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Advanced breast cancer drug to become routinely available

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A “landmark” deal has been announced on the breast cancer drug trastuzumab emtansine (Kadcyla), meaning that it can now be recommended for routine use by the NHS in England.

NHS England and the drug’s manufacturer, Roche, have agreed a new commercial access arrangement for trastuzumab emtansine on the NHS.

“Companies have responded positively and shown that they can offer good deals”

Carole Longson

It would have cost around £90,000 per patient at its full list price, but NHS England and the pharmaceutical company have agreed a confidential arrangement for reimbursement of the drug.

As a result, the National Institute for Health and Care Excellence has, as of today, recommended the drug as cost effective for routine use on the health service.

It is currently being funded through the Cancer Drugs Fund. If there are no appeals against the new draft guidance, the drug will move out of the fund into routine NHS funding later this summer.

Around 1,200 people with HER2-positive, unresectable, metastatic breast cancer would then be eligible to receive trastuzumab emtansine, according to NICE.

“This is exceptionally good news for so many breast cancer patients”

Delyth Morgan

Trastuzumab emtansine is licensed 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.

Treatment gives patients an average of an extra six months of life, with improved quality of life and less side-effects, allowing them to live much more active lives than other treatments.

In now backing the drug, the NICE committee considered a new cost-effectiveness analysis that used a revised confidential commercial access agreement.

Another key factor in the decision was the committee’s agreement – following comments received during consultation on previous draft guidance – that it was appropriate to compare trastuzumab emtansine with trastuzumab plus capecitabine, because this was now considered standard treatment for people with advanced breast cancer.

As a result, based on the analysis and incorporating the revised access agreement, the drug now comes within the range considered to be a cost-effective use of NHS resources.

Professor Carole Longson

Professor Carole Longson

Carole Longson

Professor Carole Longson, director of NICE’s centre for health technology evaluation, noted that it had taken into account comments it had previously received from patients about the drug.

In particular, she highlighted that 115,000 people had signed a petition set up by the charity Breast Cancer Now, urging NICE and the company to ensure that it remained available.

“We are, therefore, very pleased that the company and NHS England have been able to agree a deal that will achieve this,” she said.

Previously rejected by NICE in 2015 as too expensive for routine funding, trastuzumab emtansine has been available via the Cancer Drugs Fund since 2013.

In 2016-17 NHS England was given the power to redesign and renegotiate the original fund. Since then, with NICE, it has been reviewing all treatments supported through the fund to see whether they should be funded routinely on the NHS.

Ms Longson added: “Since we started reassessing the drugs available through the Cancer Drugs Fund, companies have responded positively and shown that they can offer good deals when it comes to pricing.”

NHS England chief executive Simon Stevens announced that the body had struck a deal with Roche, which was endorsed by NICE, at the NHS Confederation’s annual conference in Liverpool.

Stevens at pac

Stevens at pac

Simon Stevens

He said: “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.

“In this case, tough negotiation and flexibility between the NHS and Roche means both patients and taxpayers are getting a good deal,” he added.

Roche general manager Richard Erwin said: “Close collaboration between Roche, NHS England and NICE has resulted in NICE recommending Kadcyla as a cost effective treatment. This is a positive example of how solutions can be reached when all parties show flexibility.”

Baroness Delyth Morgan, chief executive of Breast Cancer Now, said: “This is exceptionally good news for so many breast cancer patients.”

She added: “Today’s landmark decision bodes well for patients looking for reassurances that modern cancer treatments can get through to NHS patients more quickly and can bring transformational improvements in patient outcomes for the future.”

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