The HSE has statutory responsibility for medicine pricing and reimbursement, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.
Following detailed consideration of an application for the reimbursement of Nusinersen (Spinraza) and lengthy engagement with the company, the HSE decided that it was unable to reimburse Nusinersen (Spinraza). The HSE concluded that the evidence for clinical effectiveness was still quite limited and that the price proposed by the manufacturer was not a cost-effective use of resources.
On 21 February 2019, the HSE wrote to the manufacturer involved and informed them of the proposal to refuse reimbursement at the current price offering. Under the requirements of the Health (Pricing and Supply of Medical Goods) Act 2013 the company had 28 days to respond or make representations to the HSE’s proposed decision.
I am advised by the HSE that the manufacturer submitted additional information and that the matter remains under consideration by the HSE. As the statutory process is ongoing, it would be inappropriate for me to meet with family members at this time.
As the Deputy is aware, in June 2018, I signed the BeNeLuxA Initiative on Pharmaceutical Policy to work with Austria, Belgium, the Netherlands and Luxembourg on drug pricing and supply. This Agreement is in line with my objective to work with other European countries to identify workable solutions, in an increasingly challenging environment, to secure timely access for patients to new medicines in an affordable and sustainable way.
The BeNeLuxA collaboration was established in 2015, with a view to taking a collective approach to pharmaceutical procurement and evaluation. This Initiative seeks to enhance patients' access to high quality and affordable treatments, improve the payers' position in the market through joint negotiations, increase transparency on pricing between the collaborating countries, share policy expertise and focus on knowledge building.
This Initiative is well established, with clear goals and a pragmatic approach to delivering on its objectives. Four areas of collaboration have been identified: horizon scanning, health technology assessment, information sharing and policy exchange and joint price negotiations.
The BeNeLuxA Initiative is an entirely voluntary process with a shared understanding that its workings and decisions have to accord to domestic legal frameworks.
In the case of Spinraza, two members of the BeNeLuxA Initiative (Belgium and the Netherlands) completed a joint negotiation for the reimbursement of Spinraza in July 2018. This process began before Ireland joined the collaboration and Ireland was not party to these negotiations.
