NICE recommends Takeda’s cancer drug Mepact
pharmafile | September 7, 2011 | News story | Sales and Marketing | Mepact, NICE, Takeda
NICE has reversed its stance on Mepact and recommended the bone cancer drug after re-examining discounts and a new patient access scheme proposed by its manufacturer Takeda.
The watchdog’s final draft guidance backs NHS use of Mepact (mifamurtide), in combination with postoperative multi-agent chemotherapy, as an option for treating high-grade resectable non-metastatic osteosarcoma (a rare bone cancer).
The decision comes after Takeda offered an updated patient access scheme for the drug, which will see the price reduced, and after NICE re-examined the discounts available.
As is becoming common practice, Takeda asked for details of its PAS not to be made public, but NICE said that Mepact has now been brought down to a QALY of £56,000, where previously it was estimated to be £67,000 per QALY gained.
Then, having received clarification on discounting and other factors, NICE’s Appraisal Committee accepted the resulting best-case probabilistic incremental cost effectiveness ratio (ICER) of £36,000 per QALY gained.
NICE clarification
NICE’s previous guidance said it was minded not to recommend the drug due to its high cost, but also because it was unsure on how to apply the QALY formula to treatments which work over a long-time period.
Sir Andrew Dillon, NICE chief executive, said today’s decision came after NICE had re-examined the evidence for this appraisal, following clarification from the NICE Board on how discounting should apply in cases where treatment benefits are realised over a very long time period.
“This clarification,” he said, “Along with a revised patient access scheme, means that the extra cost per unit of health gained that the NHS will be asked to pay for [Mepact] is now lower than previously determined, but still above the normal range.
“The Committee looked again very carefully in every way possible at whether there might be a case for accepting this higher than normally accepted extra cost per unit of health gained for [the drug].
“This included considering the curative potential of the drug for some people, that this is a small patient population with a rare disease, and whether the change in health-related quality of life had been inadequately captured in the economic analysis.”
Dillon added that this appraisal had “raised some important methodological issues”, and thanked the Board for their consideration of these points, which helped towards today’s decision.
Takeda UK welcomes decision
Commenting on the decision by NICE, Yasuhiro Fukutomi, managing director of Takeda UK, said: “We are grateful to all those who have been involved in this long process including those at NICE, the Department of Health, physicians and patient organisations.
“It has taken everyone’s collaboration to lead us to this successful conclusion for osteosarcoma patients today,” he added.
There have not been any medical advances in the treatment of osteosarcoma for more than 20 years and current standard treatment is chemotherapy given before and after the tumour has been surgically removed.
In clinical trials 68% of the patients receiving Mepact (231 out of 338) survived without the disease coming back, compared with 61% of the patients who did not receive it (207 out of 340). The risk of dying was also reduced by 28% in patients receiving the drug.
The active substance in Mepact, mifamurtide, is an immunomodulator and is administered to patients via infusion.
US-based firm IDM Pharma, which was acquired by Takeda for $75 million in May 2009, originally developed the drug.
It works by activating macrophages and monocytes (types of white blood cell that form part of the immune system) and is thought to cause the white blood cells to release chemicals that kill the cancerous cells.
Ben Adams
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