Factors affecting decisions of an HMO Drug Exemptions Committee on individual patient requests for coverage of non-formulary drugs

Abstract Background In Israel, coverage of health needs is delivered by four health maintenance organizations (HMOs), which are budgeted by the government according to the recommendations of the National Drug Formulary (NDF) Committee. For medications not listed in the NDF, individuals may request to cover the costs by the HMO Exemptions Committee (DEC). The objectives of the current study, a first of its kind, are to document the DEC decision process, to identify its components as formalized in the USA (Eddy criteria) and to determine the decisions' clinical outcome. Methods This retrospective cohort study included all members (≥ age 18) of the Maccabi Healthcare Service (MHS) who submitted a request to the DEC between June 2017 and December 2018. Collected data include patient demographics, clinical information and components of the decision process. Decision success was defined by clinical outcome over a one-year follow-up. Results A total of 335 requests were included. Strong evidence and rare disease were positively associated with approvals, while the availability of alternative treatments and costs were negatively associated. In the majority of decisions (75%), clinical outcome was correctly anticipated by the DEC (i.e., a successful decision). Only estimated costs were found to be associated with decision success. Conclusions Factors that reduce the potential costs of a requested drug are significantly associated with higher odds for drug approval, but only when the evidence supports potential benefit. Given that no objective measurement could predict decision outcomes, and yet > 70% were found to be correct, it appears that the mixture of committee members may in itself be a determining factor.