ICER recently released their 2023 “Assessment of Barriers to Fair Access” report. The report examines 18 drugs and defines “fair access” based on cost sharing, clinical eligibility, step therapy and switching, and provider qualifications. However, the report only formally assesses three criteria: clinical eligibility, step therapy and switching, and provider qualifications.
ICER defines “fair access” to include cost sharing policies that are based on net price, pre-deductible coverage for high-value therapies, and at least one low-cost option available in each drug class. The report also highlights the importance of limited cost-sharing if a step-through process is required, and the acceptability of high cost-sharing if no drugs in a class are deemed cost-effective.
When it comes to clinical eligibility, the report suggests that payers should offer alternatives to prior authorization protocols and document that clinical eligibility criteria are based on high-quality, up-to-date evidence. Additionally, the report emphasizes the importance of using clinical eligibility criteria that complement FDA label language and outlines the criteria for implementing step therapy and switching policies.
Regarding provider qualifications, the report suggests that restrictions of coverage to specialty prescribers are reasonable under certain justifications, and emphasizes the importance of clear communication of cost-sharing policies to consumers, as well as the availability of clear information related to insurance clinical criteria, non-medical step therapy, switching policies, and prescriber qualifications.
Overall, the report provides detailed and comprehensive criteria for fair access to medications and can be found in full at the provided link.