Under 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 therefore I have asked the HSE for an update in this matter.
The HSE has advised that it 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.
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 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.
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.
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. Ozempic® does not have a licence in the EU for weight loss.
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 [Managed Access Protocols ]https://healthservice.hse.ie/staff/information-healthcare-workers/medicines-management-programme-mmp/managed-access-protocols/.
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.