NICE rejects Takeda cancer drug over price concerns

pharmafile | July 12, 2010 | News story | Sales and Marketing Cancer, Mepact, NICE, Takeda, bone cancer 

UK cost-effectiveness watchdog NICE has rejected Takeda’s orphan bone cancer drug Mepact due to concerns over price.

In its draft guidance NICE said it was unable to recommend Mepact due to “uncertainties over the drug’s effectiveness, combined with the high cost that the NHS is being asked to pay for the treatment”.

Mepact costs £2,375 for one dose and £114,000 for a full treatment course of 48 doses. A ‘patient access scheme’ was proposed by Takeda to reduce the cost of the drug to the NHS and would have allowed the drug to be available at no charge to the NHS for the first seven doses.

The independent appraisal committee agreed the incremental cost-effectiveness ratio (ICER) based on the evidence available would be at least £50,000 per QALY (quality-adjusted life year) gained, and possibly even above £100,000 per QALY gained. Currently, QALY rates per annum are set at between £20,000 and £30,000.

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Sir Andrew Dillon, NICE chief executive, said: “We understand a diagnosis of cancer is very distressing, and especially so when children and young adults are affected. With this in mind, we are disappointed that the evidence for mifamurtide [Mepact] is not stronger.”

Dillon added that other effective treatments were available in the NHS for treating this condition, including the chemotherapy agents methotrexate, cisplatin, and doxorubicin.

Chairman of the Bone Cancer Research Trust, Michael Francis, said: “The Trust is astonished by the decision taken by NICE. We really thought that NICE would recognise that Mepact offers the first real opportunity to help these young people.

“Of course we do not begrudge funding for treatment for other cancers, but it seems perverse that we are prepared to let those young people die for the sake of £2.5 million – a sum that would dramatically allow more young people to survive.”

Takeda said in a statement that it wants to ensure that the suitable young patients that are diagnosed with osteosarcoma each year are provided with a fighting chance, and will therefore work with NICE through to the end of its appraisal.

Mepact works by stimulating macrophages, a type of white blood cell that helps the body fight infections by absorbing the disease-causing organism. These cells can normally be found in the bloodstream and connective tissue.

Mepact is licenced for treatment of non-metastatic osteosarcoma following surgical removal of the tumour in children, adolescents and young adults.

It was given orphan drug status in 2004 and given market exclusivity for ten years. It was originally developed by cancer specialist IDM Pharma but became apart of Takeda’s portfolio after the Japanese pharma firm bought the company in 2009.

NICE’s preliminary guidance is now available for public consultation until 2 August 2010. Comments can be made via the NICE website.

Ben Adams

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