typically excluded from the deductible.
However, this year’s survey shows that one-third of workers in high-deductible plans now faces a separate prescription drug deductible. These plans shift 100% of the prescription cost to the patient until the deductible is met.
After reviewing the latest data, I offer some observations on how deductibles are altering the pharmaceutical and pharmacy industries. The bottom line: Patients who must cover the costs of their drugs shop for better deals and cheaper pharmacies. Get ready for the consumerization of the pharmacy industry!"
The problem is that much of the price of drugs is being used to subsidize rebates and discounts for PBMs and insurers and the copay assistance required by higher cost sharing. Drug companies are paying rebates and then paying for the markup on the rebated prices at the backend. Where's the incentive to reduce patient costs? The fact is, even if drug prices were cut, PBMs and insurers would still get their spread and increase cost sharing.
Consumerization requires a model that rewards consumers instead of model screws them. (See below)
Read More & Comment...
The proportion of medication fills requiring patients to spend more than $100 per month out-of-pocket increased from 8.4 to 11 percent for plans subject to parity laws, while plans outside of the laws saw a slight decline.
Dusetzina said that one issue that may be impacting cost is that the parity laws do not address the affordability of cancer drugs."
Indeed, what good is parity if PBMs and health insurers continue to shift every patient who needs cancer drugs into the co-insurance or highest cost sharing tier?
Adam Fein's analysis of cost shifting underscores why oral parity is being undermined:
"In the charts below, I summarize employers’ 2017 pharmacy benefits by examining (1) cost sharing tier structures, (2) average copayments, by formulary tier, (3) type of cost sharing (coinsurance and copayment), and (4) coinsurance structures. I’ll investigate the growing role of deductibles in a follow-up article.
This year’s results show massive cost-shifting for specialty drugs. For the first time, a majority of plans have four tiers. Economically-debilitating coinsurance—in some cases with no limit on out-of-pocket expenses—is common.
When people complain about “drug costs,” they are actually thinking about the share of costs that they pay. Last week, I highlighted Prime Therapeutics’ data showing very slow growth in post-rebate drug spending. Given the new Kaiser/HRET survey, it looks like patients may not always be getting the benefit of lower costs."
In another blog Fein notes: "For 2017, about 8 out of 10 U.S. workers must meet a general annual deductible before their plan pays for most healthcare services. Prescriptions are typically excluded from the deductible.
However, this year’s survey shows that one-third of workers in high-deductible plans now faces a separate prescription drug deductible. These plans shift 100% of the prescription cost to the patient until the deductible is met.
After reviewing the latest data, I offer some observations on how deductibles are altering the pharmaceutical and pharmacy industries. The bottom line: Patients who must cover the costs of their drugs shop for better deals and cheaper pharmacies. Get ready for the consumerization of the pharmacy industry!"
The problem is that much of the price of drugs is being used to subsidize rebates and discounts for PBMs and insurers and the copay assistance required by higher cost sharing. Drug companies are paying rebates and then paying for the markup on the rebated prices at the backend. Where's the incentive to reduce patient costs? The fact is, even if drug prices were cut, PBMs and insurers would still get their spread and increase cost sharing.
Consumerization requires a model that rewards consumers instead of model screws them. (See below)
Read More & Comment...
11/08/2017 08:24 PM | Peter Pitts
FDA Commissioner Scott Gottlieb Wednesday called on branded drug companies to “end the shenanigans” they use to block generic competition, and announced new steps to rein in some anticompetitive practices.
Speaking at a Federal Trade Commission meeting on competition in prescription drug markets, Gottlieb noted that drug companies sometimes prolong negotiation over terms of a shared REMS as a tactic to delay approval of generic drugs. To counter such practices, he said FDA is making it easier for sponsors of innovative drugs to cooperate with generic companies to implement a common master file for the implementation of a REMS.
The common REMS master file is a “first step toward making it easier to implement a single shared REMS,” Gottlieb said.
FDA published draft guidance entitled “Use of a Drug Master File for Shared System REMS Submissions” in the Federal Register Wednesday.
While a shared REMS will make it easier for providers to comply with the risk mitigation programs, they can also be used to prevent drug companies from prolonging negotiations with generic companies, Gottlieb said. “Our goal is to see sponsors share REMS systems to reduce burdens on providers. But when branded drug makers drag out these negotiations -- sometimes as a way to forestall generic entry -- we’re going to be in a stronger position now to say enough is enough.”
If branded companies fail to agree on terms of a shared REMS, FDA will “have a stronger basis to issue a waiver that will allow the generic drug makers to go their own way if they have to, and develop their own REMS,” he said at the FTC meeting. In a statement issued to media, Gottlieb said FDA plans to provide more information on how and when generic companies can request a shared REMS waiver and the factors FDA intends to consider.
At the meeting, Gottlieb also vowed to use FDA’s bully pulpit to deter supply chain intermediaries like specialty pharmacies from helping pharma companies deny generic manufacturers access to samples that are needed to conduct FDA-required tests. Gottlieb said he is “going to contact pharmaceutical supply chain intermediaries to inform them of the FDA’s interest in making sure that generic firms can gain access to the doses they need to run bioequivalence studies. When intermediaries sign on to these restrictive games, I want them to know that they’re challenging a broader public health goal.”
Gottlieb made a public health case for competitive drug markets. “Our economic model, which rewards highly innovative drugs with the opportunity to hold monopolies for a limited period of time through patents and exclusivities, and to freely price their products to a measure of the value that a transformative drug offers, also depends on the generic approval process working as intended,” he said. “It depends on the ability to have vigorous competition once those patents and exclusivities have lapsed.”
Comments on the draft guidance are due in 60 days.
Read More & Comment...
Speaking at a Federal Trade Commission meeting on competition in prescription drug markets, Gottlieb noted that drug companies sometimes prolong negotiation over terms of a shared REMS as a tactic to delay approval of generic drugs. To counter such practices, he said FDA is making it easier for sponsors of innovative drugs to cooperate with generic companies to implement a common master file for the implementation of a REMS.
The common REMS master file is a “first step toward making it easier to implement a single shared REMS,” Gottlieb said.
FDA published draft guidance entitled “Use of a Drug Master File for Shared System REMS Submissions” in the Federal Register Wednesday.
While a shared REMS will make it easier for providers to comply with the risk mitigation programs, they can also be used to prevent drug companies from prolonging negotiations with generic companies, Gottlieb said. “Our goal is to see sponsors share REMS systems to reduce burdens on providers. But when branded drug makers drag out these negotiations -- sometimes as a way to forestall generic entry -- we’re going to be in a stronger position now to say enough is enough.”
If branded companies fail to agree on terms of a shared REMS, FDA will “have a stronger basis to issue a waiver that will allow the generic drug makers to go their own way if they have to, and develop their own REMS,” he said at the FTC meeting. In a statement issued to media, Gottlieb said FDA plans to provide more information on how and when generic companies can request a shared REMS waiver and the factors FDA intends to consider.
At the meeting, Gottlieb also vowed to use FDA’s bully pulpit to deter supply chain intermediaries like specialty pharmacies from helping pharma companies deny generic manufacturers access to samples that are needed to conduct FDA-required tests. Gottlieb said he is “going to contact pharmaceutical supply chain intermediaries to inform them of the FDA’s interest in making sure that generic firms can gain access to the doses they need to run bioequivalence studies. When intermediaries sign on to these restrictive games, I want them to know that they’re challenging a broader public health goal.”
Gottlieb made a public health case for competitive drug markets. “Our economic model, which rewards highly innovative drugs with the opportunity to hold monopolies for a limited period of time through patents and exclusivities, and to freely price their products to a measure of the value that a transformative drug offers, also depends on the generic approval process working as intended,” he said. “It depends on the ability to have vigorous competition once those patents and exclusivities have lapsed.”
Comments on the draft guidance are due in 60 days.
Read More & Comment...
11/07/2017 02:18 PM | Robert Goldberg
David Mitchell, the fact-challenged founder of Patients for Affordable Drugs has never been one to spend more than a nanosecond with the truth when it comes to discussing the value of medical innovation.
He also is allergic to being transparent about his background and funding. Either that or he is exceedingly modest. Mitchell is speaking at an FTC meeting entitled, “Discussion: Potential Next Steps to Encourage Entry and Expand Access through Lower Prices."
Here's his bio for that event:
David has 40 years of experience working on health care and public health policy as a communications specialist. He has worked to reduce teen smoking, increase use of seat belts, to fight drunk driving and improve child health and safety. He helped build and run for more than 30 years GMMB—a cause-oriented, public policy communications firm in Washington, DC. He retired in 2016 to focus his full energy and attention on helping bring about policy change to lower drug costs. You can follow him on Twitter here. Email him at david@patientsforaffordabledrugs.org
Here's what he left out:
Received nearly $60 million in federal contracts after Obama took office, according to an analysis by The Daily Caller News Foundation Investigative Group.
$200 million from the Clinton campaign in 2016 and $389 million from the Obama campaign in 2012
$12 million from Phrma to run pro-Obamacare ads.
Nearly $700 million to promote Obamcare enrollment.
My favorite: $575K to run ads in Jewish news outlets in support of the Iran nuclear deal.
These tidbits are important because it provides some clues about why David would get $500K from the Laura and John Arnold Foundation to set up a patient group.
Indeed, it is curious that in his FTC bio, David left out important background information about his group. Patients For Affordable Drugs claims it " is the only independent national patient organization focused exclusively on achieving policy changes to lower the price of prescription drugs."
First, it is not independent. It receives 87 percent of its funding from one source: the aforementioned Laura and John Arnold Foundation (LJAF). Second, it cooperates and coordinates with other LJAF grantees including ICER and Harvard's Aaron Kesselheim. ICER mind you have deemed most new cancer drugs marginally effective and too expensive despite evidence to the contrary. Have you heard P4AD challenge ICER? You haven't and you won't because they get cash from the same cow. Third, Mitchell's funding is never disclosed when media outlets that also receive LJAF money to run stories about drug prices quoting him. That's deliberate.
Further, it is NOT true that it is the only group pushing for lower drug prices. On the contrary, many other patient organizations who, in addition to providing counseling, funding basic research and covering expenses for cancer patients, have pushed for policies that would reduce the time and cost of drug development and promote generic competition. P4AD is silent on accelerating innovation at the FDA. Moreover, while other groups have fought for caps on drug copays, the elimination of step therapy, passing rebates directly to patients, PFAD has paid lip service to these issues.
It is simply a media outlet for dog whistle messaging about drug prices. Mitchell loves to say he is grateful for medical innovation as a myeloma survivor. But many would argue (including me) that the policies he is promoting have been proven to marginally reduce prices but substantially limit access and future innovations.
Nobody disagrees with the goal of reducing health care costs and drug prices. But P4AD is a hollow advocacy group that does nothing to advance FDA and reimbursement reforms to would make new medicines less expensive and more affordable. By excluding the Arnold affiliation and GMMB's main revenue sources, David is trying to portray himself as a lonely crusader against big Pharma. There's very little truth in that depiction.
Read More & Comment...
He also is allergic to being transparent about his background and funding. Either that or he is exceedingly modest. Mitchell is speaking at an FTC meeting entitled, “Discussion: Potential Next Steps to Encourage Entry and Expand Access through Lower Prices."
Here's his bio for that event:
David has 40 years of experience working on health care and public health policy as a communications specialist. He has worked to reduce teen smoking, increase use of seat belts, to fight drunk driving and improve child health and safety. He helped build and run for more than 30 years GMMB—a cause-oriented, public policy communications firm in Washington, DC. He retired in 2016 to focus his full energy and attention on helping bring about policy change to lower drug costs. You can follow him on Twitter here. Email him at david@patientsforaffordabledrugs.org
Here's what he left out:
Received nearly $60 million in federal contracts after Obama took office, according to an analysis by The Daily Caller News Foundation Investigative Group.
$200 million from the Clinton campaign in 2016 and $389 million from the Obama campaign in 2012
$12 million from Phrma to run pro-Obamacare ads.
Nearly $700 million to promote Obamcare enrollment.
My favorite: $575K to run ads in Jewish news outlets in support of the Iran nuclear deal.
These tidbits are important because it provides some clues about why David would get $500K from the Laura and John Arnold Foundation to set up a patient group.
Indeed, it is curious that in his FTC bio, David left out important background information about his group. Patients For Affordable Drugs claims it " is the only independent national patient organization focused exclusively on achieving policy changes to lower the price of prescription drugs."
First, it is not independent. It receives 87 percent of its funding from one source: the aforementioned Laura and John Arnold Foundation (LJAF). Second, it cooperates and coordinates with other LJAF grantees including ICER and Harvard's Aaron Kesselheim. ICER mind you have deemed most new cancer drugs marginally effective and too expensive despite evidence to the contrary. Have you heard P4AD challenge ICER? You haven't and you won't because they get cash from the same cow. Third, Mitchell's funding is never disclosed when media outlets that also receive LJAF money to run stories about drug prices quoting him. That's deliberate.
Further, it is NOT true that it is the only group pushing for lower drug prices. On the contrary, many other patient organizations who, in addition to providing counseling, funding basic research and covering expenses for cancer patients, have pushed for policies that would reduce the time and cost of drug development and promote generic competition. P4AD is silent on accelerating innovation at the FDA. Moreover, while other groups have fought for caps on drug copays, the elimination of step therapy, passing rebates directly to patients, PFAD has paid lip service to these issues.
It is simply a media outlet for dog whistle messaging about drug prices. Mitchell loves to say he is grateful for medical innovation as a myeloma survivor. But many would argue (including me) that the policies he is promoting have been proven to marginally reduce prices but substantially limit access and future innovations.
Nobody disagrees with the goal of reducing health care costs and drug prices. But P4AD is a hollow advocacy group that does nothing to advance FDA and reimbursement reforms to would make new medicines less expensive and more affordable. By excluding the Arnold affiliation and GMMB's main revenue sources, David is trying to portray himself as a lonely crusader against big Pharma. There's very little truth in that depiction.
Read More & Comment...
11/03/2017 08:36 AM | Peter Pitts
How do you spell "mistake?"
The new tax bill would eliminate tax credits used to develop rare-disease drugs. Currently, drug makers get allowed a tax credit of up to 50 percent of certain research costs for rare-disease drugs. The new tax bill would repeal the credit, which falls under the Orphan Drug Act, “for certain drugs, for rare diseases or conditions” starting after this year.
Read More & Comment...
The new tax bill would eliminate tax credits used to develop rare-disease drugs. Currently, drug makers get allowed a tax credit of up to 50 percent of certain research costs for rare-disease drugs. The new tax bill would repeal the credit, which falls under the Orphan Drug Act, “for certain drugs, for rare diseases or conditions” starting after this year.
Read More & Comment...
10/30/2017 11:24 AM | Robert Goldberg
An op-ed I was honored to co-author with BIONJ's CEO, Debbie Hart.
Article was originally published in the New Jersey Spotlight
You can learn more about BIONJ here:
OP-ED: NOW THAT’S A PATIENT-CENTERED VALUE FRAMEWORK
DEBBIE HART AND ROBERT GOLDBERG | OCTOBER 27, 2017
Insurance companies often use value frameworks to steer all patients to the least-expensive products, erecting barriers to obtaining recommended treatments
There’s been a lot of discussion about using “value frameworks” to reduce the cost of drugs and increase patient access. Value frameworks are being proposed as tools to determine which medicines will be covered, reimbursed, and made available to patients. Value-assessment frameworks attempt to assess therapeutic options based on clinical benefits, health outcomes, value to the patient, and effectiveness, compared with other potential treatment options … all in the context of cost. Unfortunately, such evaluations assume that on average, everyone will respond to all drugs in the same way. In fact, the same treatment can have different benefits to different patients, depending on their genetics, combination of diseases, severity of illness, age, gender, and race.
Moreover, value frameworks are used by insurance companies to steer all patients to the least-expensive products by imposing higher cost-sharing and more barriers to obtaining recommended treatments, even if the other drugs are not as effective or oftentimes, don't work. Coverage is already constrained through higher out-of-pocket spending, and step therapy (a patient must fail first on medicines specified by the insurance company before being eligible to receive the drug actually prescribed by the physician), and prior authorization.
In addition, value frameworks, by limiting choice further, make it even more difficult to match people to the treatments that work best. And by measuring value simply in terms of reducing other healthcare spending, such frameworks are biased against the most vulnerable patients with few or no treatment options. Not every medicine will save money, but most medicines for people with rare, life-threatening, or disabling conditions improve the quality of life. In many instances, the first new treatment allows people to enjoy the opportunity for the next round of therapy that in turn, may increase well-being and save lives.
As Mark Fendrick, the godfather of value-based health insurance has stated, “the sickest patients are often those who face the highest financial burdens and the greatest obstacles to access.” Where is the value there?
That is not to say that the cost and benefits of new products should escape scrutiny. BioNJ welcomes the opportunity to discuss the true value of medical innovation and demonstrate the importance of enabling meaningful access to innovative medicines that benefit the entire healthcare system, the economy, and society as a whole.
Long-term impact
But value frameworks ignore the long-term impact of new medicines in setting prices and rationing access. The formulations being used do not take into consideration that increasing the number of healthy people working, going to school, investing, and contributing to society will actually save healthcare costs and ensure a robust insurance system.
We need healthcare coverage that concentrates on improving quality of life and averting loss of productivity and capability due to disease. Drug prices should reflect the differentiated worth of specific features or benefits that a new treatment provides and the ability to invest in future innovative medicines. This approach will encourage increased access and lower costs based on a new medicine's value and quality.
For example, Celgene CEO Mark Alles recently wrote that his company is “proactively working with major commercial U.S. healthcare payers on arrangements designed to give eligible patients access to our most recently approved medicine — a precision therapy with an accompanying diagnostic test — without deductibles, co-pays, and co-insurance. By partnering with payers to offset and even eliminate patient cost sharing as an obstacle to treatment, our hope is to prevent some of the financial burden that leads to many of the problems currently impacting patient care.”
For BioNJ, ensuring that “patients have the right treatment at the right time” for the greatest benefit is not just a slogan: It’s our vision. We owe it to patients to provide access to innovative medicines that are transforming the trajectory of many debilitating diseases and conditions.
Consider that over the past 30 years U.S. cancer survivors have more than doubled to 14.5 million. HIV/AIDS — once a death sentence — is now a chronic manageable condition. Deaths from heart disease have declined by 50 percent. More recently, hepatitis C, once an incurable disease, can now be cured with one pill a day taken over four months.
In the absence of those medicines, healthcare would be more expensive, fewer people would be alive, and more people would live in pain.
That’s why with nearly 70 percent of medicines in the pipeline, potentially first-in-class therapies, the promise for increased life expectancy, improved life quality, and reduced healthcare costs is boundless. Because Patients Can’t Wait, BioNJ looks forward to working with insurers, consumers, employers, elected officials, physicians, and biopharma companies to speed the right medicines to the people who need — and will benefit from — them the most. Now that’s a patient-centered value framework!
Debbie Hart is president and CEO of BioNJ. Robert Goldberg, Ph.D., is vice president & co-founder of the Center for Medicine in the Public Interest. Read More & Comment...
Article was originally published in the New Jersey Spotlight
You can learn more about BIONJ here:
OP-ED: NOW THAT’S A PATIENT-CENTERED VALUE FRAMEWORK
DEBBIE HART AND ROBERT GOLDBERG | OCTOBER 27, 2017
Insurance companies often use value frameworks to steer all patients to the least-expensive products, erecting barriers to obtaining recommended treatments
There’s been a lot of discussion about using “value frameworks” to reduce the cost of drugs and increase patient access. Value frameworks are being proposed as tools to determine which medicines will be covered, reimbursed, and made available to patients. Value-assessment frameworks attempt to assess therapeutic options based on clinical benefits, health outcomes, value to the patient, and effectiveness, compared with other potential treatment options … all in the context of cost. Unfortunately, such evaluations assume that on average, everyone will respond to all drugs in the same way. In fact, the same treatment can have different benefits to different patients, depending on their genetics, combination of diseases, severity of illness, age, gender, and race.
Moreover, value frameworks are used by insurance companies to steer all patients to the least-expensive products by imposing higher cost-sharing and more barriers to obtaining recommended treatments, even if the other drugs are not as effective or oftentimes, don't work. Coverage is already constrained through higher out-of-pocket spending, and step therapy (a patient must fail first on medicines specified by the insurance company before being eligible to receive the drug actually prescribed by the physician), and prior authorization.
In addition, value frameworks, by limiting choice further, make it even more difficult to match people to the treatments that work best. And by measuring value simply in terms of reducing other healthcare spending, such frameworks are biased against the most vulnerable patients with few or no treatment options. Not every medicine will save money, but most medicines for people with rare, life-threatening, or disabling conditions improve the quality of life. In many instances, the first new treatment allows people to enjoy the opportunity for the next round of therapy that in turn, may increase well-being and save lives.
As Mark Fendrick, the godfather of value-based health insurance has stated, “the sickest patients are often those who face the highest financial burdens and the greatest obstacles to access.” Where is the value there?
That is not to say that the cost and benefits of new products should escape scrutiny. BioNJ welcomes the opportunity to discuss the true value of medical innovation and demonstrate the importance of enabling meaningful access to innovative medicines that benefit the entire healthcare system, the economy, and society as a whole.
Long-term impact
But value frameworks ignore the long-term impact of new medicines in setting prices and rationing access. The formulations being used do not take into consideration that increasing the number of healthy people working, going to school, investing, and contributing to society will actually save healthcare costs and ensure a robust insurance system.
We need healthcare coverage that concentrates on improving quality of life and averting loss of productivity and capability due to disease. Drug prices should reflect the differentiated worth of specific features or benefits that a new treatment provides and the ability to invest in future innovative medicines. This approach will encourage increased access and lower costs based on a new medicine's value and quality.
For example, Celgene CEO Mark Alles recently wrote that his company is “proactively working with major commercial U.S. healthcare payers on arrangements designed to give eligible patients access to our most recently approved medicine — a precision therapy with an accompanying diagnostic test — without deductibles, co-pays, and co-insurance. By partnering with payers to offset and even eliminate patient cost sharing as an obstacle to treatment, our hope is to prevent some of the financial burden that leads to many of the problems currently impacting patient care.”
For BioNJ, ensuring that “patients have the right treatment at the right time” for the greatest benefit is not just a slogan: It’s our vision. We owe it to patients to provide access to innovative medicines that are transforming the trajectory of many debilitating diseases and conditions.
Consider that over the past 30 years U.S. cancer survivors have more than doubled to 14.5 million. HIV/AIDS — once a death sentence — is now a chronic manageable condition. Deaths from heart disease have declined by 50 percent. More recently, hepatitis C, once an incurable disease, can now be cured with one pill a day taken over four months.
In the absence of those medicines, healthcare would be more expensive, fewer people would be alive, and more people would live in pain.
That’s why with nearly 70 percent of medicines in the pipeline, potentially first-in-class therapies, the promise for increased life expectancy, improved life quality, and reduced healthcare costs is boundless. Because Patients Can’t Wait, BioNJ looks forward to working with insurers, consumers, employers, elected officials, physicians, and biopharma companies to speed the right medicines to the people who need — and will benefit from — them the most. Now that’s a patient-centered value framework!
Debbie Hart is president and CEO of BioNJ. Robert Goldberg, Ph.D., is vice president & co-founder of the Center for Medicine in the Public Interest. Read More & Comment...
10/27/2017 11:57 AM | Robert Goldberg
In testimony as the nominee to be Secretary of the Department of Veterans Affairs, Dr. David Shulkin promised: “There will be far greater accountability, dramatically improved access, responsiveness and expanded care options…. If confirmed, I intend to build a system that puts Veterans first and allows them to get the best possible health care wherever it may be – in VA or with community care.”
Sadly, less than five months into his appointment, Dr. Shulkin’s promise was broken when The VA’s Pharmacy Benefits Management Services office (PBMS) started partnering with The Institute for Clinical and Economic Review(ICER) set drug prices and limit veteran access to new medicines.
According to ICER, the VA PBMS will use its “drug assessment reports in drug coverage and price negotiations with the pharmaceutical industry.” But given ICER’s disregard of how patient’s value medicines the partnership has generated legitimate concern.
The program’s directors - C. Bernie Good, Tom Emmendorfer and Michael Valentino recently churned out an incoherent and fact-free response to criticism of the partnership on the Health Affairs blog. They defended the ICER partnership as contributing to the VAPBMS unsurpassed ability to provide the best medicines at the lowest cost. They also claimed, with a straight face, that the VA health system provides better care than any other place. As anyone who has read the book "Thank You For Your Service" or seen the movie version knows, quite the opposite is true. And frankly, the "everything is perfect" tone of their blog suggests that they are more interested in sucking up to professional critics of the pharmaceutical industry then they are in helping making wounded warriors whole.
In fact, ICER and VAPBMS are clearly more interested in using the VA as a model for determining drug prices and access nationwide. The authors insist ICER evaluations will only be used to help the VA authors set prices for new drugs. That's nonsense. The VA pharmacy benefits program already sets prices and restricts access to new medicines. Under federal law, drug companies must the VA a price at least 24 percent lower than the best private sector price. They also must give the VA rebates if prices go up more than inflation.
So what is ICER's role likely to be? The authors assert that as “a federal organization, the VA lives within the reality of a fixed annual budget. Money spent well for high-value drugs (regardless of the overall individual cost of that drug or technology) is a good thing.”
But that is not how the VA or ICER approaches access to new medicines. Apart from mandated price controls, the VA excludes some drugs and not others to get additional discounts. This is an approach ICER has supported since its existence.
Despite the authors' support of high-value medicines, the VA as consistently limited access to them at a great cost to patients. A study by economist Frank Lichtenberg found that not only were 20 percent of drugs approved since 2000 covered by the VA and that the limited access was associated with lower life expectancy over age 65 compared to Medicare. The innovation gap has grown since then. Less access means more death.
Indeed, since Lichtenberg did his study, the innovation access gap has gotten worse. A recent Avalere study found that "The VA National Formulary covers 54 percent of drugs on the California public employee retiree plan formulary, including 46 percent of brand drugs (102 of 222) and 61 percent of generic drugs (174 of 287.) " And it covers 50 percent few medicines than most state Medicaid plans.
Yet, the authors claim lots of people get access to drugs not covered under the VA formulary. Also, untrue. Getting a drug that is not on the formulary is difficult. Most reviews are denied and over half take two weeks to process. Veterans often have to travel hundreds of miles to get the medicine from a VA pharmacy.
Indeed, the Inspector General's audit of the death of a lung cancer patient at a VA Southern Nevada Health System found that” patient had to travel 30 miles each way from his home to a system clinic for pharmacist review and approval of his physical prescription. " It took 14 days to get an off-formulary medicine approved. In the meantime, the patient had to pay $4000 out of pocket for drugs.
ICER will only make the VA’s denial of timely, effective treatment worse, if that’s possible. In the past, ICER reports have been used to limit access to cures for hepatitis C, drugs that reduce the risk of heart attacks and a wide variety of medicines for people with rare cancers. ICER’s estimate of the value of medicine is so low that many of the drugs used to treat HIV would have been rejected by the group.
The authors claim that VA patients get faster and broader access to HCV drugs than commercial patients. But until this year, the VA used the ICER guidelinesto limit access to a cure. As a Newsweek article reported, a VA memo recommended treating those with advanced liver disease but holding off for patients with mild cases of the illness. ICER’s recommendations are meant to save money, not save lives. And when the VA started paying for drugs, cure rates went up.
New medicines are what reduce the total cost of care and mortality. Price concessions and budget caps obtained by limiting access come at the expense of the most vulnerable and sickest people. If the VA uses ICER’s rationing scheme it will not only break Dr. Shulkin’s promise, it will darken and damage the lives of those veterans who need the VA the most.
Read More & Comment...
10/26/2017 11:44 AM | Peter Pitts
Per Ed Silverman over at Pharmalot:
Seeking a way to alleviate high drug prices, a Utah lawmaker hopes to introduce a bill that would allow the state to import prescription medicines from Canada, a move that is likely to accelerate a fierce debate over drug costs and patient safety.
Over the next several weeks, Rep. Norman Thurston, a Republican, plans to submit legislation to authorize state officials to designate an existing pharmaceutical wholesaler to purchase prescription drugs from a wholesaler in Canada. His hope is that retail pharmacies based in Utah would then be able to buy and sell medicines at lower prices.
“We’re still trying to work out some of the details, but we envision a safe supply chain that would result in significant cost savings for the citizens of Utah,” he told us. To allay safety concerns, he envisions the bill would require prescription medicines to be approved by regulators in both Canada and the U.S.
“And the bill would establish a chain of custody just like we have for U.S. distribution,” he said. “It shouldn’t be a significant cost to the state to set up a program, fill out paperwork and get approval (from the U.S. Human and Health Services secretary). According to federal law, that’s the only approval we need.”
Even so, the move is likely to receive considerable pushback.
In general, importation sparks debate that Americans could be exposed to counterfeit medicines.
Last year, four former Food and Drug Administration commissioners penned an open letter arguing against importation, citing such concerns. And the pharmaceutical industry has regularly lobbied against any and all efforts to allow importation. Over the years, Congress has failed to pass various bills that were proposed. And more than a decade ago, several states pursued web sites to allow residents to purchase medicines from Canada, but those efforts eventually sputtered, as well.
“Good luck with this. No HHS Secretary of either party has ever declared that importation is safe,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by the pharmaceutical industry.
“We have a closed regulatory system. Health Canada may be world class, but it doesn’t mean we can have multiple standards for drug approvals. What matters is how a drug is manufactured, stored, and dispensed. It sounds easy, but is extraordinarily hard.”
For his part, Thurston is doggedly optimistic.
In this instance (as it generally is with schemes to advance importation, “doggedly optimistic” = “deaf and dumb to reality.”
Let’s cut right to the chase. Generic drugs (85% + of all medicines volume in the US are LESS expensive than in Canada or any European country. Next, for the overwhelming number of Americans with private health insurance, the co-pays for their products are LESS expensive then buying them retail at either a brick-and-mortar of Internet Canadian pharmacy. Biologics? 85% of all biologics are administered in hospitals. Is Senator Sanders suggesting that American hospitals should import drugs that may or may not have been shipped under proper refrigeration conditions? FDA inspections speak otherwise.
The on-the-ground reality of state and local importation schemes has been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX” program? Over 19 months, only 3,689 Illinois residents used the program—that’s .02 percent of the population.
And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That’s in a state with a population of 5,167,101.
Remember Springfield, Massachusetts and “the New Boston Tea Party?” Well, the city of Springfield has been out of the “drugs from Canada business” since August 2006.
And speaking of tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city in the nation to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”
The Canadian supplier for the program was Winnipeg-based Total Care Pharmacy. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.
Programs like this wouldn’t do any better on a national basis. A study by the non-partisan federal Congressional Budget Office showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1 percent—and that’s not including the tens of millions of dollars the FDA would need to oversee drug safety for the dozen or so nations generally involved in foreign drug importation schemes.
In addition to importing foreign price controls, Americans would end up jeopardizing their health by purchasing unsafe drugs while not saving money.
A better policy for our new President and Congress to focus on is the issue of increasing insurance company co-pays and co-insurance. Dropping drug co-pays would also help patients stick to their prescribed treatment regimes. All too often, people skip a dose, don’t get a refill, or stop taking their drugs prematurely in order to save money. In the long run, though, not adhering to a drug regimen leaves patients less healthy — and increases national medical expenses by an estimated $300 billion annually.
When consumers say, “My drugs are too expensive,” what they mean is that their co-pays and co-insurance are too expensive. And they’re right. Major insurance companies and pharmacy benefit managers (PBM) receive significant discounts from the manufacturers. So why doesn’t this result in lower co-pays for consumers? That’s a good issue for our new political leadership to debate – both in Salt Lake City and Washington, DC.
Read More & Comment...
Seeking a way to alleviate high drug prices, a Utah lawmaker hopes to introduce a bill that would allow the state to import prescription medicines from Canada, a move that is likely to accelerate a fierce debate over drug costs and patient safety.
Over the next several weeks, Rep. Norman Thurston, a Republican, plans to submit legislation to authorize state officials to designate an existing pharmaceutical wholesaler to purchase prescription drugs from a wholesaler in Canada. His hope is that retail pharmacies based in Utah would then be able to buy and sell medicines at lower prices.
“We’re still trying to work out some of the details, but we envision a safe supply chain that would result in significant cost savings for the citizens of Utah,” he told us. To allay safety concerns, he envisions the bill would require prescription medicines to be approved by regulators in both Canada and the U.S.
“And the bill would establish a chain of custody just like we have for U.S. distribution,” he said. “It shouldn’t be a significant cost to the state to set up a program, fill out paperwork and get approval (from the U.S. Human and Health Services secretary). According to federal law, that’s the only approval we need.”
Even so, the move is likely to receive considerable pushback.
In general, importation sparks debate that Americans could be exposed to counterfeit medicines.
Last year, four former Food and Drug Administration commissioners penned an open letter arguing against importation, citing such concerns. And the pharmaceutical industry has regularly lobbied against any and all efforts to allow importation. Over the years, Congress has failed to pass various bills that were proposed. And more than a decade ago, several states pursued web sites to allow residents to purchase medicines from Canada, but those efforts eventually sputtered, as well.
“Good luck with this. No HHS Secretary of either party has ever declared that importation is safe,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by the pharmaceutical industry.
“We have a closed regulatory system. Health Canada may be world class, but it doesn’t mean we can have multiple standards for drug approvals. What matters is how a drug is manufactured, stored, and dispensed. It sounds easy, but is extraordinarily hard.”
For his part, Thurston is doggedly optimistic.
In this instance (as it generally is with schemes to advance importation, “doggedly optimistic” = “deaf and dumb to reality.”
Let’s cut right to the chase. Generic drugs (85% + of all medicines volume in the US are LESS expensive than in Canada or any European country. Next, for the overwhelming number of Americans with private health insurance, the co-pays for their products are LESS expensive then buying them retail at either a brick-and-mortar of Internet Canadian pharmacy. Biologics? 85% of all biologics are administered in hospitals. Is Senator Sanders suggesting that American hospitals should import drugs that may or may not have been shipped under proper refrigeration conditions? FDA inspections speak otherwise.
The on-the-ground reality of state and local importation schemes has been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX” program? Over 19 months, only 3,689 Illinois residents used the program—that’s .02 percent of the population.
And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That’s in a state with a population of 5,167,101.
Remember Springfield, Massachusetts and “the New Boston Tea Party?” Well, the city of Springfield has been out of the “drugs from Canada business” since August 2006.
And speaking of tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city in the nation to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”
The Canadian supplier for the program was Winnipeg-based Total Care Pharmacy. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.
Programs like this wouldn’t do any better on a national basis. A study by the non-partisan federal Congressional Budget Office showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1 percent—and that’s not including the tens of millions of dollars the FDA would need to oversee drug safety for the dozen or so nations generally involved in foreign drug importation schemes.
In addition to importing foreign price controls, Americans would end up jeopardizing their health by purchasing unsafe drugs while not saving money.
A better policy for our new President and Congress to focus on is the issue of increasing insurance company co-pays and co-insurance. Dropping drug co-pays would also help patients stick to their prescribed treatment regimes. All too often, people skip a dose, don’t get a refill, or stop taking their drugs prematurely in order to save money. In the long run, though, not adhering to a drug regimen leaves patients less healthy — and increases national medical expenses by an estimated $300 billion annually.
When consumers say, “My drugs are too expensive,” what they mean is that their co-pays and co-insurance are too expensive. And they’re right. Major insurance companies and pharmacy benefit managers (PBM) receive significant discounts from the manufacturers. So why doesn’t this result in lower co-pays for consumers? That’s a good issue for our new political leadership to debate – both in Salt Lake City and Washington, DC.
Read More & Comment...
10/25/2017 08:37 AM | Peter Pitts
Biosimilarity? No one said it was going to be easy.
A smart and timely cross-post from RAPS ...
Sandoz Raises Questions With FDA Draft Guidance on Statistical Approaches for Biosimilars
Martin Schiestl, chief science officer at Novartis' Sandoz, on Tuesday explained how the US Food and Drug Administration's (FDA) draft guidance on statistical approaches to evaluate analytical similarity poses risks that could end up causing true biosimilars to be rejected randomly.
Schiestl told attendees of DIA's biosimilars conference in Bethesda, MD, that the problem is related to equivalence testing, which FDA says in the draft, "is typically recommended for quality attributes with the highest risk ranking and should generally include assay(s) that evaluate clinically relevant mechanism(s) of action of the product for each indication for which approval is sought."
The draft, released about a month ago, also notes: "Determining an appropriate margin is a critical but challenging step for equivalence testing in any setting. Ideally, it would be possible to establish and pre-specify a biologically or clinically meaningful equivalence margin based on scientific knowledge or past experience. Often, however, such a margin is not readily available for every quality attribute deemed important enough for Tier 1 testing in a biosimilar development program. With this limitation, FDA currently recommends use of an equivalence margin that is a function of the reference product's variability for the attribute being tested."
But Schiestl noted that monitoring the mean is useful in process development and post approval process monitoring.
However, for lot release decisions, "Compliance with a preset mean is an impossible criteria."
He added, "Strict adherence to equivalence testing for Tier 1 attributes makes biosimilar development a gamble. Justifications which may overrule a failed equivalence test should be added in the guidance."
Such justifications may include a scientific understanding of a variation and an "inconsistent mean of the reference product which might be caused by inherent process fluctuations within acceptable ranges, manufacturing changes or movements within a design space," Schiestl added. Read More & Comment...
A smart and timely cross-post from RAPS ...
Sandoz Raises Questions With FDA Draft Guidance on Statistical Approaches for Biosimilars
Martin Schiestl, chief science officer at Novartis' Sandoz, on Tuesday explained how the US Food and Drug Administration's (FDA) draft guidance on statistical approaches to evaluate analytical similarity poses risks that could end up causing true biosimilars to be rejected randomly.
Schiestl told attendees of DIA's biosimilars conference in Bethesda, MD, that the problem is related to equivalence testing, which FDA says in the draft, "is typically recommended for quality attributes with the highest risk ranking and should generally include assay(s) that evaluate clinically relevant mechanism(s) of action of the product for each indication for which approval is sought."
The draft, released about a month ago, also notes: "Determining an appropriate margin is a critical but challenging step for equivalence testing in any setting. Ideally, it would be possible to establish and pre-specify a biologically or clinically meaningful equivalence margin based on scientific knowledge or past experience. Often, however, such a margin is not readily available for every quality attribute deemed important enough for Tier 1 testing in a biosimilar development program. With this limitation, FDA currently recommends use of an equivalence margin that is a function of the reference product's variability for the attribute being tested."
But Schiestl noted that monitoring the mean is useful in process development and post approval process monitoring.
However, for lot release decisions, "Compliance with a preset mean is an impossible criteria."
He added, "Strict adherence to equivalence testing for Tier 1 attributes makes biosimilar development a gamble. Justifications which may overrule a failed equivalence test should be added in the guidance."
Such justifications may include a scientific understanding of a variation and an "inconsistent mean of the reference product which might be caused by inherent process fluctuations within acceptable ranges, manufacturing changes or movements within a design space," Schiestl added. Read More & Comment...
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