— While many payers offer fair access across the domains evaluated, findings underscore the need for greater transparency of coverage policy information for patients —

BOSTON, November 3, 2023 — The Institute for Clinical and Economic Review (ICER) today published its third 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 18 drugs often met fair access criteria for cost sharing, clinical eligibility, step therapy, and provider restrictions.  However, the report’s findings suggest that major improvements are needed in the transparency of coverage policy information for consumers, and in detailing out-of-pocket costs for patients. 

Downloads: Report | Supplemental Materials

“Every day, patients face barriers to access because of policy choices made by payers and employers. Our report highlights key areas where payers should consider changes to improve the fairness and transparency of their coverage policies, especially for policy choices, like copay accumulators, that impact patient cost-sharing,” stated Sarah Emond, MPP, President-Elect at ICER.  “For the drugs and health plans we assessed, coverage policies were largely structured to provide fair access on paper, but it is difficult to determine how well that translates into real-world access and affordability for patients. This annual report underscores the importance of transparency and analysis in helping the system move to what we all want – fair prices and fair access.”

The report reflects analysis of both the largest and smallest formularies, as determined by the number of covered lives, offered by the five largest commercial payers, as well as small and large state health exchange plans in the four geographic regions of the US, to examine whether size impacts rates of concordance with fair access criteria. ICER did not find substantial differences in coverage between large and small formularies, suggesting that payer approaches to coverage generally did not differ according to the number of lives covered.  Given the high concordance rates across all formularies, there was not much variation across health exchange formularies in different regions of the country, nor between commercial formularies and those offered on health insurance exchanges.

Results

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 18 drugs reviewed by ICER in 2021: Benlysta and Lupkynis for lupus nephritis; Leqvio, Nexletol, and Nexlizet for high cholesterol; Abecma and Carvykti for multiple myeloma; Adbry, Cibinqo, Opzelura, and Rinvoq for atopic dermatitis; Camzyos for hypertrophic cardiomyopathy; Cinryze, Haegarda, and Tahkzyro for hereditary angioedema; Tezspire for asthma; Soliris and Vyvgart for myasthenia gravis.

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 62% (23/37) for cost-sharing policies of drugs that ICER found to be reasonably priced, 99% (257/260) for clinical eligibility criteria, 99% (261/264) for step therapy criteria and 100% (262/262) for prescriber restrictions.

Exploratory analyses this year focused on transparency of various policies for three drugs (Nexletol, Rinvoq, and Vyvgart) to individuals shopping for health insurance.  While clinical eligibility criteria were commonly posted for each drug, this information was often only found through the provider portal, which is likely confusing to patients. Furthermore, policies related to continuation of coverage, the process by which individuals can request that their new insurer cover their current prescriptions, were frequently unavailable (36-64% of formularies) or difficult to interpret.  To achieve greater transparency, payers should not only post lay-friendly clinical eligibility criteria in the patient-facing areas of their website, but also have clear descriptions of medical exception and continuation of coverage policies for all current or potential insurance plan members.

Public Webinar

ICER will host a public webinar at 12:00 p.m. ET on November 10, 2023 to discuss the key conclusions and policy implications of this assessment. Register here for the webinar.

If you have any questions about this report or the public webinar, please email info@icer.org.

ICER Blog Post

This year’s Barriers to Fair Access Analyses was supported in part by the Commonwealth Fund, a national, private foundation based in New York City that supports independent research on health care issues and makes grants to improve health care practice and policy.  Our findings are summarized in a blog posted on the Commonwealth Fund’s website today.

Sources

ICER requested policies from each insurer and, when that information was not provided, found them using the MMIT Analytics Market Access Database.  The report evaluated the insurance coverage policies of formularies of leading payers against ICER’s fair access criteria for 18 drugs reviewed by ICER in 2021.  Payer formularies assessed included the following:

  • The largest and smallest formularies by covered lives offered by the five largest payers in the United States;
  • The Veterans Health Administration (VHA);
  • The largest and smallest state health exchange formularies offered in the four geographic regions of the US (Northeast, Midwest, South, West).

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.