In draft guidance issued 11 March the UK's National Institute for Clinical Excellence (NICE) expert independent advisory committee has not recommended trabectedin (Yondelis, PharmaMar) in combination with pegylated liposomal doxorubicin (PLDH) as a treatment for ovarian cancer because of concerns over how well it works compared with the most commonly-used treatments.

This draft guidance is now with consultees who have the opportunity to appeal against the proposed recommendation. NICE has not yet issued final guidance to the NHS.

NICE has been looking at whether this combination treatment should be recommended for NHS use in patients with ovarian cancer that has returned six months or more after initial treatment with chemotherapy, which included platinum (i.e. for platinum-sensitive disease). The Appraisal Committee considered all available evidence, including clinical trial data submitted by the manufacturer and expert opinion from clinical specialists. It also took into consideration a Patient Access Scheme to make the treatment more cost-effective for the NHS.

Sir Andrew Dillon, NICE Chief Executive, said: "According to the clinical experts, re-treatment with platinum-based chemotherapy is the preferred option for relapsed platinum-sensitive ovarian cancer. The manufacturer of trabectedin did not submit any evidence comparing trabectedin with platinum-based chemotherapy, comparing it instead with drug regimens that did not include platinum. In platinum-sensitive disease, this type of treatment is usually reserved for patients who cannot have platinum-based drugs for reasons such as having had an allergic reaction to platinum in the past. This means that we cannot be sure that trabectedin extends patients' lives for longer than the most routinely used treatments.

"Our independent expert Appraisal Committee did look at other research to assess whether trabectedin should be recommended in the NHS. The manufacturer's main evidence compared trabectedin plus PLDH with PLDH alone in ovarian cancer patients with different levels of platinum sensitivity. Results suggested that the drug was most effective in women with 'partially platinum-sensitive' ovarian cancer, which is when the disease recurs between 6 and 12 months after initial platinum chemotherapy. However, the committee could not be sure that the effectiveness of trabectedin in this group was genuinely different from that seen in the wider group of patients for which the drug is licensed and concluded that the subgroup data were not robust.

"Even when taking into consideration the Patient Access Scheme, through which the manufacturer limited the total cost of the drug, the committee concluded that the cost of trabectedin was too high relative to the uncertain benefits it may provide patients."

Source: NICE