Kadcyla was rejected by National Institute for Health and Care Excellence (NICE) for use in England and Wales just a few weeks ago. Now it is one of the first drugs for treating secondary, incurable cancer to be assessed under the new approval system for end-of-life medicines recently introduced by the Scottish Medicines Consortium (SMC).
Breakthrough Breast Cancer and Scottish oncologist Dr Iain Macpherson, Consultant Oncologist at the Beatson West of Scotland Cancer Centre, are calling for Kadcyla to be approved by the SMC.
A new approach in treatment
Dr Macpherson comments:
“Kadcyla is a significant improvement on existing treatments for women with the HER2 type of secondary breast cancer. In clinical trials Kadcyla was found to extend life by an additional six months compared to our current best treatments, and this was not at the expense of lots of side effects. It is also a new approach in treatment as it is the first breast cancer medicine of its type, an antibody that carries chemotherapy directly into the cancer cells whilst sparing healthy cells. If Kadcyla was approved we would expect our patients with HER2-positive secondary breast cancer to live longer, on average, than they would without this drug.”
Lynda Luke, 45 from Edinburgh, was diagnosed with secondary breast cancer in August last year and she is passionate about seeing this new drug approved:
“It’s not just about the extra six months, it’s about the added quality of life these drugs can give. My daughter is pregnant and six months extra time with her could make a huge difference and mean the world to us both, and if I had that opportunity I’d grasp it with two hands.”
The reformed approval system gives an enhanced role for the voice of patients, placing more weight on the wider value and benefit offered by end-of-life medicines. Breakthrough is leading the call in Scotland for Kadcyla to be approved by harnessing the views of women with secondary breast cancer so the strongest possible case can be made for its approval. Breakthrough wants to see the SMC and the manufacturer Roche work together to make this drug available to women who need it.
James Jopling, Director for Scotland at Breakthrough Breast Cancer says:
“This medicine is truly ground-breaking, offering a real beacon of hope for women with secondary breast cancer. From speaking to women who receive this drug in clinical trials, it has made an incredible difference. It has given many extra months of life where the outlook was previously bleak and has given women their life back which is so important at this stage of the disease.
“With that in mind we call on the SMC to do everything within its powers to give approval, considering both the innovation of this drug and its value to patients. Equally, the manufacturer needs to set the lowest possible price and we have written to Roche urging them to set the price at a level that gives this medicine every chance of being approved.”
“There are simply not enough treatment options for secondary breast cancer. Put simply, women in Scotland deserve the extra months of quality life that Kadcyla can offer.”
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.
Kadcyla has been shown to extend life by up to six months in HER2-positive secondary breast cancer patients. It has more manageable side effects and gives a better quality of life than that provided by existing treatments, which could make a huge difference to those living with the advanced form of the disease.
In the past twelve months, the SMC has already rejected two highly effective secondary breast cancer drugs. Last month, Kadcyla was initially rejected by the National Institute for Health and Care Excellence (NICE) for use on the NHS in England as well. The price, as assessed by NICE, for Kadcyla is £5,908 per month. It has been estimated that an average course of treatment costs more than £90,000.
Kadcyla has now been submitted to the SMC for review and a decision is expected to be made in the autumn.