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    Payers need access to pre-approval drug information


    Healthcare payment in the United States is shifting toward value—a transformation that will require new approaches to how manufacturers share information with payers, according to speakers at an October 18 session at the Academy of Managed Care Pharmacy (AMCP) 2017 Nexus in Dallas.

    Fast-track regulatory mechanisms like the FDA’s Breakthrough Therapy Designation mean that drugs are coming to market faster. To assess the budgetary impacts of pending approvals, payers need more information about drugs, more quickly, panelists agreed.

    “We need as much information as soon as possible,” said Soumi Saha, PharmD, JD, director of pharmacy & regulatory affairs, AMCP. “The problem is that drugs are coming to market before clinical trial data is even publicly available. We’re denying coverage.”

    Proper planning, budgeting, and forecasting ahead of drug approvals is “increasingly important,” Saha said. “We need to open up the communication channels.”

    How the FDAMA comes into play

    That has led to renewed interest in the U.S. Food and Drug Administration Modernization Act of 1997 (FDAMA) Section 114, which regulates how drug companies disseminate healthcare economic information (HCEI) to formulary decision-makers.

    Ambiguities in the law’s interpretation persist, partly because the FDA has not until very recently sought to offer guidance. Draft guidance was issued in January 2017, just two days before the end of the Obama administration.

    Because it is unclear when FDA guidance will be finalized, determining how manufacturers can convey much-needed HCEI to payers in a timely fashion means assessing those changing needs in light of the government’s draft guidance.

    Huge disconnect for payers

    Toward that end, and to help shape future regulatory guidance on HCEI dissemination, the AMCP in 2016 conducted surveys of payers and manufacturers about their understanding and experiences with FDAMA 114.

    “On the payers’ side, we were trying to understand the use and importance of healthcare information on formulary decision-making,” Saha said.

    The surveys revealed a “huge disconnect” between payer needs and the information provided by drug manufacturers. Most HCEI provided by the industry is not what payers need, the surveys showed.

    “HCEI is promotional,” Saha noted. “Clinical data may and will likely differ from approved prescribing information.”

    Information access is “inefficient and based on ad-hoc exchanges,” Saha said.

    “Information is exchanged in limited settings and is not widely disseminated,” she said. “Rate filings play ‘catch-up’ every year to accommodate for past innovation.”

    Payers reported a “significant gap” between information received from manufacturers and the information they need, she said.

    Next: Manufacturer concerns



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