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NICE puts onus on pharma giant after rejecting 'costly' breast cancer drug

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The National Institute for Health and Care Excellence has taken the unprecedented step of expressing its “disappointment” with a multinational drug giant in a row over a new breast cancer drug and government’s pricing deal with the pharmaceutical industry.

The drug, which can extend the lives of some women with an advanced form of breast cancer, has been rejected for NHS use because, at £90,000 per patient, it is deemed too expensive.

The high price of trastuzumab emtansine (Kadcyla) makes it “impossible” to recommend for widespread use in the health service, said NICE.

The drug is used to treat patients with HER2-positive breast cancer that has spread to other parts of the body and can extend their lives by around six months.

“Although Roche proposed a discount to the full list price of Kadcyla, it made little difference to its value for money”

Andrew Dillon

But final draft guidance from NICE said the drug, which costs around £90,000 per patient at its full price, it too expensive to recommend for widespread use in the health service.

NICE has become embroiled in a row with manufacturers of the drug, Roche, saying that it is “very disappointed the company has decided not to offer its new treatment at a price that would enable it to be available for routine use in the NHS.”

Roche said that it had offered to cut the price of the drug and will be appealing NICE’s decision.

“Although Roche proposed a discount to the full list price of Kadcyla, it made little difference to its value for money, leaving it well above the top of our specially extended range of cost effectiveness for cancer drugs,” said NICE chief executive Sir Andrew Dillon.

“We are really disappointed that Roche were not able to demonstrate more flexibility to help us make a positive recommendation. The company is well aware that we could not have recommend Kadcyla at the price it proposed.”

Sir Andrew Dillon

Sir Andrew Dillon

But Dr Jayson Dallas, general manager of Roche Products Limited said: “Despite Roche offering a significant discount, we are once again disappointed that NICE has not shown any flexibility on access to Kadcyla.

“Refusing patients access to this drug is an incredible injustice and tantamount to turning the clock back in cancer research and development. We plan to appeal this decision.”

In a statement the drug company added: “Under NICE’s current process, Kadcyla would need to be discounted by 60% to meet the NICE cost-effectiveness threshold. This and other recent rejections (of therapies for advanced breast cancer) highlight that the NICE process is no longer fit for purpose to provide patients access to new cancer medicines.”

The drug is available in England through the Cancer Drugs Fund, but doctors must make special requests to access the treatment for their patients and are not able to offer it to them immediately, if at all. Patients in other parts of the UK do not have access to such a scheme.

“It is a huge blow for women with HER2-positive advanced breast cancer”

Mia Rosenblatt, Breast Cancer Campaign

Breast cancer charities noted their disappointment at the news, though some expressed sympathy with NICE’s viewpoint.

Breakthrough Breast Cancer’s senior policy officer Sally Greenbrook said: “We believe all cancer patients should be able to access the best possible treatment.

“But for this to happen within the confines of the NHS budget, prices set by the pharmaceutical industry for impressive, life-extending drugs such as Kadcyla must come down,” she said. “It’s impossible to put a price on life’s precious moments. But it’s not impossible to put a fair price on drugs.

Sally Greenbrook

Sally Greenbrook

“We want to see the Department of Health and the pharmaceutical industry working together to find a long-term solution to this ongoing problem and a sustainable system put in place by which new treatments can be made available to those that need them.”

Mia Rosenblatt, head of policy and campaigns at Breast Cancer Campaign, said: “We are very disappointed by today’s news and know that it is a huge blow for women with HER2-positive advanced breast cancer.

“It is vital that this is not the end of the line for Kadcyla in respect of NICE approval and we ask NICE and Roche to urgently re-visit their negotiations to find a solution.”

Emma Pennery, clinical director at Breast Cancer Care, added: “Kadcyla being rejected from routine NHS access will come as another devastating blow to women with HER2 positive advanced breast cancer, denying them the chance of a longer and much better quality of life.”



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