Bipartisan Sanity on Healthcare Transparency

03/06/2017 08:43 AM | Peter Pitts

Finally, some bipartisan sanity on healthcare transparency.

Representatives Doug Collins (R-GA), Buddy Carter (R-GA), Dan Loebsack (D-IA), John Sarbanes (D-MD) and John Duncan (R-TN) have introduced the Prescription Drug Price Transparency Act.

It is designed to:

* Safeguard patient information collected by a PBM (currently used to steer patients to PBM-owned/preferred outlets)
* Prohibit PBMs from requiring patients to utilize a PBM-owned pharmacy (including specialty pharmacy)
* Require maximum allowable cost transparency
* Apply these standards to both Tricare and FEHBP (the Federal Employee Health Benefit program).

In sum, the bill would establish a far more competitive marketplace for brand and generic products and lessen the monopsony of the large PBMs.

Transparency means looking at the whole ecosystem.

 Stay tuned.  Read More & Comment...

Vampire Health Policy

03/01/2017 07:33 PM | Peter Pitts

To import or not to import? Lawmakers push another bill to combat high drug prices
 
By ED SILVERMAN @Pharmalot
FEBRUARY 28, 2017
 
A group of lawmakers is introducing yet another bill that would allow Americans to import prescription medicines from Canada. And in a bid to quell long-standing criticism of the notion, the latest effort includes several provisions designed to address concerns that medicines bought from online pharmacies in other countries may not be safe.
 
Known as the Affordable and Safe Prescription Drug Importation Act, the bill would instruct the US Secretary of Health and Human Services to issue regulations allowing wholesalers, licensed US pharmacies, and individuals to import prescription drugs from licensed Canadian sellers. And the drugs would have to be made at facilities inspected by the US Food and Drug Administration.

After two years, however, the HHS secretary would have authority to permit importation from countries in the Organization for Economic Cooperation and Development that “meet specified statutory or regulatory standards that are comparable to US standards,” according to the bill. Nearly three dozen countries are members of the OECD.

“In 2014, the US spent about 40 percent more on prescriptions per person than Canada, twice as much as the average major industrialized country,” according to talking points that were distributed with the bill. “… In order to get the medicine they need, millions of people are buying their prescription drugs from other countries.”

The legislation — which is being spearheaded by Senator Bernie Sanders (I-Vt.) and Representative Elijah Cummings (D-Md.), who have conducted various probes into drug pricing — comes amid escalating national angst over the cost of prescription medicines. Poll after poll finds Americans want the federal government to take action, although there has been little movement on the national level.

As many as 77 percent of Americans reported last fall that drug costs are unreasonable, up from 72 percent a year earlier, according to a poll by the Kaiser Family Foundation. At the time, 71 percent favored allowing Americans to buy prescription drugs imported from Canada, among other measures they would like the federal government to pursue to lower their bills.

Although President Trump recently complained about “astronomical” prices,” he has not released any plan. But his remarks have placed drug makers on the defensive. A few pledged to limit annual price hikes to single-digit increases, while others have released data to argue their price increases have been reduced by rebates to middlemen that act on behalf of insurers.

Meanwhile, a bill introduced in the House is gaining support because it would presumably address some price gouging by providing incentives to drug makers to develop generics when there is a lack of competition or a shortage exists. A somewhat similar piece of legislation was recently introduced in the Senate, but it would also temporarily permit prescriptions drugs to be imported in order to mitigate shortages.

Importation is hardly a new idea. In fact, this is only the latest attempt by various lawmakers to find a way for Americans to import medicines from Canada. But given that President Trump has previously voiced support for the idea — and also accused drug makers of “getting away with murder” — they apparently see an opening to renew the call.

Whether the effort can succeed, however, is unclear. Under a 2003 law, the FDA can issue waivers for individuals to import medicines for personal use. But importation is not otherwise permitted until the HHS secretary certifies that importation would not pose a health risk and could lower consumer costs. And ensuring safety of imported drugs has been cited by both drug makers and regulators as a concern. Nearly all Republicans have also dismissed the idea and this latest bill is being pushed by a mix of Democrats and Independents.

“I’ve seen this bill in various iterations many different times and they never really address two major concerns — safety and pricing,” 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 exist in a closed regulatory system and when you bring in drugs from outside FDA control, I don’t care how you phrase it, it’s still caveat emptor. The products can’t be guaranteed, because there are holes [in the legislation], such as not being able to guarantee that product labeling is correct,” he told us.

And no drug from Canada is going to cost less than a co-pay, which is $20 or $30 for many people, so it’s highly unlikely that it will do anything for the majority of Americans with health insurance. So it offers a largely useless alternative. I think this is a good political talking point, but won’t deliver what it promises. Importation is a vampire issue — you can drive a stake through its heart, but it won’t die.”

To assuage safety concerns, the bill states that legally imported drugs must be purchased from an FDA-certified foreign seller and have the same active ingredient, route of administration, and strength as drugs approved in the US. And certain types of drugs, such as certain biologics, could be imported only by wholesalers or pharmacies.

In order to be a so-called certified foreign seller, the bill states that the operation must be a wholesale distributor or licensed foreign pharmacy that is current with applicable registration fees and sells only qualifying prescription drugs. There is a list of criteria to be met, which you can read here.
Americans can buy medicines only from pharmacies licensed in Canada, and only for personal use in quantities that do not exceed a 90-day supply. They must also have a valid prescription issued by a health care practitioner licensed to practice in the US. Any pharmacy selling a counterfeit drug is subject to a $250,000 penalty and 10 years imprisonment. And the HHS is required to ask the US Government Accountability Office to run a report after 18 months to assess the impact.

But the Pew Charitable Trusts raised concerns and argued that it may be difficult to enforce the requirement that medicines must be purchased from an FDA-certified foreign seller and there is no mechanism to make it possible for medicines to have the same electronic security and tracking system, which is used in the US to weed out counterfeits.

“This poses a safety risk with respect to imported product, but also undermines the entire system,” wrote Allan Coukell, who is senior director of the Pew health programs, in a letter to Sanders. And while he acknowledged that competition from imports could prompt drug makers to lower prices in the US, he also speculated that foreign governments might eventually limit imports to the US if domestic supplies become strained.

One backer of importation called it a “step in the right direction.” Gabriel Levitt, who is the president of PharmacyChecker.com, which vets online pharmacies, wrote us that “if passed, the new bill … simply instructs the FDA to finally help Americans do what they already do, purchase lower cost medication from safe, international online pharmacies.”

We should note that one of the lawmakers who is co-sponsoring the bill is Sen. Cory Booker (D-NJ), who last month was one of 13 Democratic Senators who voted against an amendment to a budget procedure that would have allowed imports from Canada. His vote angered progressive Democrats. New Jersey is home to a few large drug makers and numerous smaller ones. The amendment was introduced by Sanders and Sen. Amy Klobuchar (D-Minn).  Read More & Comment...

Trump's FDA Reform Critics Rage Against Patients

03/01/2017 07:28 PM | Robert Goldberg

 
 
Megan and John Crowley (Courtesy of the Crowley Family)

Last night President Trump was attacked for speaking about Megan Crowley a 20-year-old freshman at Notre Dame who was diagnosed at birth with an orphan illness called Pompe Disease.

The reason?  The President used the opportunity to call for more medicines to keep young women like Megan alive. 
 
Here’s what the President said:
 
"Megan was diagnosed with Pompe Disease, a rare and serious illness when she was 15 months old. She was not expected to live past 5.
 
On receiving this news, Megan's dad, John, fought with everything he had to save the life of his precious child. He founded a company to look for a cure, and helped develop the drug that saved Megan's life. Today she is 20 years old -- and a sophomore at Notre Dame.

Megan's story is about the unbounded power of a father's love for a daughter.
 
But our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan's life, from reaching those in need.
If we slash the restraints, not just at the FDA but across our Government, then we will be blessed with far more miracles like Megan."
 
He had not even finished his speech when cynics on Twitter and in the media, belittled the Crowley family’s courage because, in their view, they were tools for what they hysterically call Trump’s reckless gutting of the FDA.  (Note that they never specify what would be gutted but assure us that if Trump got his way, the FDA would turn America into The Walking Dead.
 
Of all the sniping and snide observations, Former FDA commissioner David Kessler and Washington Post reporter Carolyn John stand out as the most obnoxious and condescending.
 
For his part, David Kessler posted on Twitter   @DavidAKesslerMD
 
Trump mischaracterizes Pompe drug approval process. Approved in 9 months based on 39 patients. Not "slow and burdensome."
 
First,  Trump never even mentioned the Pompe drug (Myozyme, the drug Crowley’s company developed) approval. 
 
Second,  “approval” refers to the FDA’s review of all the other studies and data the agency requested.  The FDA is required by law to review such completed applications in 180 days.  Not. Nine. Months. 
 
Meanwhile, it took about 6 years to complete the studies used to establish the drug’s safety and efficacy.  That’s a lot less than the 10 years it takes to evaluate drugs for larger groups of patients. 
 
But third, and most important, Crowley was in the audience because if the FDA was using its current regulatory approach to orphan drugs in 2001, the drug still wouldn’t be approved. Nor is Crowley is calling for gutting the FDA as critics hysterically claim.   As Crowley points out in an op-ed in the New York Observer: “the FDA must always put patient safety first.” 
The problem is that despite having a decade of experience in dealing with rare pediatric conditions like Pompe or Fabry, the FDA now often requires more information than ever before to approve orphan drugs.  As a result, they take as much time and money to get through the FDA as do medicines more common conditions,

But the award for the most sneering and fact-free hit piece goes to the Washington Post’s Carolyn Johnson:
 
“The actual drug, that saved Megan’s life is manufactured in Belgium and was developed by a biotech company founded by a Dutch immigrant — a company that is today owned by a French firm. The drug was invented through a scientific experiment that couldn’t have happened without international collaboration. And a president who has said he wants to bring down drug prices just held up as a shining example of innovation a drug that costs an average of $298,000 a year, per patient.”
 
Key omissions:
 
The company was Genzyme, a US biotech company founded in Boston – not Europe --  to bring orphan drugs to market.  Genzyme was sold to Sanofi, which invests most of its R&D in the United States.
 
Moreover, the cheap shot about drug prices (“a shining example of innovation” Johnson snarks) ignores the fact that the average price of hard to manufacture medicines for very small groups of patients has declined since Genzyme developed Ceredase for Gaucher’s disease in 1990 for a list price of $360000. (That’s $558000 in 2016 dollars.)  
 
The sneering continues:

"It’s also unclear whether the Crowley’s inspiring story and the development of the drug Myozyme (also called Lumizyme) is really an example of how “our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need,” as Trump described.
 
Other companies have pointed to Myozyme as an example of the agency’s flexibility in getting drugs approved quickly, based on small amounts of data.
 
Briefing materials prepared by the drug company Sarepta Therapeutics to support the approval of their drug last year cited Myozyme as an “approval precedent” that they hoped to follow.
 
Last April, at a hearing in support of Sarepta’s drug, one of the researchers involved in Myozyme’s approval testified to the advisory committee that its passage through the regulatory process as a helpful parallel to consider.
 
Against the recommendation of its advisory committee, which wanted to see more evidence, regulators approved that drug."
 
Omission: In fact, FDA reviewers virtually told the FDA advisory committee not to approve the Saretpa drug because it followed the Myozyme approach. 
 
No one is suggesting that Myozyme was delayed by the FDA or that the agency in the last couple of years has been quicker in reviewing applications for drug approval. 
 
The issue is whether the FDA could move more quickly by requiring data that has less to do with establishing the safety and benefit of medicines and more to do with employees demanding an increasingly higher degree of statistical certainty that has nothing to do with those goals
 
The issue is whether the Amicus drug for Fabry Disease – approved in Germany, Japan, and Great Britain – requires another randomized study and two more years of data to determine whether patients are more likely to have diarrhea. 
 
The issue is whether patients and their families should have as much to say about the drugs that shape whether they live or die as well how they live, as the naysayers who claim that the experts know better. 
 
The smug elite – like Kessler and Johnson -- realize their power over the FDA review process is slipping away and they are beside themselves that Donald Trump is determined to wrest their control away.  How can you tell?  Because they turned a courageous young woman and her father’s decade-long struggle to save her life into objects of their rage against the new President.   Read More & Comment...

UN gets it wrong on drug access

03/01/2017 01:41 AM | Peter Pitts

From today's Pittsburgh Tribune --

U.N.'s errant prescription for drug access

What's the best way to improve health care for billions of people in the developing world? If you answered, “Attack health care firms,” you qualify for a job with the United Nations.

You'd also be dead wrong.

The U.N. recently released a plan to severely weaken patent protections and other forms of intellectual property (IP). U.N. officials believe that this will bring down the price of medicine in the developing world, thereby improving people's access to drugs.

Their recommendations would do the exact opposite. Dissolving IP protections would disincentivize drug research and slow the discovery of new treatments. Patients in both the developing and developed worlds would be worse off.

Drug development is an enormously expensive endeavor. It costs, on average, $2.6 billion to bring a new medicine to market. Just one out of every 5,000 promising compounds makes it from the lab through clinical trials to the pharmacy shelf. And just two out of every 10 approved drugs ever turn a profit.

IP rights are what make risky drug research a worthwhile bet for investors. By temporarily preventing the production of generics and creating a market monopoly, they ensure that the original innovator has a chance to profit from successful new products.

America has the strongest IP protections in the world, and they've driven a spectacular rate of innovation.

We've created more than 500 new medications in the past 15 years alone. That's more than the rest of the world combined. And we account for 70 percent of the 7,000 new drugs now under development globally. We're also home to 12 of the top 20 medical-device companies in the world.

These research efforts are aimed at the most devastating diseases. Today, American scientists are working on 74 new asthma medicines, 92 new arthritis treatments, and 93 therapies for Alzheimer's disease. They're also developing over 800 cancer treatments.

These products lead to longer lives for people all over the world. Consider HIV/AIDS: Back in the 1980s, a diagnosis was a death sentence. Today, antiretroviral cocktails keep patients living for decades. There's no way firms would have plowed billions into researching and developing these therapies without strong patent protections.

Patent protections are not the reason poor patients in the developing world can't access breakthrough medications. Among the 375 drugs the World Health Organization has deemed essential, just 25 are still patented.

Cost isn't a problem either. Poor patients pay just 6 percent of the U.S. retail price for 350 off-patent drugs.

The U.N.'s war on IP rights ignores the real barrier to drug access: insufficient medical infrastructure.

For instance, many developing countries suffer from a severe shortage of health care professionals, particularly in rural areas. In Nicaragua, 50 percent of health personnel work in the country's capital, yet only 20 percent of the country's population lives there.

The U.N. needs to ditch its fixation on intellectual property rights and instead focus on the real problems of the developing world. Undermining IP protections would deter drug development and ultimately deprive needy patients of lifesaving treatments.

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.  Read More & Comment...

ICER's Attack on Rare Diseases

02/28/2017 05:24 PM | Robert Goldberg

Today is Rare Disease Day.  It should be an occasion for raising awareness about the fact that, despite progress in treating rare diseases, nearly 27 million people suffering from one of 7000 uncommon medical conditions do so with any effective treatment or cure. 
 
Instead, the rare disease community finds itself under assault as little more than front groups for pharma companies who – critics claim – want the freedom to bankrupt our health care system by charge hundreds of thousands of dollars for medicines that aren’t that safe or effective.
 
The critics are attacking patient groups for strategic reasons: shut down patient groups or at least neutralize their influence and their organizations – anointed as objective and expert – will consolidate their power over the development, pricing and use of new medicines.
 
One of the leaders of this movement is Steven Pearson, the founder of the Institute for Clinical and Economic Review – an organization that claims it’s “a trusted non-profit organization that evaluates evidence on the value of medical tests, treatments, etc.”  Pearson claims the influence of patient groups will drive our health care system and economy into bankruptcy.  As the number drugs for rare diseases for small groups of patients increase, their higher prices (relative to medicines for common medical conditions) will become unaffordable.  And the driving force is the ability of rare disease groups to advocate for new medicines. 
 
Or as he puts in an article entitled, “Which Orphans Will Find a Home? The Rule of Rescue in Resource Allocation for Rare Diseases,” publicity can be a powerful and important tool for advocacy groups, “but it is not an appropriate ethical justification for coverage of particular orphan drugs over others.”   Pearson writes, our nation needs a framework that will restrain “society’s desire to help those weakest among us, especially when their small numbers allow us to see them as unique individuals.”
 
Armed with this noble sentiment (and about $5 million from health insurers and the Laura and John Arnold Foundation) Pearson is positioning ICER to develop this ‘value framework.’
 
In May, ICER will be meeting with patient groups and others to recommend “fair prices that reflect the value of orphan drugs to patients and the health system to allow for broader insurance coverage for innovative new treatments.”  (It is targeting Spinraza™ (a new drug for spinal muscular atrophy and Exondys-51™ for Duchenne muscular dystrophy (DMD))
 
Pearson believes that a “bright line between what constitutes a fair claim on health benefits and what does not will be difficult to draw.” 


To ICER and Pearson, that bright line is $150000 for an additional year of life.  Most new medicines for rare diseases are expensive and don’t save health insurers money.  And ICER measures value from the insurer or government health program perspective.  So most new orphan drugs would have been discounted more than 90 percent of the rebated price a medicine just to stay behind Pearson’s bright line.
 
Next, ICER sets a limit of $915 million on what should be spent on each new drug. It multiplies the price of the drug by the number of people who could benefit.  Going over the cap mean that many people with rare diseases will be denied access to a growing array of new medicines.  ICER uses these bright lines to “improve affordability” with changes to pricing, payment, or patient eligibility 
 
ICER justifies such limits because beyond that cap it “…we’re siphoning off resources for other things we need like better schools and more resources for local police, roads, and bridges. “
 
These claims of budgetary Armageddon are overhyped. Between 2007 and 2014, orphan drugs have increased as a percentage of spending on drugs (from about 2 percent to 4 percent in Europe and 5 percent to 8 percent in the United States) even as the percentage spent on drugs has remained the same.  And a study by Dr. Frank Lichtenberg shows new medicines for rare diseases are reducing the number of life years lost by about five percent a year.
 
Conversely, ICER’s limits on access will hurt people and rob them of their lives. Lichtenberg’s study found in France, which took longer to pay for fewer orphan drugs relative to the US, the number of deaths declined by 1.8 percent.   

It is precisely our moral sense to save lives in immediate danger and at any expense that sustains humanity and economic progress.  We need more orphan drugs not just because more people will be able to enjoy life and live longer. It’s because civilization is enriched when we provide people who are marginalized because of their medical condition the opportunity to contribute to our well-being and happiness.

Pearson and ICER are a threat to that moral vision. They threaten the remarkable advances in medicine that Rare Disease Day celebrates, made possible in large part by the patient advocacy groups that ICER seeks to replace.    Read More & Comment...

Pharma Cap on Price Increases Benefit Insurers Not Consumers

02/28/2017 01:00 PM | Robert Goldberg

WSJ reporters Jonathan Rockoff and Peter Loftus suggest how PBMs and health plans pocket rebates while charging patients list price even as pharma limits price increases ("Facing Criticism, Drug Makers Keep Lid On Price Increases" 2/16/2017) At the same time, the American Cancer Society Cancer Action Network warns that under the ACA “most plans place many, or even all, covered cancer drugs on the highest cost-sharing tier.”

Specifically, Rockoff and Loftus report:  most of the increases in list prices are not paid by insurers.  PBMs and insurers have their drug costs reduced by rebates and discounts, while consumers (patients) pay the full price.   Here's the chart that demonstrates this fact.
 

Source IMS Health

In addition to pocketing rebates, PBMs and insurers make money by charging consumers of the newest drugs up to 50 percent of the list – not rebated price of the drug.  Indeed, Rockoff and Loftus try to skate past this ripoff by blandly noting: "regardless of discounts to middlemen, patients who have high-deductible health plans may have to pay close to full price for at least part of the year.   Indeed, patients who have high deductible plans are not paying anywhere near full price for any other medical service except prescription drugs. 
 
The article notes: "The discounts mean that manufacturers must share the increased revenue with others, but they can still leave buyers such as insurers paying the higher price, or most of it. And regardless of discounts to middlemen, patients who have high-deductible health plans may have to pay close to full price for at least part of the year."

As if on cue the American Cancer Society Cancer Action Network released its most recent review of drug cost sharing for cancer patients on Obamacare plans and concluded:

 "Unfortunately, most plans place many, or even all, covered cancer drugs on the highest cost-sharing tier. Among the formularies we studied, even generic cancer drugs appeared on the most expensive tier with regularity (41 percent of the time in the case of Etopside, and 61 percent for Imatinib Mesylate). Most of the time, the highest cost-sharing tier requires coinsurance rather than a flat copayment; but it is very difficult for consumers to manually estimate their coinsurance costs because the negotiated drug price on which coinsurance is based is not shown.”

So if drug companies are keeping the lid on drug prices, why aren't cancer patients seeing any difference at the pharmacy?  
   Read More & Comment...

Mooning Healthcare

02/27/2017 07:18 AM | Peter Pitts

An interesting post at OhMD discusses a new study showing that “96% of patients report leaving their doctor’s office with limited knowledge of how to use the patient portal. Of the 40% of patients who said they had attempted to use the patient portal in 2016, 83% said it was too complicated to use.” That means only 7% of patients find it simple enough to use, and actually care to use it.

As the folks at OhMD quip, “As a point of reference, 7% of the American population also believes the moon landing was faked, if that helps give you some perspective.”

Why? Consumer technology (the apps we all use in our daily lives) typically solve a problem in a very simple way.

As I’ve said before – healthcare app-ens.
   Read More & Comment...

ProPublica Hides Own Conflicts While Challenging Others

02/24/2017 02:45 PM | Robert Goldberg

ProPublica, although calling itself "journalism in the public interest,” remains silent about its own funding and conflicts of interest while it brazenly challenges others. 

A recent article, " Big Pharma Quietly Enlists Leading Professors to Justify $1,000-a-Day Drugs," questions the credibility of respected academic experts who explain and defend the high cost of developing new treatments and cures, simply because they get funding from the pharmaceutical industry. 

Yet, ProPublica receives funding from Arnold Foundation, dedicated to attacking drug pricing, drug spending and by extension the pharmaceutical industry.

Since 2013 ProPublica has received $4 million from the Arnold Foundation.  The support is part of nearly $20 million in multiyear grants to organizations that are being paid by the foundation to develop new policies to attack drug prices in a way that will reduce the development of new treatments and cures.  

In addition, the foundation is funding news outlets like ProPublica to report on the organizations it is funding, and to support a group called Patients for Affordable Drugs who advocate for policies the other Arnold entities are creating and publicizing.  So ProPublica is part of what the foundation calls a 'portfolio of investments' in attacking drug pricing and drug spending. That's journalism in ProPublica's financial interest, not in the public interest.

The piece claims that the scholars (who have a firm called Precision Health Economics of PHE) enlisted by drug companies to defend prices didn’t regularly disclose funding, In fact, the economists who  such as Tom Philipson, Dana Goldman and Darius Lakdawalla have been conducting such research for nearly 20 years and they have been disclosing their funding when required or relevant.  In any event their relationship with companies was well known to everyone in the field.  


Ironically, ProPublica alleges monkey business because of PHE’s failure to disclose in an article But Propublica has also has conflicts which,unlike PSE, it doesn’t disclose at all.

That’s not just being “quietly enlisted: That’s keeping quiet to avoid being criticized for hypocrisy. 

Indeed, Annie Waldman, the author of the article, interviewed several individuals and discusses alternative value frameworks who disagree with the PHE methodology and belittle their assertions about prices reflecting values.   

These sources are funded by the Arnold Foundation as well. 

To discredit the claim that new drugs cost a lot to develop Waldman cites Dr. Aaron Kesselheim who states: “There is substantial evidence that the sources of transformative drug innovation arise from publicly funded research in government and academic labs.” Kesselheim is “an associate professor at Harvard Medical School whose research looks at the cost of pharmaceuticals. Pharmaceutical pricing, he says, is primarily based on what the market can bear.”

And Kesselheim also gets funding from the Arnold Foundation.  

Waldman also discusses the role of ICER in setting drug prices based upon its opinion of value.  She describes ICER as an organization vigorously attacking US drug prices. Waldman states that: “Some patient groups have contended that ICER emphasizes cost savings because it receives funding from health insurers. However, foundations are ICER’s biggest source of funding, and it is also supported by the pharmaceutical industry and government grants. “

ICER does NOT get money from the drug industry. Waldman fails to mention funding from California Blue Cross Blue Shield Foundation or that ICER receives most of its funding -- $4.6 million from the unmentioned Arnold Foundation.

It is perfectly acceptable to criticize PHE approach on substance.  But as a colleague of mine observed: “foundation money is no different than pharma money if the purpose is the same: to support advocacy-driven research.” I applaud the Arnold Foundation for supporting groups that advance its drug pricing agenda and I am grateful to receive funding to advance other ideas about how to make medical innovation accessible and affordable. 

However, if you are going to make funding sources an issue, it should apply to thee and me.   And more to the point, if you are a media outlet receiving money from an organization that also funds the groups you cite in your article and use to research your piece, you should at least tell the public that.   That’s not just nondisclosure.  That’s misleading.   It certainly isn’t journalism.    Read More & Comment...

USA Today: Patient Groups That Get Money Anywhere But Pharma are Conflict Free.

02/22/2017 12:25 PM | Robert Goldberg

Jayne O' Donnell believes that patient groups that get money from biotech and pharma are corrupt.  Her USA Today article: "New patient group focuses on drug prices amid bipartisan concern" starts off with this guilt by association meme:

"A new patient advocacy group launches Wednesday that distinguishes itself by focusing only on drug prices and eschewing money from the pharmaceutical industry at a time when drug makers are pouring millions into a campaign fighting efforts to regulate them."

In otherwords,  groups that get money from biopharma companies are not legitimate.   O' Donnell claims the new group -- Patients For Affordable Drugs -- is the only organization tackling policies to bring down drug prices because they are pharma free.   That is untrue.  What is true is that most patients groups -- and not PAFD focusing on the rigged system wherein PBMs, insurers and government health programs that set drug prices to maximize rebate revenue.  Those are the prices that matter.   If you want to reduce launch prices and price increases of drug companies, change the way drugs are paid for and the cost of drug development.  PFAD ignores both.  Why?

They focus on the immoral practice of getting $100 billion in rebates (that reduce drug prices) and then forcing the sickest patients to pay up to 50 percent of the retail price of the same drugs.  (That's another $30 billion from less than 3 percent of all patients)   But PFAD is perfect because it doesn't take 'drug' money.  So what if it ignores the rebate games, the forced drug switching, fail first step therapy, etc.  So what if it ignores the fact that by passing through rebate dollars the patient share of any drug cost could be zero, without raising premiums.  

PFAD is perfect because it doesn't get drug money and supports government negotiated drug pricing for Medicare without acknowledging that such practices have hurt patients in Medicaid, the VA and everywhere price controls are used around the world. 

Guess what other organizations share the same approach or seek to promote it?  ICER,  the drug pricing group at the   Oregon Health & Science University, and several others.  And they all get money from the John and Laura Arnold Foundation which has publicly stated it wants to build a network of groups attacking drug prices and the 'grass roots' entities to lobby for the policies and approaches the other entities produce. 

So the real debate is how to best increase the pace of medical innovation and ensure that they are accessible.   The Arnold-funded family of groups pursue administrative approaches and regulations to limit price and the pace of drug development.   No mention of PBMs, insurers, etc.   Patient groups are focusing on the system as a whole.  And patient groups are less likely to support more government control over prices and access.  They want a patient-centered drug development process.  Arnold-funded 'experts' want more randomized trials where patients are exposed to placebos half the time. 

To assert that Arnold foundation money is less tainted than money from a biotech company is ridiculous.  If patient groups got money from the Merck Foundation instead of Merck for instance, would it pass O'Donnell's purity test?

(Many companies fought against eugenics in the early part of the 20th century.  Foundations supported eugenics, accusing corporations of simply wanting more immigrants to work in their factories. ) 

It is time to stop branding patient groups as tainted because of their funding sources.  Let's focus on the issues.   The Arnold Foundation is seeking to change policy.   So are patient groups.   Read More & Comment...

A Virtual Ounce of Prevention

02/21/2017 07:40 AM | Peter Pitts

The best way to reduce opioid abuse is to reduce the number of opioid tablets being dispensed. That means we need smarter physician prescribing habits. According to the results of a Columbia University Medical Center (published in American Journal of Psychiatry), “people with moderate or more severe pain had a 41 percent higher risk of developing prescription opioid use disorders than those without, independent of other demographic and clinical factors.”

In other words, it’s not just fewer opioids for patients with less severe pain or with conditions for which there are non-opioid alternatives (such as fibromyalgia and diabetic neuropathy). It means we need better ways of tracking the patient experience. One solution to narrowing the gap between prescription and outcomes measurement are mobile apps. The gathering and appraisal of real world evidence can expedite identification of problems before they become deadly. If we can identify misuse earlier, we can help eradicate abuse and addiction.

Apps present us with just that opportunity – a virtual ounce of prevention.
   Read More & Comment...

ICER’s policy prescriptions will cripple MS patients

02/16/2017 07:48 PM | Robert Goldberg

ICER CEO Steve Pearson has tried to salvage what's left of the organization's shredded credibility by claiming ICER's mission is to help patients.  Specifically, ICER argues that it all it wants to do is "spur discussion among stakeholders to ensure that patients have access to the medications at prices that are aligned with the value they bring to patients.” 

In fact, ICER was established to evaluate whether the price of drugs reflected value from the perspective of PBMs and health insurers.  As ICER notes, it uses a "US health system perspective (i.e., focus on direct medical care costs)."  

So when Pearson told MS patients today at an ICER meeting that the institute cannot quantify the benefits of new drugs to MS, it was just another evasion.   In fact, ICER excludes the patient perspective because its mission to maximize the benefits to insurers and PBMs.  Indeed, if spending exceeds that cap and therefore hurts the health system, ICER recommends changes in which MS patients would get medicines and how many would benefit.   Of course none of these components of the ICER analysis were discussed.  The same goes for the impact of limiting spending on each new drug to $915 million.   The goal is to hide ICER's real face, which it shows to a fawning media and its PBM and insurer constituency. 

Similarly, every time discussion turned to step therapy, how patients pay a share of the list price of a drug even as PBMs and insurers grab more rebates through price increases,  Pearson steered the conversation in a different and self-serving direction.   Instead, Pearson reminded everyone how drug prices rose and asserted that if MS drug prices had remained the same, then all of the medicines would be cost-effective.  

Let's deal with this claim before turning to how ICERs value framework affects MS patients

To be sure,  since 2011 the list price for Copaxone, Betaseron, Avonex, and Rebif have risen substantially to keep pace with the launch price of newer MS drugs in an apparent effort to maximize revenue as these injectable products lost market share.   It also turns out that since 2011, rebates and discounts (which go to PBMs and insurers) were 60 percent of the price increase of these older products.  

Further, since 2011 the primary driver in MS drug spending was the introduction of new medicines and greater use of oral MS medications. As the IMS study of drugs use notes: "Oral medicines now account for half of new treatment starts in 2015, steadily increasing since the introduction of these new treatment options six years ago and up from 26% in 2011."   

But here too, rebates and discounts whittled down the actual increase in spending by about 30 percent according to my estimates based on Credit Suisse rebate data. 

Further, even though ICER now attempts to calculate drug prices net of rebates, it is silent about the fact that these savings are pocketed by PBMs and insurers.  (Indeed, Pearson is afraid to raise the issue.)  And ICER is quiet about the fact even as payors rake in cash rebates that reduce the cost of medicines; they continue to charge patients up to 50 percent of the list price of medicines.  

And price increases don't change the fact that If ICER had been in place 15 years ago, not one of the medicines used today would be considered cost effective at $150K per QALY  

Between 2000-2015 the combined deficit in life years lost (those that would not be saved and the additional years lost) would have been 59000 with a loss of $17 billion in value.

Similarly, ICER claims not one MS drug developed since 2015 is cost effective.  I estimate that between 2017-2022 limited use of these medicines would cost patients 11300 life years and $3.9 billion a year.

ICER’s public relations campaign to portray itself as the voice of the patient is deadly deception.   It cannot be trusted to protect patients or fully include the value of new medicines to the people who are most in need of medical innovation. 

In short, ICER’s policy prescriptions will cripple MS patients. 



 

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Vaccine Denial: The Original Alt Fact

02/16/2017 08:14 AM | Peter Pitts

President Trump will ask prominent vaccine safety skeptic Robert F. Kennedy Jr. to lead a planned commission to study vaccine safety, Kennedy said Wednesday. Commission members will include "household names" who "have not taken a position on the issue" of vaccine safety, he said.

Hm.

Kennedy said that in a Jan. 10 meeting, Trump told him he expected an "uproar" from the pharmaceutical industry concerning vaccines, and that the industry "would try to make him back down and he wouldn’t back down.” Immediately after the meeting, Kennedy told reporters that Trump had asked him to lead a vaccine safety commission, a claim Trump staff quickly denied.
At a press conference Wednesday, Kennedy said he has since spoken with Trump staffers twice.

"They say they are still going forward with” a commission, he said.
Kennedy spent much of the press conference repeating widely discredited theories about links between thimerosal in vaccines and neurological disorders in children. In fact, almost no pediatric vaccines contain the preservative, according to an FDA document.

Kennedy also vilified the CDC as a “cesspool of corruption,” and accused FDA, the drug industry, and the scientific and medical establishment of colluding to poison American children.

Actor Robert De Niro, who was also in attendance, said he "agreed 100%" with Kennedy’s comments. Kennedy and De Niro said they are not "anti-vaxxers," but they remained silent when Tony Muhammad, a representative of the Nation of Islam, told reporters that polio vaccines had caused 95 million cases of cancer in America.

Considering Mr. De Niro’s macho man video aimed at the President during the election, he’s come a long way – except that he hasn’t.

Shame. Shame. Shame.

How about a Presidential commission on how to educate the American public (and particularly the parents of young children) on the safety and urgency of vaccinations?  Read More & Comment...

Psst -- Wanna see some DNA?

02/16/2017 07:54 AM | Peter Pitts

Via Forbes …

The Privacy Delusions Of Genetic Testing
BY: Peter Pitts

Mr. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.

Genetic testing promises a revolution in healthcare. With just a few swabs of saliva, diagnostics can provide an unprecedented look into a person’s family history and potential health risks. Within a decade, global sales of genetic tests are expected to hit $10 billion. Direct-to-consumer companies such as 23andMe and Genos have proven particularly popular, with tens of thousands of people purchasing at-home testing kits every year.

But the industry’s rapid growth rests on a dangerous delusion: that genetic data is kept private. Most people assume this sensitive information simply sits in a secure database, protected from hacks and misuse.

Far from it. Genetic-testing companies cannot guarantee privacy. And many are actively selling user data to outside parties.

The problem starts with the Health Insurance Portability and Accountability Act (HIPAA), a 1996 federal law that allows medical companies to share and sell patient data if it has been “anonymized,” or scrubbed of any obvious identifying characteristics.

In 2013, 23andMe CEO Anne Wojcicki speaks at an announcement for the Breakthrough Prize in Life Sciences on UCSF’s Mission Bay. In 2015 the Google-backed genetic testing company pledged to reintroduce some health-screening tools that regulators had forced off the market, due to concerns about accuracy and interpretation.

The Portability Act was passed when genetic testing was just a distant dream on the horizon of personalized medicine. But today, that loophole has proven to be a cash cow. For instance, 23andMe has sold access to its database to at least 13 outside pharmaceutical firms. One buyer, Genentech, ponied up a cool $10 million for the genetic profiles of people suffering from Parkinson’s. AncestryDNA, another popular personal genetics company, recently announced a lucrative data-sharing partnership with the biotech company Calico.

Customers are wrong to think their information is safely locked away. It’s not; it’s getting sold far and wide. Many testing firms that generally don’t sell patient information, such as Ambry and Invitae, give it away to public databases. Such transfers, as privacy consultant Bob Gellman puts it, leave a “big gap in protections.” Hacks are inevitable. Easily accessible, public genetic depositories are obvious targets.

If genetic data does fall into the hands of nefarious actors, it’s relatively easy for them to de-anonymize it. New lab techniques can unearth genetic markers tied to specific, physical traits, such as eye or hair color. Sleuths can then cross-reference those traits against publicly available demographic data to identify the donors.

Using this process, one MIT scientist was able to identify the people behind five supposedly anonymous genetic samples randomly selected from a public research database. It took him less than a day. Likewise, a Harvard Medical School professor dug up the identities of over 80% of the samples housed in his school’s genetic database. Privacy protections can be broken. Indeed, no less than Linda Avey, a cofounder of 23andMe, has explicitly admitted that “it’s a fallacy to think that genomic data can be fully anonymized.”

Once genetic data has been linked to a specific person, the potential for abuse is vast and frightening. Imagine a political campaign exposing a rival’s elevated risk of Alzheimer’s. Or an employer refusing to hire someone because autism runs in her family. Imagine a world where people can have their biology held against them. Such abuses represent a profound violation of privacy. That’s the risk inherent in current genetic-testing practices.

For their part, direct-to-consumer testing companies have been less than forthright about these dangers, usually burying privacy disclaimers deep in their contracts and refusing to disclose how long they keep customer data or how it can be used.

23andMe customers have to wade through pages of fine print before finding out that their information may be “shared with research partners, including commercial partners.” AncestryDNA’s contract claims a “perpetual, royalty-free, worldwide, transferable license to use your DNA.” New research published in the journal Nature found that genetic-testing companies frequently fail to meet even basic international transparency standards.

Genetic testing has tremendous benefits. We are provided a closer look at our own biology. Medical researchers develop a deeper understanding of the origins of disease and can create powerful new treatments. But today, far too many donors are operating under a false sense of security, handling profoundly intimate data without appropriate protections.  Read More & Comment...

Panicking PBMs

02/15/2017 07:46 AM | Peter Pitts

No wonder PBMs are scared. When their profits and practices are made transparent they should be afraid – very afraid. BioCentury reveals the extent of their panic.

PBMs launch attack on drug companies

PBMs have launched an aggressive campaign to persuade the Trump administration to attack drug company profits while leaving the PBM business model untouched. The strategy was outlined in a leaked email and documents sent by Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt to the organization's board on Feb. 6.

PBMs want to discourage the Trump administration from replacing private sector drug price negotiations with government negotiations. Much of the industry’s strategy is aimed at countering messages from PhRMA and its members that drug price complaints are the result of a bloated supply chain and insurance plan designs that place too much financial burden on consumers. 
PCMA, a trade association for PBMs, has sent the Trump administration a list of proposals for lowering drug prices.

With a few exceptions, it reads like a drug industry nightmare. The list includes reducing biologic exclusivity to seven years, eliminating pay-for-delay deals and ending tax deductions for expenses related to direct-to-consumer advertising.
PCMA also wants CMS to eliminate protected classes from Medicare Part D, create a competitive acquisition program for Part B drugs, and sharply limit the use of manufacturer coupons. PCMA estimates that over a ten-year period, ending tax deductions for direct-to-consumer ads would save $37 billion, while reducing the biologics exclusivity period and implementing the Part B acquisition program would each yield $4 billion in savings.

Merritt wrote that PCMA was rolling out the new strategy before key Trump administration health officials were in place because quick action was needed, "given the political uncertainty, headline risk, and other unique challenges that come with a President more inclined toward quick, instinctive action than the traditional, deliberative decision-making process."

He outlined efforts to build relationships with top White House staff to counter drug companies' influence, and said PCMA may try to reach the president through television. "Given the President’s interest in a select number of news programs, PCMA will also explore other forms of advertising that target those particular venues."

The trade association also plans to use a "grassroots" coalition it created with “more than 73,000 recruited allies who can be leveraged as needed to help drive our message in key districts around the country,” Merritt wrote.
PCMA declined to comment on the leak.

PhRMA and PCMA are also operating from the same advertising playbook. In massive campaigns targeting policymakers and key opinion leaders, both have promoted their messages online, in print and through video. As of Feb. 6, PCMA said it was attracting 1,100 viewers a day to its website, and digital ads launched on Jan. 16 had received 14 million views, including three million who watched video ads. 
PCMA and drug companies share some common ground. The PBM industry is pushing to exempt insurance plans in Affordable Care Act exchanges from the Medicaid best price requirement in order to allow value-based pricing. Like PhRMA and BIO, PCMA also has proposed an FDA safe harbor for drug companies and payers to discuss drugs prior to approval.  Read More & Comment...

Marathon Pharma Has a Golden Opportunity to Lead a Revolution on Drug Pricing

02/14/2017 08:09 AM | Robert Goldberg

When Marathon Pharmaceuticals announced the list price for deflazacort – a steroid that helps kids with Duchenne Muscular Dystrophy maintain muscle strength – I am betting it didn’t expect to be headline news for anything other than taking a generic medicine in short supply and making it widely available in an FDA approved form.  

After all, it explained that the $89000 list price would wind up being sold to PBMs for $54000 and that after additional discounts and cost sharing most patients would pay about $20 a month for the product.  And it explained that as a company that was making the drug available for free under an expanded access program during its development, that was not going to be profitable for year and was already repurposing other generic drugs for rare conditions, the money had to come from somewhere. 

Didn’t matter.   Marathon got hammered.  And worse, if the news accounts are accurate, the list price surprised and concerned the patient groups that it had been supporting and working with to identify medicines to bring to market.  

But Marathon has wisely decided to re-launch deflazacort with a different approach to pricing. 
Since the company has been receiving criticism for free, perhaps they would not mind being told – gratis – that it has a great opportunity to lead a drug pricing revolution.  Scrapping the initial pricing model was the first step.  Here are the rest:

1.    Pledge to make the drug available for $20 a month forever and with no price increases.
2.    Make the same pledge for any new medicines it develops
3.    Use the rebates, discounts and givebacks that cut the price to $54000 and use it to reduce consumer cost at point of sale.
4.    Use the rebates, discounts, etc., to give insurers and consumers a money back guarantee if the drug does not work.
5.    Partner with specialty pharmacies that get paid for dispensing the drug and helping patients stick to regimens, report outcomes, etc., vs paying off Express Scripts, CVS and the bunch.
6.    Partner with health plans and provider networks to come up achievable outcomes from using the drug.  Studies suggest that maintaining muscle strength in kids with DMD reduces other health care costs by about $40000 a year.   It gives the kids, parents and caregivers more independence.   Then figure out how factor in the cost of the drug.  Marathon could even finance part of the cost with the freed up rebates.
7.    Use the money raised from the sale of its FDA priority review voucher (a ticket that gets you to market faster) to invest in its other pipeline products.

In doing so, Marathon could break the chokehold rebates are having on access and how they skew drug pricing.  It could focus on making sure its medicine was used in ways that generate the most value to its customers.   And best of all, it could shut up Bernie Sanders (Love the Bern but less is more).  I’d pay real money for that!



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PBM Lobby Memo Tells Trump: Give Us More Power To Pocket Rebates

02/09/2017 02:31 PM | Robert Goldberg

The Pharmaceutical Care Management Association, the lobbying group for pharmacy benefit management companies, produced a memo outlining a strategy to fight back against efforts to disgorge them of the rebates that are the only reason for PBMs existing.

Here's the essence of the PCMA memo:  

Dear President Trump and Congress,

We save you money so give us even greater control who gets what drugs and at what price.    Read More & Comment...

Reduce Drug Prices by Cutting Out PBM Rebates

02/08/2017 12:25 PM | Robert Goldberg

The pharmacy benefit management lobbying organization and Express Scripts are running ads claiming that PBMs are reducing drug prices for consumers.

Express Scripts Fights Back Against Irresponsible Drug Pricing

"At Express Scripts, we put medicine within reach - making it more accessible and affordable for the employers and patients we serve. It's why we exist.

In a year where the high cost of prescription medications dominated headlines, Express Scripts delivered value beyond and practiced pharmacy smarter, protecting employers and patients by driving down costs and improving outcomes.

Our country needs affordable medicines, and Express Scripts is best positioned to deliver them. The proof is in the data."

That's false advertising.  Express Scripts didn't put medicines in reach.  Rather it manipulated prices and access to maximize rebates and out of pocket consumer costs. 

It's an incredibly rigged system.   Nearly $130 billion of drug spending goes to PBMs and insurers in the form of rebates.  And the spread between what PBMs get and what they pay for drug prices continues to soar:


Sources:  Berkley Research Group,  IMS-Quintiles

The industry says that amount reduces drug prices for consumers.

In fact,  the PBMs pocket the rebates and share them with insurers.  Very little, if any, of that money, goes to the patients whose prescriptions make the rebate revenue happen.


Even more,  the PBMs make the most rebate money on medicines for the sickest patients.   Of the $100 billion in brand rebates they get each year,  half are from medicines for cancer, MS, HIV, hepatitis C, etc. 

What's more, the spread between the net price increase of drugs and list price increase is growing.  



Source:  IMS, Express Scripts

In addition to pocketing these increasing margins, PBMs turn around and make the sickest patients pay up to 50 percent of the list price of a drug. 


Take diabetes for an example. Rebates for diabetes drugs average about 44 percent of list price. And they have been climbing as a share of list price since 2013.

The chart below shows how rigged the system is. The out of pocket cost of consumers is going up. Part of that increased is covered by drug companies. That means the drug companies give PBMs 44 percent of the list price of drugs in the form of rebates AND a percentage of the list price of the drug at the retail level.



The sickest one percent who use these specialty medicines pay about $10 billion a year.  That brings the total PMB revenue to $60 billion.  That's 60 percent of the price of the drug pocketed by PBMs.   
In essence, each patient (about 2.8 million) is being overcharged $23000.   That's delivering value to PBMs and their clients, not patients. 




Since cost sharing is associated with reduced use of medicines,  that means people are sicker than they should be and wind up costing more.

I estimate the medicines spent on the 1 percent are responsible for saving nearly 1 million life years since 2005.   We could have saved even more if drugs weren't put out of reach by rebate rigging. 

While PBMs should be criticized, it's important to note that they are playing with house money.  That is,  the rebates come from drug companies.  There is no reason why drug companies couldn't pass rebates directly to patients AND eliminate high-cost sharing.   

The proof is in the data. 

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Trump Misunderstands Drug Pricing

02/02/2017 08:44 AM | Peter Pitts

From the pages of the Washington Examiner:

President Trump misunderstands what government drug price negotiations entail
By Peter J. Pitts

President Trump recently pledged to let federal officials negotiate the prices of drugs covered under Medicare. He claims this will save taxpayers billions of dollars.

Nobody doubts that Trump and his team are shrewd negotiators. But the sorts of "negotiations" that Trump refers to have nothing in common with haggling over a real estate deal. Instead, the action that Trump has proposed — repealing the non-interference clause, originally drafted by Democratic Senators Ted Kennedy and Tom Daschle — would result in Medicare drug prices going up and patient choice going down.

This clause has been the key to Medicare's success. Between 2004 and 2013, the Medicare "Part D" prescription drug benefit program cost an extraordinary 45 percent less than initial estimates. Premiums for the program also are roughly half of the government's original projections. These unprecedented results are largely due to Part D's market-based structure. Beneficiaries are free to choose from a slate of private drug coverage plans, forcing insurers to compete to offer the best options to American seniors. This year, seniors can choose from among 746 plans nationwide, with an average monthly premium of around $35.

Such great choice and low costs have led to widespread support for the program. In fact, nine out of ten seniors report satisfaction with their Part D coverage, according to a recent survey.

Through their own negotiations with drug makers, private insurers that offer Part D plans have had great success in keeping pharmaceutical prices down. In fact, the Congressional Budget Office observed that Part D plans have "secured rebates somewhat larger than the average rebates observed in commercial health plans." The non-interference clause prohibits government officials from intruding in these negotiations.

Doing away with the non-interference clause, on the other hand, "would have a negligible effect on federal spending." In a report from 2009, the CBO reiterated this view, explaining that such a reform would "have little, if any, effect on [drug] prices."

In fact, allowing the feds to negotiate drug prices under Part D likely would have a negative effect on the program. The CBO explains that to achieve any significant savings, the government would have to follow through on its threats of "not allowing [certain] drug[s] to be prescribed."

In other words, the government might drop some drugs from Medicare's coverage. Patients who need those drugs would then be forced to pay for them out-of-pocket, which would make medicines vastly more expensive for the seniors that Trump wants to help.

If patients couldn't afford the prescription, then they might switch to a less effective drug or stop taking the medicine altogether. Their health would suffer.

Unfortunately, this isn't a hypothetical consequence. Just look at what's happening with the Veterans Affairs formulary, which permits government interference. The VA covers barely 80 percent of the 200 most popular drugs in the country. Medicare, which doesn't allow for government meddling, covers 95 percent of these medicines.

Letting Medicare go the way of the VA would be devastating for seniors. Senators Kennedy and Daschle knew what they were talking about. The president should pay close attention.

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
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ICER's New Value Framework Still Discriminates Against the Sick

02/01/2017 06:06 PM | Robert Goldberg

ICER released its proposed new value framework approach with the usual display self-congratulation and condescension. 

ICER stated, "To succeed in our mission, we constantly listen to patients and other stakeholders. This draft contains proposed updates to our Value Assessment Framework that are a direct result of the thoughtful input we have received, and of our ongoing conversations with all stakeholders.” 

Despite the conciliatory language, nothing's changed.   It's all smoke and mirrors and process,  a me-too version of ICER's anti-patient framework.  Cuba has changed more under Raul Castro. 

The update proposals will be open to further public comment for 60 days. But it doesn’t take even 6 hours to see that ICER’s clever combination of confusing statistics, assumptions and price controls remain dangerous and discriminatory.

1.    ICER will to ignore the value of new medicines to employers, caregivers, families, and patients. 

2.    ICER will continue to use the quality-adjusted life year (QALY) to measure the value of treatment for all patients. A QALY, often used in the UK where the availability of cancer therapeutics is limited by cost, equals one year in perfect health. That means anyone who is ill is measured as LESS than a QALY, diminishing the value of their treatment.  ICER uses the QALY, despite acknowledging that the QALY can vastly underestimate and devalue the quality of life and ignores patient perspectives.

3.    ICER claims that estimating rebates taken off of list drug prices will more accurately reflect cost.  It ignores the fact that rebates are pocketed by the PBMs and insurers funding ICER.  So under ICER's framework,  health plans and PBMs pocket rebates and the out of pocket share of the list price of a drug that patients must pay. 

4.     ICER still maintains that given the additional benefit these new drugs provide is worth no more than $150, 000 for each additional year of life,  an arbitrary ceiling on the cost of new therapeutics, no matter how much they achieve.

6.     ICER still assumes health systems shouldn't spend more than $900 million a year on each new medicine without cutting spending somewhere else. 

7.    ICER still assumes that new drugs will drive up insurance costs and crowd out pothole repair.  In fact, new medicines reduce the cost of treating disease over time and promote greater productivity and tax revenue. New therapeutics can save money AND save lives!

In short, ICER is therefore still a tool for discriminating against the sick.  The new ICER is the bad old ICER:


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Virginia partners with Purdue on PMPs

01/26/2017 09:57 AM | Peter Pitts

Governor McAuliffe Announces Grant to Integrate PMP with Health Records
~ Purdue grant will help doctors spot potential opioid abuse ~

Richmond – Governor Terry McAuliffe today announced that the Prescription Monitoring Program has been awarded a grant to help integrate use of its data in doctors’ and pharmacists’ regular work flow.

The $3 million grant from PurduePharma will allow the Department of Health Professions to connect the state PMP with electronic health records (EHR ) used by Virginia doctors and pharmacies.

This is an additional step in Virginia’s fight against the epidemic of opioid addiction and overdose.

“The epidemic of opioid addiction is a public health emergency in Virginia, and combating it is a top priority for my administration,” said Gov. McAuliffe. “The Prescription Monitoring Program is a critical prevention tool that helps curb abuse of prescription medications, and I applaud this enhancement that makes the PMP easier and more likely for physicians to use.”

The Virginia PMP allows physicians and pharmacists to check a patient’s prescription history, through the PMP database, for certain prescriptions as reported by in-state and out-of-state pharmacies. Doctors and pharmacists already check the PMP database when prescribing or dispensing controlled substances both to enhance patient care and to help prevent “doctor shopping,” abuse, or diversion of prescription medications.

Integrating the PMP with EHR – through “NarxCare” technology developed by Kentucky-based Appriss – will make the step of checking the PMP easier for prescribers and pharmacists by integrating the PMP query into the existing workflow. The goal is to improve the performance, access and usability of the PMP program data for 18,000 prescribers and 400 pharmacies in the Commonwealth of Virginia by the end of 2017. Appriss is the vendor DHP uses to operate the PMP.
 
“The PMP is an important resource to help us track prescription data and spot potential abuse,” said Virginia Secretary of Health and Human Resources Dr. Bill Hazel. “Integrating that data with electronic health records strengthens the PMP and is an important step in our ongoing battle against the epidemic of opioid abuse.”

This upgrade of Virginia’s prescription drug monitoring program will allow health providers and pharmacists to more effectively flag at-risk patients and curb prescription drug abuse as we fight against our commonwealth’s drug abuse epidemic,” said Virginia Attorney General Mark Herring.

“Purdue Pharma has supported prescription drug monitoring programs to help reduce the overprescribing of opioids for more than a decade, through funding, and by working with state governments, regulatory agencies and healthcare organizations,” said Mark Timney, President and Chief Executive Officer, Purdue Pharma L.P. “We recognize the immediate need for technology innovations, such as this, to improve access to the PMP data through workflow integration.”
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