Jay Jackson, Nikita Jeswani and Corinna Sorenson are all consultants for Avalere Health and provide strategic counsel to life sciences clients on a variety of policy-related issues. Jackson specializes in regulatory affairs, Jeswani in evidence generation and communication, and Sorenson in evidence-based medicine.
As cost pressures continue to mount across the health care landscape, stakeholders, including biopharmaceutical manufacturers, are expected to demonstrate the value of health care interventions and treatments. To achieve this, these companies increasingly see the need to communicate the value of their prescription medicines to health care providers and payers, which can inform their decision making. Evidence regarding their value can come in several forms, including health care economic information, comparative effectiveness research (CER) and real-world evidence (RWE).
While the demand is high for such information, ambiguity remains about what types of data biopharmaceutical manufacturers can proactively share with health care professionals. A number of U.S. laws and U.S. Food and Drug Administration (FDA) regulations govern how and under what circumstances manufacturers can communicate evidence about medicines to physicians, patients, and health plans. Regulators generally require that clinical claims are substantiated by two adequate and well-controlled trials, are consistent with FDA-approved labeling, and provide fair balance. Section 114 of the FDA Modernization Act (FDAMA 114) sets different parameters for how health care economic information can be presented to formulary committees or other similar entities. Nonetheless, in the absence of FDA guidance, dissemination of economic information under the auspices of FDAMA 114, particularly as it relates to permissible standards of evidence and possible audiences for communication, has varied significantly across the industry.
Avalere’s recent research on this topic found that 86 percent of manufacturers would invest more in studies to support the development of health care economic information if provided additional statutory or regulatory clarity. Ninety-three percent of respondents also expressed similar interest in CER generation. However, in the absence of clarity from FDA, manufacturer concerns about agency enforcement action are likely to continue to limit the generation and communication of valuable data.
Our research also found that manufacturers generally believe that additional guidance to interpret and apply FDAMA 114 would be helpful and would encourage greater generation and communication of economic, comparative, and real-world evidence. The 21st Century Cures Act, which is legislation pending before Congress, includes provisions with the potential to address some of the law’s ambiguities by providing clearer parameters about what evidence manufacturers can communicate. However, regardless of whether these improvements make it through Congress, future guidance from FDA will remain a necessity.
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