Tommy Broughan (Dublin Bay North, Independent)
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670. To ask the Minister for Health when the medical supplement Kuvan will be approved for persons with phenylketonuria; and if he will make a statement on the matter. [30850/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the 2013 Act. The Act specifies the criteria for decisions on the reimbursement of medicines. The 2013 Act does not give the Minister for Health any powers in this regard. The HSE does not require approval or consent from the Minister or Government when making a reimbursement decision.

This process ensures that treatments that are clinical and cost effective are reimbursed. In circumstances where a company has failed to demonstrate the clinical benefit to support the price that they are seeking for their treatment, the HSE reaches a decision not to reimburse the medicine.

Kuvan (Sapropterin) is a medicinal product for the treatment of PKU Phenylketonuria. It is an expensive medicine and treatment once initiated would be expected to be lifelong.

The NCPE health technology assessment of Sapropterin was completed on the 15th September 2017 and they did not recommend reimbursement as it was not deemed cost effective.

The application was considered in detail by the HSE Drugs Group in January 2018 and it was referred to the Rare Diseases Technology Review Committee for more detailed consideration and consultation with expert clinicians and patients’ groups.

This engagement process is still on-going. It is expected that the Rare Diseases Technology Review Committee will  report back to the HSE Drugs Group by July 2018. Following on from these final recommendations, a decision will be made on the reimbursement of Kuvan.