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

On behalf of the Minister, Deputy Simon Harris, I thank the Senator for raising this matter.

Medicines play a vital role in improving the overall health of Irish patients. Ensuring access to new and innovative medicines in a timely manner is a key objective of the health service. The challenge is to deliver on the objective in an affordable and sustainable way. However, new medicines are often very expensive. There is a large number of applications in the reimbursement process which, if all approved, would have a significant impact on an already overstretched health budget.

Spinraza is indicated for the treatment of 5q spinal muscular atrophy, SMA, a disorder characterised by progressive muscle atrophy and weakness. The Minister understands access to potentially beneficial drug treatments is an important issue for all people with serious illnesses and fully appreciates that SMA sufferers and their families face enormous day-to-day challenges in dealing with this progressive and debilitating condition. 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 reimbursement decisions, which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources available to the HSE. In reaching its decision the HSE will examine all of the relevant evidence and take into account such expert opinions and recommendations as are appropriate, including from the National Centre for Pharmacoeconomics, NCPE. This ensures reimbursement decisions are made on objective, scientific and economic grounds. The NCPE is a team of clinicians, pharmacists, pharmacologists and statisticians who evaluate the clinical benefits and costs of medical technologies and provide advice for the HSE. NCPE reports are important inputs to assist the HSE in its decision-making process. The HSE received an application for the reimbursement of the drug in question in July 2017 and referred it to the NCPE for advice. The NCPE conducted a health technology assessment of Spinraza and did not recommend reimbursement at the price sought by the applicants.

I make it clear that the HSE has yet to make a final decision on the pricing and reimbursement application submitted by Biogen for the reimbursement of Spinraza and that the statutory process is ongoing. The HSE is the decision-making body for the reimbursement of medicines under the Health (Pricing and Supply of Medical Goods) Act 2013 and will make the final decision on whether Spinraza will be reimbursed, taking into consideration the statutory criteria as specified in the 2013 Act.