Response From Minister Harris on my Question Regarding PKU and Kuvan Availability

I wish to thank Senator Noone for raising this issue.

Medicines play a vital role in improving the overall health of Irish patients. Securing access to new and innovative medicines in a timely manner is a key objective of the Irish health service. The challenge is to deliver on this objective in an affordable and sustainable way.

Under the community pharmacy schemes alone, over 70 million prescription items will be dispensed in 2017, at an estimated cost of approximately €1.7 billion – taking account of fees and ingredient cost.

In addition, the HSE will spend in excess of €500 million in 2017 on medicines through a range of other schemes, in hospitals and in other care settings, for example in nursing homes.

Spending on medicines represents one of the largest areas of expenditure across the health service, and it will continue to grow in the years ahead as our health service continues to meet the needs of our citizens.

This is most welcome and can have a transformative impact on the health of patients. However, as the Minister has stated previously, the cost that some companies seek to charge for their medicines may result in a situation where certain treatments will never become available to patients. This is the case not only in Ireland but across Europe.

That is why it is essential that Ireland has a scientific, robust and evidence based assessment process in place. This ensures that decisions in relation to the reimbursement of medicines are made on an objective and scientific basis, recognising the health needs of the population and other factors.

The Health (Pricing and Supply of Medical Goods) Act 2013 provides the legal framework in Ireland for such a process. This Act gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of expert opinion as appropriate. The HSE follows the process set out in the Act for the assessment of all drugs.

In reaching its 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 it may have sought, including, for example, advice from the National Centre for Pharmacoeconomics (NCPE).

In December 2015, the company Merck Serono advised the HSE that the market authorisation for Kuvan was transferring to Biomarin in 2016.  The HSE met with the new market authorisation holder in May 2016, which advised the HSE that it would be submitting a health technology assessment dossier for Kuvan.

The NCPE assessment of the new dossier was completed in September 2017 and the NCPE did not recommend Kuvan for reimbursement as it was not deemed cost effective.

The HSE assessment process is ongoing and the HSE will take into account the expert advice of the NCPE when making its decision, in line with the Health (Pricing and Supply of Medical Goods) Act 2013.

The robust nature of this evidence based assessment process helps to ensure that the Irish health service makes the most efficient use of its finite resources.

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