India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
Communicating the spreadsheets: Evolving regulations over how to present health economic data to payers
A burning topic at the annual international meeting of ISPOR here in Philadelphia has been the ongoing discussions over how pharmaceutical companies are allowed to communicate the output of healthcare economics to payers. Everyone agrees that healthcare economic data is important and can play a critical role in expressing the overall value of a treatment - however, what a pharma company is allowed to say, and to whom, has been far too unclear, for far too long.
Legislation on this topic focuses on FDAMA Section 114 which dates back over 18 years - a period of remarkable legislative stasis considering the simultaneous explosion in the field of health economics which has revolutionised the way new treatments are looked at. And not only has there been a lack of progress - but the legislation itself is riddled with ambiguities and uncertainties that put pharma companies in almost an impossible position.
But the wheels are beginning to move - the FDA last year talked about developing draft guidance on clarifying Section 114 and as recently as last week the House Energy and Commerce Committee released its bipartisan draft of the 21st Century Cure Act which specifically addresses some of the existing ambiguities...and the agreement at ISPOR is that there certainly is momentum for action in the year ahead, even if it is currently unclear precisely how it will pan out (or, as Peter Neumann from Tufts Medical Center put it, "We have movement, or at least talk of movement").
One of the sticking points has been over where to draw the line over health economics promotion. FDAMA points to promotion that "directly relates to an indication approved" - but it is not clear what that means or how far a company can go without touching on off-label promotion. It appears that regulations might open up some flexibility here by focusing only on "relates" (as opposed to "directly relates") - but for the moment this is primarily speculation.
The implications, of course, are vast, particularly in terms of how value propositions are designed and how communication with payers occurs. With clearer guidelines and a reduction of grey areas around adherence, burden of illness, utilisation endpoints and extrapolations to other populations and doses, there is a strong potential to open up the field of health economics and validate database-driven research alongside clinical trial work.
The US is relatively unique in this discussion due to its multiple layers of interest on health economics, through multiple, competing managed care organisations, ACOs, payers and a variety of other stakeholders - the guidelines are generally already much clearer in Europe where there is one key stakeholder and promotion is more strictly regulated, as Dr. Neumann later noted.
Currently, this is clearly one of those "watch this space" issues, and the discussions between the variety of interests and stakeholders mean that it is almost impossible to predict where the dialogue will end.
Gustav Ando is the director of life sciences at IHS
Posted 19 May 2015
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