Scope of assessment limited by gaps in availability of payer policies and inability to evaluate how policies are implemented, highlighting importance of improving transparency to assure fair access

First-ever scorecard of several key appropriate access criteria reveals variation across largest payers but high concordance for clinical eligibility criteria, step therapy, and provider restrictions; lower concordance found for formulary tiering criteria —

During the course of ICER’s assessment, six payers improved 10 policies to meet fair access standards, demonstrating that assessment and greater transparency may lead to positive change —

BOSTON, December 1, 2021 — The Institute for Clinical and Economic Review (ICER) today published its first annual “Barriers to Fair Access” assessment of prescription drug coverage policies (Report | Supplemental Materials). Using a leading proprietary database of formulary coverage information, the report evaluates 15 of the largest commercial formularies in the United States to determine the rate of concordance with fair access criteria for 28 drugs ICER has determined to be fairly priced. Can we assess whether payers provide fair access to these fairly-priced drugs? Analyses have been performed to evaluate concordance of available payer policies with fair access criteria related to the design of cost sharing and prior authorization for each drug, across all drugs in each of the major domains of fair access, and by payer formulary. 

A comprehensive assessment of concordance with fair access criteria was not possible given limitations to the available data, highlighting that greater transparency is needed in how insurers frame and implement their coverage policies. With these limitations in mind, this first-ever scorecard provides insights into variations in coverage across large payers and suggests high concordance overall for clinical eligibility criteria, step therapy, and provider restrictions. Important exceptions are noted in the report. Lower concordance overall was found with formulary tiering criteria that represent whether cost sharing is structured to provide fair access.

This report represents an exploratory analysis intended to chart a roadmap for future research. But one of the most notable results of this early effort is the change in coverage policies made by six payers following discussion of draft results of the assessment. These changes all served to bring coverage into alignment with fair access criteria.

“As US drug pricing continues to drive national headlines, it is equally important that everyone have a clear picture of what fair access looks like, and how to hold health plans and PBMs accountable when restrictions are unreasonable,” said ICER’s President Steven D. Pearson, MD, MSc. “Insurance coverage done right uses evidence and input from clinical experts and patients to ensure appropriate clinical use of health care interventions. Evidence can also justify scaling the out-of-pocket costs required of patients to reward the use of higher value care options. In our assessment, we found that most of the payer policies available to us were structured appropriately in a way to support many key elements of fair access. But there are significant caveats to our findings. Among the most important are these three: we couldn’t evaluate all the criteria that are essential for fair access; not all policies were available to us even for the criteria we were able to evaluate; and we could only evaluate the content of the policies, not their implementation. These limitations mean that our report does not negate the experience of many patients and clinicians who have struggled to get fair access, particularly when the barriers are related to poor implementation that can lead to prolonged delays and unnecessary administrative burden.

“Ultimately, therefore, perhaps the most salient conclusion that can be drawn at this time is that there should be greater transparency regarding how insurers frame and implement their coverage policies. Transparency certainly for affected patients and their clinicians, but also for the broader research community and the public. Coverage policies and tiering have been treated by some companies as competitive assets, held in confidence, and used to seek advantages against rivals. Only with greater transparency across the entire industry will payers be able to demonstrate fully their commitment to the appropriate application of evidence to insurance coverage. And only with greater transparency will payers’ call for fair drug pricing be heard by the public with the power it deserves.”


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.

ICER used MMIT’s market access Analytics solution to evaluate the coverage policies of 15 of the largest commercial payers in the US: CVS Health (Aetna), Express Scripts, UnitedHealthcare, Cigna Health Plans, Kaiser Foundation Health Plans, Anthem, MC-RX, Blue Cross Blue Shield of Massachusetts, Elixir PBM, Blue Shield of California, Health Care Services Corporation, Florida Blue, Highmark, MedImpact Healthcare Systems, and Blue Cross Blue Shield of Minnesota. For each formulary, ICER examined tiering, step therapy requirements, and elements of the prior authorization criteria for 28 specific drugs — all of which ICER has previously found to be priced fairly at a cost-effective level — to determine if coverage policies are in concordance with seven of the 20 criteria for fair patient access that were established in the white paper.

Key limitations of the assessment include:

  • Among the full set of fair access criteria contained in the white paper, many were not able to be assessed given that they cannot be determined from viewing insurance coverage and tiering information.
  • One of the largest US commercial payers — OptumRx — only makes its formulary information available to licensed clinicians and therefore was not able to be assessed.
  • While ICER is able to assess the concordance of written policies with fair access criteria, we are not able to assess how prior authorization policies are implemented, including the relative level of documentary burden and the ease of obtaining reasonable exceptions, both of which are critical to achieving fair access.
  • For judgments of cost-sharing, ICER could only use tiering as a signal of the relative magnitude of out-of-pocket payment required, an approach that does not capture the wide variety of levels of copayments and co-insurance that can be used by plan sponsors within any tiering structure.

Public Webinar

ICER will host a public webinar at 12:00 p.m. ET on December 3, 2021 to discuss the key conclusions and policy implications of this assessment. Webinar presenters will include:

  • Sarah Emond, MPP, Executive Vice President and Chief Operating Officer, ICER
  • Cat Davis Ahmed, MBA, Vice President of Policy and Outreach, FH Foundation
  • Rebecca Kirch, JD, Executive Vice President of Policy and Programs, National Patient Advocate Foundation
  • Douglas White, MD, PhD, Chair, Rheumatology Department, Head, Rheumatology Research Lab, Gundersen Health System and Gundersen Medical Foundation; Clinical Adjunct Assistant Professor, Department of Medicine, University of Wisconsin School of Medicine and Public Health; President-elect, American College of Rheumatology

If you have any questions about this report or the public webinar, please email

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.