OBJECTIVES: Drug Policies [DPs] are often developed by US payers to assist the administration of health benefits. DPs typically express whether a healthcare service (e.g., drug, medical device, procedure) is proven to be effective based on the clinical evidence available, also noting if the service is medically necessary. Our goal is to examine the sources of clinical evidence used by payers to inform drug DPs.

METHODS: Secondary research was performed to identify DP guidelines (or equivalent publications) from N=3 payer archetypes (Managed-care organizations [MCOs], Integrated Delivery Networks [IDNs], and Medicaid), covering N=7 US payer organizations (United Healthcare, Anthem Blue Cross Blue Shield, Aetna, Geisinger, Kaiser Permanente, Medicaid fee-for-service [FFS], and Managed Medicaid). Secondary research search terms included ‘coverage determination guidelines’, ‘coverage determination policies’, ‘formulary guidelines’ and ‘clinical policies’.

RESULTS: While all N=7 payer organizations refer to the FDA-approved label in their formulary guidelines, only MCOs (United Healthcare, Anthem Blue Cross Blue Shield, and Aetna) detail the use of data from pivotal trials and published literature as sources for DPs. IDNs and Medicaid do not mention which data sources are considered to inform DPs.

CONCLUSIONS: The data sources used by payers to inform DPs are heterogeneous, which illustrates the need for more research to better understand the value drivers of DPs across different US payer archetypes. While MCOs provide some detail to which data sources are consulted to inform coverage decisions, this is not the case for IDNs and Medicaid. To note, despite the growth of the Institute for Clinical and Economic Review (ICER) in the US, a key organization to inform cost-effectiveness of healthcare services, none of the 7 payer organizations mentioned ICER as a source of data to inform DPs.