Menopause is an important health and wellbeing issue affecting many women in Ireland. Much important work has been done to expand awareness and treatment in this area, driven by the Women’s Health Taskforce and the Women’s Health Action Plans.
In accordance with the Health (Pricing and Supply of Medical Goods) Act 2013 the HSE has sole statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes. Under the 2013 Act, reimbursement is for licenced indications which have been granted market authorisation either by the European Medicines Agency (EMA) or by the Health Products Regulatory Authority (HPRA).
The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.
The HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to patients.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.
The HSE considers the following criteria prior to making any decision on pricing / reimbursement of medicines including GLP-1 medicines of the Health (Pricing and Supply of Medical Goods) Act 2013.
(1) The health needs of the public,
(2) The cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,
(3) The availability and suitability of items for supply or reimbursement,
(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,
(5) The potential or actual budget impact of the item or listed item,
(6) The clinical need for the item or listed item,
(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,
(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and,
(9) The resources available to the HSE.
Medicines are added to the formal Reimbursement List following detailed assessments which include assessment of the clinical evidence, the economic evidence and the budget impact of a decision to reimburse specific indications of a medicine. The Primary Care Reimbursement Service (PCRS) of the HSE is required to reimburse in line with approved decisions of the HSE’s Senior Leadership Team (SLT). The HSE is required to formally assess each medicine and each specific use of such medicines before reimbursing them.