Published

May 11, 2025

Acalabrutinib monotherapy [ACA2]

For the treatment of patients with previously treated chronic lymphatic leukaemia where the following criteria have been met:

  1. This application for acalabrutinib is being made by and the first cycle of this systemic anti-cancer therapy with acalabrutinib 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 chronic lymphatic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
  3. The patient has been tested for 17p deletion and for TP53 mutation and the results are as shown below: negative for both 17p deletion and TP53 mutation
  • positive for 17p deletion and negative for TP53 mutation or
  • negative for 17p deletion and positive for TP53 mutation or
  • positive for both 17p deletion and TP53 mutation
  1. The patient has symptomatic disease which requires systemic therapy.
  2. The patient has been previously treated with systemic therapy for CLL/SLL.
  3. The patient is treatment naïve to a Bruton’s kinase inhibitor or the patient has been previously commenced on zanubrutinib or ibrutinib monotherapy for previously treated CLL/SLL and the zanbrutinib or ibrutinib has had to be discontinued solely because of dose-limiting toxicity and in the clear absence of disease progression or the patient has previously been treated with the 1st line combination of ibrutinib plus venetoclax and was still in response on completion of treatment but has since relapsed and this application will be the first use of a BTK inhibitor since the 1st line combination of ibrutinib plus venetoclax. Please mark which of the 4 scenarios below applies to this patient:
  • the patient has not received any previous therapy for CLL/SLL with a Bruton’s kinase inhibitor or
  • the patient previously commenced zanubrutinib for relapsed/refractory CLL/SLL and zanubrutinib has had to be stopped solely because of dose-limiting toxicity and in the clear absence of disease progression or
  • the patient previously commenced ibrutinib for relapsed/refractory CLL/SLL and ibrutinib has had to be stopped solely because of dose-limiting toxicity and in the clear absence of disease progression or
  • the patient has previously been treated with the 1st line combination of ibrutinib plus venetoclax and was still in response on completion of treatment but has since relapsed and this application will be the first use of a BTK inhibitor since the 1st line combination of ibrutinib plus venetoclax
  1. The patient has an ECOG performance status of 0 or 1 or 2.
  2. Use of acalabrutinib in this indication will be as monotherapy. Note: AstraZeneca did not submit evidence to NICE for consideration of acalabrutinib in combination with an anti-CD20 monoclonal antibody in this indication.
  3. The prescribing clinician is aware that whereas the bioavailability of acalabrutinib CAPSULES is reduced by co-administration of an antacid or a proton pump inhibitor, acalabrutinib TABLETS can be safely co-administered with gastric acid reducing agents such as proton pump inhibitors, H2-receptor antagonists and antacids (see acalabrutinib’s Summary of Product Characteristics). Note: this distinction between acalabrutinib capsules and tablets is also important as stocks of acalabrutinib capsules will no longer be available from mid November 2023; existing stocks of acalabrutinib capsules should be used as soon as possible. Acalabrutinib tablets are currently available.
  4. Acalabrutinib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner. Note: Patients entered into the NIHR STATIC trial (NIHR ref: 52879) may be randomised to receive intermittent treatment as part of the trial protocol
  5. A formal medical review as to whether treatment with acalabrutinib 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.
  7. Acalabrutinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 20 July 2021

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA689 (21 April 2021)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 13 May 2025 at 19:45.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.