acalabrutinib (Calquence)

following an abbreviated submission:

acalabrutinib (Calquence®) is accepted for restricted use within NHSScotland.

Indication under review: As monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

SMC restriction: For adults with relapsed/refractory CLL who have had at least one previous therapy, in whom chemo-immunotherapy is unsuitable.

Acalabrutinib offers an additional treatment choice in the therapeutic class of BTK inhibitor in this setting.

Another medicine within this therapeutic class has been accepted via the end of life and orphan medicine process.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.