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NICE approves funding for IMBRUVICA® (ibrutinib) as second-line therapy for adult CLL patients with del(17p), TP53 mutation, or in whom chemotherapy is unsuitable

Feb 3, 2017

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), TP53mutation, 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 versusofatumumab in R/R CLL 2

  • Ibrutinib had a significantly longer PFS than ofatumumab (median, not reached vs1 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 versuschlorambucil in previously untreated CLL 3

  • 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% vs85%; 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 CLL 4

  • 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. 1Per 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

  1. NICE U-turn on Imbruvica sees the leukaemia therapy backed for NHS use. 2017 Jan 27. [Accessed 2017 Feb 2].
  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.
  3. 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.
  4. 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.
  5. PharmaTimes Online. CLL patients get routine NHS access to Janssen’s Imbruvica. 2017 Jan 26. [Accessed 2017 Feb 2].