The U.S. Food and Drug Administration (FDA) has issued final guidance documents outlining the types of information that drug companies may share with insurers, including information not expressly described in the drug’s FDA-approved label. The policy is part of a broad shift toward value-based health care; providing insurers with more access to economic and off-label information will allow insurers to better assess the true value of a medication, the agency argued.
Under the new rules, pharmaceutical companies will be permitted to share information about how the drug impacts a patient’s overall health-care spending, as well as whether there are additional unapproved uses or dosages for the drug. The document also states that drug companies will be obligated to provide “a conspicuous and prominent statement describing any material differences between the health-care economic information and the labeling approved for the drug.”
The move expands a policy developed under the previous FDA administration to clarify the link between the value of a drug and its cost, allowing insurers to make more informed decisions about which treatments to cover and how much to charge for therapies.
FDA Commissioner Scott Gottlieb, MD, described the new guidelines as a step toward a more competitive and efficient health-care market. “Already, the ability to harness this information and use it to help establish the value of medicines is providing the foundation for a shift toward innovative, value-based payment arrangements.”
Sources: STAT News, June 12, 2018; FDA news release, June 12, 2018.