Regulatory Focus™ > News Articles > UK's NICE Rejects Roche's Breast Cancer Drug Kadcyla, Citing Major Cost Concerns

UK's NICE Rejects Roche's Breast Cancer Drug Kadcyla, Citing Major Cost Concerns

Posted 08 August 2014 | By Louise Zornoza

UK's NICE Rejects Roche's Breast Cancer Drug Kadcyla, Citing Major Cost Concerns

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The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance confirming its earlier rejection of Roche’s breast cancer drug treatment Kadcyla for National Health Service (NHS) coverage.

Kadcyla (trastuzumab emtansine) treats women with metastatic HER2-positive breast cancer that cannot be surgically removed and has stopped responding to initial treatment. On average, it extends the life of the patient by six months.  About a fifth of breast cancer cases are HER2-positive, and it is thought the drug could benefit 1,500 women a year.

Despite the clear evidence of benefit to patients, NICE took issue with the price of the treatment. At its full price, the drug costs £90,000 per patient.  Although Roche agreed to lower the price since the initial rejection in April, NICE concluded that “its high price made it impossible for it to recommend”, and – in uncharacteristically strong language - expressed disappointment in the approach taken by the company.

"We are really disappointed that Roche were not able to demonstrate more flexibility,” commented NICE Chief Executive Sir Andrew Dillon. "The company is well aware that we could not have recommended Kadcyla at the price it proposed."

Although this latest guidance is only the final draft version, there is typically little change when the final, official version is published, normally a few months after this stage. As a result of the coverage denial, the only way women will be able to get access to the treatment is through the Cancer Drugs Fund, for which their doctors would have to make special requests.  Since April more than 200 women have been treated with Kadcyla in this way, but the Cancer Drugs Fund is due to end in 2016.

While NICE’s guidance applies only in England, Wales have said they will follow suit. Officials in Northern Ireland and Scotland are considering the NICE recommendations. Neither country currently funds the drug.

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