Jim Daly (Cork South West, Fine Gael) | Oireachtas source

I thank the Deputies for raising this issue. It was raised this morning as well during Leaders Questions. I acknowledge the people in the Gallery who have more than a passing interest in this serious issue and in ensuring that we get a satisfactory outcome.

Securing access to new and innovative medicines in a timely manner is a key objective of the Minister for Health and the Health Service Executive. However, these new products are often very expensive, with significant potential impact on the health service budget. The Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. The Act specifies the criteria to be applied in the making of reimbursement decisions which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE. In reaching its decision, the HSE will examine all the relevant evidence and will take into account such expert opinions and recommendations as are appropriate including from the National Centre for Pharmacoeconomics, NCPE.

This ensures that reimbursement decisions are made on objective scientific and economic grounds. The HSE has advised the Department that, following an intensive process, it has decided not to reimburse Vimizim, which is for the treatment of Morquio A syndrome. I appreciate that this condition is a serious one and that the families of children diagnosed with this illness are extremely anxious to obtain any treatment which they believe will alleviate its symptoms. The HSE drugs group, which reviewed the effectiveness of the drug, did not consider the evidence for its clinical benefit to be sufficiently strong in the context of the proposed cost and budget impact.

The applicant company was notified on 7 November 2017 of the HSE’s decision not to add Vimizim to its reimbursement list. The HSE advised the company that it would be open to reviewing any additional clinical evidence if this becomes available. The company submitted a new application for reimbursement in December 2017. This was discussed at the January 2018 drugs group meeting and will be considered further by the HSE leadership in the coming weeks.

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