OBJECTIVES : To review the level of manufacturer engagement with the Institute for Clinical and Economic Review (ICER) and determine whether this has led to meaningful changes in ICER’s Final Evidence Report (FER).

METHODS : The ICER website was searched in November 2018 and completed assessments with public comments on the Draft Scoping Document (DSD) and responses to comments on the Draft Evidence Report (DER) were reviewed. Manufacturer comments on these documents were categorized as concerning ‘Comparative Clinical Effectiveness (CCE)’, ‘Comparative Value (CV)’, the ‘Process or Methods of the ICER Assessment’ or ‘Other’ topics. Whether manufacturer comments on the DER led to a ‘meaningful change’ in the approach, content or interpretation of the FER was also assessed. Moreover, to evaluate the possibility of passively influencing ICER before the assessment process, DSD bibliographies were reviewed for economic models published by manufacturers involved in the assessment.

RESULTS : Fourteen assessments were reviewed, representing 54 manufacturers. In 6 (42.9%) assessments, at least 1 manufacturer did not provide comments at any stage; overall, however, 46 (85.2%) manufacturers commented at least once. On average, manufacturers made 7 and 13 comments on the DSD and DER, respectively, with the largest proportion of comments concerning ‘CV’ in both cases. Across all categories, only 13.3% comments on the DER were deemed to lead to meaningful changes in the FER, ranging from 2.7% of ‘Other’ comments to 21.3% of ‘CCE’ comments. Of the citations listed in the DSDs, only 1 published economic model was identified for which author affiliations included a relevant manufacturer.

CONCLUSIONS : Manufacturers actively participate in ICER assessments. However, most manufacturer comments do not seem to lead to meaningful changes, although those regarding ‘CCE’ appear more likely to be accepted than comments elsewhere. Based on this review, there is little evidence that published manufacturer models have been used by ICER.