HTA and reimbursement timelines: How long does it take to get reimbursement in Ireland?
The Market Access (MA) process in Ireland looks simple:
- a Market Access authorisation is submitted to the European Medicines Agency (EMA)
- pricing is based on a cost-effective threshold, guided by international price referencing of 14 countries
- all products undergo a Rapid Review (RR) appraisal and in some cases also a full health technology assessment (HTA)
- Following a positive RR or full HTA recommendation, a formal offer will be considered by the Health Service Executive (HSE) and, once approved, the product will be added to the relevant reimbursement scheme.
However, in reality the timeline of the HTA process is usually unpredictable and there are significant delays in post-HTA recommendation due to limited government staff capacity and drug budget.
In some cases, though a full HTA was recommended following a RR, the pharmaceutical company may choose not to make a submission for a full HTA but enter a price negotiation with the HSE and get reimbursement.
In some cases, though a full HTA and reimbursement was not recommended, the company could also have a negotiation with the HSE and secure reimbursement.
To better understand the real-world timeline of MA in Ireland, the MAP Online team tracks all RR and full HTA appraisals in Ireland and provides up-to-date analysis of the changing timeframes of the various MA stages between the initial RR submission and reimbursement.
Our latest analysis shows that where there was no full HTA, that is where reimbursement was approved after a RR, regardless of the RR recommendation, it took around 300 calendar days for a medicine to get reimbursement in Ireland.
The timeframe between RR submission and reimbursement slightly declined from 335 calendar days in 2017, to 300 days in 2020 and 256 days in 2021.
Where there was a full HTA completed following a RR, it took around 800 days for a medicine to get reimbursement. The timeframe between RR submission and reimbursement fluctuated from 848 days in 2018 to 998 days in 2019, and then declining to 873 days in 2020 and 701 days in 2021.
Our regularly updated analysis displayed in interactive charts within MAP Online also offers timelines of every stage of the full HTA process as well as the HTA and reimbursement timelines of orphan drugs.
For the detailed analysis and insights, please log in to your MAP Online account or, if you're not a member, contact us via email.