28 November 2019

The National Institute for Health and Care Excellence (NICE) has today (28 November 2019) approved palbociclib in combination with hormone therapy fulvestrant as a new breast cancer treatment for NHS use in England via the Cancer Drugs Fund1.

This combination will offer a new treatment option for patients with hormone receptor positive, HER2 negative locally-advanced or metastatic breast cancer after prior hormone therapy.
Palbociclib (Ibrance, Pfizer) is one of a new class of drugs known as CDK4/6 inhibitors, which work by targeting two crucial cell division proteins called CDK4 and CDK6. Two similar drugs called abemaciclib and ribociclib are already available in combination with fulvestrant on the Cancer Drugs Fund (CDF) for treating this patient group, and today’s decision will now see a third option made available to patients and their doctors.

For patients who have received prior hormone therapy, a major trial (PALOMA-3) has shown that giving palbociclib in combination with fulvestrant extends the time before a patient’s disease progresses (progression-free survival) by 6.6 months on average, compared to fulvestrant alone. 

It is estimated that around 3,000 patients who have already had hormone therapy could now be eligible for this option via the Cancer Drugs Fund (CDF). The CDF enables NICE to conditionally approve promising treatments whilst more data is collected. Following this period of data collection, NICE will reconsider the treatment and make a final decision on its use on the NHS.
Palbociclib is already available for routine use in combination with an aromatase inhibitor as a first-line treatment for patients with previously untreated hormone positive, HER2 negative locally-advanced or metastatic breast cancer.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, the research and care charity said: 

It’s fantastic news that palbociclib with fulvestrant can be offered as an alternative treatment option to thousands of people living with metastatic, incurable breast cancer who have already received hormone therapy. 

Palbociclib is one of an exciting new generation of medicines that can slow the spread of the disease. In combination with fulvestrant, this treatment can offer patients with metastatic breast cancer an extra six months before their disease progresses – time to live well and continue with daily activities for as long as possible. This combination treatment can also delay the need for chemotherapy and the debilitating side effects it can bring, which will be a relief for many patients.

The addition of palbociclib with fulvestrant to NHS care after initial hormone therapy, alongside similar drugs abemaciclib and ribociclib, will help offer patients more choice of treatments and more control over their quality of life as they come with different side effects. It’s vital that all patients receive the support and information they need to make the treatment decision that’s right for them.

We hope NICE will be able to approve this combination for routine use following its time on the Cancer Drugs Fund and look forward to further trial results to understand whether this treatment could also extend patients’ lives overall.”


Notes to Editors

1. The Cancer Drugs Fund provides access to patients in England, but drugs on the fund also benefit patients in Wales and Northern Ireland. In Wales, drugs on the CDF are covered by the New Treatment Fund and the Northern Ireland Department of Health now also provides access to drugs recommended for use on the CDF.

The Scottish Medicines Consortium (SMC) approved palbociclib with fulvestrant for routine use on Scotland’s NHS in July 2019.