The National Institute of Health and Care Excellence (NICE) has today issued its final decision recommending that trastuzumab emtansine (Kadcyla) is made routinely available in England for women with HER2-positive breast cancer, which is inoperable, advanced, or has spread to other parts of the body and who have previously received Herceptin® (trastuzumab) and a taxane, separately or in combination.

Patients should have either received prior therapy for locally advanced or metastatic disease or developed disease recurrence during or within 6 months of completing adjuvant therapy.

More than 53,000 cases of breast cancer are diagnosed every year in the UK, and between 15 and 25 per cent of those patients will have HER2-positive disease.

This decision reverses previous draft guidance issued in December 2016, which rejected trastuzumab emtansine’s use on the NHS in England.

It ends four years of inequality of access across the UK, bringing the country in line with Scotland and 15 other countries across the EU.

Nearly 1,000 women across the UK are expected to be eligible to receive trastuzumab emtansine each year, which has been shown in the pivotal study EMILIA (n=991) to increase the median overall survival in women with advanced HER2-positive advanced breast cancer previously treated with Herceptin and a taxane, by 5.8 months compared with lapatinib and capecitabine (30.9months vs. 25.1months, p<0.001).

Most common adverse events seen with trastuzumab emtansine treatment in the EMILIA study were thrombocytopenia (28.0%), fatigue (35.1%) and nausea (39.2%).

Commenting on today’s decision, Dr Andreas Makris, Consultant Clinical Oncologist, Mount Vernon Cancer Centre, Middlesex said “This is the news we have been waiting four years for. For patients with incurable HER2-positive breast cancer, trastuzumab emtansine is an important treatment option, able to extend life for an average of six months, giving women the invaluable time to spend with their loved ones that they deserve. Importantly, it allows them to maintain a relatively good quality of life so they can work, socialise with friends and enjoy the remainder of their lives. It is only right that eligible patients have routine access to this life-extending medicine, which is already widely available across Europe.”

Despite trastuzumab emtansine recently qualifying for NHS funding in Scotland in April 2017, its availability in England has been restricted due to changes in the Cancer Drug Fund – with patients in Wales and Northern Ireland having been denied access to it. 

Richard Erwin, General Manager of Roche, said “Roche’s commitment to bringing trastuzumab emtansine to all eligible patients across the UK has never waned. We are delighted that it is now sustainably funded in England as well as in Scotland, and that it’s finally available on the NHS for the first time in Wales and Northern Ireland."

He continued “Following the publication of the provisional negative guidance last year, close collaboration between Roche, NHS England and NICE has resulted in NICE recommending Kadcyla as a cost effective treatment. This is a positive example of how solutions can be reached when all parties show flexibility”.

Source: Roche