Package advice acalabrutinib (Calquence®) for the treatment of chronic lymphatic leukaemia
The National Health Care Institute has completed its assessment whether acalabrutinib (Calquence®) can be included in the insured package. Acalabrutinib is indicated for the treatment of adult patients with chronic lymphatic leukaemia (CLL). The reason for this advice was the placing of acalabrutinib (for this indication) in the lock procedure for expensive medicinal products. The National Health Care Institute has concluded that acalabrutinib meets the statutory criterion of ‘established medical science and medical practice’ for the indication mentioned. The National Health Care Institute advises the Minister to include acalabrutinib in the package, provided the price negotiations with the marketing authorisation holder successfully deliver a net price that does not exceed that of the existing treatment. In March 2022, the Minister decided to include acalabrutinib in the package, from 1 April 2022.
Registered indication
Reimbursement is requested for:
- adult patients with previously untreated CLL with chromosome 17p (del17p) deletion or a tumour suppressor gene TP53 mutation and non-fit patients not eligible for anti-CD20 treatment;
- adult patients with CLL who have had at least one prior treatment for CLL.
Package advice
The National Health Care Institute has concluded that acalabrutinib meets the established medical science and medical practice for the treatment of the groups of patients with CCL that were mentioned above.
The National Health Care Institute advises the Minister to include Calquence® in the health insurance package, provided the price negotiations with the marketing authorisation holder successfully deliver a net price that does not exceed that of the existing treatment. Since there is an equal value compared to ibrutinib, which is already being reimbursed, and there are no indications that one product is preferable to another, we advise you to take the net price of ibrutinib into account during the price negotiations. We would like to point out that the Insured Package Advisory Committee has recommended that the price for a treatment should be reduced when more resources are available.