Latest Drugwonks' Blog
Proposed Swedish Pharma Pricing Model Suggests VBP Is Not Enough To Control Costs
The Swedish government published on Sept. 22 a framework directive designed to revolutionize the pricing, reimbursement of and access to patent-protected pharmaceuticals.
This will alarm pharma manufacturers that the VBP systems now being implemented by countries such as Germany, France and the U.K., simply may not go far enough in terms of controlling costs and that harsher measures may follow.
The directive examines the possibility of introducing a mechanism that would ensure that drug prices in Sweden are below or the same as prices in other comparable countries such as Norway, Great Britain and Denmark - known as a reference pricing system, the government suggests it could lead to annual savings of between SEK 500 million ($74 million) to SEK 2 billion ($294 million).
Sweden also is examining the possibility of introducing reimbursement limits for certain products - which should generate savings of SEK 900 million over a three-year period. The Rapporteur's report will be presented to government on Sept. 1, 2012.
"This implies that some of the proposals could be implemented as soon as in the beginning/middle of 2013," said Anders Blanck, Director General of the Swedish pharmaceutical industry association, Lif.
tinyurl.com/4y67ndh
Today's news that Blue Shield of California will no longer pay for Avastin to treat breast cancer, though "exceptions may be considered on a case-by-case basis," makes a new nationwide survey by the Coalition of State Rheumatology Organizations (CSRO) big news. The survey shows broad dissatisfaction with the insidious practices of preauthorization and step therapy – specifically the ways in which it impacts the ability of physicians to treat patients.
(Prior authorization, also known as pre-authorization, pre-certification or prior notification, is an extra set of steps some insurance carriers require before determining whether they will pay for a medical service or prescription medication. The physician, or other medical provider, is required to obtain approval from the insurance carrier before the carrier will agree to cover the cost of the medical service or prescription medication. Step therapy, also referred to as “fail-first,” requires patients to “fail’ on one or more less costly medications before the health insurance carrier will agree to cover a more expensive medication, even if a physician thinks it is a better option for the patient.)
“Rheumatologists around the country have increasingly voiced their concerns about the impact of health insurance protocols such as prior authorization and step therapy on patient care,” said Reuben Allen, CSRO Executive Director. “These practices are stripping rheumatologists of the ability to direct the most appropriate and effective courses of treatment, which causes patients to suffer delays or outright denials of proper medical care. Individualized treatment plans that can restore, enhance, and preserve quality-of-life over time are essential to rheumatology patients and their struggle against autoimmune and destructive arthritic disorders.”
Specific findings of the CSRO survey include:
Nearly 99% of rheumatologists surveyed say they have had to alter treatment plans including changing prescription medications to accommodate restrictions imposed by patient health insurance carriers;
91.5% of survey respondents say prior authorization has a “negative” to “very negative” effect on their ability to treat patients;
Nearly 97% of rheumatologists surveyed agree, “There should be enforceable legislation to regulate restrictions that insurance companies place on health care providers in regards to treatment modalities they prescribe for their patients;”
Nearly 98% of survey respondents agree that decisions about what medications are best for a patient should be made by the patient’s own health care provider and not by the health plan or insurance company;
Nearly 73% of respondents say they are only “sometimes” or “rarely” able to easily determine what procedures will be covered by a patient’s health plan at point-of-service;
52.2% of rheumatologists surveyed say they have considered re-establishing their practices as fee-for-service only because of prior authorization constraints.
Currently, prior authorization and fail-first protocols are primarily paper-based, and non-standardized. Each insurance carrier has its own set of requirements, which can vary among plans, even within the same carrier’s portfolio of coverage options. To meet prior authorization requirements physicians must complete a time-consuming series of faxes, phone calls, emails, input of data into insurance carrier web sites and, in some cases, letters.
Prior authorization should be standardized and improvements in the current process can be made by the adoption of a universal prior authorization form;
Electronic prescribing platforms are provided on neutral and open platforms that do not advance the commercial interests of any particular participant (e.g., health insurers, hospitals, pharmacy benefits managers, pharmaceutical companies, etc.) to the potential detriment of the patient;
Adjudication of prior authorization requests occurs within a reasonable time frame (hours as opposed to days or weeks); and communication between physicians and payers should be on a peer to peer basis;
Electronic prescribing platforms include access to information about all FDA-approved medications and medical services without restrictions;
Complete, up-to-date information about prior authorization and fail-first criteria is available through electronic prescribing platforms at point-of-service;
Prior authorizations should not be required on a repeated basis. It should only be necessary with a change in medication dictated by a change in clinical status;
Prior authorization should not be necessary for low cost medications; for example, prednisone and methotrexate.
“Physicians are responsible for the administrative costs associated with meeting prior authorization and fail first requirements.
“Prompt diagnosis and specially tailored treatment can improve the long-term outcomes of patients with rheumatologic diseases," said CSRO's Allen. "State legislatures and insurance commissioners should take appropriate steps to ensure that patients suffering from chronic rheumatic diseases and chronic pain do not have to needlessly suffer.”
The complete CSRO survey can be found at http://www.csro.info/
In April, the Food and Drug Administration approved a first-of-its kind study to test whether marijuana can ease the nightmares, insomnia, anxiety and flashbacks common in combat veterans with post-traumatic stress disorder.
But now another branch of the federal government has stymied the study. The Health and Human Services Department is refusing to sell government-grown marijuana to the nonprofit group proposing the research, the Multidisciplinary Association for Psychedelic Studies.
The HHS official in charge of the review, Sarah A. Wattenberg, declined to answer questions when reached by phone.
Can you imagine the hue and cry if this had happened under the previous administration?
Embed head firmly in sand and repeat after me in your best Dorothy in Oz cadence, “Pens and Pizza and Biscuits. Oh my!”
Now consider this new British Medical Journal commentary piece by Iona Heath, the president, Royal College of General Practitioners” --
The politics of drug industry sponsorship
Earlier this month I received a letter from a senior politician inviting me to attend a meeting on a public health topic … I failed to notice that the letter included the sentence: "The meeting is being supported by the healthcare company, Bristol-Myers Squibb." However, when I arrived, the tabled agenda had a similar sentence across the bottom: "The logistical aspects of this meeting are being supported by Bristol-Myers Squibb (BMS)."
The usual round of introductions revealed that there were two representatives of the company in the room listening to everything that was being said … Although I welcome unreservedly the transparent disclosure, when I tried to express concern about the process, the said politician assured me, more than a little abruptly, that it was only the coffee and the biscuits … Not surprisingly, the biscuits were much more tempting than usual … Sadly the politician in question seemed not to be aware of the relevance of any of this to the coffee and biscuits.
Dr. Heath’s complete commentary can be found here.
Sadly Dr. Heath (while certainly entitled to her opinion and desire to tow the party line) seems unaware of the evidence to the contrary.
For example, in the January 2010 issue of Academic Medicine (Adad. med. 2010; 85:80-84), four researchers from the Cleveland Clinic published a paper entitled, "The Effect of Industry Support on Participants of Bias in Continuing Medical Education." The purpose of the study: "To obtain prospective evidence of whether industry support of continuing medical education affects perceptions of commercial bias in CME."
The method: "The authors analyzed information from the CME activity database (346 CME activities of numerous types; 95,429 participants in 2007) of a large, multi-specialty academic medical center to determine whether a relationship existed among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support."
The study's conclusion: "This large prospective analysis found no evidence that commercial support results in perceived bias in CME activities. Bias level seem quite low for all types of CME activities and is not significantly higher when commercial support is present."
Further, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have adopted a new policy regarding the disclosure of conflicts of interest. Here's the key paragraph:
"There is no inherent conflict of interest in the working relationships of physicians with industry and government. Rather, there is a commonality of interest that is healthy, desirable, and beneficial. The collaborative relationship among physicians, government, and industry has resulted in many medical advances and improved health outcomes."
What a unique perspective -- a "commonality" rather than a "conflict" of interest.
And in a recent editorial in The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research, and the pharmaceutical industry are artificial at best—and dangerous at worst. They are dangerous, because all three constituencies are working towards the same goal—improved patient outcomes.
His point is that we must dismantle the battlements and embrace of philosophy of “symbiosis not schism.” It’s what’s in the best interest of the patient.
Nature Biotechnology puts it this way, “The great unspoken reality is that relationships between companies and researchers are not only becoming the norm, but they are also essential for medicine to progress.”
Suffice it to say that we disagree with Dr. Heath’s position – but we will certainly defend her right to have an opinion and express it.
Alas, the same cannot be said for another fellow traveler – Dr. Steve Nissan.
Recently my friend and co-conspirator Dr. Tom Stossel (the American Cancer Society Professor of Medicine at Harvard, and Director of the Translational Medicine Division of the Brigham and Women's Hospital) was invited to give a Grand Rounds lecture given at Case Western University. Here’s the verbatim e-mail that Dr. Nissen sent to his colleagues at Case Western:
“This guy is an embarrassment to the medical profession. Can’t believe you would have him provide Grand Rounds. Your trainees deserve better.”
Talk about professional discourtesy!
The good news is that Tom’s lecture was standing room only.
Yesterday I was honored to attend and participate in the 2nd annual Galien Forum (part of the Prix Galien celebration). The topic under debate for my panel was, “What is value and how can it be measured and demonstrated in therapeutic innovations?”
I was joined on the dais by Jeff Berkowitz (SVP, Pharmaceutical Development and Market Access, Walgreens; Robert Epstein, Chief Clinical Research and Development Officer, Medco; Barry Gertz, SVP, Head of Clinical Research and Regulatory Affairs, Merck; and Roger Longman, CEO, Real Endpoints. Our moderator was Dick Pasternak, a former Merck VP, Harvard Medical School associate professor and past director of Preventive Cardiology at Mass General).
The combination of a meaty topic and a high-octane panel made for a robust conversation. When the video of the panel is available, I will post it.
The audience was engaged and one question was particularly thought provoking. Not surprisingly, it came from Nobel Laureate Dr. Michael Brown (Professor of Molecular Genetics and Internal Medicine at UT Southwestern Medical Center and a board member of Pfizer). Dr. Brown asked why innovative companies like Apple have such high public esteem while innovative pharmaceutical companies are at the other end of the spectrum of public opinion.
Perhaps the answer (or at least a piece of the answer) is that Apple defines itself in terms of innovation and the value it brings. How, in contrast, do pharmaceutical companies (and the people who populate it) define themselves? Too many see their jobs as “selling drugs.” And while that is certainly a part of it (and an important and worthy part at that) should that be how they define their jobs and their employers?
Until and unless pharmaceutical companies and their employees define themselves as being in the advancing healthcare business (as all their mottos proclaim), they will not be given the credit for the innovation that they truly deliver.
Many believe such image issues are the responsibility of PhRMA. And while the trade organization certainly has an important role to play, ask yourself this – does Apple rely on its trade association to promote its innovativeness?
Another panel featured (among others) Dr. Steve Nissen on the topic of “Perspectives on Innovation, Patient Safety and Global Access.” Here’s one direct quote from Dr. Nissen:
“No one should ever stop taking a medicine because of something they saw on television.”
Please pass the remote.
“Every time I put my line in the water I said a Hail Mary, and every time I said a Hail Mary I caught a fish.” Fredo Corleone
To use a pop culture metaphor, if IPAB is Michael, MedPac is Fredo.
The Medicare Payment Advisory Commission (aka – MedPac, the body that advises Congress on Medicare payment policy) is proposing to fix the Sustainable Growth Rate by sharing the cost of repealing the SGR among physicians, other health professionals, providers in other sectors and beneficiaries.
MedPAC’s draft plan suggests instituting a 10-year payment rate freeze for primary care physicians and three years of reduced payments at 5.9 percent each for specialists followed by a seven-year payment freeze. It also recommends offsets totaling about $235 billion. Those offsets would come from cuts to Medicare Part D drug plans (32 percent); post-acute care facilities (21 percent); Medicare benefits to seniors (14 percent); hospitals (11 percent); laboratories (9 percent); durable medical equipment (6 percent); Medicare Advantage (5 percent).
Not surprisingly, physicians are none too thrilled about the proposed cuts and freezes to their payment rates. In a statement, the American College of Surgeons said that, “The recommendations do not value the role all physicians have in the continuum of care and would have a devastating impact on access to surgical care.”
It certainly took long enough the physician community to stand up and speak out for patient care. Too bad it took the harsh realities of the bottom line to do it.
Avorn claims that academic detailing is "evidence based medicine" put to use. But their is very little evidence that anti-innovation detailing improves the health of patients. There are no large scale clinical trials to look at the effect on health outcomes. Or should we just take Avorn's word that his business model is better? A study last year seemed to suggest that doctors who were subject to marketing to use the guidelines from ALLHAT and prescriibe diuretics as the treatment of choice for high blood pressure were more likely to do so. Let's ignore the fact that the claim diuretics reduced death as well or better than other drugs is based on based on secondary endpoints and that the primary endpoint (fatal coronary heart disease and nonfatal myocardial infarction) was similar for the 3 drugs. ALLHAT guidelines also hurt minorities: ALLHAT steered African-Americans to a combination of an ACE inhibitor and a [beta]-blocker in black patients. Blacks randomized to an ACE-inhibitor had 40% excess stroke rate compared to whites which explains the overall benefit of diuretics found in ALLHAT.
So Avorn peddles a protocol whose design kills black patients. He also opposed the FDA approval of BIDil -- combination of two drugs that showed overwhelming reduction in death from heart failure among blacks until scientists conduct a study that tells us why white and black patients differ in response. In doing so he ignored 3 well-controlled trials suggesting or showing a mortality benefit in black patients. As the FDA noted in response to Avorn the was "apparently unimpressed by the 43% mortality risk reduction demonstrated.. and apparently believed that the racial difference hypothesis was based on a post hoc analysis of a single trial." www.annals.org/content/146/1/57.full#ref-list-1
Actually Avorn is not only not unimpressed, he doesn't care. He makes money pushing cheaper drugs and ignoring evidence that would undermine his racket. If it harms minorities in the process, well that's just a cost of doing business.
Whether it’s allergy medications, treatments for erectile dysfunction or high cholesterol, the issue of Rx-to-OTC switching is complicated, important – and timely.
And not just because of certain high profile LOE dates.
A new draft guidance (issued Sept. 16th) provides a valuable resource for those thinking about proceeding with OTC switches based on self-selection studies. The Pink sheet opines that “support of Rx-to-OTC switches reflects FDA's interest in drilling down for greater insight into consumers' thought processes.”
“Some experts contend there are no more switches for conditions that are relatively easy to self-diagnose, meaning the bar to convince the agency that consumers can appropriately self-select for an Rx drug in an OTC setting has been raised.”
Can a patient self-diagnose and self-dose? Do symptoms hide another, potentially more serious, underlying condition? And what of safety concerns?
Does this open the door for a so-called “behind the counter” (BTC) category? CDER Director Janet Woodcock has spoken out in favor of such strategies since they would allow switch candidates with greater self-selection obstacles to be available without a prescription.
A BTC category would almost certainly reopen the conversation about the “statin quo.”
In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.
Pharmaceutical sponsors across therapeutic categories may have breathed a sigh of relief when FDA’s Cardiovascular and Renal Drugs Advisory Committee said that Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) need not show it is “as effective” as Boehringer Ingelheim GmbH’s anticoagulant Pradaxa (dabigatran) in atrial fibrillation patients.
At the September 8th meeting focused on efficacy data from the pivotal ROCKET AF study and whether the Factor Xa inhibitor was studied against an appropriate comparator. FDA sought the advisory committee’s input on whether warfarin or dabigatran was the appropriate comparator for rivaroxaban in light of a 1995 agency policy that requires new therapies be “as effective” as approved treatments when the disease at issue is life-threatening or capable of causing irreversible morbidity.
At a Sept. 8 meeting, the majority of panel members said Xarelto’s sponsors should not be required to directly show comparable efficacy to dabigatran, a drug approved 11 months ago.
According to the Pink Sheet, panelists commented that requiring drugs for serious or life-threatening diseases to be compared head-to-head against the newest treatment on the block could “throw a wrench in long-planned and ongoing clinical development programs that use a well-established standard of care as a comparator agent.”
Office of Drug Evaluation I Director Bob Temple on the question as to whether or not the ROCKET AF study population represented a sufficiently different group of patients from those in RE-LY as to render the “as effective” policy inapplicable to rivaroxaban:
“This was not my favorite question.” Dr, Temple then proceeded to point out the bigger issue inherent in applying FDA’s “as effective” policy in a dynamic development and regulatory environment.
“There is an interesting and provocative issue here. Suppose in the course of the study, something new and really hot comes along. Do we ever say, ‘I’m sorry, you compared it to a dog, we have something better now?’ We don’t usually do that, but I wouldn’t rule out the possibility. And this is a little bit about that possibility, but I don’t think we really meant to get too much into that discussion.”
PCORI Executive Director Joe Selby wants to be clear that while the institute's main focus will be on patient-centered activities, it will wants participation from all interested parties.
"We want a director of stakeholder engagement to engage providers, caregivers, employers, health plans, health systems, health services researchers and other researchers, government and industry," Selby said September 19th during the PCORI Board of Governors meeting in Seattle.
Good idea. And the selection process (and the selected candidate) should be carefully watched to see how Dr. Selby and the PCORI board defines “interested parties.”
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
