GVS advice ivacaftor (Kalydeco®) extension of further conditions
Zorginstituut Nederland carried out a review to extend the further conditions for reimbursement of ivacaftor (Kalydeco®). Since 1 June 2015, ivacaftor (Kalydeco®) has been included in the medicine reimbursement system (GVS) on List 1B, subject to further reimbursement conditions. The Zorginstituut advices to extend the List 2 conditions with the application for cystic fibrosis patients aged 6 months and older with an R117H mutation in the CFTR gene.
Extension of the indication
The current further conditions for ivacaftor are:
- only for cystic fibrosis (CF) patients with ’gating mutations’ for which ivacaftor is registered;
- only in combination with tezacaftor/ivacaftor for the treatment of cystic fibrosis (CF) patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene.
The application for the extension of the further conditions is related to patients 6 months and older with cystic fibrosis and an R117H mutation in the CFTR gene.
Zorginstituut's advice
Ivacaftor (Kalydeco®) is already included on list 1B with further conditions. Based on the new research results, the Zorginstituut advises the Minister to extend the List 2 conditions for Kalydeco® with the application for CF patients aged 6 months and older with an R117H mutation in the CFTR gene.
Extension further condition for ivacaftor
Only for cystic fibrosis (CF) patients with the R117H mutation for which ivacaftor is registered.