NICE Issues Technology Appraisal Guidance for Ibrutinib for Previously Treated CLL and Untreated CLL with 17p Deletion or TP53 Mutation

It is recommended in adults who have had at least one prior therapy or who have a 17p deletion or TP53 mutation and in whom chemo-immunotherapy is unsuitable

On 25 January 2017, the NICE issued technology appraisal guidance in which recommended ibrutinib alone within its marketing authorisation as an option for treating chronic lymphocytic leukaemia (CLL) in adults who have had at least one prior therapy or who have a 17p deletion or TP53 mutation, and in whom chemo-immunotherapy is unsuitable and only when the company provides ibrutinib with the discount agreed in the patient access scheme.

The appraisal committee concluded that idelalisib plus rituximab was the most relevant comparator and, for those who cannot take idelalisib plus rituximab, best supportive care was the best comparator in both populations. The appraisal committee was aware that it had not been presented with evidence comparing ibrutinib with best supportive care.

The appraisal committee concluded that ibrutinib offered a more preferable toxicity profile, and was likely to offer progression-free and overall survival benefits compared with idelalisib plus rituximab, but was mindful that the extent of this benefit was uncertain.

No evidence was presented for ibrutinib compared with best supportive care. However, the appraisal committee concluded that it was likely that ibrutinib would be more effective compared with best supportive care than when compared with idelalisib plus rituximab.

The appraisal committee agreed that ibrutinib represented an important and effective treatment in CLL. It was satisfied that, in both populations of this appraisal, the incremental cost-effectiveness ratios (ICERs) for ibrutinib fell within the range normally considered as a cost-effective use of NHS resources for a treatment that fulfils the end-of-life criteria, when incorporating the confidential updated patient access scheme for ibrutinib and the existing patient access scheme for idelalisib.