Kadcyla, also referred to as trastuzumab emtansine, or T-DM1, is a unique combination drug made up of trastuzumab (Herceptin) and a very potent chemotherapy drug, DM1, linked together. Linking the drugs in this way specifically targets HER2-positive cancerous cells, leaving healthy cells relatively untouched, meaning that the side effects normally associated with chemotherapy treatment are reduced.

Every month in the UK, 1,000 women die from metastatic, or secondary, breast cancer and this treatment has the potential to provide some of them not only with additional time, but also, importantly, quality time to spend with their friends and families.

Breakthrough Breast Cancer’s 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.  

“Drug development and research is moving at a pace that the system can’t seem to keep up with. 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.  

“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. Until then it appears NICE will be forced to reject these cutting-edge treatments, some of which are capable of providing women facing terminal breast cancer diagnoses with extra time with their loved ones, which is the very least they deserve.”

Kim Mawby, 44, was told that she had stopped responding to other treatments in December 2011 and was given six months to live. Since then she has been treated with Kadcyla/T-DM1 as part of a clinical trial and couldn't be happier with the effects:

“So far this drug has given me two extra years with my husband and boys, and I'm hoping for many more as it continues to keep the cancer at bay. I still get tired sometimes, but if you didn't know me, you wouldn't know that I am ill.

"Given this news I now appreciate even more how lucky I am to be on the trial. As far as I'm concerned it's a wonder drug and no one should be denied it."

This initial ruling will now be open for consultation for a number of weeks before NICE makes its final decision in the summer.

While Kadcyla is currently available to patients in England through the Cancer Drugs Fund, this is a finite arrangement and is not a long-term solution for patients. In addition, in Wales, where NICE’s draft decision also applies, there is no Cancer Drugs Fund, so Welsh patients will not usually be able to access the drug. We expect the Scottish Medicines Consortium (SMC) to likely assess Kadcyla during the summer of this year.

Breakthrough's involvement

Before a draft decision on a new drug is made by NICE, they invite submissions from interested parties. When appropriate, Breakthrough responds in its role as a patient interest group to make sure the patient voice is heard as part of the NICE process. You can find our patient carer organisation statement about Kadcyla by clicking on the link below. Please note, this statement was submitted in January, before Kadcyla was made available to patients via the Cancer Drugs Fund.

Have your say

NICE invited comments from members of the public, patients and healthcare professionals during a consultation period regarding this decision which ended on 19 May 2014.