Yondelis trabectedin regulatory update

The U.K.'s NICE issued a second final appraisal determination (FAD) recommending against the use of Yondelis trabectedin from PharmaMar in combination with pegylated liposomal doxorubicin hydrochloride (PLDH) to treat relapsed ovarian cancer - its approved indication. The appraisal committee said the cost of Yondelis was too high relative to its "uncertain benefits," even with a patient access scheme in which PharmaMar would pay the cost of Yondelis after the fifth cycle of treatment.

NICE said the best estimate of the incremental cost effectiveness ratio (ICER) was £68,000 ($110,800) per quality-adjusted life year (QALY) gained. The committee reconsidered the appraisal after the Department of Health approved the patient access scheme. PharmaMar submitted the scheme after NICE issued a FAD against Yondelis last year (see BioCentury, Sept. 27, 2010 & Feb. 14). It is generally accepted that a technology must have an incremental cost less than or equal to £20,000-£30,000 per QALY for the agency to consider it cost effective. ...