NICE says YES to Ibrutinib to treat England and Wales NHS CLL patients


CLLSA are extremely pleased by the NICE decision to approve Ibrutinib to treat NHS England and Wales chronic lymphocytic leukaemia patients.

Today’s Final Appraisal Determination (FAD) recommends that:

1.1Ibrutinib alone is recommended within its marketing authorisation as an option for treating chronic lymphocytic leukaemia in adults:

· who have had at least 1 prior therapy or

· who have a 17p deletion or TP53 mutation, and in whom chemoimmunotherapy is unsuitable and

· only when the company provides ibrutinib with the discount agreed in the patient access scheme.

Today’s decision to make ibrutinib available for use by England and Wales NHS through routine commissioning is the result of a third appraisal committee meeting that re-evaluated evidence and considered a new value based proposition offered by the company, this has overturned earlier negative appraisal committee decisions (see below).  You can dwnload the full FAD detail here 

NICE reverses decision on CDF leukaemia drug after price drop Hundreds of people could benefit as NICE decision means ibrutinib can come off the Cancer Drugs Fund (CDF) and be routinely available to treat chronic lymphocytic leukaemia. Read NICE news article

Ibrutinib is the first in a new class of medicines known as Bruton’s tyrosine kinase (BTK) inhibitors, with a unique and targeted mode of action. It has been designed to specifically block the BTK protein from causing malignant B cells to multiply and spread. 3 The FAD recommendation was based on the results of multiple trials, including RESONATE (PCYC- 1112)4 and PCYC-1102/3. 5 NICE concluded that ibrutinib represents a clinically and cost effective treatment for patients with CLL. The UK now joins 39 countries in making ibrutinib routinely available to patients with this form of cancer. Janssen

This is a major step change in how CLL will be treated into the future and provides a much needed effective treatment option for this group who previously had very few. CLLSA members and volunteers have worked hard to maintain pressure to evidence the need for this new treatment to extend and improve the lives of CLL patients. CLLSA volunteers have participated with other charities for 18 months as consultees to provide the groups collective experiences during the health technology assessment process itself, while CLLSA members have lobbied their local MPs and health policy makers and stakeholders to raise awareness of CLL challenges and make the case for access. You can read the joint CLLSA and Leukaemia CARE patient group submission here.

We hope that today’s positive NICE announcement enables the NICE appraisal of Ibrutinib for first line use to proceed in accordance with the extension to the marketing authorisation, and that the company and NICE will continue discussions to progress this.

You can access the Final Appraisal Determination committee papers here.


We reported on June 1st that we were extremely disappointed with the second preliminary decision by the National Institute for Health and Care Excellence (NICE) not to recommend ibrutinib to treat relapsed refractory CLL, and that the  preliminary decision also confirmed  NICE were ‘minded’ not to recommend ibrutinib for treating patients with a 17p deletion or TP53 mutation

 On March 2nd we were extremely disappointed with the negative outcome of the first NICE appraisal committee meeting