Dáil Éireann Debate, Wednesday - 19 September 2018
106. Deputy Dara Calleary asked the Minister for Health the funding available to provide life-saving treatment to persons with spinal muscular atrophy; the discussions that have taken place between him, his Department and an association (details supplied) regarding the possible availability of such drugs; and if he will make a statement on the matter. [37958/18]
View answerThe HSE has statutory responsibility for medicine pricing and reimbursement decisions, 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. The Minister for Health does not have any statutory power or function in relation to reimbursement of medicines
Under the 2013 Act, if a company wishes to have a medicine reimbursed through the community drugs schemes, it must first submit an application to the HSE to have the medicine added to the Reimbursement List. The HSE deals directly with the applicant during this statutory process and not representative bodies, such as the Irish Pharmaceutical Healthcare Association.
HSE decisions on which medicines are reimbursed are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.
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 on-going basis. This can lead to a protracted deliberation process.
Nusinersen (Spinraza) is for the treatment of 5q spinal muscular atrophy (SMA).
An application for the reimbursement of Nusinersen (Spinraza) is currently being processed by the HSE. No decision has been arrived at as yet as the statutory assessment process is still ongoing.
