acalabrutinib (Calquence)

Following a full submission:

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

Indication under review: as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

SMC restriction: as monotherapy for the treatment of adult patients with previously untreated CLL without a del(17p) or TP53 mutation and who are ineligible for fludarabine, cyclophosphamide and rituximab (FCR) therapy.

Acalabrutinib, compared with chlorambucil-obinutuzumab, significantly improved progression-free survival in adults with previously untreated CLL with co-morbidities.

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.

For SMC advice relating to the use of acalabrutinib as monotherapy for the treatment of adult patients with previously untreated CLL who have a del(17p) or TP53 mutation and in whom chemo-immunotherapy is unsuitable please refer to SMC2346.