Tuesday, 26 March 2019
Department of Health
Medicinal Products Reimbursement
700. To ask the Minister for Health his plans to review the systems, structures and resources in place to support the decision making process for the reimbursement of medicines; if this review will consider whether Ireland applies a disproportionately high threshold for clinical evidence supporting medicines for small patient populations; the reason medicines are frequently unable to secure reimbursement here despite their broad availability elsewhere in Europe; and if he will make a statement on the matter. [13201/19]
My Department has completed a tender process for a review of the HSE reimbursement and pricing decision-making process and is in the process of appointing a consultancy firm to complete this review.
This review will examine governance arrangements (including the systems, structures, processes) and the resources which support the decision-making process for the consideration of an application for reimbursement of a medicine.
The Deputy will be aware that 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. The Minister for Health has no role or powers in relation to such matters.
The decisions on which medicines 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 conducts health technology assessments (HTAs) of medicinal products for the HSE, and makes recommendations on reimbursement to assist the HSE in its decision-making process.
Over the past number of months, the HSE has introduced new measures, within the confines of the 2013 Health Act, to strengthen and improve the assessment and consideration process for new drug applications, including:
- expanded membership of the Drugs Committee to include patient representation and more clinical expertise in the area of rare diseases.
- establishment of a Rare Disease Technology Review Group
- additional resources provided to the NCPE and HSE’s Pharmaceutical Unit in order to improve processing times for new applications.
The Act provides for a fair, transparent and rigorous process for the assessment of all drugs which has delivered tangible results in the pricing and supply of medicines for patients. To date in 2019, 17 new medicines and 3 new uses of existing medicines have been approved by the HSE, an investment of in excess of €150 million over five years. Eleven of these new medicines are orphan medicines.
The challenge of securing affordable access to innovate medicines is not unique to Ireland and we have been engaging with other EU countries in an effort to identify solutions. In the region of 45 new molecules are due to receive market authorisation in Europe each year over the next five years. It is in this high-tech space, including orphan drugs, where the greatest challenges will arise in the years ahead. Expenditure on the High-Tech arrangement, through which most new, high-cost medicines, including orphan medicines, are funded in Ireland, has increased from about €400 million in 2012 to approximately €700 million in 2018.
In June 2018, Ireland joined the Beneluxa Initiative on Pharmaceutical Policy. 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.
In addition to Beneluxa, Ireland is participating in a number of other voluntary EU forums. These platforms are currently exploring possible areas for cooperation including information sharing, horizon scanning and possible price negotiations and joint procurement. Such platforms could also lead to faster access for patients for some treatments.