Pharmaceuticals Regulation

What information can pharmaceutical firms share with payers?

The government strictly regulates what information that pharmaceutical firms can share with payers.  There is good reason for this.  We don’t want drug companies making false claims that a drug can treat/cure a disease when there is no evidence to support that claim. Randomized controlled trials are the gold standard of clinical evidence and studies derived from those trials represent robust evidence that should be able to be communicated with payers. But what about the use of real-world evidence?  What about simulation models?  Economic models?  There has been a lot of uncertainty around what information pharmaceutical firms can and cannot share with payers.

A recent Health Affairs blog by Peter Neumann and Harry Weissman (“The FDA’s New Guidance On Payer Communications: Implications For Real-World Data And Value-Based Contracts“) reviews some recent FDA guidance updating the information pharmaceutical firms can share with payers.

For example, in the payer communication guidance, the FDA takes an expansive view of what it means to “relate” to an approved indication, expressing the idea that in their economic analyses drug companies can extrapolate long-term endpoints based on validated surrogate markers and use quality-adjusted life years (QALYs). In the past, questions have arisen about whether such information would mislead payers, given that long-term endpoints and QALYs are seldom studied in randomized clinical trials and included in product labels. The FDA’s guidance on information consistent with labeling should also help in that it indicates drug (and medical device) companies can promote post-marketing studies based on analyses of real-world databases (for example, on patients’ adherence to therapy) and use such data to support value-based contracts.

The article also notes that evidence provided in support of value-based contracts will be exempted from FDA reporting requirements.  In other words, pharmaceutical firms can use health care economic information (HCEI) flexibly in support of advancing value-based contracts.

Why has FDA made this decision?  They believe that payers unlikely to be duped by weak evidence.

“FDA believes that the risk that payers will be misled is relatively low. Payers are a sophisticated audience with established procedures to carefully consider the full range of relevant evidence about new use of products. Payers possess financial resources and motivation to closely scrutinize information from firms. In making decisions on a population basis, payers can draw on a range of expertise in multiple disciplines that allows them to critically evaluate information presented to them by firms, including an evaluation of the limitations and reliability of that information.”


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