Regulator to reject ovarian cancer treatment

Editor's note - 11th March 2011 - NICE has today issued further draft guidance saying a lack of appropriate evidence has forced it to turn down trabectedin.

18th June 2010 - The health regulator, The National Institute for Health and Clinical Excellence (NICE), says a new treatment for ovarian cancer is not recommended for the NHS because the manufacturer did not submit sufficient evidence that the medication benefits patients more than the most widely-used treatments.

NICE is appraising trabectedin (Yondelis) in combination with pegylated liposomal doxorubicin (PLDH) for the treatment of relapsed ovarian cancer that is sensitive to platinum-based therapies.

Its independent advisory found that the evidence submitted by the manufacturer was not robust because it did not compare trabectedin against a current ‘gold-standard’ treatment for relapsed ovarian cancer: paclitaxel in combination with platinum-based chemotherapy. This meant NICE couldn’t confirm whether or not the treatment extends patients’ lives for longer than one of the more effective and commonly-used treatments.

Ovarian cancer

NICE says ovarian cancer is the fifth most common cancer in women in the UK with nearly 6,600 women diagnosed with the disease each year. It is thought the cancer returns after initial treatment in around 80% of cases and just over two fifths of these patients would be eligible for trabectedin, if the drug were to be approved.

Not just costs

Sir Andrew Dillon, NICE Chief Executive, says in a statement: “In current clinical practice, paclitaxel in combination with platinum-based chemotherapy is widely regarded as one of the most effective treatments for women with platinum-sensitive, relapsed ovarian cancer.

“Unfortunately, the manufacturer did not provide any evidence directly comparing trabectedin with this combination of drugs. The studies that were submitted as evidence compared trabectedin with less commonly-used treatments. The evidence did, however, show that trabectedin is associated with high rates of toxicity on the body’s blood system compared with other, currently available drugs. It was these factors and not necessarily the cost of the treatment that concerned the committee most.”

He added: “It’s important to remember that not everyone whose cancer has relapsed would be suitable for trabectedin. A range of treatment options do already exist for ovarian cancer and especially for tumours that have returned. In 2005, NICE approved a number of drugs shown to be effective in treating relapsed disease, including paclitaxel in combination with platinum-based chemotherapy, which is now one of the most widely used treatments in clinical practice.”

The draft guidance has been issued for consultation before it becomes final.