Why are we campaigning again on Kadcyla?

This time last year, we were concerned that the secondary breast cancer drug Kadcyla would be removed from the Cancer Drugs Fund (CDF). We called on Roche, Kadcyla’s manufacturer, to lower the price of the drug and ensure its continued availability for all patients in England via the CDF. As a result of our campaign, Roche lowered the price and Kadcyla remained available.

Due to changes in the CDF, however, Kadcyla has recently been subject to another appraisal by the National Institute for Health and Care Excellence (NICE), which assesses the clinical and cost-effectiveness of drugs. Devastatingly, it has been provisionally rejected, which means that it could be withdrawn from new patients as early as June 2017- depending on a final decision that will be made early in 2017.

We believe that while Roche has offered a substantial discount they must now lower their price further. But critical to this outcome is NICE’s decision to use a comparator drug to calculate the cost-effectiveness of Kadcyla that is not even available to patients. We feel that this must be reconsidered and that had an appropriate comparator drug been selected, the discounted price may have seen Kadcyla fall within the cost-effectiveness threshold.

It’s time NICE and Roche put patients’ lives first and come up with a deal to ensure Kadcyla remains available to those whose lives are dependent on it. Women with secondary breast cancer have no time to lose.

On 23 January the petition closed, with over 115,000 signatures – a clear demonstration of the strength of public feeling about Kadcyla. We hope NICE and Roche have listened and will take the required action to keep this drug available.

What is Kadcyla – which patients benefit from it and what side effects does it have?

Kadcyla is a breast cancer drug benefiting patients with HER2-positive secondary breast cancer, which has either spread or come back following treatment with the breast cancer drug Herceptin. As a ‘last-line’ option, Kadcyla can prolong the lives of those taking it by an average of 5.8 months – although for some patients, this time extends to years.  

Kadcyla has been developed from Herceptin; both offer targeted treatment using therapeutic antibodies. These therapeutic antibodies work by preventing proteins, known as HER2, found in excess on cancer cells from triggering the cells to grow and divide, effectively stopping the growth of tumours. Kadcyla is unique in that each antibody is combined with a dose of chemotherapy, which is released directly into the heart of each cancer cell.

Importantly, patients taking Kadcyla usually experience far fewer side-effects, meaning they can spend the extra time they are given making memories with the people that matter to them most.

However, no breast cancer treatment comes without side effects. In rare cases, Kadcyla can cause severe liver problems. Symptoms include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine and/or itching. Kadcyla can also cause heart problems, including problems without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). 

What does this decision mean for patients?

A final decision will be made in January 2017. If the draft decision to withdraw Kadcyla is confirmed, then from June 2017, Kadcyla will no longer be available to new patients on the NHS. From then on, anyone not already receiving the drug would not get access to it, although a few patients may be able to apply for the drug via the Individual Funding Request route.

According to its manufacturer, delisting Kadcyla would affect around 1,200 patients per year.

What do I do if I have secondary breast cancer and am worried about not being able to access Kadcyla?

In the first instance, you should speak to a healthcare professional about the potential benefits and side effects of taking Kadcyla.

Will there be any way for patients to access Kadcyla if it’s rejected for use on the NHS?

Women in England may, in some cases, be able to get access to these drugs via Individual Funding Requests made by their healthcare team, but these would likely be approved on a case by case basis.

Could someone pay for Kadcyla privately?

Yes, and in some cases they do - but at great expense. Kadcyla is given intravenously and the £90,000 price tag for an average treatment course does not include hospital time, staff time or other costs associated with the administration of the drug. In reality, paying privately for this treatment is not an option for the vast majority of patients.

What’s the situation in Northern Ireland, Scotland and Wales?

Kadcyla is not currently routinely available across the other UK nations, although some patients have been able to get hold of the drug via individual funding requests. Wales and Northern Ireland usually follow NICE recommendations, so the rejection will mean that Kadcyla will also not be available in Wales and Northern Ireland.

At Breast Cancer Now we’re campaigning hard to make sure that women have access to the most effective and innovative drugs wherever they are in the country.  

The Scottish medicines approval body, the Scottish Medicines Consortium (SMC), is currently considering whether to offer Kadcyla on the NHS in Scotland.  A decision on this is expected in the first quarter of 2017. Working with women living with secondary breast cancer and their families, we believe we have submitted a really powerful case to the SMC calling for them to approve Kadcyla for use in Scotland. We hope that the SMC and drug company do all they can to reach an agreement. 

On top of that, our amazing supporters in Scotland have recently managed to secure some big changes to the way medicines are assessed in the future. We’ve reviewed the Scottish Government’s latest proposals and here are the five things you need to know about them.     

More information

If you have any questions that aren’t answered here, please get in touch with us by emailing campaigns@breastcancernow.org and we will get back to you as soon as we can.