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

TL;DR

This study examines how a drug exemptions committee in Israel decides to cover non-formulary drugs, finding that cost and evidence of benefit are key factors.

Contribution

This is the first study to analyze the decision-making process of an HMO Drug Exemptions Committee and its clinical outcomes in Israel.

Findings

Strong evidence and rare diseases increase the likelihood of drug approval.

Availability of alternatives and higher costs decrease approval chances.

Estimated costs are the only factor directly linked to decision success.

Abstract

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 and to determine the decisions’ clinical outcome.

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 (i.e., clinical outcome correlated with DEC decision) was determined by clinical outcome over at least one-year follow-up.

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. The majority of decisions (75%) met predicted clinical outcomes. Only estimated costs were found to be associated with decision success.

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.

The online version contains supplementary material available at 10.1186/s13584-024-00617-9.