The Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021 (the “Bill”), proposes certain amendments to the Health (Pricing and Supply of Medical Goods) Act 2013 (the “Act”). The Bill is currently in the early stages of passing through the Government’s legislative process. The Government has committed to expedite the Bill through the process but a clear timeline is not available yet. If passed, the Bill would:

• define Orphan Medicinal Products for the purposes of the Act;
• remove threshold incremental cost-effectiveness ratios or similar assessments from reimbursement decisions for orphan drugs; and
• define exhaustive qualitative criteria required to be considered by the HSE in making reimbursement decisions for orphan drugs, which would include, amongst other criteria, the health needs of the public and the cost-effectiveness of meeting health needs by supplying the item concerned rather than providing other health services to the same patient population.

At present, when considering a reimbursement application, the HSE must take into account a number of factors, including a Health Technology Assessment (“HTA”), carried out by the National Centre for Pharmacoeconomics. A HTA seeks to determine the cost-effectiveness of a product by reference to its clinical effectiveness and health benefits. Approval is usually granted where drugs are deemed cost-effective, which is when a drug is determined to have an incremental cost-effectiveness ratio of €45,000 or less per quality-adjusted life year. When a medicine exceeds this threshold, it will be subject to further assessment.

Orphan medicinal products treat rare diseases which affect a small cohort of the population. As a result, there is usually less clinical data available for their assessment in comparison with non-orphan medicinal products. Under the quality-adjusted life year analysis for cost-effectiveness, which is currently part of HTAs, orphan medicinal products are generally not deemed to be cost-effective, leading to delays in their approval for reimbursement. It is hoped that the Bill, when enacted, would reduce these delays significantly.

For further information, please contact Colin Kavanagh or Bridget Clinton.