NICE gives final no to PharmaMar’s Yondelis
pharmafile | April 27, 2011 | News story | Sales and Marketing | NICE, PharmaMar, Yondelis, ovarian cancer
A lack of evidence and an unconvincing patient access scheme has seen PharmaMar fail to win NICE backing for its cancer drug Yondelis.
In final guidance published today NICE has not recommended PharmaMar’s Yondelis (trabectedin) in combination with pegylated liposomal doxorubicin hydrochloride (PLDH) as a treatment for ovarian cancer.
The cost-effectiveness regulator criticised PharmaMar for not comparing Yondelis against the current ‘gold-standard’ treatment for relapsed ovarian cancer, paclitaxel, in combination with platinum-based chemotherapy.
Chief executive of NICE Sir Andrew Dillon said it was unfortunate that the Institute could not recommend the drug.
He said that expert clinical opinion states that platinum-based chemotherapy is the preferred option for this type of ovarian cancer that has relapsed.
“However, because [PharmaMar] did not submit any evidence comparing the treatment with this type of chemotherapy, comparing it instead with drug regimens that did not include platinum, we cannot be sure that trabectedin extends patients’ lives for longer than the most routinely used treatments.
“Clinical trial data suggested that the drug might be more effective in women with ‘partially platinum-sensitive’ ovarian cancer, which is when the disease recurs between six 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 was not robust.”
PharmaMar’s patient access scheme also failed to sway the Institute, which said it did not improve the drug’s cost-effectiveness enough to justify its use for this indication given the uncertain benefits it may provide patients.
Ben Adams
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