NICE recommends against skin cancer drug

In collaboration with the Press Association

NICE has issued draft guidance saying the NHS should not offer the drug vemurafenib (Zelboraf) as a treatment for melanoma due to its expense.

The healthcare guidance body said it was too difficult to weigh the benefits of vemurafenib against the high cost, based on the current evidence available.

Although the treatment has been shown to relieve symptoms and extend life by months for some patients, the high cost meant that NICE was unable to approve it for use on the NHS.

Pharmaceutical company Roche, which manufactures vemurafenib, provided data from a trial called BRIM3 for NICE to consider. This research compared the new drug with the current treatment, dacarbazine.

In the short term the findings were positive for vemurafenib's ability to increase patients' quality of life, but the longer-term effects were harder to calculate because many patients taking dacarbazine were moved on to drugs such as vemurafenib or ipilimumab as their disease progressed.

Weekly treatments of vemurafenib cost around £1,750, although Roche has a confidential agreement with the Department of Health to offer a discount under a patient access scheme.

Typically, NICE recommends treatments that cost around £30,000 per quality-adjusted life year (QALY) or less - the QALY is a measure of both the quantity and quality of life provided by the treatment. However, if a drug fulfills certain criteria for use at the end of life - which vemurafenib does - treatments costing up to £50,000 per QALY may be approved. However, Roche estimated that the cost of the drug would be £56,400 per QALY, putting it above this cut-off.

Sir Andrew Dillon, Chief Executive of NICE, said: "We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost the NHS is being asked to pay. Vemurafenib is an expensive drug and its long term benefits are difficult to quantify.

"When assessing the cost effectiveness of a treatment, NICE appraisal committees will take numerous factors into account. These include how effective the drug is, its side effects, the effect it can have on the patient's quality of life and also the financial cost. This enables them to determine the cost of using the drug to provide a year of the best quality of life available."

Professor Peter Johnson, Cancer Research UK's chief clinician, said: "It's frustrating that vemurafenib is too expensive for NICE to approve. Although it's not a cure and often only works for a short time, it's an effective drug for some melanoma patients. We want to see Roche offer a price that the NHS can afford.

"If this decision stands, vemurafenib will be available in England on the Cancer Drugs Fund until 2014, but it won't be available in Wales or Northern Ireland, and possibly Scotland. There needs to be a better way to quickly get effective treatments to all patients who could benefit. We hope value-based pricing - a new scheme which will come into force in 2014 - will help solve this and we look forward to seeing the details of this scheme soon."

Copyright Press Association 2012