acalabrutinib (Calquence)

following an abbreviated 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 who have a 17p deletion or TP53 mutation and in whom chemo-immunotherapy is unsuitable.

Acalabrutinib offers an additional treatment choice in the therapeutic class of Bruton tyrosine kinase 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.

For SMC advice relating to the use of acalabrutinib in previously untreated adults with CLL outwith the restriction described above, please refer to SMC2347.