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NICE set to block use of 'unaffordable' new breast cancer drug

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A new breast cancer drug that can extend women’s lives by almost six months will not be recommended for routine NHS use, under draft guidance issued by the National Institute for Health and Care Excellence.

Trastuzumab emtansine (Kadcyla) can cost more than £90,000 per patient and is not effective enough to justify the price the NHS is being asked to pay, according to NICE.

Its guidance for trastuzumab emtansine, manufactured by Roche, is currently in draft form and is now open for public consultation. The decision, if made final later this year, would mean the drug would not be recommended for routine use in England on the NHS.

“We had hoped that Roche would have recognised the challenge the NHS faces”

Andrew Dillon

Instead, women would have to rely on local doctors making successful applications to the Cancer Drugs Fund, which maintains a separate budget of £200m each year for drugs deemed too expensive by NICE.

NICE chief executive Sir Andrew Dillon said he hoped Roche would “act in the best interest of patients” and use the consultation period to look again at their evidence and consider if there was “more” they could do.

“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,” he said.

“This drug is already being funded through the special Cancer Drugs Fund. Our job is to recommend whether it should transfer into the NHS budget,” he said.

He added: “We are very aware of the importance that people place on life-extending cancer drugs and a decision not to recommend a cancer treatment for routine NHS funding is never taken lightly.

Sir Andrew Dillon

Sir Andrew Dillon

“We apply as much flexibility as we can in approving new treatments, but 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.”

But Professor Paul Ellis, a consultant oncologist at King’s College, London and lead triallist for the drug in the UK, described the NICE draft guidance as a “huge blow”.

“Kadcyla represents a significant advance in HER2-positive breast cancer.

“The drug tackles the disease in a different way to any other breast cancer medicine and provides women with valuable extra time with their families and loved ones.

“Not only this, Kadcyla is also much better tolerated by women than current standard treatment options, causing much less in the way of traditional chemotherapy associated side effects.”

“Kadcyla represents a significant advance in HER2-positive breast cancer”

Paul Ellis

Trastuzumab emtansine is a new kind of targeted treatment and works in two ways.

It stops cancer cells overexpressing the HER2 protein. It then delivers a targeted shot of chemotherapy directly into the cancerous cells. It is not a cure for advanced breast cancer, but can help to control the disease.

It is licensed as a second-line treatment for breast cancer patients who have failed on conventional treatment with trastuzumab (Herceptin) and chemotherapy.

The drug is only suitable for patients with the defective Her2 gene. It is administered intravenously, with a recommended dose of 3.6 mg/kg body weight administered every three weeks, according to prescribing information.

Clinical trial results have shown that women on the drug survived 30.9 months compared with 25.1 months for patients treated with lapatinib (Tyverb) and capecitabine.

Charities said they were disappointed by the draft decision from NICE and that a change in the system for funding access to expensive cancer drugs was needed.

Breakthrough Breast Cancer said currently an estimated 1,500 women in Britain could benefit from trastuzumab emtansine every year.

Senior policy manager Dr Caitlin Palframan said: “The drug appraisal process in England, and the cost of drugs, must change if prospects for patients are going to improve.

“This is the third highly effective breast cancer drug to be rejected by NICE on the basis of cost in the last year and we will be responding to this latest decision, as well as the wider proposed changes to NICE’s drug appraisal process, in due course.”

Caitlin Palframan

Caitlin Palframan

She added: “We are now looking to the Department of Health and the pharmaceutical industry to find a way to work together to bring the cost of expensive drugs down and put a sustainable system in place by which new treatments can be made available on the NHS on a routine basis.”

Emma Pennery, clinical director at Breast Cancer Care, said: “It’s extremely disappointing news for those living with advanced breast cancer and their families that yet another treatment has not been recommended by NICE.

“We recognise that decisions about approval of cancer drugs are based on many complex factors, but we are concerned by the increasing number of people we support telling us how anxious they are about being able to access treatments when they need them,” she said.

“We await the results of the consultation period and the final guidance from NICE and hope Kadcyla will become widely available for eligible patients,” she added.

“It’s extremely disappointing news for those living with advanced breast cancer and their families”

Emma Pennery

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

A spokeswoman for Roche added that the company would be working closely with NICE as part of the consultation period before final guidance is issued.

She said trastuzumab emtansine costs £5,908.16 per month and in trials patients were treated for an average of 9.6 months at a cost of just under £57,000. But she noted that every patient responded differently to treatment.

The Cancer Drugs Fund was set up for patients in England to access drugs approved by doctors but which have not been given the go-ahead for widespread use on the NHS.

The scheme was set to run until March this year but prime minister David Cameron announced last September that the funding programme will run for a further two years to March 2016.


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