Tuesday, 9 October 2018

Ceisteanna (242)

Thomas P. Broughan


242. Deputy Thomas P. Broughan asked the Minister for Health when the diet supplement Kuvan will be available to late treated adults with PKU; and if he will make a statement on the matter. [40711/18]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The Health Service Executive (HSE) has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. 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 phenylketonuria (PKU) and treatment once initiated would be expected to be lifelong.

The National Centre for Pharmacoeconomics completed a health technology assessment of sapropterin 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 referred to the Rare Diseases Technology Review Committee for more detailed consideration and consultation with expert clinicians and patients’ groups.

The Rare Diseases Technology Review Committee is responsible for:

1. Reviewing proposals received from industry or expert groups in Ireland for funding of new products for rare diseases, or expanded indications for existing products for rare diseases and making recommendations as to the implementation of the relevant recommendations from the National Rare Diseases Plan 2011-2018; and

2. Providing contributions to the development of clinical guidelines for relevant Orphan Medicinal Products (OMPs) and supporting the implementation of guidelines in conjunction with the National Drugs Management Programme Office where applicable.

The Committee’s recommendations for reimbursement of OMPs are not intended to replace any part of the existing medicines appraisal or reimbursement process.

The HSE Leadership are scheduled to meet in October and will deliberate on the recommendations received from the Rare Diseases Technology Review Committee in relation to sapropterin.

Reimbursement of sapropterin will be considered in line with the 2013 Act.