Zanubrutinib [ZAN1]

Zanubrutinib monotherapy for the treatment of patients with previously treated Waldenstrom’s macroglobulinaemia and who would otherwise be next treated with bendamustine plus rituximab where the following criteria have been met:

  1. This application is being made by and the first cycle of this systemic anti-cancer therapy with zanubrutinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has been previously diagnosed with Waldenstrom’s macroglobulinaemia.
  3. The patient has symptomatic disease which requires systemic therapy.
  4. The patient has been previously treated with at least 1 prior systemic therapy for Waldenstrom’s macroglobulinaemia. Note: NICE could not recommend the use of zanubrutinib in treatment-naïve patients in whom chemo-immunotherapy is unsuitable as the company did not submit evidence for the clinical and cost effectiveness of zanubrutinib in this patient group.
  5. In the absence of this access to zanubrutinib, the patient would otherwise be next treated with the combination of bendamustine and rituximab. Note: the only previously treated patient group for which NICE concluded that zanubrutinib was clinically and cost effective was in those patients who would otherwise be next treated with bendamustine plus rituximab. NICE did not recommend zanubrutinib in patients who would otherwise be next treated with the combination of dexamethasone, rituximab and cyclophosphamide or any other therapies.
  6. The patient is treatment naïve to a Bruton’s kinase inhibitor or the patient has been commenced on zanubrutinib via the manufacturer’s (BeiGene) early access scheme for previously treated Waldesntrom’s macroglobulinaemia and all other treatment criteria on this from are fulfilled or the patient has been previously commenced on ibrutinib for previously treated Waldenstrom’s macroglobulinaemia and the ibrutinib has had to be discontinued solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression. Please mark which of the 3 scenarios below applies to this patient:
  • the patient has not received any previous therapy for Waldenstrom’s macroglobulinaemia with a Bruton’s kinase inhibitor or
  • the patient previously commenced zanubrutinib via the manufacturer’s (BeiGene) early access scheme for previously treated Waldenstrom’s macroglobulinaemia and all other treatment criteria on this form are fulfilled or
  • the patient previously commenced ibrutinib for relapsed/refractory Waldenstrom’s macroglobulinaemia and the ibrutinib has had to be stopped solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression
  1. The patient has an ECOG performance status of 0 or 1 or 2.
  2. The use of zanubrutinib in this indication will be as monotherapy.
  3. The prescribing clinician is aware that zanubrutinib has clinically significant drug interactions with CYP3A inhibitors and inducers as described in zanubrutinib’s Summary of Product Characteristics.
  4. Zanubrutinib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
  5. A formal medical review as to whether treatment with zanubrutinib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
  6. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment, including as appropriate if the patient had an extended break on account of Covid-19.
  7. Zanubrutinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 17 January 2023

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CDF Managed Access: NA

NICE Technology Appraisal: TA833 (19 October 2022)

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