NICE rejects Roche’s Kadcyla for NHS; price still too high
pharmafile | November 17, 2015 | News story | Manufacturing and Production, Sales and Marketing | Cancer Drugs Fund, Kadcyla, NHS England, NICE, Roche
NICE has published final draft guidance on Roche’s Kadcyla as a breast cancer treatment, deciding that the drug’s price remains too high for it to be recommended for routine use on the NHS.
The decision comes despite NHS England’s November U-Turn in which it decided to keep Kadcyla (trastuzumab-emtansine) on the Cancer Drugs Fund List following negotiations over a price reduction with the Swiss manufacturer.
Roche was said to have dropped the price from £90,000 to £70,000 per patient treatment course.
The draft guidance follows news that the manufacturer of Kadcyla, Roche, recently agreed a significant price discount with NHS England to stop the drug being removed from the Cancer Drugs Fund. A different, smaller discount was offered to NICE for use in this appraisal, but nice says the company has offered no further discounts since.
Kadcyla is licensed to treat HER2-positive breast cancer which has spread to other parts of the body, cannot be surgically removed and has stopped responding to initial treatment.
Sir Andrew Dillon, NICE chief executive, says: “We recognise that Kadcyla has a place in treating some patients with advanced breast cancer and we have been as flexible as we can in making our recommendation. However, the price that the manufacturer is asking the NHS to pay in the long-term is too high.”
Despite Roche’s discount offer, NICE’s independent Appraisal Committee found that it did not reduce the price enough to make it cost-effective for the NHS, despite using the specially-extended range of cost-effectiveness for cancer drugs, which allows more expensive treatments to be recommended if they are shown to benefit people reaching the end of their lives.
The Appraisal Committee was also asked to look at whether the current Pharmaceutical Price Regulation Scheme (PPRS) would affect the drug’s cost-effectiveness. The committee, using NICE’s position statement on the PPRS scheme, concluded that any potential rebate to the Department of Health could not be taken into account as there is no direct connection between the rebate and the resources that the NHS needs to make available to buy Kadcyla.
Sir Andrew adds: “Despite a growing public campaign for a fair deal on the cost of important new cancer medicines, it is disappointing that there appears to have been no meaningful attempt by Roche to reconsider its price to secure Kadcyla’s long-term future in the NHS, outside of the Cancer Drugs Fund.”
Part of the public campaign mentioned by Dillion came in the form of a petition from the charity Breast Cancer Now and later a letter from its chief executive Baroness Delyth Morgan, in which she called on Roche to “drop the price down to a level that the NHS can afford” short-term.
Responding to today’s development and the final negative verdict, Dr Caitlin Barrand, assistant director of Policy & Campaigns at Breast Cancer Now, said:
“This is hugely disappointing news, particularly for anyone who could benefit from Kadcyla in Wales, as they are also not covered by the Cancer Drugs Fund.
“We simply cannot continue in this way, with highly effective new cancer drugs being held just out of reach for patients in certain areas of the UK. This drug isn’t available to those that need it in Scotland either, and had Roche failed to collaborate with NHS England in the last round of delisting from the Fund, patients in England might be missing out too.
“It’s time that the Prime Minister showed real leadership on this issue. People living with incurable cancer don’t have time to lose, and a fairer, more flexible system that enables access to the best treatments available on a routine, UK-wide basis is long overdue.”
NICE’s draft guidance is now subject to an appeal process whereby consultees can appeal against the recommendation, subject to certain criteria.
Joel Levy
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