By Joshua T. Cohen, PhD, Deputy Director and Chief Science Officer
Because the Institute for Clinical and Economic Review (ICER) uses cost-effectiveness analysis (CEA) to estimate a “value-based” price for prescription drugs, pharmaceutical companies have a substantial interest in their work. They, along with other stakeholders, are provided several opportunities to offer input to ICER, including a chance to comment on ICER’s draft technical assessments.
In our newest publication in the December issue of Value in Health (available for free download until mid-January), we wondered how much of an impact this input has on ICER’s conclusions. The answer seems to be: not much.
- Of 53 cost-effectiveness ratios we examined, only six changed enough to shift value categories (e.g., from above to below $50,000 per QALY).
- Even among these six ratios, only one might have shifted because of drug company input.
ICER explains in writing how it handles every submitted comment. Reviewing ICER’s feedback, we found that in response to industry comments:
- About a third of the time, ICER revises its assumptions.
- In only about 2% of cases, ICER revises its conclusions.
Which begs the question: why? It may be that in its capacity as both author and review referee, ICER may resist making revisions. Or, ICER’s analyses may be technically strong to start with. Finally, industry comments may fail to make a compelling case for revision.
We believe that industry comments can be improved as they are often unclear or fail to offer an alternative assumption (e.g., a specific set of alternative risk reduction estimates for a therapy). Crucially, industry comments almost never characterize the impact of their proposed revisions on ICER’s cost-effectiveness estimate. In short, they fail to answer the “so what?” question, which makes these points easily dismissed, even if they are technically sound.
This represents a huge missed opportunity because the health and resource implications are substantial. Greater precision in industry comments would improve the assessment of value for medical technologies.