Mepact mifamurtide regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending against the use of Mepact mifamurtide from Takeda in combination with postoperative multi-agent chemotherapy to treat high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection - its approved indication. NICE said it was unable to recommend Mepact due to its high cost and uncertainties about its effectiveness. Comments are due by July 30, with a second appraisal meeting scheduled for August 18.

NICE estimated an incremental cost-effectiveness ratio (ICER) for Mepact plus methotrexate, doxorubicin and cisplatin of £109,296 ($165,726) per quality-adjusted life year (QALY) gained. Takeda's submission included a patient access scheme, in which the pharma would provide the first seven doses free of charge. Excluding the discount, Takeda said a full treatment course of 48 doses over 36 weeks would cost a total of £114,000 ($172,858), with each dose priced at £2,375 ($3,601). It is generally accepted that a technology must have an incremental cost less than or equal to £20,000-£30,000 per QALY for NICE to consider it cost-effective. ...