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NICE rejects Kadcyla

pharmafile | April 23, 2014 | News story | Sales and Marketing CDF, Cancer, Genentech, Kadcyla, NHS, NICE, Roche 

NICE has delivered a severe blow to Roche by rejecting its breast cancer ‘smart bomb’ Kadcyla for NHS use in draft guidance.

Kadcyla (trastuzumab emtansine) which was approved a year ago in the US and launched in February in the UK, combines the manufacturer’s ageing breast cancer brand Herceptin (trastuzumab) and ImmunoGen’s DM1 chemotherapy in one molecule.

Roche says it is ‘extremely disappointed’ with NICE’s verdict. But in a withering comment on the Swiss pharma giant’s pricing strategy, NICE chief executive Sir Andrew Dillon says: “We had hoped that Roche would have recognised the challenge the NHS faces in managing the adoption of expensive new treatments by reducing the cost of Kadcyla to the NHS.”

In short, NICE believes that the drug, which can cost more than £90,000 per patient, is not effective enough to justify the price that the NHS is being asked to pay.

It has rejected many cancer medicines that cost far less than Kadcyla in the past, and the average cost of the NICE-approved, once-weekly regimen of Herceptin is currently £28,000 per patient.

Roche told Pharmafile that Kadcyla costs around £44,310 per patient. It is used as a treatment until disease progression – the average time to which, in the EMILIA Phase III trial, was 9.6 months.

However, NICE highlights the fact that Kadcyla is already available to patients via the Cancer Drugs Fund (CDF).

“The reality is that, given its price and what it offers to patients, it will displace more health benefit which the NHS could achieve in other ways, than it will offer to patients with breast cancer,” Sir Andrew insists.

He urges Roche to “look again at their evidence and consider if there is more they can do” before the consultation on this guidance closes on 19 May.

“Roche is extremely disappointed that NICE has failed to safeguard the interests of patients with this advanced stage of aggressive disease,” says Jayson Dallas, general manager of Roche Products.

The manufacturer points out that this is the eighth consecutive treatment for advanced breast cancer to be rejected by NICE since 2011 – and Breakthrough Breast Cancer has also slammed NICE’s decision, saying that the process by which the watchdog reaches its verdicts needs to be overhauled.

The charity’s senior policy manager Caitlin Palframan says: “This is the third highly-effective breast cancer drug to be rejected by NICE on the basis of cost in the last year.”

“Drug development and research is moving at a pace that the system can’t seem to keep up with,” she continues. “Kadcyla is a very impressive drug that has been shown to extend life by up to six months in HER2-positive secondary breast cancer patients, and with more manageable side effects than alternative drugs.”

“With NICE currently consulting on guidelines for ‘value-based assessment’, it will be important that they arrive at a sustainable solution that builds upon the success of the CDF, and ensures that patients continue to have rapid access to much needed cancer medicines,” Dallas concludes.

Administered intravenously once every three weeks, Kadcyla is the first antibody-drug conjugate (ADC) for treating HER2-positive metastatic breast cancer.

The antibody, trastuzumab, binds to the HER2-positive cancer cells, and is thought to block signals that make the cancer grow while also mobilising the body’s immune system. Once Kadcyla is absorbed into cancer cells, it releases the DM1 to destroy them.

Adam Hill 

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