Acalabrutinib monotherapy [ACA3]

For the treatment of patients with previously untreated chronic lymphatic leukaemia which does not have a 17p deletion or a TP53 mutation and in whom chemotherapy with FCR or BR is unsuitable 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 diagnosed with chronic lymphatic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
3. The patient has been tested for 17p deletion and the result is negative.
4. The patient has been tested for TP53 mutation and the result is negative.
5. The patient has symptomatic disease which requires systemic therapy.
6. In the absence of this acalabrutinib treatment option, the patient would otherwise have been considered as UNSUITABLE for treatment with the combination of fludarabine, cyclophosphamide and rituximab (FCR) or the combination of bendamustine and rituximab (BR). Note: AstraZeneca did not make a submission to NICE for the assessment of clinical and cost effectiveness of 1st line acalabrutinib in patients suitable for chemotherapy and hence NICE was unable to make a recommendation for this patient population.
7. The patient has not received any previous systemic therapy for CLL/SLL unless 1st line acalabrutinib was previously commenced via an AstraZeneca early access scheme or the patient commenced 1st line zanubrutinib and the zanubrutinib has had to be stopped solely because 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 systemic therapy for CLL/SLL i.e. is completely treatment-naive or
• the patient previously commenced 1st line acalabrutinib via an AstraZeneca early access scheme and all other treatment criteria on this form are fulfilled
• the patient previously commenced 1st line zanubrutinib and the zanubrutinib has had to be stopped solely because of dose-limiting toxicity and in the clear absence of disease progression

8. The patient has an ECOG performance status of 0 or 1 or 2.
9. 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.
10. 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.
11. Acalabrutinib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
12. 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.
13. 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.
14. Acalabrutinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 20 July 2021

Additional information

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 08 May 2025 at 22:10.

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.