Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank the Deputy for raising this issue. The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs scheme, under powers this House gave to the HSE in the Health (Pricing and Supply of Medical Goods) Act 2013. In reaching a decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which it has sought including, for example, advice from the NCPE.

Kuvan was considered under the national pricing and reimbursement process in 2009. At that time, insufficient evidence was available to support the pricing and reimbursement application submitted. In 2016, the HSE was advised that a new health technology assessment dossier would be submitted on the drug. The NCPE completed its assessment of the new dossier in September 2017 and did not recommend the drug for reimbursement as it was not deemed cost-effective at the price sought by the company. I highlight that point. The HSE assessment process is ongoing and the HSE will take into account any relevant expert advice when making its decision.

I have been assured by the HSE that commercial discussions are ongoing. I cannot answer the Deputy's question about whether the meeting has taken place. I do not know but I am told commercial discussions are ongoing. I am also told the HSE has received additional submissions from patient groups, via a Member of this House, which will be considered as part of the process. Both the commercial negotiations and the consideration of the patients' submissions will take place before the drugs group finally reviews the matter and takes a decision to the HSE leadership.

I have heard parents campaigning for this drug make a very valid point. They are concerned the system we have in place for assessing drugs for rare diseases is not adequate. A new committee called the rare diseases medicinal product technology review committee has been established by the NCPE. The terms of reference of the committee have been finalised and its responsibilities include the review of proposals for funding of new products for rare diseases or expanded indications for existing products for rare diseases. It will also contribute to the development of clinical guidelines. It is a valid point. We have quite a good assessment process.

Parents argue about the need for a better review when it comes to rare diseases. This committee will carry out a review that is in addition to and separate from the assessment process.

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