Acalabrutinib is indicated as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and as monotherapy for the treatment of adult patients with CLL who have received at least one prior therapy.
The Applicant is seeking reimbursement for a subgroup of the licensed population i.e. as monotherapy only
- for the treatment of previously untreated CLL in the presence of 17p deletion or TP53 mutation in adult patients unsuitable for chemoimmunotherapy.
- for the treatment of adult patients with CLL who have received at least one prior therapy
|NCPE Assessment Process||Complete|
|Rapid review commissioned||22/12/2020|
|Rapid review completed||04/02/2021|
|Rapid Review outcome||A full HTA is not recommended. The NCPE recommends that acalabrutinib not be considered for reimbursement at the submitted price*. This recommendation is contingent on restriction of reimbursement to the proposed place in therapy which is narrower than the licensed indication.|
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations October 2021