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

I thank Senator Swanick for raising this matter.

Spinraza is indicated for the treatment of 5q spinal muscular atrophy, SMA, a disorder characterised by progressive muscle atrophy and weakness. I am mindful of the fact that access to potentially beneficial drug treatments is an important issue for all people with serious illnesses. I fully appreciate that SMA sufferers and their families face enormous day-to-day challenges in dealing with this progressive and debilitating condition.

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. 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 making a reimbursement decision, 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 take into account such expert opinions and recommendations that are appropriate, including from the National Centre for Pharmacoeconomics, NCPE. This ensures that each reimbursement decision is made on objective, scientific and economic grounds.

The HSE received an application for the reimbursement of Spinraza in July 2017 and referred it to the NCPE for advice. The NCPE conducted a health technology assessment on Spinraza and did not recommend reimbursement at the price sought by the applicant. The application for the reimbursement of Spinraza is currently being considered by the technology review committee on rare diseases and the HSE drugs group. These expert bodies are carefully reviewing the clinical effectiveness and cost effectiveness of the product in light of the prices being charged by the company which make it a very high cost treatment.