I want to take a weekend moment (often when less pharma company-related news breaks) to point readers to an excellent Health Care Reform analysis published recently by The Third Way.
Obviously, there are very high stakes in this game for "old-line" pharma concerns. Largely gone will be the days when one pharma's offerings would be compared solely to a placebo, and not the competing treatments. There will be some big winners in pharma as a result of this "head-to-head" testing, but there will be more losers. Why?
Because a substantial number of currently prescribed drugs are of marginal actual benefit to outcomes. [Think Vytorin here.] Once studies establish -- beyond a reasonable doubt -- which drug is the most likely to give the best outcome, reimbursement and prescribing patterns will shift markedly away from the marginal drugs -- and toward the most-effective ones. And that will ultimately be better, for all of us.
Do go read it all, but here is a snippet:
. . . .A principal reason that many doctors don’t currently have the best possible research on effective patient care is that there’s no broad incentive to conduct head-to-head (“comparative”) research. New drugs and new devices only have to prove they are safe and effective, not whether they are better than existing therapies. Second, there is no infrastructure in place to collect research findings and disseminate it to doctors and hospitals.
The House and Senate bills would fix both problems by providing more funding to comparative effectiveness research and creating a new center that would collect, organize and share the data.
The House and Senate bills would provide over $110 million annually toward comparative effectiveness research. This investment would build on the $1.1 billion in funding for comparative effectiveness research included in the economic recovery package passed earlier [in 2009]. The funding would come from an annual fee of roughly $2 per person paid by public and private health plans. The bills also create a Center for Quality Improvement that would spread the adoption of best practices developed from effectiveness research and other sources.
Estimates of savings from comparative effectiveness range widely from $8 billion to $480 billion over ten years. This uncertainty about the extent of potential savings stems from uncertainty over how the research will be used. Indeed, in some cases, comparative effectiveness research may increase costs in cases where it shows that newer, more expensive technology is in fact better. For that reason, the aim of this research is most appropriately targeted toward improving patient care, not just reducing costs. . . .
Quite so. Now, let it be so.
5 comments:
Ah, think Tredaptive, and its biased trial underway (HPS2-thrive) as a case study. Protecting the unbranded brand with a placebo controlled trial versus using niacin as a more appropriate comparator to niacin + laropriprant (with all of its vast unknowns). The trial design deprives the populace of comparative effectiveness data when the opportunity to "do the right thing" was there for merck. HPS2-thrive? I think not. HPS-dePRIVE, depriving through inappropriate trial design.
Couldn't agree more. This combination should remain "non-approvable" even after "de-PRIVE" (love that one!) is completed- until merck has the scientific integrity to fully determine the adverse cardiovascular potential of a prostaglandin receptor blocker. Regulators take note- merck is counting on regulatory authorities laying down for their self serving study design. That might have worked in 5 years ago- but hopefully not now.
So, why spend the money on a Center? If a companty puts forward a 'me too' drug, why not just empower the FDA to 'deny' approval until a comparison is performed?
Great dialogue here, one and all --
As to the last, I think the Center will be primarily to address cases of drugs that are already FDA-approved, and on the market.
That is, it will seek to help physicians sort through the maze of not directly comparable data sets, on so many of the existing "me-too" drugs.
But yes, I think your more general point is sound: FDA could withhold approval until comparative advantage in efficacy is established by independent studies.
Namaste
I understand but..given that it will take about 1 year before a Center is up and running (being optimistic) and then another year to just start a clinical trial (again, being optimistic) if a Center was to be created 'now' it would be 2 years before a trial starts. Given that these types of trials would take 3-4 years to show a difference between 2 compounds (and longer if multiples were tested) and that many of the questionable entities are now nearing patent expirations....wouldn't it just be better to 'grandfather' any compounds already approved then...really be stringent for those that are coming on board?
JMHO
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