AQW 21935/17-22

Ms Paula Bradshaw
Alliance Party
South Belfast

Tabled Date: 07/09/2021
Answered On Date: 23/09/2021
Priority Written: No

Question:
To ask the Minister of Health to outline the timeline under which Kuvan will be made available to people aged under 22 living with Phenylketonuria, in line with the decision of the National Institute for Clinical Excellence published on 20 August 2021.

Answer:

Final draft guidance (FAD) is published by the National Institute for Health and Clinical Excellence (NICE) to allow stakeholders 15 days to appeal against the FAD recommendations. Where there are no appeals, the guidance is formally issued as a technology appraisal (TA).

NICE expects to publish a sapropterin (Kuvan) TA on 22 September 2021, after which my Department will consider it under the process set out in circular HSC (SQSD) 2/13 available at: https://www.health-ni.gov.uk/sites/default/files/publications/dhssps/hsc-sqsd-2-13.pdf

New medicines are adopted in Northern Ireland via the Managed Entry process. Where a positive FAD is issued, the Commissioner (HSC Board) can initiate interim commissioning arrangements via a Cost per Case (CPC) mechanism where providers are in a position to comply with the specifications contained in the FAD.

Delivery is dependent on the availability of the drug from the manufacturer and the practicalities associated with delivering the treatments to patients. At this moment precise timing is not yet known for sapropterin (Kuvan).