Catherine Byrne (Dublin South Central, Fine Gael) | Oireachtas source

I apologise for the Minister not being here. The last time I saw him he was attending a committee meeting. He must be still there. I have been asked to take this Topical Issue on his behalf and I thank Deputy Ó Caoláin for raising it.

Nusinersen or Spinraza is indicated for the treatment of spinal muscular atrophy, SMA, a disorder characterised by progressive muscle atrophy and weakness. The Minister appreciates that this debilitating and progressive condition places enormous pressure on SMA sufferers and their families and carers and that access to potentially beneficial drug treatments is an extremely important issue for people with spinal muscular atrophy. As the Deputy is aware, 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 gives 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 relevant evidence and will take into account such expert opinions and recommendations that are appropriate, including from the National Centre for Pharmacoeconomics, NCPE.

The HSE received an application for the reimbursement of Spinraza in July 2017. The NCPE conducted a health technology assessment on Spinraza and did not recommend the reimbursement of Spinraza at the submitted price. The statutory assessment process involves a health technology assessment followed by detailed consideration by the HSE expert groups on new drug therapies, including the technology review group for rare diseases and the drugs committee. The assessment is particularly centred on reviewing the evidence of the clinical effectiveness of this new drug therapy, for example the benefits for patients undergoing clinical trials. The application is currently undergoing the final stages of assessment and the various reports are due to be considered shortly by the HSE leadership team, following which the final decision will be notified.

In July 2018, two members of the BeNeLuxA initiative on pharmaceutical policy, Belgium and the Netherlands, completed a joint negotiation for the reimbursement of Spinraza. However, this joint negotiation process commenced when Ireland had only opened negotiations with Belgium, the Netherlands, Austria and Luxembourg with a view to joining the existing collaboration between these four countries. As a candidate country, Ireland was not notified due to confidentiality arrangements that negotiations were occurring for the reimbursement of Spinraza and we were not party to the negotiations and proceedings that occurred. I understand the Deputy's frustration.

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