Does the Institute for Clinical and Economic Review Revise Its Findings in Response to Industry Comments?

Joshua T Cohen; Madison C Silver; Daniel A Ollendorf; Peter J Neumann

doi:10.1016/j.jval.2019.08.003

Does the Institute for Clinical and Economic Review Revise Its Findings in Response to Industry Comments?

Value Health. 2019 Dec;22(12):1396-1401. doi: 10.1016/j.jval.2019.08.003. Epub 2019 Oct 7.

Authors

Joshua T Cohen¹, Madison C Silver², Daniel A Ollendorf², Peter J Neumann²

Affiliations

¹ Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA. Electronic address: jcohen@tuftsmedicalcenter.org.
² Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.

PMID: 31806196
DOI: 10.1016/j.jval.2019.08.003

Abstract

Background: The Institute for Clinical and Economic Review (ICER) has gained prominance through its work conducting health technology assessments of pharmaceuticals in the United States.

Objective: To understand the influence of industry comments on pharmaceutical value assessments conducted by ICER.

Methods: We reviewed 15 ICER reports issued from 2017 through 2019. We quantified ICER's revisions to its cost-effectiveness analysis (CEA) estimates between release of its draft and revised evidence reports and whether ratios shifted across ICER-specified categories of high, intermediate, or low value. We also reviewed industry-submitted comments recommending revision to ICER's CEAs, noting ICER's response as no change, text revised, assumption(s) revised, or conclusion revised. We evaluated each comment in terms of clarity, whether it offered an alternative to ICER's approach, and whether it characterized the expected impact of revision on ICER's analysis.

Results: We identified 53 ICER-reported ratios. Of these, 45 (84.9%) changed between the draft and revised report, but 26 changes (57.8%) were small (<10%). Six ratios shifted across value categories. We identified 256 industry comments recommending that ICER revise its CEA. Of these, 159 (62%) lacked clarity, 145 (57%) offered no alternative, and 243 (95%) did not characterize their impact on ICER's estimated ratio. Ninety-one comments (35.5%) caused ICER to revise its assumptions, but only 5 (2.0%) caused ICER to revise its conclusions. Four of these 5 comments characterized their impact on ICER's findings.

Conclusions: Changes in ICER's estimates of cost-effectiveness between its draft and revised evidence reports are generally modest. Greater precision in industry comments could increase the influence of industry critiques, thus enhancing the dialogue around pharmaceutical value.

Keywords: ICER; cost-effectiveness; health technology assessment; value frameworks.

MeSH terms

Academies and Institutes / standards*
Cost-Benefit Analysis
Drug Costs / statistics & numerical data
Drug Industry / methods*
Drug Therapy / economics*
Humans
Models, Economic
United States