The Institute for Clinical and Economic Review (ICER) assesses comparative clinical and economic evidence for new health technologies in the US to make recommendations on their long-term value. In various published commentaries, stakeholders have voiced concerns that these assessments might have negative effects on patient access to innovative medications. Since its inception in 2006, ICER's reviews have gained influence among those involved in drug pricing decisions. The organization's process appears to have evolved rapidly in the past several years. Yet, there is little consensus among stakeholders about how to collaborate with ICER to ensure their reports reflect the best evidence.
To address this concern, RTI Health Solutions researchers have published a study that identifies changes in ICER's evaluation processes from 2018-2019, evaluates the effectiveness of different stakeholder engagement approaches, and informs stakeholders of their potential role in collaborating with ICER.
A critical assessment of 172 letters from stakeholders during 2018-2019 reviews showed that nearly all resulted in some type of editorial revision accommodated by ICER. However, only 30% of the letters based on comments related to cost-effectiveness models resulted in any revision in base-case analyses.
Study authors further analyzed comments incorporated by the organization. They identified four main types of comments seen in successful recommendations:
- specific alternative data or a published article to rationalize recommendations
- observations relating to inconsistent methods used to derive model inputs across different treatments
- remarks based on clinical justifications
- statements supported by patient perspectives.
The study found that ICER accepted actionable, evidence-based recommendations more often than other recommendations.
Although the researchers discovered that these revisions rarely affected conclusions on the cost-effectiveness of evaluated interventions, many stakeholders have been able to leverage ICER evaluations as opportunities to promote dialogue for a better understanding of the value of technologies.
Ronquest NA, Paret KE, Barnett CL, Mladsi D, Gould I. The evolution of ICER's review process for new medical interventions and a critical review of economic evaluations (2018-2019): how stakeholders can collaborate with ICER to improve the quality of evidence in ICER's reports.