The National Institute for Health and Clinical Excellence has granted patients with small cell lung cancer restricted access to GlaxoSmithKline’s oncology drug Hycamtin on the National Health Service.

The cost regulator has published a Final Appraisal Determination recommending use of the drug in patients suffering a relapse of the disease but only when retreatment with the first-line therapy “is not considered appropriate” or the combination of cyclophosphamide, doxorubicin and vincristine chemotherapies is contraindicated.

Furthermore, the Institute concluded that only the oral form of Hycamtin should be used by doctors to treat patients with SCLC as it considers the intravenous version too expensive for the NHS. Based on a body surface area of 1.8 m2, the cost per cycle for intravenous Hycamtin is £1,495, which equates to an average cost per patient of around £5,980, while for the pill form costs are much lower at £638 and £2,552, respectively.

Lung cancer accounted for 15% of cancers in men and 11% of cancers in women in 2005, making it one of the most common cancers in England. There are over 33,000 new cases in England and Wales a year, of which between 10% and 20% are thought to be the small cell type although this figure is in decline. Reasons for the downturn in cases of SCLC are unclear, but it is thought that a change in smoking habits over the years is a significant factor, the Institute noted.

Still, the prognosis for people with SCLC – a particularly aggressive disease - remains poor, with a life expectancy of just 3.5 months without treatment for the limited-stage type, where the disease remains confined to the lungs, and six weeks for extensive-stage, when it has spread to other parts of the body.

With treatment, median survival is increased to 14–18 months for limited-stage and nine–12 months for extensive-stage disease. According to NICE, 20%-40% of patients with limited-stage and less than 5% of patients whose disease has spread survive for up to two years, and those that two will often continue to relapse up to five years after prognosis.

Hycamtin, which is also being backed by NICE to treat cervical cancer, works by inhibiting the topoisomerase I, an enzyme necessary for DNA replication, which leads to cell death. Clinical trials of the drug have demonstrated its ability to boost median overall survival, with 25.9 weeks for patients receiving the drug compared to 13.9 weeks for those given best supportive care alone, and so both patients and doctors will surely welcome the availability of a new treatment option for this aggressive disease.