Tezacaftor/ivacaftor (Symkevi®) with ivacaftor monopreparation (Kalydeco®) for the treatment of cystic fibrosis
The National Health Care Institute carried out an assessment in relation to extending the specific conditions for the medicinal product tezacaftor/ivacaftor (Symkevi®) with ivacaftor monopreparation (Kalydeco®). Tezacaftor/ivacaftor in combination with ivacaftor monopreparation was compared with lumacaftor/ivacaftor (Orkambi®) in this pharmacotherapeutic report. The National Health Care Institute was advised by the Scientific Advisory Committee (WAR).
Registration
Symkevi® is a combination tablet. Each film-coated tablet contains 100 mg tezacaftor and 150 mg ivacaftor. The registered indication reads as follows: tezacaftor/ivacaftor (Symkevi®) is indicated in a combination regimen with ivacaftor (Kalydeco®) 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation.
The National Health Care Institute's advice
The therapeutic value of the combination product Symkevi® (in combination with Kalydeco®) is equal to that of the combination product Orkambi® for the indication assessed. Orkambi® has been included on List 1B. For technical reasons, we advise the Minister to place Symkevi® on List 1B of the Medicines Reimbursement System (GVS) and to stipulate the following condition for both Symkevi® and Kalydeco®.
Price agreements have already been made for Orkambi®. In view of its identical therapeutic value, Symkevi® will only be eligible for inclusion in the GVS if the price of Symkevi® in combination with Kalydeco® does not exceed that of Orkambi®.
Conditions for Symkevi®
Only for use in combination with Kalydeco® for the treatment of cystic fibrosis (CF) patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene.
Conditions for Kalydeco®
Only for use in combination with Symkevi® for the treatment of cystic fibrosis (CF) patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene.
This report is a summary of recommendations by the National Health Care Institute. The original text of this excerpt is in Dutch.