Access to Kadcyla and other breast cancer drugs

This Debate Pack has been prepared ahead of the debate on access to Kadcyla and other breast cancer drugs, to be held on Thursday 26 January.

The subject for the debate has been chosen by the Backbench Business Committee, following a representation by Siobhain McDonagh.

Assessment and availability of cancer drugs in the UK

The process for the assessment of drugs’ clinical effectiveness and value for money varies in different parts of the UK. In England and Wales, the National Institute of Health and Care Excellence (NICE) produces guidance about which drugs should be available on the NHS. They look at how effective a drug is and how much it costs through a process called Technology Appraisal. Local health bodies in England and Wales must make arrangements to fund drugs that have been recommended by NICE. The Department of Health, Social Services and Public Safety in Northern Ireland also uses guidance issued by NICE in helping to determine its funding decisions.

In Scotland, the Scottish Medicines Consortium (SMC) advises NHS boards about new drugs. Like NICE, they look at how effective a drug is and how much it costs. A sub-group of the SMC called the New Drugs Committee assesses all the evidence around a newly licensed drug to help the SMC make a decision about whether or not to recommend it. NHS Quality Improvement Scotland may also review NICE guidance and decide if it should apply in Scotland.

England is the only part of the UK that has a specific fund to pay for cancer drugs (the Cancer Drugs Fund) that have not yet been reviewed for use in the NHS. However, cancer drugs may also be funded by the Scottish Government’s New Medicines Fund, set up to expand and replace the Rare Conditions Medicines Fund.

Further information about how each part of the UK decides which drugs to fund can be found on the Cancer Research UK website.

Kadcyla (trastuzumab emtansine)

Kadcyla is the brand name of a drug combining trastuzumab with another substance, emtansine. It is licensed to treat HER2-positive breast cancer which has spread to other parts of the body, cannot be surgically removed and has stopped responding to initial treatment.

The drug costs around £90,000 per patient at its full list price and recent data shows that people taking Kadcyla could live up to 9 months longer than those taking the alternative, lapatinib plus capecitabine.

In August 2014 NICE decided not to recommend funding for Kadcyla, finding that the price per patient set by the manufacturer Roche is too expensive. The SMC reached a similar decision in October 2014.

Kadcyla has been available on the Cancer Drugs Fund (CDF) in England but has not been available in Wales and Scotland. Following changes to the Cancer Drugs Fund that took place in July 2016 NICE has reconsidered its advice on drugs previously available through the Fund. Once NICE publishes its final guidance it will cease to be available through the Cancer Drugs Fund.

Around 700 patients in England access Kadcyla through the CDF in 2015/16, and it has been estimated that around 1,200 people with HER2-positive, unresectable, metastatic breast cancer would be eligible to receive Kadcyla if it were routinely funded by the NHS.

On 29 December 2016 NICE published draft guidance, confirming its original recommendation that Kadcyla should not be routinely funded on the NHS. NICE is currently consulting on its draft guidance and is expected to take a final decision in March 2017. (Consultation on the draft guidance was open until 20 January 2017. Kadcyla will continue to be available through the Cancer Drugs Fund while the NICE appraisal is ongoing:

https://www.nice.org.uk/news/article/kadcyla-too-expensive-for-routine-funding-on-nhs

If the final NICE guidance remains negative patients already receiving the drug via the CDF will continue to receive it until the patient and their prescribing physician consider it appropriate to discontinue treatment. From 90 days after the publication of the final guidance no new patients will be able to receive Kadcyla from the CDF.

Breast cancer patients and charities have raised concerns about the potential withdrawal of access to Kadcyla. See Sections 2 and 3 of this briefing pack for further information.