Roche says it will appeal final draft guidance issued today by the National Institute for Health and Care Excellence which does not recommend routine NHS access to its targeted breast cancer drug Kadcyla (trastuzumab emtansine).

Roche says it had offered “a significant discount” on Kadcyla’s price through a Patient Access Scheme (PAS), and that is “once again disappointed” that NICE had not shown any flexibility on access to the drug, which is currently available and routinely reimbursed without restriction in many European countries including Finland, Denmark, Austria, Norway, Sweden and Switzerland.

“Refusing patients access to this drug is an incredible injustice and tantamount to turning the clock back in cancer R&D,” said Jayson Dallas, general manager at Roche Products. NICE’s rejection of Kadcyla “demonstrates quite simply that their current system is broken, not fit for purpose and in need of a complete overhaul when it comes to advanced cancer,” he added.

Announcing the final draft guidance, NICE said it was “very disappointed” that Roche had “decided not to offer” the drug at a price that would enable it to be available for routine use in the NHS. Kadcyla is estimated to cost more £90,000 per patient at its full list price, and the final draft reiterates the conclusion of draft NICE guidance in April that the drug’s high price made it impossible for it to recommend, despite evidence of its benefit to patients.

“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. “The company is well aware that we could not have recommended Kadcyla at the price it proposed,” he added.

Roche says that NICE’s decision also underlines the systemic failure to implement the recently-negotiated Pharmaceutical Price Regulation Scheme (PPRS) agreement to cap the overall NHS drugs budget so that patients get access to the latest treatments.

Under its current process, Kadcyla would need to be discounted by 60% to meet the NICE cost-effectiveness threshold, says the firm.

 Sir Andrew noted that Roche considers that the PPRS “includes an expectation that NICE will ignore the price a company asks for its product,” because it provides for a rebate to be paid by industry to the NHS where expenditure on branded drugs rises above an agreed level. However, he said, the PPRS does not contain this expectation, because “both the Association of the British Pharmaceutical Industry and the Department of Health agree that obtaining value for money from new drugs is in the interests of the industry and the NHS.” 

The charity Breakthrough Breast Cancer said the decision had not come as a shock. 

“Kadcyla is a brilliant drug, but it’s also incredibly expensive. NICE have gone over and above their usual processes to try to approve it, but despite this, and the discount offered by the manufacturer, the revised price for Kadcyla is still too high to be considered cost-effective,” said Sally Greenbrook, the charity’s senior policy officer.

She urged the Department of Health and the pharmaceutical industry to work together to find a long-term solution to this ongoing problem. “Until then, NICE will be forced to reject these cutting-edge treatments, leaving people facing terminal illnesses with fewer treatment options,” said Ms Greenbrook.

Kadcyla is currently available in England only through the Cancer Drugs Fund.