The National Institute for Health and Care Excellence on Tuesday published final draft guidance rejecting the routine use of Roche's Kadcyla (trastuzumab emtansine) on the NHS because the price of the breast cancer therapy "remains too high." The agency issued similar guidance in 2014.
NICE chief executive Andrew Dillon said "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." The agency noted that the new guidance followed an agreement reached between Roche and NHS England, which included "a significant price discount," to stop the drug being removed from the UK's Cancer Drugs Fund.
According to NICE, a "different, smaller discount" had been offered to the agency for use in its assessment of the drug. NICE added that it "has not received any further offers from Roche to reduce the price of Kadcyla." The therapy, which is approved to treat HER2-positive breast cancer that has spread to other parts of the body, cannot be surgically removed and has stopped responding to initial treatment, costs about 90 000 pounds ($136 890) per patient at its full list price.
Dillon remarked "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." NICE noted that its appraisal of Kadcyla also looked at whether the current Pharmaceutical Price Regulation Scheme (PPRS) would affect the drug’s cost effectiveness. However, the agency's assessment committee 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.
Roche contends that the cost of Kadcyla is lower than estimated, as the drug is typically given for shorter periods than NICE assumes. Deborah Lancaster, director of Roche UK, said "our concern with this NICE decision on Kadcyla is that it highlights the confusion at the heart of our drug access system and destroys patients’ faith in the system that is supposed to ensure they have access to the treatments they need." Lancaster noted "it is significant that performance for five year breast cancer survival in the UK is in on par with the Czech Republic, and behind many countries where Kadcyla is routinely available," adding "it is vital that a solution is found today, so that we can continue to meet the needs of patients in the future."
The drugmaker and other consultees now have until November 17 to appeal the draft guidance.
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