Although its preliminary recommendations said otherwise, it seems the National Institute for Health and Clinical Excellence has had a small change of heart and is now backing GlaxoSmithKline’s Hycamtin as a therapy for recurrent cervical cancer on the National Health Service, under certain conditions.

Just two months ago appraisal documents published by the cost watchdog were leaning towards a outright rejection, largely because of “considerable uncertainty” about the differences in effectiveness between combination chemotherapy regimens and the potential for more frequent side-effects such as neutropenia.

But now following a second appraisal committee hearing and additional data submitted by GSK, the Institute has published a final appraisal determination recommending the use of Hycamtin (topotecan) in combination with the chemotherapy cisplatin to treat women with recurrent or stage IVB cervical cancer, but only under the proviso that they have not received previous therapy with cisplatin.

According to clinical specialists, around 90%-95% of the current licensed population for Hycamtin will have already received therapy with cisplatin in some form or another, so the number of patients eligible for treatment with the drug is actually relatively small.

Difference in response
But the Institute’s decision is based on evidence showing that previous use of cisplatin has “a significant effect on response rates to subsequent cisplatin-containing chemotherapy regimens”. Response rates in cisplatin-naïve women are around 45% but can be as low as 10% in those who have already been exposed to the drug.

Initially, the Institute’s Expert Review Group concluded that the use of Hycamtin/cisplatin would not be cost-effective for the NHS, however, following a further analysis based on the new data – which churned out cost of £26,800-£34,000 per QALY (quality assured life year) - it has now ruled that the therapy could indeed offer value-for-money when used in the small subgroup of women who have not previously received the chemotherapy.