UK’s NICE agency decides not to play so nice with Roche and Takeda

Great Britain’s health cost watchdog group deals a blow to Roche for the use of Avastin in breast cancer patients, and to Takeda’s Mepact for bone cancer treatment

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LONDON— The National Institute for Health and Clinical Excellence (NICE), the United Kingdom's healthcare cost watchdog organization, has dealt blows to two Big Pharma players this week, spurning both Roche and Takeda Pharmaceutical Co. Ltd.—for Avastin and Mepact, respectively.

In the case of Roche, NICE rejected Avastin, whose generic name is bevacizumab, for patients whose breast cancer has become metastatic, due to what it calls "uncertain evidence." This despite the fact that the drug is widely used for treating bowel, lung, breast and kidney cancer in other countries and had worldwide sales of $5.9 billion in 2009. This move isn't a new one for NICE, however—although Avastin is licensed as a treatment for a number of cancers, the watchdog group hasn't approved the drug for any of those in the past.

The British agency, which decides if drugs should be paid for by the country's taxpayer-funded National Health Service (NHS), wrote in its draft guidance that it had concluded that evidence failed to show that Avastin significantly improved or extended lives in breast cancer.

"The clinical trial results for bevacizumab were disappointing in that they were unable to prove definitively that the drug could extend the lives of patients with metastatic breast cancer over and above currently available treatments," said NICE Chief Executive Andrew Dillon. "Evidence of the length of time bevacizumab could keep the cancer under control was not robust. There was also no proof that the drug can give patients a better quality of life [than chemotherapy alone]."

In related news, the U.S. Food and Drug Administration advisory panel will meet July 20 to consider whether to recommend full approval of Avastin for breast cancer in the United States.

Roche has said that Avastin, when added to chemotherapy, has been shown to reduce the risk of a woman's disease progressing by half and noted it would work with the government of the U.K. to explore "all possible ways" of making Avastin available to patients. But the sticking point, of course, is cost—to the tune of about $39,400 for each patient. NICE feels this doesn't justify Avastin's use as a first-line therapy in combination with paclitaxel chemotherapy for patients with metastatic breast cancer.

Reportedly, Roche has submitted a patient access scheme to NICE that would place a cap on the amount the NHS would pay, but the scheme wasn't included in this round of NICE's evaluation because the plan is still pending approval from the Department of Health.

In separate draft guidance from NICE the same day, Takeda got much the same treatment for in terms of the use of Mepact for dealing with bone cancer (osteosarcoma) in children, adolescents and young adults.

Takeda and others, such as the Bone Cancer Research Trust, have taken exception to this ruling, with Takeda noting that this decision follows "NICE's inability to recommend Mepact due to its strict criteria for cost-effectiveness—which does not currently accommodate the assessment of rare, ultra orphan diseases—and despite the fact that Mepact meets many of the criteria for 'Deviating from the Threshold' by the NICE Citizen's Council reviewed by the NICE Board on 20 May 2009. This stated that if the treatment in question is life saving, the patients are children, the intervention will have a major impact on patient's family and the illness is extremely severe and/or rare, then the medicine is of additional value to society and shouldn't have to meet NICE's current cost-effectiveness criteria."

Roger Wilson, the director of the group Sarcoma UK, was particularly scathing of NICE in regard to this decision, saying, "If we take the decision down to its essentials, this means that NICE is prepared to sacrifice children on its self-justified altar of cost-effectiveness. I believe that our society has higher moral principles and will not allow an academic process, which has already been shown to be flawed, to take this unprincipled route."

"The Trust is astonished by the decision taken by NICE," added Michael Francis, chairman of the Bone Cancer Research Trust. "We really thought that NICE would recognise that Mepact offers the first real opportunity to help these young people… it seems perverse that we are prepared to let those young people die for the sake of GBP2.5 million."

For its part, NICE cited the drug's limited effectiveness and high cost, saying that a clinical trial showed no significant increase in overall survival in patients treated with Mepact and chemotherapy after surgery.

Takeda, based in Osaka, Japan, told NICE the cost to the NHS of a full 48-dose course of Mepact, also known as mifamurtide, would be $172,687. Takeda offered seven doses of the drug, which was introduced in Europe in February, for free, but this wasn't sufficient to overcome the agency's concerns about Mepact's value to patients.

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