The Minister recognises the importance of providing the best care possible to patients with this condition. Women’s Health has been and will continue to be a focus of the Department. The Government has made real progress in improving the healthcare available to women in Ireland.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, I have asked the HSE for an update in this matter.
The HSE has advised that it follows statutory processes around the addition of medicines to the reimbursement list/schemes. Under those statutory processes, the HSE is legally required to consider a range of criteria which include unmet need, clinical evidence, economic evidence, budget impact and the resources available when making reimbursement decisions (i.e. add a medicine to the reimbursement list). The reimbursement decisions have to be in line with the relevant legislation, namely the Health (Pricing and Supply of Medical Goods) Act 2013 (the legislation the HSE operates under for pricing and reimbursement of medicines).
In accordance with the legislation, a medicine must have a marketing authorisation (licence) to be included in the formal list of reimbursable items. A pharmaceutical company can apply to the HSE for reimbursement for a specific indication (use) of a specific licensed medicine. Medicines can have more than one licensed (market authorised) indication and each indication represents a separate application.
The European Medicines Agency (EMA) is a centralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA plays an integral role in the authorisation of medicines in the EU via the centralised procedure. The Health Products Regulatory Authority (HPRA) is the competent authority responsible for the regulation of human medicines in Ireland. A company can submit an application for a marketing authorisation directly to the HPRA if the product in question is not required to be approved through the centralised procedure.
Glucagon-like peptide-1 (GLP-1) receptor agonists licensed in Ireland do not currently have an EU marketing authorisation for the treatment of Polyendocrine Metabolic Ovarian Syndrome (PMOS) or similar endocrine conditions.
Controls are in place within PCRS on claiming processes to ensure that only HSE approved indications are reimbursed across a range of medicines. Controls are currently in place for the GLP-1 agonists to restrict reimbursement support to the HSE approved indications. Off-label prescribing of GLP-1 agonists are not supported for reimbursement under Community Drug Schemes.
It is incumbent on a company to apply to the appropriate regulatory body for a marketing authorisation to extend the licence for a GLP-1 receptor agonist for the treatment of PMOS and then to submit a new pricing and reimbursement application for any new indication approved by the EMA to the HSE.
The HSE will process and assess any pricing and reimbursement application ,if received from a company, as efficiently as possible.
