Ibrutinib [IBR5]

For the treatment of relapsed/ refractory mantle cell lymphoma in patients who have either only received 1 prior line of systemic therapy or been treated with prior lines if 2nd line therapy was initiated before NICE’s recommendation in January 2018 where all the following criteria are met:

  1. The application has been made by and the first cycle of systemic anti-cancer therapy is to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has a confirmed histopathological diagnosis of mantle cell lymphoma
  3. Either the patient has previously been treated with one prior line of rituximab-containing chemotherapy ONLY or the patient has received ≥2 lines of therapy as long as 2nd line therapy was commenced before January 2018, the time at which NICE issued its guidance restricting use to 2nd line therapy only. Please enter below which of these scenarios applies to this patient:
  • 1 prior line of rituximab-containing chemotherapy or
  • ≥2 lines of prior systemic therapy as long as 2nd line therapy was initiated before January 2018, the time at which NICE issued its guidance recommending use as 2nd line therapy only. NB. Patients treated with more than 1 line of prior therapy are not eligible for treatment with ibrutinib unless 2nd line therapy was commenced before January 2018. ≥2
  1. The presence of relapsed/refractory mantle cell lymphoma with documented progression of disease during or following rituximab-containing 1st line chemotherapy or ≥2 lines of prior systemic therapy as long as 2nd line therapy was initiated before January 2018, the time at which NICE issued its guidance recommending use as 2nd line therapy only
  2. The patient has never received any B cell receptor therapies (ibrutinib or other Bruton’s tyrosine kinase inhibitors)
  3. Ibrutinib is to be used as a single agent
  4. Ibrutinib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment
  5. The patient’s performance status is 0 or 1 or 2
  6. The patient is not on concurrent therapy with warfarin or CYP3A4/5 inhibitors
  7. No treatment breaks of more than 6 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve)
  8. Ibrutinib will be otherwise used as set out in its Summary of Product Characteristics

[NHS funded]{.badge .rounded-pill .bg-success} From: 01 May 2018

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CDF Managed Access: NA

NICE Technology Appraisal: TA502 (31 January 2018)

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