Last month, the National Institute for Health and Care Excellence (NICE) has approved funding for IMBRUVICA® (ibrutinib) for use by the NHS in England as a second-line therapy for adult CLL patients with del(17p), TP53 mutation, or in whom chemotherapy is unsuitable.1
Originally in March 2016, NICE rejected funding due to “numerous uncertainties in the evidence base and economic modelling”.
The change in decision is based on results of the RESONATE trials:
RESONATE (NCT01578707): ibrutinib versus ofatumumab in R/R CLL2
- Ibrutinib had a significantly longer PFS than ofatumumab (median, not reached vs 1 months)
- HR for progression or death in the ibrutinib group, 0.22; P < 0.001
- Ibrutinib had significantly better OS than ofatumumab (HR for death, 0.43; P = 0.005)
- At 12 months, OS rate was 90% and 81% in ibrutinib and ofatumumab groups, respectively
- ORR was significantly higher with ibrutinib (42.6%) than with ofatumumab (4.1%; P < 0.001)
RESONATE-2 (NCT01722487): ibrutinib versus chlorambucil in previously untreated CLL3
- Ibrutinib had a significantly longer PFS than chlorambucil (median, not reached vs9 months) and a 84% lower risk of progression or death (HR, 0.16; P < 0.001)
- Ibrutinib had a significantly better OS than chlorambucil, estimated survival rate at 24 months was 98% vs 85%; relative risk of death that was 84% lower with ibrutinib than with chlorambucil (HR, 0.16; P = 0.001)
- ORR was higher with ibrutinib (86%) than with chlorambucil (35%; P < 0.001)
RESONATE-17 (NCT01744691): ibrutinib in R/R CLL4
- Median follow-up = 11·5 months (IQR 11.1–13.8)
- Overall response by independent review committee = 92/144 patients (64%; 95% CI, 56–71)
- Overall response by investigator assessment: 119/144 patients (83%; 95% CI, 76–88)
- In extended analysis (median follow-up = 27.6 months [IQR 14.6–27.7]); overall response by investigator assessment: 120/144 (83%; 95% CI, 76–89)
- 2-yr PFS = 63% (95% CI, 54–70); 2-yr OS = 75% (95% CI, 67–81)
- Treatment discontinuation was due to progressive disease (n = 34, 24%), adverse events, unacceptable toxicity, or death (n = 24, 17%)
Now, 43 countries consisting of the US and 27 European nations (including the UK) routinely use IMBRUVICA® as a CLL treatment.1 Per patient, one year’s worth of IMBRUVICA® treatment costs over £55,000 (excluding the Janssen patient access scheme discount). Before now, IMBRUVICA® was only made available to UK patients through the Cancer Drugs Fund (CDF).5
- NICE U-turn on Imbruvica sees the leukaemia therapy backed for NHS use. 2017 Jan 27. http://www.pmlive.com/pharma_news/nice_u-turn_on_imbruvica_sees_the_leukaemia_therapy_backed_for_nhs_use_1185299. [Accessed 2017 Feb 2].
- Byrd J.C. et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. New England Journal of Medicine. 2014 Jul 17;371(3):213-23. DOI: 10.1056/NEJMoa1400376. Epub 2014 May 31.
- Burger J.A. et al. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. New England Journal of Medicine. 2015 Dec 17;373(25):2425-37. DOI: 10.1056/NEJMoa1509388. Epub 2015 Dec 6.
- O’Brien S. et al. Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study. Lancet Oncology. 2016 Oct;17(10):1409-1418. DOI: 10.1016/S1470-2045(16)30212-1. Epub 2016 Sep 13.
- PharmaTimes Online. CLL patients get routine NHS access to Janssen’s Imbruvica. 2017 Jan 26. http://www.pharmatimes.com/news/cll_patients_get_routine_nhs_access_to_janssens_imbruvica_1185265. [Accessed 2017 Feb 2].