NICE decision moves Roche's Kadcyla from Cancer Drugs Fund to routine NHS funding

The National Institute for Health and Care Excellence on Thursday issued final draft guidance recommending routine NHS reimbursement of Roche's Kadcyla (trastuzumab emtansine), meaning that the breast cancer therapy will move out of the Cancer Drugs Fund (CDF). The decision by the regulator was taken after Roche agreed to provide an undisclosed discount for Kadcyla, which has a list price of 90 000 pounds ($114 882) per patient.

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. NICE initially rejected NHS funding of the drug in 2014, issuing similar decisions in 2015 as well as last year. Kadcyla was also one of a number of drugs that had been slated to be removed from the CDF, before Roche agreed to an undisclosed discount in order to retain coverage.

NICE said Thursday that along with the discount on Kadcyla, another "important factor" in its decision was the appraisal committee's agreement that it was appropriate to compare Roche's drug with Herceptin (trastuzumab) plus capecitabine, which is now considered to be standard treatment for people with advanced breast cancer. The agency noted that it previously compared Kadcyla's efficacy against a different combination of treatments.

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"Today's announcement on Kadcyla shows that for companies who are willing to work with us, there are concrete gains for them, for the NHS and, most importantly, for patients able to get new and innovative drugs," commented NHS England chief executive Simon Stevens. "In this case, tough negotiation and flexibility between the NHS and Roche means both patients and taxpayers are getting a good deal," Stevens added.

Meanwhile, Richard Erwin, general manager at Roche, said "this is a positive example of how solutions can be reached when all parties show flexibility." NICE noted that final guidance on Kadcyla is expected next month, adding that approval will permit 1200 patients to routinely receive the therapy.

Carole Longson, director of the centre for health technology evaluation at NICE, remarked "since we started reassessing the drugs available through the [CDF], companies have responded positively and shown that they can offer good deals when it comes to pricing." NICE indicated that it is evaluating 24 drugs available in the CDF and of the drugs considered so far, all 17 have been approved for routine use. The agency noted that in each case, drugmakers have reduced the price of the products to the NHS.

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