Dáil Éireann Debate, Tuesday - 20 November 2018
368. Deputy Róisín Shortall asked the Minister for Health his plans to engage with other members of the BeNeLuxA group to negotiate jointly to obtain reimbursement for Spinraza similar to that completed by the Netherlands and Belgium earlier in 2018; and if he will make a statement on the matter. [47786/18]
View answerIn July 2018, two members of the Beneluxa Initiative on Pharmaceutical Policy (Belgium and the Netherlands) completed a joint negotiation for the reimbursement of nusinersen (Spinraza). However, this joint negotiation process commenced when Ireland had only opened negotiations with Belgium, the Netherlands, Austria and Luxembourg on 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 nusinersen and we were not party to the negotiations and proceedings that occurred.
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 specifies the criteria for making reimbursement decisions, which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources available to the HSE.
The HSE received an application for the reimbursement of nusinersen in July 2017.
The National Centre for Pharmacoeconomics conducted a health technology assessment on nusinersen and did not recommend its reimbursement at the submitted price.
The application is being considered by the Rare Diseases Medicinal Products/Technology Review Committee and the HSE Drugs Group and is due to be considered by the HSE Leadership Team shortly, following which the final decisions will be notified.
The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an ongoing basis. This can lead to protracted deliberative processes, which are usually bound by strict confidentially clauses at the insistence of applicant companies.
