Summary

The economic evidence in this report includes comparator modeling and a third-party bezuclastinib pricing assumption, but no bezuclastinib budget impact model. The systematic review included 15 articles published between 2005 and 2020. A separate modeling study simulated sunitinib 37.5 mg daily versus no treatment; its pharmacometric framework predicted an additional 142,756 euros per quality-adjusted life-year. That estimate does not evaluate bezuclastinib or the bezuclastinib-sunitinib combination. The bezuclastinib pricing excerpt assumes pricing similar to another product rather than documenting a manufacturer-announced price. The sponsor's filing states that reimbursement may not be available.

Reimbursement

“We cannot be sure that reimbursement will be available for any product candidate that we may commercialize” (opens the source at this quote in a new tab)

Pricing assumption

“If we assume that Cogent will price bezuclastinib similarly to Sanofi’s KIT TKI Ayvakit (approved in 2020)” (opens the source at this quote in a new tab)

Cost-effectiveness of tyrosine kinase inhibitors: systematic review

“Published between 2005 and 2020, 15 articles were incorporated into the systematic review.” (opens the source at this quote in a new tab)
“For advanced GIST, imatinib followed by sunitinib was considered cost-effective” (opens the source at this quote in a new tab)

Sunitinib cost-utility modeling

“A two-arm trial comparing sunitinib 37.5 mg daily with no treatment was simulated using a pharmacometric-based pharmacoeconomic model framework.” (opens the source at this quote in a new tab)

Sunitinib pharmacometric model: incremental cost-utility result

“an additional 142,756 euros per quality adjusted life year (QALY) compared with no treatment” (opens the source at this quote in a new tab)

Bezuclastinib

Modeling overview