Kadcyla to stay on Cancer Drugs Fund, but system ‘must change’

Breast cancer treatment Kadcyla, will remain available to patients after a last-minute deal on its price between NHS England and pharma company Roche.

The drug was one of dozens marked for de-listing from England’s Cancer Drugs Fund in September, with companies given two months to negotiate on prices on some of the drugs.

Kadcyla was one such drug judged to be clinical beneficial but too costly for use on the NHS, and Roche and NHS England has agreed a deal to keep it on the controversial CDF.

The decision has been hailed as a victory by breast cancer charities – but the news has been bad for most other cancer types. Eleven different cancer drugs across 17 different indications have been cut, including treatments for bowel cancer, kidney cancer, lymphomas and leukaemias.

The de-listing process has been condemned by charities and pharma companies, who says the entire drug appraisal and patient access system in England must be reviewed.

Charity called on Roche to lower price

Kadcyla was one of the most expensive drugs on the CDF, costing up to £65,000 per patients, and charity Breast Cancer Now took the unusual step of calling on Roche to lower its price.

Baroness Delyth Morgan, Chief Executive of Breast Cancer Now, said: “More than 42,000 people joined our call on Roche to reduce the price of Kadcyla, and keep it available through the Cancer Drugs Fund, so we’re pleased that our voices have been heard.

However she said the de-listing of Roche’s Avastin for breast cancer patients was ‘devastating’ for some relying on it.

“There’s a bigger problem with our drug access and pricing system that will not go away.”

Morgan said the charity was calling on the Prime Minister to take a lead. “A better, more flexible system will benefit the pharmaceutical industry, healthcare professionals, and – most importantly of all – the patients whose lives depend on these treatments.

“We mustn’t let today’s victory on Kadcyla distract from the bigger job at hand. It’s time for the government to act. Patients cannot wait any longer for a system that works.”

Roche response

In its response to the news, Roche said it had secured Kadcyla’s continued funding through negotiations with NHS England, but wouldn’t reveal the price cut involved.

The company’s new UK managing director Richard Erwin said it had worked ‘tirelessly’ with NHS England to secure continued funding for Kadcyla for breast cancer and Avastin for cervical cancer patients, but could not stop Avastin being de-listed for colorectal and triple negative breast cancer patients.

He added: “This means that patients in England will no longer have access to medicines that are routinely available as standard of care across most of Europe,” and said an estimated 2,000 patients would lose out because of these decisions.”

Roche says it ‘the norm’ in Europe to be able to negotiate prices on any drug, and saw no reason why the UK should be an exception.

Underlining the great anxiety caused to patients, their carers and families by the de-listing process, Erwin called for a “pragmatic, flexible and sustainable system” for assessing medicines that prioritises clinical value.

NHS England has already put forward plans for reforming the CDF, which looks set to become a ‘managed access’ fund overseen by NICE from April 2016. However the formal consultation on the changes have yet to be launched, causing concern about the delay.

Meanwhile, the Accelerated Access Review recently put forward its own suggestions for a new system, allowing faster access via more ‘conditional yes’ approvals for new drugs which show promise.

Drugs saved from de-listing

Takeda’s Adcetris (brentuximab) refractory systemic anaplastic lymphoma; CD30+ Hodgkin’s lymphoma

Roche’s Avastin (bevacizumab) metastatic cervical cancer

Janssen’s Caeylx (pegylated liposomal doxorubicin) treatment of named sarcomas

Janssen’s Imbruvica (ibrutinib) for Mantle Cell Lymphoma

Roche’s Kadcyla (trastuzumab emtansine) HER2+ locally advanced/unresectable or metastatic breast cancer 

Appeal pending

Bayer’s Xofigo (radium-223 dichloride) Castration resistant prostate cancer in patients with bone metastases

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