IQWiG: Halaven offers 'no additional benefit' over chemo

The German Institute for Quality and Efficiency in Health Care (IQWiG) said breast cancer drug Halaven eribulin mesylate from Eisai Co. Ltd. (Tokyo: 4523; Osaka:4523) provides "no additional benefit" over chemotherapy. IQWiG's report compared Halaven to monotherapy consisting of capecitabine, 5-fluorouracil, or vinorelbine, as well as anthracycline or taxane-containing therapy for those patients for whom it is still an option. The agency said Halaven may have an overall survival (OS) benefit for patients for whom taxanes or anthracyclines are no longer an option, but it is unclear whether the benefit is significant. IQWiG also said it lacked adequate data to conclusively analyze the risk-benefit profile.

Eisai has until Feb. 22 to respond to the assessment, after which the Federal Joint Committee (G-BA) will review IQWiG's recommendation before making a final decision on Halaven's benefit, expected in mid-April. Eisai would then negotiate the price with the Statutory Health Insurance Funds Association (GKV-Spitzenverband) under the AMNOG pricing scheme. Under AMNOG, the price of a new drug is set based on a government assessment of cost-effectiveness. If the assessment finds no clinical benefit beyond available treatments, the drug will be added to the reference pricing system, which gives the same base price to all comparable drugs. ...