OBJECTIVES:

Research aims to understand the impact of cost-effectiveness assessments on coverage decisions in the USA and, specifically, the access-related influence of the Institute for Clinical and Economic Review (ICER).

METHODS:

Eight FDA-approved medicines assessed 2019 to 2020 by ICER, representing a variety of disease areas, were analyzed alongside their 2021 coverage and prior authorization criteria at five national commercial plans. This research aims to understand the relationship between ICER evaluations and payer coverage decisions, with a supplemental review of media publications to assess reactions to cost-effectiveness outputs in the USA.

RESULTS:

Manufacturer-driven strategies don't reflect the ICER-recommended prices, as none of the FDA-approved therapies within scope of this research reflected list prices below their respective recommended ceilings. In the Ulcerative Colitis and Cystic Fibrosis assessments, ICER recommended price cuts between 73% and 95% from current list prices; manufacturers maintained or raised list prices.

Despite ICER’s outputs and the subsequent inaction from manufacturers to reconsider their price, health plans maintained their coverage policies to provide access to these therapies. The unchanged coverage policies reflect the limited impact of ICER assessments on payers’ management approach.

Although ICER is a leading USA advocate for drug cost-effectiveness, the relationship between cost-effectiveness assessments and payers’ willingness to cover or manage drugs remains limited, especially since systemic costs are not disclosed. Additionally, the unknown impact of confidential net price discounts further complicates the relationship between cost-effectiveness and access.

CONCLUSIONS:

ICER analysis currently has limited impact on payer decision-making in the USA. However, public and private payer decision-making increasingly reflects cost-effective thinking through consideration of total cost-of-care, value-based agreements, HCRU, and other factors, though without formal reference to ICER. Regardless of ICER’s evolving influence moving forward, there may be benefits to manufacturers addressing cost-effectiveness concerns through other economic evidence to demonstrate the value of their therapies.