26 February 2021

The National Institute for Health and Care Excellence (NICE) has today (Friday 26 February 2021) announced its decision to approve ribociclib with fulvestrant for routine use on the NHS, following its time on the Cancer Drugs Fund since July 2019.

Ribociclib (Kisqali, Novartis) is one of a new class of drugs known as CDK4/6 inhibitors (abemaciclib, ribociclib, palbociclib), which work by targeting two crucial cell division proteins called CDK4 and CDK6. Ribociclib with fulvestrant is for treating patients with hormone receptor positive, HER2 negative secondary breast cancer after prior endocrine (hormone) therapy.

For patients who have received prior hormone therapy, a major trial (MONALEESA-3) showed that giving ribociclib in combination with fulvestrant extends the time before a patient’s condition progresses (progression free survival) by 5.5 months on average, compared to fulvestrant alone. Updated data also demonstrated that the treatment combination can improve overall survival, providing an additional 7.7 months on average, compared with fulvestrant.

The treatment could be an option for up to 3,300 women who have already had endocrine treatment and where exemestane plus everolimus would be the most appropriate alternative to a CDK 4/6 inhibitor. Any patients already receiving ribociclib with fulvestrant will continue to receive the drug, and this decision means that the treatment will remain an option on the NHS for future eligible patients.

Earlier this month abemaciclib with fulvestrant [link to press release], a similar treatment, was provisionally not recommended for routine use on the NHS following its time on the Cancer Drugs Fund. Palbociclib with fulvestrant has not yet been through the reappraisal process following its use on the Cancer Drugs Fund.

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

“It’s fantastic news that NICE has approved ribociclib with fulvestrant for routine use on the NHS – this life-changing treatment will now bring thousands more women living with incurable secondary breast cancer hope of precious extra time to live well.

“As well as offering certain patients with incurable breast cancer extra time with loved ones, this innovative drug combination1 can help delay the need for chemotherapy and its debilitating side effects.

“The Cancer Drugs Fund (CDF) plays a crucial role in making promising treatments available to patients sooner, while further data is collected, but today’s decision is significant in making this treatment, previously only available on the CDF, available indefinitely for patients on the NHS.

“This positive news follows the recent devastating blow for patients when a similar treatment, abemaciclib with fulvestrant, was provisionally rejected2. This treatment can come with different side effects to ribociclib with fulvestrant, and it’s vital that clinicians and patients have a choice of CDK 4/6 inhibitor treatments available on the NHS so that women can benefit from the treatment that brings them the best quality of life. As such, we stand firm in our call on NICE, NHS England and Lilly UK to urgently explore every solution to see this draft decision reversed.

“Anyone affected by breast cancer can call our free Helpline on 0808 800 6000 for information and support.”

Ends

Notes to Editor

1 Ribociclib with fulvestrant is for treating patients with hormone receptor positive, HER2 negative secondary breast cancer after prior endocrine (hormone) therapy.

2 Ribociclib is from a class of drugs known as CDK4/6 inhibitors and is similar to palbociclib and abemaciclib which were also approved for use on the CDF in 2019 for this indication. Earlier this month, abemaciclib with fulvestrant was provisionally not recommended for routine use on the NHS. Palbociclib with fulvestrant has not yet been through the reappraisal process following its time on the Cancer Drugs Fund.