Tuesday, 27 September 2016
Topical Issue Debate
Medicinal Products Availability
I thank the Deputy for raising this important issue. Sativex is indicated for the relief of symptoms of spasticity for people with multiple sclerosis where other conservative treatments have failed to provide adequate benefits. Deputy Kenny will be aware that access to potentially beneficial drug treatments is an important issue for people with multiple sclerosis, MS, and also that MS sufferers and their families face enormous day-to-day challenges in dealing with this progressive and debilitating condition.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Decisions on which medicines are licensed for use in Ireland and which are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics, NCPE. The NCPE is a team of clinicians, pharmacists, pharmacologists and statisticians who evaluate the benefits and costs of medical technologies and provide advice to the HSE. The NCPE conducts health technology assessments of pharmaceutical products for the HSE and can make recommendations on reimbursement to assist the HSE in its decision-making process.
Since July of this year a revised and more transparent assessment process for the reimbursement of new medicines by the HSE has been in place. This process includes consideration of the budget impact of individual new medicines, the opportunity cost of the treatment and resources available to the HSE, as allocated by Dáil Éireann. The new assessment process is available on the Department of Health website.
In regard to the reimbursement of Sativex, on 11 July 2014, the Misuse of Drugs Regulations 1998 were amended to allow for certain cannabis-based medicinal products to be used in Ireland. The Health Products Regulatory Authority subsequently granted a marketing authorisation for the cannabis-based medicinal product Sativex to be marketed in this State. It was then open to the holder of that authorisation to make the product available for prescription in Ireland. In early September 2014, the HSE received an application for inclusion of Sativex under the community drugs schemes high tech arrangements. A health technology assessment on Sativex was completed by the NCPE, which did not recommend reimbursement of Sativex at the submitted price, which appears to be at the core of the Deputy's question. The report by the NCPE is an important input to assist the HSE in its decision-making process and informed further engagement between the HSE and the supplier in regard to potential pricing arrangements for this product. Sativex is not currently reimbursed. The HSE is awaiting further engagement from the supplier. It is appropriate that these should not be ministerial decisions and that a scientific and evidence-based approach is taken to determining the extent to which patients would benefit from treatment with expensive new drugs and whether this represents cost-effectiveness for the health service and the taxpayer.