The current Obesity Policy and Action Plan (OPAP) was launched in September 2016 under the auspices of the Healthy Ireland Framework (Healthy Ireland: A Framework for Improved Health and Wellbeing 2013-2025). OPAP covers a 10-year period up to 2025 and the overall aim is to reverse obesity trends, prevent health complications, and reduce the impact of overweight and obesity on health outcomes for individuals, families, the health system, and the wider society and economy. It recognises that obesity is a complex, multi-faceted problem and needs a multi-pronged solution, with every sector of society playing its part. OPAP is well aligned with the World Health Organisation in terms of the breadth of policy measures that have been introduced or are being considered in order to address the obesity epidemic.
Under OPAP, Ireland put in place a comprehensive, cross-Government strategy to address obesity and overweight. Since 2016 significant progress has been made in delivering on the Ten Step Programme of OPAP and to drive policy initiatives and actions, ranging from health promotion and education initiatives and obesity prevention measures through to establishing services to treat and manage obesity within the health care system.
The Department of Health is currently in the process of developing a new obesity strategy. Over the last year, extensive consultation has been carried out with public health experts and the public through a number of workshops, focus groups and a public consultation. The results of these will be used to inform the development of the new strategy, which is expected to be published this year.
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.
Controls are in place within the HSE on claiming processes to ensure that only HSE approved indications are reimbursed across a range of medicines. Controls are currently in place for the Glucagon-like peptide-1 (GLP-1) receptor agonists to restrict reimbursement support to the HSE approved indication of Diabetes. This includes Ozempic® (semaglutide) and Trulicity® (Dulaglutide). Therefore, these products are not reimbursed under the Drugs Payment Scheme (DPS) and are confined to those persons with full General Medical Services (GMS/Medical Card) and Long-Term Illness (Diabetes Mellitus) eligibility.
Diabetes is one of the Long-Term Illness (LTI) conditions for which eligible LTI persons can access their medicines to treat their Diabetes free of charge. Patients diagnosed with Diabetes Mellitus are entitled to be registered under the LTI Scheme.
Liraglutide (Saxenda®) 6 mg/ml solution for injection in pre-filled pen is the only product currently approved under Community Drug Schemes (GMS/Drugs Payment Scheme (DPS)) for weight management with a managed access system in place.
In line with the HSE reimbursement approval above, the HSE Medicines Management Programme (MMP) developed a Managed Access Protocol (MAP for liraglutide (Saxenda®) as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients, with an initial BMI of 35 kg/m2 with prediabetes and high-risk for cardiovascular disease.
This MAP outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of liraglutide (Saxenda®); further information is available on the MMP website:www.hse.ie/eng/about/who/cspd/ncps/medicines-management/managed-access-protocols/liraglutide-saxenda-/liraglutide-saxenda.html.
Clinicians are required to submit an application for reimbursement support of liraglutide (Saxenda®) for their patients through an online application system.
Applications are reviewed by the MMP on a case-by-case basis, and a reimbursement recommendation is communicated back to the clinician or further information may be requested if required.
Mounjaro® (tirzepatide) and Wegovy® (semaglutide) are not reimbursable under Community Drug Schemes as they are currently undergoing formal pricing and reimbursement assessments by the HSE.
