The high price of Kadcyla makes it “impossible” to recommend for widespread use in the health service, the National Institute for Health and Care Excellence (Nice) claimed.
Trialled at The Sheffield Cancer Centre, it is used to treat breast cancer patients with HER2-positive breast cancer that has spread to other parts of the body. It is employed when the cancer cannot be surgically removed and the patient has stopped responding to initial treatments. It can offer patients a last hope, extending their lives by about six months.
Final draft guidance from Nice says that the drug, which costs about £90,000 per patient at its full price, it too expensive to recommend for widespread use in the health service.
The NHS financial watchdog has become embroiled in a row with manufacturers of the drug, saying that it is “very disappointed that Roche has decided not to offer its new treatment at a price that would enable it to be available for routine use in the NHS”.
But Roche claimed 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.”
The drug is available in England through the Cancer Drugs Fund, but doctors must make special requests to access the treatment 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.
Dr Jayson Dallas, 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.”
The drug company added: “Under Nice’s current process, Kadcyla would need to be discounted by 60 per cent 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.”
Breast cancer sufferer Rose Merritt, 36, a mother from York, admitted Kadcyla would not help in her case, but it was still “very frustrating and sad” news.
Mrs Merritt, who is undergoing chemotherapy and normally works for Yorkshire Cancer Research, said: “It’s endlessly frustrating to see the battles that it takes for these drugs to get into use.”
Mia Rosenblatt, of the Breast Cancer Campaign, claimed the charity is “very disappointed” by the “huge blow” for women with HER2-positive advanced breast cancer, and added: “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, the clinical director at Breast Cancer Care, said: “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.”