A new FDA draft guidance on how pharma companies can communicate healthcare economic information with payers may open the door to more information-sharing with formulary decisionmakers. But it is also expected to increase the reporting burden on drugmakers.
The FDA released the draft guidance last week. The document’s release marks the first time in 20 years that the agency has provided meaningful guidance on the issue since the FDA Modernization Act passed in 1997, according to Kellie Combs, an attorney for Ropes & Gray who also works with the Medical Information Working Group, a coalition of drug and medical-device makers.
The guidance is “certainly a win for these types of communications” and is “the first official document really laying out the FDA’s position on key terms and providing meaningful guidance,” she said.
A spokesperson for PhRMA, a lobbying group for the pharma industry, said it was still reviewing the draft guidances and would not yet comment.
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While the guidance is expected to clarify how drugmakers can share healthcare economic information related to a drug’s approved label with payers, it does not change the kinds of information that can be shared. Drugmakers can still only share information that relates to an approved indication.
Peter Weissberg, group director of market access for Intouch Solutions, welcomed the new guidance, saying that previous framework set out was ambiguous and not well-articulated, and as such the proposed new framework is “an important positive step.”
The non-binding draft guidance works to clarify, through a 15-page question and answer section, how to prepare healthcare economic information (HCEI); what parties with which drugmakers can share HCEI; examples of HCEI analyses that relate to an approved indication; and what supporting information companies should have for their HCEI, among other questions.
While this information may be a boon for these kinds of communications going forward, the agency also set out additional reporting requirements. Before the FDA issued this draft guidance, Weissberg noted, information shared with payers had to be made available upon request. “Now, they’re mandating that all this information be trackable and auditable,” he said.
“You [now] have to create a content strategy where you have to [be] very particular on monitoring where this information is being shared,” he explained, pointing out that new technology platforms have made this kind of tracking easier.
Now, if a pharma company shares Phase-II trial information with a payer, and the drugmaker’s Phase-III trial does not confirm those results, the FDA’s draft guidance recommends they share that information, for example.
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Weissberg explained that this draft guidance could also lead to a breaking down of the corporate wall between commercial and medical and scientific teams at drug companies.
“Now, payers are demanding an integrated approach,” he said. “They don’t want to talk to a commercial account manager one day, and then a medical-science liaison the next day, and the field healthcare economic and outcomes information liaison another day. They want an integrated singular representation, and this guidance can accelerate that change. This can be a net positive for industry if they embrace it and update their ways of working.”
The FDA is accepting comments on the draft guidance until April 19.