The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).
The HSE received an application for pricing / reimbursement of Liraglutide (Saxenda®) on the 17th September 2019 from Novo Nordisk (the applicant) as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of 30 kg/m² (obesity), or 27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
The HSE commissioned a rapid review process on the 18th September 2019. Following receipt of a rapid review dossier, the National Centre for Pharmacoeconomics (NCPE) advised the HSE (24th October 2019) that a full Health Technology Assessment (HTA) was required for this medicine. The HSE commissioned a full Health Technology Assessment on the 29th October 2019 as per agreed processes.
The NCPE Health Technology Assessment (HTA) report was received by the HSE on the 10th February 2021. The NCPE recommended that Liraglutide (Saxenda®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. The HTA was conducted in a defined subgroup of the full licensed indication, namely Liraglutide (Saxenda®) as an adjunct to a reduced calorie diet and increased physical activity for weight management in adult patients with a body mass index of 35kg/m2 with pre-diabetes and high risk of cardiovascular disease.
The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. CPU engaged in commercial negotiations with Novo Nordisk in March 2021 regarding their application for Liraglutide (Saxenda®). Novo Nordisk confirmed their intent to pursue reimbursement for a defined subgroup of the full licensed indication, namely as an adjunct to a reduced calorie diet and increased physical activity for weight management in adult patients with a body mass index of 35kg/m2 with pre-diabetes and high risk of cardiovascular disease.
The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. Liraglutide (Saxenda®) was considered by the Drugs Group in September 2021. The final HTA report was reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations, and the patient group submission received during the HTA process. The HSE Drugs Group made a recommendation to support reimbursement of Liraglutide (Saxenda®) as an adjunct to a reduced calorie diet and increased physical activity for weight management in adult patients with a body mass index of 35kg/m2 with pre-diabetes and high risk of cardiovascular disease. The positive recommendation is conditional on the implementation of a managed access programme.
The decision making authority in the HSE is the HSE Executive Management Team. The HSE Executive Management Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE EMT considered the recommendation of the Drugs Group and subsequently supported reimbursement of Liraglutide (Saxenda®) under the Community Drugs Schemes.
As a condition of reimbursement, an individual patient approval system will now be implemented by the Primary Care Reimbursement Service (PCRS) to enable reimbursement for patients who meet the pre-defined criteria as per a Medicines Management Programme (MMP) devised managed access programme. The processes necessary to implement this required managed access programme (MAP) are currently being developed by the HSE MMP along with relevant internal stakeholders.