26 October 2021

The National Institute for Health and Care Excellence (NICE) has today (Tuesday 26 October 2021) announced its provisional decision to not recommend breast cancer treatment tucatinib with trastuzumab and capecitabine for routine use on the NHS in England for treating HER2 positive, locally advanced or secondary breast cancer after at least two prior anti-HER2 treatment regimens.

Tucatinib (also known as Tukysa), manufactured by SeaGen, is a targeted therapy known as an oral tyrosine kinase inhibitor (TKI) and works by blocking a specific area of the HER2 gene in cancer cells, which stops the cells from growing and spreading.

The latest data from the HER2CLIMB clinical trial presented at ASCO 2021 showed that tucatinib with trastuzumab and capecitabine can extend the time before a patient's condition progresses (progression-free survival) by 2.7 months on average, compared to trastuzumab with capecitabine. The tucatinib combination also improved overall survival, giving patients an additional 5.5 months on average, compared with trastuzumab and capecitabine. The improvement in progression-free and overall survival was observed in people with and without brain metastases.

The cost-effectiveness estimates for the treatment are higher than what NICE considers a cost-effective use of NHS resources and there will now be a period of consultation, until 16 November, followed by a further NICE committee meeting after which a final decision will be made.

The Scottish Medicines Consortium (SMC) is also currently assessing this treatment for use on the NHS in Scotland. We expect an SMC decision in early 2022. Wales and Northern Ireland normally follow NICE decisions.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“We’re immensely disappointed that NICE has provisionally been unable to approve tucatinib with trastuzumab and capecitabine for certain patients* with HER2 positive, locally advanced or secondary breast cancer - a treatment which could extend the lives of hundreds of people.

“It’s particularly devastating that this new, effective treatment could remain out of reach for people whose breast cancer has spread to the brain whose only treatment options have limited effectiveness, meaning they continue to face the bleak reality of potentially shorter prognoses and a poorer quality of life.

“This draft decision on tucatinib must be turned from a ‘no’ into a ’yes’ so that people with incurable breast cancer get the chance of more quality time before their disease progresses, and potentially even an extension to their life. Pharmaceutical company SeaGen, NICE and NHS England must urgently work together during the consultation period to consider every possible solution so that this drug becomes routinely available at a price that the NHS can afford.

“Today’s provisional rejection highlights the further work needed to ensure earlier discussions between NICE and drug manufacturers do deliver rapid access to clinically and cost-effective treatments that patients so desperately need, and without agonising waits when they simply don’t have time for any delays.”

ENDS

Notes to Editors

*After two or more other treatments specifically for HER2 positive breast cancer, i.e. anti-HER2 treatments