NICE rejects PharmaMar’s ovarian cancer drug Yondelis
pharmafile | March 14, 2011 | News story | Sales and Marketing | Cancer, NICE, PharmaMar, Trabectedin, Yondelis, ovarian cancer
NICE has rejected PharmaMar’s ovarian cancer drug in final draft guidance due to a lack of ‘robust’ data.
Yondelis (trabectedin) was being assessed in combination with pegylated liposomal doxorubicin (PLDH) as a treatment for ovarian cancer, but NICE said PharmaMar did not provide sufficient evidence the drug helps patients more than established treatments.
In particular, PharmaMar did not compare Yondelis against the current ‘gold-standard’ treatment for relapsed ovarian cancer, paclitaxel, in combination with platinum-based chemotherapy.
NICE advisors said because of this they could not confirm whether or not it extends patients’ lives for longer than one of the more effective and commonly-used treatments for this form of cancer.
The Final Appraisal Determination means that unless there are any further objections by 25 March NICE will following this recommendation in its final guidance on Yondelis.
NICE did take into consideration a Patient Access Scheme that would have seen PharmaMar pay the cost of its drug after the fifth cycle of treatment for partially platinum-sensitive patients, but said it was not enough to ease doubts over the drug’s cost-effectiveness.
Sir Andrew Dillon, NICE chief executive, explained: “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.
“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.”
A number of treatments are recommend by NICE for relapsed ovarian cancer, including paclitaxel in combination with a platinum compound in platinum-sensitive or partially platinum sensitive disease and pegylated liposomal doxorubicin hydrochloride in partially platinum-resistant disease.
Yondelis is recommended by NICE as a possible treatment for people with advanced soft tissue sarcoma.
Ben Adams
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