Institute for Clinical and Economic Review Publishes Protocol for Annual Assessment of Drug Coverage Policies That Present Barriers to Fair Access

— This year’s analysis will include the top ten commercial formularies by covered lives, and include drugs reviewed by ICER in 2022; data obtained from payers, MMIT’s Market Access Analytics solution, and IQVIA will be leveraged to

perform the analyses —

BOSTON, June 5, 2024 – The Institute for Clinical and Economic Review (ICER) today posted a Protocol outlining how it will conduct the fourth annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards. These standards were developed by ICER with expert input from patient advocates, clinician specialty societies, payers, pharmacy benefit managers, and life science companies.

In September 2020, ICER published the white paper: “Cornerstones of ‘Fair’ Drug Coverage: Appropriate Cost-Sharing and Utilization Management Policies for Pharmaceuticals.” This paper analyzes the ethical and practical dimensions of insurance coverage policy, while presenting a corresponding set of criteria that will support a more transparent discussion among all health care stakeholders about whether specific policies are delivering “fair” patient access to prescription drugs. The criteria to be evaluated in this year’s assessment include those related to patient cost sharing, clinical eligibility criteria, step therapy, and provider restrictions. As in past years, the analysis will also explore the availability of certain coverage policies to prospective plan members.

ICER will use MMIT’s market access Analytics solution to identify the formularies that will be included, and will solicit coverage policies directly from payers, supplementing their responses with information from the MMIT database. For this report, ICER will review the ten largest formularies offered by the ten largest US commercial payers (by covered lives that are not associated with a specific employer) and the Department of Veterans Affairs’ formulary. New this year, ICER will analyze data from IQVIA that will explore the rates of denials, appeals, and % of claims by patient out-of-pocket cost ranges for the drugs in scope across commercial payers.

For each of the drugs reviewed by ICER in 2022 we will perform analyses of the proportion of selected fair access criteria that are met in these formularies, analyzed across drugs, conditions, and payers.

The complete timeline for this initiative is available here.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.