GSK melanoma drug sees quick NICE nod
pharmafile | September 18, 2014 | News story | Sales and Marketing | Cancer, GSK, NICE, Tafinlar, Yervoy, dabrafenib, melanoma, skin cancer
NICE is recommending GlaxoSmithKline’s new melanoma treatment Tafinlar (dabrafenib) after the firm offered a discount for its medicine.
In final draft guidance issued today the watchdog is saying yes to the drug for the treatment of melanoma which has spread, or can’t be completely removed by surgery.
Patients must also test positive for the BRAF V600 mutation, as it is this mutation that the drug works against. Around half of all melanoma patients are suspected to express the BRAF V600 gene.
NICE usually takes around nine months and several rounds of draft guidance to recommend a medicine, but this has been sped up in GSK’s case as the drug was given to NICE within the exact framework of its European licence – and with a price cut from the outset.
If it gains a final recommendation which would likely be in the coming months, Tafinlar will sit alongside Roche’s BRAF inhibitor Zelboraf (vemurafenib) and the immuno-therapy treatment Yervoy (ipilimumab) from Bristol-Myers Squibb as a NICE-approved option for advanced melanoma, the deadliest and rarest form of skin cancer.
GSK may find itself the luckier of the three firms as both Yervoy and Zelboraf had a much more difficult path to a final NICE yes, with both drugs originally rejected by the watchdog in early guidance.
Professor Carole Longson, centre for health technology evaluation director at NICE, says that for a long time the treatments available for skin cancer which had spread were ‘very limited’, and until 2011 was restricted to a chemotherapy agent which had been used since the 1970s.
“However, in recent years a number of breakthrough treatments that can potentially significantly improve the prognosis for some people with malignant melanoma have become available,” she explains, referring to BMS and Roche’s medicines.
“The information provided by GlaxoSmithKline suggested that Tafinlar works just as well as Zelboraf which also targets melanoma with the BRAF V600 mutation. Drugs like Tafinlar 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.”
In a deal between GSK and Novartis, the Swiss firm will soon buy into GSK’s cancer medicines, inclduing Tafinalr, and will become repsonsible for marketing them in the UK.
Pricing and competition
GSK’s drug costs £1,400 for a pack of 75mg capsules (28 capsules per pack) and around £933 for a pack of 50mg capsules. The recommended dose is 150 mg twice daily, although the price will be lower given the patient access scheme. Just how low, however, has not been made public.
Analysts see GSK’s treatment bringing in blockbuster sales, especially after it bested Zelboraf in a recent head-to-head trial when used in combination with GSK’s other new melanoma drug Mekinist (trametinib).
NICE is also currently cost-assessing a combination treatment of Tafinlar and GSK’s MEK inhibitor Mekinist, although no guidance has yet been issued.
Roche’s Zelboraf was the first in a new class of BRAF inhibitors to be approved for melanoma back in 2011, and is currently only approved as a singular treatment.
GSK’s BRAF inhibitor Tafinlar gained approval much later in 2013, but unlike Roche GSK secured approval for a combination approach with both Tafinlar and Mekinist earlier this year.
In the UK Zelboraf costs £1,750 per week and for an average treatment of seven months, meaning the drug would cost the NHS £52,000. Roche too offered a price cut for its medicine, but again this remains confidential.
Yervoy was one of the most expensive medicines ever assessed by NICE, costing around £80,000 for a full course of treatment. BMS also offered a price cut and worked closely with NICE on its appraisal, and was given approval for the NHS to fund its use in a first-line setting earlier this year.
Sales of Yervoy are expected to reach $1.5 billion per year at their peak.
Ben Adams
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