Nearly a year after gaining access to GlaxoSmithKline’s ($GSK) melanoma drugs, Novartis ($NVS) is set for a final recommendation from England’s NICE to sell the two together as a new skin cancer therapy to NHS patients.
The two melanoma drugs Mekinist and Tafinlar--which prior to last year’s $20 billion asset swap were both owned by London-based GSK--have today received a final draft recommendation for use in combination to treat advanced melanoma patients.
But, as you might expect, there is a catch: The drugs will only be allowed a NICE stamp if Novartis follows through on its promise to discount the meds. By just how much the price tag will be lowered is, as ever, not being released by the Institute or Novartis. The list price (i.e., before the discount) is around £10,000 ($14,600) per month, per patient.
The combo has, in a rare occurrence, also fallen under NICE’s “end-of-life criteria” which allows the agency to recommend new cancer drugs that can significantly increase a person’s life, even though its cost may be higher than it would normally accept.
Both drugs were recommended for singular use in England’s NHS back in 2014 when they were marketed by GSK--but they have not until now been recommended together in the country. The combo treatment was approved separately in 2013 by the FDA and together a year later by the U.S. regulator, but the European regulatory route for the combo has been more difficult.
In 2014 GSK had to pull its European filing for the treatment as the CHMP questioned its trial data. GSK later resubmitted its combo form of the treatment with an updated Phase III trial, which saw the European Commission finally approve the drug last November. NICE cannot assess the cost-effectiveness of a drug until it has been approved in the EU, and its entire process usually takes around 9 months.
The key to the combination is that the drugs interact with tumors in different ways: Tafinlar is a BRAF inhibitor designed to target the V600E mutation, while MEK inhibitor Mekinist tackles both the V600E and V600K mutations.
Analysts predict the drugs could make more than $2 billion a year by the decade’s end, and together they made $147 million for Novartis in the fourth quarter. It has competition in the form of Roche’s ($RHHBY) Zelboraf, a BRAF inhibitor, but back in 2014 Tafinlar and Mekinist bested its rival in a head-to-head study with an increased overall survival rate.
NICE has also recommended a host of other new drugs for the disease that kills around 1,750 people in England each year, including most recently Bristol’s ($BMY) Opdivo as well as its older Yervoy, and its rival Keytruda from Merck ($MRK).
Professor Carole Longson, health technology evaluation center director at NICE, said: “This combination treatment is the latest in a line of promising new drugs for advanced melanoma we have recommended that look set to significantly extend the life of people with the condition.
“I know from testimonies presented to the committee that patients and healthcare professionals alike will welcome this positive recommendation.”
This being NICE, the final draft doesn’t actually mean that a final decision has been made--this will come in the coming months after consultees have had a chance to appeal against it. But this rarely happens at this late stage on a positive recommendation, and it is set to be recommended in NHS England by the summer.
-check out NICE’s final draft guidance
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