Institute for Clinical and Economic Review Publishes Fourth Annual Assessment of Barriers to Fair Access Within US Commercial Insurance Prescription Drug Coverage

— Most payers evaluated offer fair access across the domains reviewed; findings underscore the need for greater transparency of coverage policy information for patients —

BOSTON, December 19, 2024 — The Institute for Clinical and Economic Review (ICER) today published its fourth annual “Barriers to Fair Access” assessment of prescription drug coverage policies (Report | Supplemental Materials) within US commercial insurance, and the Veterans Health Administration. The analysis found that major payer coverage policies for the 11 drugs in scope often met fair access criteria for several categories, while areas for improvements were identified in the transparency of coverage policy information for consumers and in detailing out-of-pocket costs for patients. 

The assessment also found payer coverage policies have largely improved since ICER’s first report was published, aligning more closely with ICER’s criteria for fair cost sharing, clinical eligibility, step therapy and provider restrictions. New for this year, ICER partnered with IQVIA, a leading healthcare data and analytics provider, to gain insights into national level cost sharing and prior authorization metrics from real-world claims data.

Downloads: Report  | Supplemental Materials

“Over the years, our systematic approach to assessing the barriers faced by patients to fairly accessing prescription drugs has sought to highlight where the system is doing well, and where the system can improve.  As in previous years, our findings have identified areas where the policy choices made by payers and employers can better align with the fair access goals,” stated Sarah K. Emond, MPP, President and CEO at ICER.  “For the drugs and health plans we assessed, coverage policies were largely structured to provide fair access, but it is difficult to determine how well that translates into real-world access and affordability for patients, especially since consequential decisions about patient cost-sharing are often left to the discretion of purchasers, and those data are hard to find. Evaluating fair access to therapies is a critical part of ICER’s mission, and we will continue to work towards fair prices and fair access for patients.”

ICER applied several key criteria from the Cornerstones of “Fair” Drug Coverage: Appropriate Cost-Sharing and Utilization Management Policies for Pharmaceuticals White Paper to the real-world coverage policies for 11 drugs reviewed by ICER in 2022: Mounjaro for type 2 diabetes; Wegovy, Saxenda, Qsymia, and Contrave for obesity management; Radicava ORS for amyotrophic lateral sclerosis; Cosela for chemotherapy-induced neutropenia; Veozah for vasomotor symptoms of menopause; Zynteglo for beta thalassemia; Roctavian for hemophilia A; and Hemgenix for hemophilia B.

ICER assessed coverage policies for the selected drugs across 11 formularies and identified the 10 largest commercial payers in the US and selected their largest formulary by number of covered lives, based on information from the MMIT Analytics Market Access Database. ICER also included the single formulary of the Veterans Health Administration (VHA). At the time the research was conducted, these formularies represented coverage policies governing pharmaceutical access for approximately 57 million Americans. 

Results

This report compared coverage policies against ICER’s “Fair Access” criteria in four areas:

1) Cost Sharing to Patients, with a single criterion requiring that fairly priced drugs or an equivalent option be placed on the lowest relevant tier of the formulary;

2) Clinical Eligibility, with criteria requiring that coverage for fairly priced drugs not be narrowed from the FDA label (except to use clinical trial inclusion/exclusion criteria or clinical guidelines to define vague terms such as “moderate” or severe”);

3) Step Therapy Policies, requiring that each step meet standards for clinical appropriateness without a risk for irremediable harm to patients, and that there are no more than three steps to access a drug;

4) Provider Qualification Restrictions, where fair access requires that there be specific risk for misuse that merits restrictions to specialized prescribers.

The assessment found a high degree of alignment between coverage policies and fair access criteria across the evaluated formularies.  Across all relevant payer policies, ICER gave concordance ratings of 81% (25/31) for cost-sharing policies of drugs that ICER found to be reasonably priced, 96% (93/97) for clinical eligibility criteria, 100% (97/97) for step therapy criteria and 100% (97/97) for prescriber restrictions.

This year, we conducted exploratory analyses on the transparency of various policies for three drugs (Zynteglo, Hemgenix, and Roctavian) to individuals shopping for health insurance.  Clinical eligibility criteria, when available, were typically buried in provider sections rather than patient-facing pages. Furthermore, information related to site of care, the location where a patient could receive gene therapy, was unavailable across all payers in scope.  To achieve greater transparency for current or potential insurance plan members, payers should post clinical eligibility criteria and clear contact information for site of care details in the patient-facing areas of their website.

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.