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NICE fast-tracks GSK's skin cancer drug Tafinlar

But only on condition the company cuts its price

GSK - logo on building

GlaxoSmithKline has won quicker than usual NICE backing for Tafinlar (dabrafenib), but only if the company reduces the skin cancer drug's price.

The Institute's final appraisal determination supports Tafinlar's use in adults with melanoma that has been shown to have a specific mutation called BRAF V600 and has spread to other parts of the body or cannot be surgically removed.

The recommendation was entirely inline with Tafinlar European marketing authorisation and so NICE decided the drug could skip its usual interim appraisal stage of its consultation process.

Carole Longson, director of NICE's Centre for Health Technology Evaluation, said: “For a long time the treatments available for skin cancer which has spread have been very limited. The information provided by GlaxoSmithKline suggested that dabrafenib works just as well as vemurafenib [Roche's Zelboraf], which also targets melanoma with the BRAF V600 mutation.

“Drugs like dabrafenib are also thought to have very rapid positive effect for patients, even in those who are very unwell or bed-ridden. In some cases, it has enabled people to resume everyday activities.”

However, just as Roche was forced to discount Zelboraf's price before NICE recommended it, the new Taflinar guidance was only issued on the basis GSK discount its drug's list price though a patient access scheme - details of which, as is usually the case, remain confidential.

Taflinar was approved in Europe in August 2013, based on phase III results showing it provided patients a median of 6.9 months free from disease progression compared with 2.7 months on chemotherapy. The drug also showed a 59% overall response rate compared to only 24% with chemotherapy.

NICE said GSK's estimated cost per QALY (quality adjusted life year) for Taflinar was £11,000 gained compared with Roche's Zelboraf, but was thought to be much lower than this. Taflinar's list price £1,400 for a pack of 28, 75mg capsules and £933.33 for a pack of 28, 50mg capsules, excluding VAT and the pill's recommended dose is 150mg twice daily.

Nikki Yates, general manager of GSK UK Pharmaceuticals, said: “We are delighted that the NICE's evaluation of dabrafenib has resulted in a positive recommendation, and this is testament to the strength of its clinical and cost-effectiveness evidence.

“We look forward to the ratification of this guidance and to implementing the agreed patient access scheme.”

Melanoma is one of the most common types of cancer in people between the ages of 15 to 34 in the UK. This form of skin cancer has the highest mortality rate and is increasing - between 2002 and 2011, new cases of melanoma have increased by 66%.

Article by
Kirstie Pickering

19th September 2014

From: Sales

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