NICE unmoved on Takeda bone cancer drug
pharmafile | October 13, 2010 | News story | Sales and Marketing | Mepact, NICE, Takeda
NICE has refused to recommend Takeda’s Mepact because of its “exceptionally high cost” and the “substantial uncertainty” about the osteosarcoma drug’s benefit over current treatments.
This was despite the UK drugs watchdog’s final appraisal determination finding that Mepact (mifamurtide) plus multi-agent chemotherapy may be more effective than multi-agent chemotherapy alone.
Sir Andrew Dillon, NICE chief executive, said: “Although the independent advisory committee thought mifamurtide could become a valuable new treatment for osteosarcoma, when used in combination with post-operative chemotherapy, the evidence presented by the manufacturer highlighted substantial uncertainty around the size of the treatment effect relative to standard UK clinical practice.
“This uncertainty, together with the drug’s exceptionally high cost, meant the committee considered mifamurtide not to be an appropriate use of NHS resources.”
NICE was assessing Mepact in combination with post-operative chemotherapy drugs for the treatment of high-grade non-metastatic, surgically treatable osteosarcoma
NICE’s independent appraisal committee agreed the best-case incremental cost-effectiveness ratios based on the evidence available would be at least £70,100 per QALY gained (based on the deterministic analysis) and £67,000 per QALY gained.
This includes a proposed patient access scheme by Takeda to reduce the cost of the drug to the NHS, under which Mepact would be available at no charge to the NHS for the first seven doses.
Although rare, osteosarcoma is the most common form of bone cancer. Around 150 new cases are diagnosed each year in the UK.
Mepact works by stimulating macrophages, a type of white blood cell that helps the body fight infections by absorbing the disease-causing organism and is indicated for use in children, adolescents and adults.
Takeda may appeal NICE decision
Takeda said it “will continue to fight” to get Mepact available on the NHS so all eligible patients can be treated with it and plans to look at all options, including appealing against the decision.
Ian Lewis, professor of cancer studies at St James University Hospital, Leeds, said: “I am saddened and very disappointed by this NICE decision because it means it will be much harder for children with this rare form of cancer to receive Mepact.
“The largest trial ever completed in osteosarcoma has been done with Mepact … this showed an improvement in the most important endpoint of all, overall survival.”
Current treatment for osteosarcoma involves chemotherapy before and after surgery, first to shrink the tumour and then to destroy any remaining cancer cells, and surgery to remove the part of the bone or limb affected.
Ben Adams
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