Ivacaftor (new indication: cystic fibrosis; F508del mutation, heterozygous, and other or unknown mutation; patients aged ≥ 6 - ≤ 11 years; in combination with ivacaftor / tezacaftor / elexacaftor)

Subject:

• Active Substance: Ivacaftor
• Name: Kalydeco^®
• Therapeutic area: Cystic fibrosis
• Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

• Start: 15.02.2022
• Final decision by G-BA: 04.08.2022

Final decision:

• No additional benefit proved