The Health (Pricing and Supply of Medical Goods) Act 2013 provides a rigorous process for the assessment of new medicines for reimbursement. This allows taxpayers to be confident both that the right medicines are chosen, and that those medicines are approved at a price that can sustainably be afforded in a budget-limited health service. Economic assessment is valuable to stretch the funds granted to the HSE as far as possible, allowing them to provide a range of services as well as innovative medicines for all citizens.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the 2013 Act. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority. In line with the 2013 Act, and the national framework agreed with industry, a company must first submit an application to the HSE to have a new medicine added to the reimbursement list.
The timing of company applications for reimbursement in different countries can vary for a number of reasons, not least the available market share in each country. Once a company responsible for the commercialisation of a new medicine receives market authorisation, it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. Describing timelines for reimbursement from EMA approval to HSE reimbursement approval does not consider this important factor and misrepresents the process, as statutorily the HSE is precluded from approving or assessing a drug for reimbursement a drug until an application is received from the company holding the market authorisation.
When an application is made to have a product added to the reimbursement list in Ireland, the HSE is required, under the 2013 Act, to decide within 180 days of receiving the application, to either add the medicine to the reimbursement list or refuse to reimburse the medicine. In assessing the application, the HSE is required by statute to consider a range of criteria including the magnitude of the clinical effect, cost effectiveness, budget impact, opportunity cost and unmet need.
The principal factors in determining how quickly a reimbursement decision is made are the price at which a manufacturer applies for the reimbursement of a product and the level of engagement by the applicant company with the HSE’s rigorous assessment process as to its clinical and cost-effectiveness.
In terms of the time taken from application to a decision on reimbursement, the HSE advise that the biggest impediments to achieving the 180-day timeline is often the failure of companies to provide sufficient evidence to support the efficacy of some medicines, and the need for the HSE to get involved in protracted negotiations in seeking to achieve better prices for the State.
In 2024, there will be significant investment in additional staff resources to enhance the HSE’s medicines pricing and reimbursement process. This is a recommendation of the working group established following the publication of the Mazars ‘Review of the Governance Arrangements and the Resources in place to support the HSE’s reimbursement and pricing decision-making process’ in February 2023.
Investing in this capacity will support agencies to operate to the fullest of their ability, providing timely and efficient evaluation of medicines for reimbursement.
The State?is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 - 2023 provided almost €100 million of dedicated funding for new drugs. This enabled the HSE to approve 148 new drugs, 61 of which are for cancer.
I have secured a further €20 million in funding for new medicines in 2024. I will also ensure that my Department, the HSE and all relevant agencies and stakeholders place a priority focus on achieving the most efficient and effective use of available resources across the acute and community settings, supporting cost reduction which can then be considered for reinvestment, as appropriate.
As Minister for Health, I regulate the private health insurance market. This is a voluntary market, which is underpinned by certain principles, including minimum benefit, that are set out in law. The Health Insurance Act 1994 (Minimum Benefit) Regulations 1996 require insurers to offer a minimum level of cover to every insured person. I do not have a role in the commercial decision-making of any private health insurer.
Private Health Insurance companies operate as commercial entities in a competitive private health insurance market. Beyond prescribing under the Regulations the minimum level of coverage that health insurers must provide, I am not in a position to direct any insurer to provide cover for any particular procedure or service or medicine, or direct how that cover is to be provided.
