Stivarga (regorafenib) — CareFirst (Caremark)

Initial criteria

• Used as a single agent for locally advanced, residual, unresectable, tumor rupture, or recurrent/metastatic GIST following disease progression on imatinib and either sunitinib or ripretinib
• OR used for treatment of residual, unresectable, tumor rupture or recurrent/metastatic GIST in combination with everolimus for disease progression after failure of at least four FDA-approved therapies (e.g., imatinib, sunitinib, ripretinib, avapritinib)
• OR used for treatment of residual, unresectable, tumor rupture or recurrent/metastatic succinate dehydrogenase (SDH)-deficient GIST as a single agent

Reauthorization criteria

• No evidence of unacceptable toxicity while on current regimen

Approval duration

12 months