ARTICLE | Company News

Exelixis, Genentech, Roche sales and marketing update

June 27, 2016 7:00 AM UTC

The U.K.’s NICE issued draft guidance recommending against the use of Cotellic cobimetinib from Exelixis plus Zelboraf vemurafenib to treat adults with metastatic or unresectable melanoma with a BRAF V600 mutation -- its approved indication in the EU. According to NICE, the treatment “offers life extending benefit” vs. vemurafenib as monotherapy but was not cost-effective. The recommended dose for Cotellic is 60 mg daily for a 21-day cycle and 1,920 mg daily for vemurafenib. The cost for Cotellic and Zelboraf excluding VAT is L4,276 ($6,051) and L7,000 ($9,906), respectively, for 28 days. The agency noted the most plausible incremental cost-effectiveness ratio (ICER) for the combination therapy was over L100,000 ($141,511) per quality-adjusted life year (QALY) gained.

Separately, Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) said in an updated dossier assessment that Cotellic plus Zelboraf provides “considerable added benefit” over Zelboraf monotherapy in adults with metastatic or unresectable melanoma with a BRAF V600 mutation. In March, the agency said that Cotellic plus Zelboraf provides “an indication of a minor added benefit” over Zelboraf monotherapy. The agency’s new decision was based on additional data analyses provided by Exelixis in an addendum that demonstrated the combination therapy provides “additional positive effects.” ...