GVS advice extension further conditions for elexacaftor/tezacaftor/ivacaftor (Kaftrio®) in combination with ivacaftor (Kalydeco®)
The National Health Care Institute has completed its assessment whether the further conditions of elexacaftor/tezacaftor/ivacaftor (Kaftrio®) in combination with ivacaftor (Kalydeco®) could be extended. The application for the extension of the further conditions is related to patients aged 12 and older with cystic fibrosis having at least one F508del mutation in the CFTR gene. The National Health Care Institute advises the Minister to amend the further conditions for elexacaftor/tezacaftor/ivacaftor and ivacaftor mono preparation as below and extend them with the assessed indication.
Indication for which reimbursement is requested
Kaftrio® is a combination tablet. Each film-coated tablet contains 100 mg elexacaftor, 50 mg tezacaftor and 75 mg ivacaftor. The licensed indication being evaluated is elexacaftor/tezacaftor/ivacaftor (Kaftrio®) in a combined regimen with ivacaftor (Kalydeco®) 150 mg tablets for treating CF in patients aged 12 and older with at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Kaftrio® combined with Kalydeco® has already been included on List 1B in the Medicine Reimbursement System (GVS) with further conditions on List 2. Therefore, this assessment only concerns the therapeutic value for the following patient groups:
- CF patients aged 12 and older with a heterozygous F508del mutation plus a gating mutation;
- CF patients aged 12 and older with a heterozygous F508del mutation plus residual CFTR function;
- CF patients aged 12 and older with a heterozygous F508del mutation plus an unknown CFTR mutation.
National Health Care Institute's advice
The National Health Care Institute advises the Minister to amend the further conditions for elexacaftor/tezacaftor/ivacaftor and ivacaftor mono preparation as below and extend them with the assessed indication. The National Health Care Institute also recommends that the combination therapy be regularly evaluated based on the start and stop criteria established by the physicians' association. During previous assessments of CFTR modulators, agreements were already reached about this; this assessment will be taken into account.
Expansion of the condition for elexacaftor/tezacaftor/ivacaftor (Kaftrio®)
Only in combination with ivacaftor for the treatment of cystic fibrosis (CF) patients aged 12 and older who have at least one F508del mutation in the CFTR gene.
Expansion of the condition for ivacaftor (Kalydeco®)
Only in combination with elexacaftor/tezacaftor/ivacaftor for cystic fibrosis (CF) patients aged 12 and older who have at least one F508del mutation in the CFTR gene.