Acalabrutinib (Calquence®). HTA ID: 23012

Assessment Status Company no longer intend to submit a full HTA dossier
HTA ID 23012
Drug Acalabrutinib
Brand Calquence®
Indication Indicated as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The Applicant is seeking reimbursement in a subgroup of the licensed population: as monotherapy for previously untreated CLL without 17P deletion or TP53 mutation, in adult patients unsuitable for chemoimmunotherapy and venetoclax in combination with obinutuzumab.
Assessment Process
Rapid review commissioned 24/02/2023
Rapid review completed 31/03/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of acalabrutinib for this subgroup of the licensed population compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 25/04/2023
Pre-submission consultation with Applicant 20/02/2024

The company has not submitted a HTA dossier to the NCPE; therefore the cost-effectiveness of the technology could not be proven.