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At least that seems to be the position of some state Medicaid plans.
Case in point, pregabalin (Lyrica) and Iowa (coincidentally, the state represented in the United States Senate by Charles Grassley).
Iowa Medicaid requires preauthorization for pregabalin -- which is FDA-approved for (among other indications) fibromyalgia. In Iowa a patient with a diagnosis of fibromyalgia must first fail on at least two of the State's "preferred" agents -- trycyclic anti-depressants, topical lidocaine, or gabapentin. None of these three agents are approved by the FDA for the treatment of fibromyalgia.
But they are less expensive than the on-patent, on-indication product. So what we've got here is step-therapy based on off-label usage. Not unheard of, certainly , but it does start sending some interesting policy messages about the appropriateness of off-label use in various circumstances. (And it's more than a little bizarre when you consider that Pfizer, the manufacturer of pregabalin, had to pay a $430 million fine for off-label promotion of gabapentin.)
The actions of the Hawkeye State Department of Human Services are even more peculiar considering that Senator Grassley (R, IA) asked the U.S. Government Accounting Office (GAO) to investigate off-label prescribing -- and not because he thought it was a valuable tool for patient care.
So here's where we stand: Off-label use of on-patent medications is bad, but off-label use for generics is good. Translation: off-label use is good when it saves the payer money.
Is cost-based trial-and-error medicine really the path we want to take in the era of personalized medicine?
What about science?
What about relying on the professional judgment of the physician?
What about what's best for the patient?
It's a Q&A. Here's a sample:
DIA: Do you think that the general public -- the average "patient on the street" -- would recognize the concept of patient-centered care?
JB: "I think that if they experience it, they can tell the difference, but at the moment we're setting up barriers to patient-centered care.
To find out what that means, have a look at the compete interview here. It begins on page 18.
"We adopted a societal perspective, discounted costs and benefits by 3% annually, and expressed benefits as quality-adjusted life-years (QALYs) gained. After eliminating strategies that were more costly and less effective or less costly and less cost-effective than an alternative strategy, incremental cost-effectiveness ratios were calculated as the additional cost divided by the additional health benefit associated with one strategy as compared with the next-less-costly strategy. Although there is no consensus on a cutoff point for good value for resources, we interpreted our results in terms of a commonly cited threshold of $50,000 per QALY gained, as well as an upper-bound threshold of $100,000 per QALY gained."
Hmm, and what does that cover...
"The routine vaccination of 12-year-old girls, in the context of current screening and assuming lifelong vaccine-induced immunity, had an incremental cost-effectiveness ratio of $43,600 per QALY gained, as compared with screening alone (Table 2). The addition of a 5-year catch-up program for girls between the ages of 13 and 18 years cost $97,300 per QALY, and extension to 21 years of age cost $120,400 per QALY. The extension of the catch-up program to 26 years of age cost $152,700 per QALY, as compared with the catch-up program to 21 years of age."
The extra $52 K is really society saying, we have decided after $100K we will roll the dice and see if we have to pay for all the costs relateded to screening, treatting, etc. cevical cancer. It does not even address what a 26 year old woman might think a catch up shot is worth....
Oh, and the additional benefits. like avoiding screening and the worry or other illnesses were never counted either.
"when the potential benefits associated with preventing noncervical HPV-16–related and HPV-18–related cancers and HPV-6–related and HPV-11–related juvenile-onset recurrent respiratory papillomatosis were included, cost-effectiveness ratios were reduced"
So of course the NEJM runs an editorial claiming the vaccine is not cost effective, it's press department hypes that and not the guts of the study and the rest of the media takes the lead and will ikely cite (via misrepresentation) the study as proof that many new products are not worth their cost. .
Still believe cost-effectiveness will certainily be a patient-centered and objective process taking into account all stakeholder concerns.
http://content.nejm.org/cgi/content/full/359/8/821
Here's what he has to say:
Peter Pitts’ depiction of the almost ten year old “cost-effectiveness” wars in
"This is in addition to Merck's efforts to make the vaccine mandatory for young U.S. girls, with many wondering if the rise in cervical cancer vaccines are due to increased awareness or to Merck's aggressive, award winning and highly controversial marketing schemes. "
First of all, is the above an actual sentence written by a journalist whose first language is English or was it translated from the original Vulcan?
Second, given the increasing reliance on other blogs with a bias as a primary source instead of real background, it is obvious that FiercePharma believes that arsenic causes diabetes, all marketing is a ploy and vaccines are dangerous.
Third, the argumentation of the piece is consistent with tendency of bio-Luddites to use their belief than medical innovations are just an excuse to rape the public as evidence instead of a fearful emotional response.
Note the lack of clear deductive or inductive reasoning balanced with a complete lack of empirical information. For instance there is a problem with increased used through marketing but not public awareness....is there a difference? Or are those responding to Merck marketing brainwashed and the those that received it from on high enlightened? Does evidence of adverse events mean the vaccine should NOT be marketed. What is the marketing was less aggressive? And what about the trend towards not covering by insurance companies? Obviously sales are lagging so what good is awareness is the so-called health maintenance organizations won't pay for prevention? They cover chicken pox vaccines but not cervical cancer?
Previously Fiercepharma claimed a article relying upon memos redacted and provided by tort lawyers that was published in the Archives of Interna Medicine (or was it annals? Who cares, right?) alleging the Advantage study Merck conducted was primarily for marketing "proves" that it was so because it was run in a "peer reviewed journal." It is my humble opinion that the Advantage study was designed to assauge fears, but that is just my opinion and publishing it here or even in JAMA using documents from a biased source does not make it fact.
I am supposed to be on vacation.
Leading the ISPOR hit parade is "German Recommendations on Health Economic Evaluation: Third and Updated Version of the Hanover Consensus."
Consider these tidbits:
"All benefit parameters that are relevant for the study situation in question should be incorporated in the assessment. It may be that data from various sources must be taken into account, which can be acomplished with the help of models. Possible essential data sources include medical meta-analyses, randomized clinical studies, as well as epidemiological observational data on the disease or long-term impacts of the disease. Additional relevant sources are cohort studies, data from health-care services research, data on current therapy standards, and possibly also expert opinions wherever other evidence is not available." (p.540)
And:
"The comparative quantification of the effectiveness of treatment alternatives requires studies that have a scientific design comparable to the designs in randomized, controlled studies. As a prerequisite for economic considerations in a specific case, clinical studies evaluating medical efficacy are indispensible. Nevertheless, as mentioned before, clinical studies often cannot serve as the sole basis of information for a health economic assessment. A realistic estimate of the costs can be limited under study conditions, if the use of some health-care services only arises from the study plan." (pp.541-542)
In the same blockbuster (block that metaphor!) issue, Peter L. Kolominsky-Rabas ((IQWiG) and J. Jamie Caro (Department of Medicine and Epidemiology and Biostatistics, McGill University) offer a sort of minority report in the form of an editorial.
In speaking about the updated Hanover Consensus, Kolominsky-Rabas and Caro write that:
"It is a remarkable achievement to being together most of the health economics community in Germany. To reach consensus in such a large group, however, much must be left unspecified and the exercise tends to be a search for the lowest common denominator." (p. 545)
And, they conclude:
"Little seems to have been changed from the previous HCG version published almost a decade ago. Meeting the worthy goals of the HCG -- to provide standards and yet promote methodological progress and scientific innovation in health economics -- requires more than a compilation of disparate current approaches. Actual recommendations must be concrete, tailored to the German context, coherent, and carefully justified, if they are to be helpful to German decision-makers." (p.546)
Ouch.
Does it seem counter-intuitive that “universal” care results in restricted access and poor outcomes? Not when you consider the facts.
A recent report published in The Lancet was the first international analysis of cancer survival that provides comparable data across countries. Across all cancers studied, survival in the
The researchers attributed the variation in survival to “differences in access to diagnostic and treatment services.”
Similarly,
Is the conventional wisdom that medicines for the very ill are healthcare budget busters? Not when you consider the facts.
A recent study published in Health Affairs found that for the severely ill, commercially-insured population, the costs of medical services account for more than 75% of health plan costs. Hospitalization costs accounted for half of this amount. In contrast, medications accounted for just over 20% of health spending for this group, whose annual costs are more than nine times higher than the overall plan population. The authors concluded that medication costs “do not seem to be the driver of health care costs for these members.”
Among the 2.5% of members with the highest spending, specialty medicines (defined in this study as "biologic-derived agents that target specific immune processes and proteins”) were used by 45% and accounted for 32% of spending on medicines and just 6.6% of total plan spending.
Pharma is not the enemy – disease is the enemy.
(But that’s not a convenient political sound-bite.)
Let’s not forget the wise words of Aldous Huxley, “Facts do not cease to exist because they are ignored.”
“If I were designing a system from scratch, I would probably go ahead with a single-payer system.”
Coming on the heels of last week's announcement by Great Britain's National Health Service (NHS) that, “Patients cannot rely on the NHS to save their lives if the cost of doing so is too great," that's quite a statement.
Perhaps Senator Obama is planning on naming the Grim Reaper as his Veep selection.
"Designing from scratch?" Back to the drawing board, Senator.
Yes. I read Reader’s Digest.
And I’m honored to be included in their September story, “Prescription Medicines New and Old; What to consider when your doctor prescribes a new drug.”
Here’s the teaser blurb from the Digest’s website:
All things being equal, it's prudent to take older drugs whose side effects are known instead of new drugs that have less data.
"It has always been unfortunate but unavoidable that some adverse effects may not become apparent until a drug has been in wide use," says Peter J. Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner for the FDA. Sometimes it takes years and millions of users for a pattern to emerge.
When you get a prescription for a new drug, ask your doctor why the new drug is a better choice for you than something long on the market. Also ask about any known serious side effects. And read any printouts from the pharmacy before you take a new medication.
Speak up. Trust your instincts. If you experience any new physical or mental symptoms, consult your pharmacist or physician as soon as possible. Report any adverse side effects to the FDA (www.fda.gov/medwatch or 800-332-1088) and the pharmaceutical manufacturer.
I haven’t seen the complete article yet, but during my interview I spoke at length about the importance of (1) avoiding the Precautionary Principle -- the luddite tenet that preaches that we do nothing until we know everything, and (2) moving towards personalized medicine – and why molecular diagnostics is the key to providing “the four rights” -- the right medicine in the right dose at the right time to the right patient.
So it’s exciting to hear that Medco Health Solutions (the large
Medco, will help the FDA assess obstacles to the use of existing genetic tests as they relate to the prescribing of medicines, as well as new opportunities for such tests.
Medco will deliver a series of reports to the FDA under the agreement, which runs until Aug. 31, 2010. Areas of study include the safety of prescription drugs, physician participation in pharmacogenomic testing, and the usefulness of such tests in prescribing.
The first projects will likely be determined this fall and that the initial areas of study may be oncology and HIV/AIDS.
According to Reuters, "Medco seeks to lower drug spending for its clients, which include health plans and large.employers, and sees pharmacogenomics as a potential way to control costs and improve quality of care."
That’s the way to lower costs the right way. Rather than denying care, we need to focus on the four rights. That will lead to better care more swiftly and reduce adverse events.
The complete Reuters story can be found here.
In the Reuters story, Medco Chief Medical Officer Robert Epstein said, "The big-picture goal is to facilitate the uptake of appropriate pharmacogenetic testing in the marketplace. It can't really happen if you don't have good information about both the science but also the practice of medicine."
Epstein added that a more comprehensive understanding and use of genetic testing "should take trial and error out" of prescribing and "make people feel more confidence in the drugs they're being placed on because they know for them personally that drug should work.”
And that’s something that’s important not just to us healthcare policy wonks – but to the readership of Reader’s Digest. The real
It's time for America to stand up and demand that our elected representatives allow the FDA to aggressively pursue a well-funded Critical Path program. It's time for America to stand up and demand its rights-- "the four rights" -- to personalized medicine.
From this view I see the attacks on the commercialization of biomedical knowledge quite differently. Indeed, l can lump the hypocritical attack of Marcia Angell on FDA pre-emption over the regulation and labeling, the effort to eliminate DTC, CME and private sector investment in academic research, the effort to impose administrative controls on the use of new medicines, the rants of those think that attacking CMPI's funding sources is a rational response to the question of appropriate use of medicines for mental illness into one broad category:
Neo-Luddites... described in a wiki in the following manner:
Opposition to neo-Luddites consists largely of those who believe that technology is beneficial or, at worst, neutral. This opposition has sometimes been hindered by a focus on specific issues, and on occasion by a belief that the benefits of certain new technologies are obvious when in fact many people do not understand the technology in question.
A main concern of technological proponents is to question whether it is always worth saving those things that neo-Luddites seek to protect. The actions of the Luddites are perceived to be emotion-driven and therefore irrational. One form of this objection begins by noting their defense of traditional cultures, and then pointing out culture as a static force enslaves people to its strictures, and is counterproductive to adaptation resulting in cultural if not ethnic extinction. Further arguments would state that elements (real or imagined) of certain traditional cultures that modern societies find abhorrent, such as cannibalism and slavery. Another form is to note some problem that most people would like to minimize or eliminate - such as cancer (which many people agree can eventually be reliably treated or cured), or the sometimes crippling effects of advanced age (see Geriatrics) - and argue that the main effect of neo-Luddism would be to delay or prevent solutions to these problems.http://en.wikipedia.org/wiki/Neo-Luddism
I call the whole bundle of anti-commercialization forces Bio-Luddites because the they are a subgroup of the NL. Like the Luddites efforts of old, both the thinking and the administrative apparatus furiously being erected by today's Bio-Luddites will be swept away by a river of innovation that is spreading rapidly than any entity can control. Witness the note of exasperation in this op-ed in the Times of London about how NICE is unable to keep up with the current wave of new cancer drugs. I have highlighted the remarkable last sentence in this one section:
To judge from the genuine shock of oncologists, the decision may yet be revised - as has happened for several other drugs that NICE originally rejected. Yet even if this ruling turns out to have been misguided, NICE is going to have to make more tough choices of this nature. The reason is that the increasing success of medical research will make rationing an ever- greater challenge for the NHS.
http://www.timesonline.co.uk/tol/life_and_style/health/article4539008.ece
That's right... rationing must rise to beat back the increasing success of medical research. Anyone want to be on THAT side of the argument.
This won't happen. NICE and NHS are being besieged now by advancing innovation. What will the Bio-Luddites do when the next generation of genomic based medicines come flooding through a high-speed regulatory pipeline that is biomarker based?
It will crumble as all effort to stem innovation do. Unless we or they resort to a police state, a sort of Stalinist approach to health care where the both the intellectual freedom and the scientists who thrive in it are forced to investigate only government approved projects and private companies are reduced to merely formulating the compounds for a royalty.
But that won't happen. The Bio-Luddites are not just losing. The have lost. The equate vitriol and bullying with success. But the opposite is occuring. Innovation is on the march and market forces are and will play a key role in that victory. Just as they did when the Luddites became -- after a few decades -- a bunch of cranks meeting in dusty libraries and socialist bookstores.
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.
