An Analysis of Manufacturer and Patient Engagement with Institute for Clinical and Economic Review Assessments

OBJECTIVES: To assess manufacturer and patient organization (PO) engagement with Institute for Clinical and Economic Review (ICER) assessments and their influence on ICER’s approach.

METHODS: Completed ICER assessments from January 2022–October 2023 were reviewed.

Draft Scoping Document (DSD) comments were categorized into “scope of Clinical Evidence Review (CER)”, “scope of Comparative Value Analyses (CVA)”, or “Additional”. Draft Evidence Report (DER) comments were categorized into “Clinical Evidence (CE)”, “Economic Evidence (EE)”, or “Additional”.

“Accepted” comments resulted in changes in approach, content, or interpretation of Revised Scoping Documents or Final Evidence Reports.

RESULTS: Thirteen assessments were reviewed, representing 38 and 43 unique manufacturers and POs, respectively. At least one manufacturer and PO commented on all assessments.

On average, there were more DSD comments from manufacturers (17 per assessment) vs. POs (9); 27.1% of manufacturer and 40.0% of PO comments were accepted. “CER” comments were the most common for both manufacturers (43.6% of comments) and POs (40.8% of comments) (acceptance rate: 32.7% and 40.8%, respectively). “Additional” comments had the highest acceptance rate (manufacturer: 41.7%; PO: 61.4%) and “CVA” the lowest (manufacturer: 15.4%; PO: 3.7%).

For DERs, manufacturers and POs made a similar number of comments on average (manufacturer: 21; PO: 20 per assessment); 38.7% and 25.7%, respectively, were accepted. Most (55.4%) manufacturer comments concerned “EE” (acceptance rate: 31.3%). Most (54.7%) PO comments concerned “Additional” topics (acceptance rate: 34.5%). “Additional” comments from manufacturers and POs on factual inaccuracies had a relatively high acceptance rate (78.9% and 58.1%, respectively).

CONCLUSIONS: Manufacturers and POs actively engage with ICER, and this feedback does influence ICER assessments. “Additional” manufacturer and PO comments were most likely to lead to changes at both stages of assessment. “CVA” and “EE” comments were least likely to be accepted, indicating a low likelihood of manufacturer/PO input leading to changes in modeling approach.