Roche gets NICE approval for breast cancer drug Kadcyla after years of battles

breast cancer
The U.K. has finally given its recommendation that Roche's Kadcyla be routinely available to treat breast cancer.

Following four years of beating up on each other over the cost-benefit of Roche’s cutting-edge breast cancer drug Kadcyla, and heavy lobbying from cancer advocacy groups, the Swiss drugmaker and the U.K. drug cost watchdog have come to an accommodation.

After changing its parameters for consideration, the National Institute of Health and Care Excellence (NICE) today in a final decision recommended routine use of Kadcyla in England for women who have advanced and inoperable HER2-positive breast cancer even after treatment with Herceptin and a taxane, separately or in combo.

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The drug has been available only to some patients through funding by the country’s cancer drug fund, but NICE and Roche have been under pressure from cancer advocacy groups to work out a compromise for routine use of the drug, which has been shown to extend median overall survival by 5.8 months on average.  

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So a deal was struck. Roche offered an undisclosed discount off the £90,000 ($115,000) per patient cost, and the National Health System this time around decided to compare Kadcyla with Herceptin plus capecitabine, instead of a different combo of treatments. NICE said the change was made because that is now considered the standard for care.

Whether Roche offered up a bigger discount than it previously negotiated was not stated. The Swiss drugmaker had said last year that it would be open to negotiating a pay-for-performance deal.  

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“The committee acknowledged the comments received from patients during the consultation, … in particular that 115,000 people had signed a Breast Cancer Now petition urging NICE and the company to ensure that it remains available,” Carole Longson, NICE director of health technology evaluation, said in a statement. “We are therefore very pleased that the company and NHS England have been able to agree a deal that will achieve this.”

Richard Erwin, general manager of Roche, pointed out that with the decision, not only will the drug be paid for all eligible patients in England and Scotland but it will now be available to women in Northern Ireland and Wales for the first time, about 1,000 total right now.

“Roche’s commitment to bringing Kadcyla to all eligible patients across the U.K. has never waned,” Erwin said.

The two sides have had a very rocky relationship. Roche CEO Severin Schwan castigated cancer fund administrators a couple of years ago when they decided to drop the breast cancer treatment, along with more than a dozen other cancer drugs, to rein in costs. "It's stupid from a cost point of view," Schwan said at the time. "How the hell can you ignore all these benefits?"

The fund later agreed to cover Kadcyla in one form of breast cancer, but the drugmaker took another hit when NICE refused to cover the drug for the general population, even after Roche offered to discount the drug to £90,000 per patient.

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