Our lives are better and longer due to decades of successful pharmaceutical innovation providing tremendous value to individuals, healthcare systems, and society. However, opaque and poorly designed health insurance policies still create barriers for patients trying to access the high-value therapies they need, regardless of whether the treatment prices are “fair” or heavily discounted.
Multiple stakeholders advocate for benefit design reforms to eliminate these barriers to patient access. Most efforts focus on the fairness and clinical rationale for utilization management and cost-sharing requirements, which can place an undue administrative and financial burden on patients and put their health at risk. As recent examples, the American Medical Association has issued their “Prior Authorization and Utilization Reform Principles,”  NPC convened a multi-stakeholder panel to assess the appropriateness of step therapy protocols and areas of consensus that could inform industry standards , and the Institute for Clinical and Economic Review (ICER) published a white paper on “fair” access for drug coverage that identified specific “Fair Access Criteria” for implementing appropriate cost-sharing and utilization management strategies.
These initiatives have increased attention on the importance of patient access, even as formularies narrow beyond clinical guidelines  and the number of excluded medications has grown.  Today’s release of ICER’s 2022 Assessment of Barriers to Fair Access Report seeks to illustrate how far we have yet to go. Like the previous Fair Access Report, the current edition builds on a 2020 white paper to assess how coverage policies from 18 healthcare payers perform against select Fair Access Criteria (15 of 28 criteria, including new exploratory analyses) for 29 prescription drugs. This report continues ICER’s contribution to ongoing stakeholder efforts aimed at identifying and eliminating medication access barriers and provides a platform for discussions about these barriers.
While some concerns persist about the methodological rigor of the findings, ICER’s report underscores a longstanding problem on which many stakeholders have been vocal: patients face needless barriers to accessing effective treatments because of poor health benefit designs. Health insurance is only valuable to patients if they can readily access the medicines their physicians prescribe. Step therapy and formulary exclusions unnecessarily hurt patients and waste time and money.
Nevertheless, the 2022 Fair Access report has several data limitations and reporting biases. As ICER notes, “This assessment has been presented as much as a sign of the limitations in the evidence available…as it has been a report that can give important insights into the current status of insurance coverage for drugs in the U.S.” Readers of the Report should not use it to conclude whether payers are providing meaningful patient access to needed medications, as limited transparency of payer policies still precludes a full and objective assessment of access barriers.
Furthermore, this report continues ICER’s trend toward mischaracterizing net prices in value assessment. This report is particularly impacted by this view, failing to account for variation in actual plan net price and neglecting to adjust for the non-contracting-related discounts that are incorporated into SSR data (which is the source of ICER’s fundamental data). Fixing these shortcomings can inform ongoing stakeholder conversations on research methods and help patients seeking evidence-based care.
 Stakeholders find that step therapy should be evidence-based, flexible, and transparent: assessing appropriateness using a consensus approach
Karmarkar, T. et al., Journal of Managed Care & Specialty Pharmacy 2021 27:2, 268-275