We know that health care stakeholders rely on different types of data and evidence to inform their decision-making. But what kinds of evidence do they really want and need?
A new white paper from Xcenda/AmerisourceBergen and the National Pharmaceutical Council (NPC) highlights survey findings from payers and providers on what types of evidence are most important to them when it comes to making population coverage decisions for formularies and care pathways. Recognizing the importance of these decisions on patients’ lives, it’s not surprising that payers and providers use multiple sources of information that offer a more complete picture about a treatment and its outcomes and impact on cost and quality, rather than just a snapshot.
According to payer respondents to the Xcenda/NPC survey, the majority of payers found that at least six aspects of a medication are extremely or very important to understand when making policy or medical decisions. Only three of these are typically available in a Food and Drug Administration (FDA)-approved drug label: how well patients do clinically, comparative information from clinical trials, and potential side effects. The other aspects, such as whether the medication helps reduce the utilization of other medical services, how effectively it can meet quality measures, and how it works in the “real world,” are typically not included in the FDA-approved product label. While this information may be consistent with the FDA-approved label, it could still be considered “off label,” making it subject to myriad regulations that govern whether it could be shared by biopharmaceutical companies with payers and providers.
And with the U.S. health care system shifting payment and reimbursement models from volume- to value-based payment, both payers and providers surveyed expect new types of information to be impactful in guiding decisions in the next three to five years. They also expect that the potential benefits of having additional information in hand outweigh the potential risks.
Changes to existing laws and regulations could make it easier to access or exchange this information in the near future. In particular, FDA Administrator Dr. Scott Gottlieb has expressed an interest in clarifying some of the restrictions on the exchange of information, and his agency also is charged with putting communications provisions from the 21st Century Cures Act into effect, along with drafting comprehensive communications guidance documents.
Additionally, the U.S. House Energy and Commerce Subcommittee on Health held a hearing on July 12 to discuss the types of health care information that can be exchanged among biopharmaceutical companies and payer entities.