The cost regulator for England and Wales has issued the final go-ahead for doctors to prescribe GlaxoSmithKline’s Hycamtin on the National Health Service for women with cervical cancer, but only under certain conditions that significantly restrict the treatment population.

The National Institute for Clinical Health and Excellence has pushed ahead with its decision to allow a mix of Hycamtin (topotecan) and the chemotherapy cisplatin for the treatment of recurrent cervical cancer on the NHS, but only in women who have not previously received any treatment with cisplatin as this seems to have a substantial affect on treatment success.

Appraisal documents published by the Institute claim that previous use of cisplatin has “a significant effect on response rates to subsequent cisplatin-containing chemotherapy regimens”, and stress that response rates are around 45% in cisplatin-naïve patients but can be as low as 10% in those who have already been exposed to the drug.

Whilst the recommendation is certainly good news for the small portion of patients who are eligible for treatment, clinical specialists have previously pointed out that around 90%-95% of the current licensed population will have already been given the chemotherapy and so only a very small minority will be given access to the drug on the NHS.

Hycamtin, which attacks cancer by preventing DNA replication, was given the green light for recurrent cervical cancer back in 2006 on the back of Phase III data that showed a survival advantage from adding the drug to cisplatin compared with the chemotherapy alone, but clearance also came with the proviso that patients with prior exposure to cisplatin “require a sustained treatment-free interval to justify treatment with the combination”.

Uncertainty over clinical evidence
Just a few months ago it was looking likely that Hycamtin wouldn’t make it onto the NHS at all, as “considerable uncertainty” about the differences in effectiveness between combination chemotherapy regimens and the potential for more frequent side-effects such as neutropenia lead an expert review group to conclude that the regimen would be too expensive for the NHS.

However, following a further analysis incorporating subsequent data submitted by GlaxoSmithKline the Institute finally agreed that the use of Hycamtin in the small subgroup of women who have not previously received cisplatin is indeed an effective use of NHS resources.