- The U.K.'s cost agency will not cover Roche's combination therapy of Cotellic with Zelboraf for treatment of melaboma, citing the cost of the drugs, reports PharmaTimes.
- The National Institute for Health and Care Excellence (NICE) acknowledged the drugs extended median survival but found the drug's cost-effectiveness ratio was "substantially above" the desired range.
- Cotellic and Zelboraf are designed to treat unresectable or metastatic melanoma in adults with a BRAF V600 mutation.
The European Commission approved Cotellic/Zelboraf last November, based on the strength of phase 3 study data. The study showed that treatment-naive patients with BRAF V600 mutation-positive advanced melanoma who were treated Roche's combo treatment had a median progression-free survival period of 12.3 months, compared with 7.2 months with Zelboraf alone.
However, when NICE looked at the data, it decided the treatment failed to meet its cost-effectiveness standards, measured by the quality-adjusted life year. The cost agency had previously agreed to cover Zelboraf alone for treatment of metastatic BRAF V600 mutation‑positive malignant melanoma. Cotellic is not approved as a monotherapy.
Roche had proposed to provide the same discount on the cost of Zelboraf used in combination as the discount already provided on Zelboraf alone. Cotellic would cost just over $600 for a 63-tablet pack of 20-mg tablets. Dosing of Cotellic is 3 tablets per day for a repeated 21-day cycle.
The decision was published in an appraisal consultation document which now goes out for further consultation before a final consultation document is issued. NICE will meet again on July 19 to review comments.