The National Institute for Health and Clinical Excellence is leaning towards a ‘no’ for the use of GlaxoSmithKline’s oncology drug Hycamtin in patients with recurrent cervical cancer on the National Health Service.

The medicines cost watchdog for England and Wales has published appraisal documents rejecting the drug’s use in combination with cisplatin because it claims the regimen fails to provide an effective use of NHS resources in this setting.

There is currently no standard treatment for women with recurrent and stage IVB cervical cancer, simply because, according to clinical specialists, no single therapy regimen has been proven to induce clinically significant gains in response rates or overall survival.

But experts agree that combination therapies are generally more effective than single agents, and so in current clinical practice patients might be given Hycamtin (topotecan) plus cisplatin, cisplatin alone, or paclitaxel plus either carboplatin or cisplatin.

While reviewing all the evidence the Committee considered the clinical effectiveness of Hycamtin plus cisplatin compared with cisplatin alone, and concluded that data submitted by the manufacturer showed that the combination was indeed more effective.

'Considerable uncertainty'
However, it noted that while an indirect comparison of Hycamtin plus cisplatin with paclitaxel plus cisplatin seemed to suggest that the former regimen was more effective, the results were not statistically significant. And after considering all the evidence, the Committee concluded that there was “considerable uncertainty” about the differences in effectiveness between combination chemotherapy regimens.

Furthermore, looking at the drug’s safety profile, the Committee recognised that women receiving Hycamtin/cisplatin may have experience side effects compared with those receiving cisplatin alone. In particular, clinicians highlighted that neutropenia and febrile neutropenia, which may lead to hospital admission, may be a more frequent occurrence than with other regimens, although still manageable.

In terms of cost, its own review of all the data submitted by GSK found an ICER (incremental cost-effectiveness ratio) for Hycamtin/cisplatin compared with cisplatin alone of £59,000 per QALY (quality adjusted life year) gained, and for the combo compared with paclitaxel/cisplatin £117,000 per QALY gained, which is well over NICE’s acceptable cost threshold.

A second appraisal committee hearing is scheduled for July 23, after which the Institute will publish a Final Appraisal Determination.