Eli Lilly applied for HSE reimbursement of Mounjaro for diabetes treatment more than one year ago
The latest groundbreaking new treatment for diabetes and obesity will become available in Ireland in ten days’ time – but is still waiting for a decision on public reimbursement, despite beginning the application process over a year ago.
Manufacturer Eli Lilly has announced that Mounjaro (tirzepatide) will be available at pharmacies in Ireland from February 17 via private prescription.
Tirzepatide is the first and only approved treatment which activates the receptors for two incretin hormones, GIP and GLP-1. Tirzepatide is approved for the treatment of adults with type 2 diabetes, and for weight management in adults.
On January 24 last year Eli Lilly applied to the HSE for reimbursement of the drug for type 2 diabetes. This was followed by another application for reimbursement in cases where the medicine is used for the treatment of obesity, made on June 24.
However, no decision on reimbursement has yet been made in either of these applications. In both cases, the National Centre for Pharmacoeconomics (NCPE) recommended a full health technology assessment (HTA) to assess the clinical and cost effectiveness of tirzepatide compared with the current standard of care.
As a result, the HSE commissioned HTAs on March 1 and August 27. On its website the NCPE states that a full HTA takes ‘approximately 18 weeks to complete, exclusive of the duration the HTA is queried with the Applicant (approximately five weeks as part of the stop/clock process)’.
However, in its latest update for the assessment of tirzepatide for type 2 diabetes, the NCPE states that ‘pre submission consultation’ has been scheduled, 11 months after the HTA was commissioned.
Regarding the assessment of the drug for obesity, the NCPE’s website states that officials are ‘awaiting full HTA submission from applicant’. A pre-submission consultation with the applicant took place in October.
The HSE did not provide a timeline for when a decision on reimbursement will be made in either case.
Research published by the Irish Pharmaceutical Association last year found that public patients are waiting two years or longer for access to new medicines.
Of the 23 medicines the industry body’s member companies made available to public patients during 2023, the average time to availability from application to the HSE was 729 days.
For medicines which a HTA was required, the average time to reach patients was more than 1,000 days.
In a statement released at the time the IPHA said: “In most cases, clinicians are well aware of the medicines that are pending. They wish to prescribe them to patients in the public service, as they build on and improve existing standards of care and health outcomes.
“However, an increasing consequence of the lengthy timelines is that some private patients can avail of cancer treatments under health insurance immediately, on the granting of a licence by the European Commission. Public patients typically wait two years after this point before accessing the same medicine.”
The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. Once complete, the pharmacoeconomic report will be reviewed by the HSE Drugs Group along with the outputs of any commercial negotiations, and any patient group submission/s received.
The HSE Drugs Group will consider all of the evidence and make a recommendation to the HSE Senior Leadership Team, which is the decision-making authority in the health service.
Tirzepatide will be available at pharmacies in Ireland initially in doses of 2.5 mg and 5 mg, with availability of higher doses expected in the coming months. Tirzepatide is administered subcutaneously once-weekly and is delivered in a ‘KwikPen’, a pre-filled, multi-dose pen.
In the SURMOUNT-1 study of people living with obesity, tirzepatide showed weight loss of up to 22.5 per cent (23.6kg) at the highest dose, and 96 per cent of participants on the highest dose achieved body weight reduction of at least five per cent. The most commonly reported adverse events in SURMOUNT-1 for tirzepatide were gastrointestinal-related, and were generally mild to moderate in severity, usually occurring during the dose escalation period.
The drug comes in the wake of the global popularity of semaglutide, trading as Ozempic/Wegovy, with significant shortages experienced here as a result.
“Diabetes and obesity are chronic, long-term conditions with a huge impact on people’s health and quality of life. We recognise there is significant unmet need in these areas and are pleased to be able to bring this treatment option to Ireland,” said Khalil Asmar, Associate Vice President, Cardiometabolic Health, Lilly Northern Europe.
