Michael Healy-Rae
Question:378. Deputy Michael Healy-Rae asked the Minister for Health if the prescribing of a drug (details supplied) is correct practice; and if he will make a statement on the matter. [30400/23]
View answerThursday, 22 June 2023
Questions (378)
Written answers
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the Community Drug Schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).
In line with the 2013 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. 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.
Ozempic® (Semaglutide) was approved by the HSE in 2018 for addition to the reimbursement list for the treatment of diabetes. Ozempic® (Semaglutide) has not been approved for reimbursement for any other indication. Reimbursement support for Ozempic® (Semaglutide) for the treatment of diabetes only is available to those with eligibility under the General Medical Services (GMS) Scheme or the Long-Term Illness (LTI) Scheme.
To date, there have been particular challenges in the supply of Ozempic® to all markets, including to the Irish market. Novo Nordisk anticipates that intermittent supply will continue throughout 2023. These supply issues are not unique to Ireland. Increases in demand for these medications and supply constraints have been observed in the UK, throughout the EU, and across the world in recent months. Shortages of Ozempic® are linked to the increased demand which has been attributed to the off-label use of the product to treat obesity.
Novo Nordisk has implemented monthly allocation to pharmacies to help ensure continuity of supply and equitable distribution of Ozempic® stock to Irish patients. The company has issued advisory letters to healthcare professionals to ensure they are aware of these supply issues and how to manage them. In one such recent communication to healthcare professionals, the company stated that Ozempic is only indicated for treating adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Any other use, including for weight management, represents off-label use and currently places the availability of Ozempic® for the indicated population at risk. Reimbursement support from the HSE is available for the licensed indication and approved dosage only.
The Department of Health, along with relevant experts from the HSE, the HPRA, the Pharmaceutical Society of Ireland and the Medical Council are continuing to work together during times of limited supply to mitigate the impact of the shortages on patients. Those patients that have been prescribed Ozempic® by their doctor and are struggling to source it, are encouraged to speak to their doctor and to the pharmacies in their area as early as possible, in order to seek support in accessing appropriate treatment for their medical condition.