NHS England and The National Institute for Health and Care Excellence (NICE) has today announced that secondary breast cancer drug trastuzumab emtansine (Kadcyla, Roche Products) is to be made available for routine use on the NHS, in new (final) guidance following its reappraisal.
Kadcyla has been available in England through the Cancer Drugs Fund since 2014. This decision means it will continue to be available on the NHS in England.
Kadcyla is a targeted treatment for patients with HER2 positive metastatic (secondary) breast cancer. It is a combination of a drug called Herceptin (trastuzumab) and a drug called emtansine (also known as DM1), and is usually given as a second-line treatment to those patients whose condition has progressed since they first received treatment for secondary breast cancer.
Around 1,200 women with incurable secondary breast cancer will be eligible to receive Kadcyla in England each year.
Kadcyla gives significant and precious extra time to women with incurable secondary breast cancer and has been shown to offer on average around 6 months of extended life compared to existing treatments. Kadcyla also has fewer side effects than other options, enabling women to spend more quality time with their families and loved ones.
After Kadcyla’s provisional rejection by NICE on 29 December 2016, Breast Cancer Now launched an urgent petition to overturn this draft decision to both Sir Andrew Dillon, Chief Executive at NICE, and Richard Erwin, General Manager at Roche Products. In less than one month, the petition amassed over 115,000 signatures from across the country, and was delivered directly to NICE and Roche on 24 January 2017.
Today’s decision sees an eagerly-awaited and hugely welcome solution found between NHS England, NICE and Roche Pharmaceuticals, to see this lifeline drug become routinely available on the NHS throughout England. Kadcyla is currently being funded through the Cancer Drugs Fund in England.
Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:
“This is exceptionally good news for so many breast cancer patients. We are absolutely delighted that tough negotiation and flexibility by NICE and NHS England, and the willingness of Roche to compromise on price, have ensured that thousands of women with incurable breast cancer will be given precious time to live.
“We want to congratulate and thank the hundreds of thousands of supporters across the country for their relentless campaigning to ensure this crucial lifeline drug is routinely available to those that need it.
“This outcome also demonstrates vital signs of life for the drug appraisal system in this country. Today’s landmark decision bodes well for patients looking for reassurances that modern cancer treatments can get through to NHS patients more quickly and can bring transformational improvements in patient outcomes for the future.
“However, this news comes at a time when there is a real possibility that Perjeta – the first-line treatment for this group of patients – could soon be removed from NHS use, with a decision imminent.
“Perjeta’s benefits are extraordinary, offering nearly 16 additional months of life to women with incurable breast cancer, and it is imperative that a solution is found to save this drug, at a cost affordable to both the NHS and the taxpayer.”
Fiona Leslie, 49 from Aylesbury, is living with secondary breast cancer and has been on Kadcyla for just over two years to date:
"I am absolutely thrilled and overcome at the decision. Kadcyla gives women with secondary breast cancer many extra months, and even years, of life with their families and friends. I have been taking it for just over two years and enjoy a wonderful quality of life and have been able to work and live as normally as possible.
"To know that this opportunity was going to be taken away from other patients, many with young children, condemning them to an earlier death was simply horrific and cruel. The wait since we handed over the petition in January has been horrendous, and we had to grasp at the straw that 'no news was good news'.
“But this is not the end. The fight must go on as there are other effective drugs still being reviewed which may not be approved, putting other patients at risk too."
Bonnie Fox, 39 from Croydon, was 37 when she was diagnosed with both primary and secondary cancer 18 months ago – her son Barnaby was just four months old. When her current treatment becomes ineffective, Kadcyla will be her next viable treatment option:
“It's such an enormous weight off my mind and I feel immensely reassured that my next line of treatment is in place and available for whenever I’ll need it. If the decision was a no this would mean the need to start crowd funding so I had the funds available.
“I'm so thankful to Roche, NICE and NHS England for reaching a solution. It's not just what it means to me, but to all the other women depending on it and to all our families who desperately want us to be around as long as possible. More precious time with our loved ones is absolutely everything to us.
“We’re immensely grateful to everyone who supported this campaign – who signed and shared the petition, emailed their MP, to the MPs who supported it and to Breast Cancer Now for making the campaign possible. It means the absolute world to finally have confirmation that this drug has been approved.”
Rosalie Marshall, 33 and a mother of two in Barnet, was diagnosed with HER2+ primary and secondary breast cancer at the same time in 2014 at the age of 31:
"I’ve been absolutely thrilled to hear the news about Kadcyla. NICE reversing their decision means no more women dying unnecessarily when they could have years more with their families and friends.
“My fear about the cancer coming back is no longer the focus of my life. I can live knowing there is a drug for me if the disease returns, a drug that could extend my life by years. This removal of fear from my life and the life of my children means the whole world to me.
“I’d like to particularly thank Breast Cancer Now and all the MPs who spoke up for women like myself.”