It looks like ovarian cancer patients suffering from a relapse of the disease will not be allowed access to PharmaMar’s Yondelis on the National Health Service, following a rejection by its cost regulator in this setting.

The National Institute for Health and Clinical Excellence has now published draft guidance turning down a combination of Yondelis (trabectedin) and pegylated liposomal doxorubicin in patients in whom ovarian cancer returns six months or more after initial treatment.

Around 6,600 women are diagnosed with ovarian cancer every year. It is estimated that the cancer returns following first-line treatment in about 80% of cases, and just over two fifths of these patients would meet the criteria for treatment with Yondelis, a marine-based anticancer drug derived from the sea-squirt designed to damage cancer cell DNA and thus prevent cell growth and spread.

But according to the Institute, it is unable to recommend the drug because PharmaMar has failed to submit any evidence comparing Yondelis to platinum-based chemotherapy regimens in treating relapsed disease, despite the latter being the preferred option of clinical specialists in such cases.

Uncertain benefit

“This means that we cannot be sure that trabectedin extends patients’ lives for longer than the most routinely used treatments currently available,” said NICE chief executive Sir Andrew Dillon, explaining the decision.

Furthermore, based on the evidence available, the committee concluded that the incremental cost-effectiveness ratio (ICER) for Yondelis could be higher than £95,000 per QALY gained, which is far above what would normally be considered a cost-effective use of NHS resources.

Earlier this year the Institute overturned its initial rejection of Yondelis for soft tissue carcinoma after the drugmaker proposed a patient access scheme, under which it picks up the tab for any treatment with its drug beyond the fifth cycle to help reduce the burden on NHS resources.