New drug approval system is vital for change , says James Jopling
I RECENTLY attended the funeral of a supporter of Breakthrough Breast Cancer who had secondary breast cancer. Her death was a stark reminder that, despite advances in breast cancer treatment, we are still a considerable way from being able to offer reassurance that when the disease spreads to other parts of the body we can stop it. More immediately, the system of access to drugs in Scotland has not been effective at ensuring those secondary breast cancer medicines that can delay spread and extend life are made available to women at this incurable stage of the disease.
So we are hopeful that the new system recently introduced in Scotland to assess medicines for those at the end of their life, such as cancer patients, will make a difference. The approval body – the Scottish Medicines Consortium (SMC) – has amended its process to place much greater value on the views of patients when deciding whether a medicine is approved or not. One of the problems of the old system was that good medicines were often rejected on the grounds of cost, with less attention paid to the views of those affected. But we hope to have a new system which will give patients a far greater say and much bigger influence over decisions to approve or reject.
The system is designed to take account of the value of a new medicine in the eyes of patients and of clinicians, especially those with a price tag higher than what historically has been acceptable. This is important to increase the number of medicines available to patients. To fully meet this, all parties involved must take a fresh look at the part they play.
Firstly, charities such as Breakthrough Breast Cancer need to ensure the patient voice is not only heard loud and clear but also that the case for the benefit and value of each medicine is convincingly made. Secondly, the SMC needs to consider not just the impact on patients but also the innovation behind medicines, so that Scotland does not lag behind other countries in offering the best possible cancer treatments. You may have read recently about the decision to reject a medicine for secondary breast cancer patients called Kadcyla – also known as TDM1 – for use on the NHS in England. It may well be this is one of the first medicines to be considered under the new system in Scotland and for us, it is arguably one of most exciting medicines to emerge in years.
Kadcyla is the first targeted chemotherapy drug for breast cancer. For women with a particular type of secondary breast cancer, this drug targets the cancer cells and releases chemotherapy into only these cells. Normally, chemotherapy affects healthy and unhealthy cells, often giving women significant side-effects. Kadycla minimises damage to healthy cells meaning side effects are reduced. So this is a very novel and innovative medicine that has also been proven to be very effective. In clinical trials, it has been shown to extend life in women by around six months, which could make a huge difference to those living with this advanced form of the disease. While we still don’t know how to stop women from dying from secondary breast cancer, medicines that provide additional time to live should be seen as a real breakthrough. That’s why we are urging the SMC to recognise how innovative this drug is, along with its huge value to patients, and do everything in its power to approve it.
Finally, the pharmaceutical industry must price drugs realistically, at a level that offers the best chance of approval – and the new system offers manufacturers fresh impetus. We believe the industry needs to respond in kind to the efforts the Scottish Government, Scottish Parliament and the SMC have gone to in developing a system to increase the number of available medicines.
Ensuring access to medicines is only one side of the challenge of making medicines available to those who need them. The other is developing medicines in the first place. As a charity that funds millions of pounds of breast cancer research every year, Breakthrough is leading the way to find out more about secondary breast cancer – which kills 1,000 women a year in Scotland. That’s around three women each day, every day. Our work is focused on finding out how breast cancer spreads and how can we stop that from happening. When we know the answers to these questions, we will have gone a long way towards stopping breast cancer from taking the lives of people we know.
• James Jopling is Director for Scotland at Breakthrough Breast Cancer www.breakthrough.org.uk