AQW 22142/17-22

Mr Andrew Muir
Alliance Party
North Down

Tabled Date: 09/09/2021
Answered On Date: 23/09/2021
Priority Written: No

Question:
To ask the Minister of Health, pursuant to AQW 21174/17-22, why Kaftrio is not available to people under the age of 12; and whether there are any plans to review this decision.

Answer:

The current marketing authority (license) for Kaftrio covers patients aged 12 years and older. An application to expand Kaftrio to children aged 6 to 11 years has been sought by the manufacturer from both the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). The timing of these regulatory decisions are as yet unknown and the marketing authorisations for Kaftrio has not changed.

Younger children and those over 12 years who are not eligible for Kaftrio will continue to benefit from access to other cystic fibrosis drugs where clinically appropriate.