Final NICE guidance confirms rejection of Roche's breast cancer drug Kadcyla over cost

The National Institute for Health and Care Excellence issued final guidance Wednesday confirming that the price of Roche's breast cancer therapy Kadcyla (trastuzumab emtansine) is "too high" for routine NHS funding. A spokesperson for the agency said "although Roche recently agreed a price discount with NHS England to allow Kadcyla to be retained on the Cancer Drugs Fund, they made no changes to the patient access scheme available for the NICE appraisal, which means it is still above the top of our specially extended range of cost effectiveness for cancer drugs."

NICE published final draft guidance last month recommending against the routine use of Kadcyla on the ground of cost-effectiveness, after issuingsimilar decision in 2014. In its conclusion, NICE noted that Kadcyla has a list price of 90 000 pounds ($135 095) per patient.

Roche agreed to an undisclosed discount last month to ensure that Kadcyla would retain coverage by the UK's Cancer Drugs Fund. The drug was one of several therapies slated to be removed from coverage by the fund, with Roche CEO Severin Schwan describing the decision as "completely arbitrary" (for related analysis, see ViewPoints: Roche CEO – democracy rules in drug pricing).

In response to NICE's latest ruling, Roche noted that it was "prepared to offer the same discount that was required to retain Kadcyla" on the Cancer Drugs Fund, continuing "we are willing to be collaborative and continue discussions with NICE to ensure that Kadcyla remains available to patients in England with advanced breast cancer for the long term." According to Roche, Kadcyla is reimbursed in 16 European countries including Greece and Italy. The drug, which analysts predict will generate sales of more than 1 billion Swiss francs ($1 billion) next year, 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.

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