Analysis of the new NHS White Paper – Part 2

Focus on Ireland: HTA timeframes and reimbursement

The Market Access process in Ireland is 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 appraisal and in some cases also a full health technology assessment (HTA).

One of the biggest challenges of Market Access in Ireland is the unpredictable timeframe of the HTA process and delays in funding due to a very limited government drug budget.

To help our members understand the real-world timeframes between the initial rapid review submission and reimbursement, and for the various stages of the full HTA process, the MAP Online team conducted a pilot study of 12 drugs which have completed a National Centre for Pharmacoeconomics (NCPE) appraisal and have been reimbursed by the Health Service Executive (HSE) between 2019 and 2021. 

Of the 12 drugs:

  •  3 received a reimbursement recommendation following a rapid review

  •  1 was not recommended for full HTA or reimbursement

  •  8 were recommended for a full HTA following a rapid review.

Of the 8 drugs that went through a full HTA:

  •  all received a negative recommendation

  •  price and related budget impact are the main reasons for the negative outcome.

Of the 8 drugs that went through a full HTA:

  •  the longest timeframe is the HSE’s commissioning of a full HTA (following the NCPE’s recommendation for a full HTA, the HSE commission the NCPE to conduct a full HTA for the product) which on average took 185 days

  •  the second longest timeframe is the applicant’s preparation for a full HTA submission which on average took 129 days

  •  the timeframes for the subsequent stages were much shorter.

If an applicant wants to speed up the HTA process, the preparation for submission is a potential stage where time can be saved.

Based on the 12 reimbursed drugs where a product completed only a rapid review and received a reimbursement recommendation or received a negative rapid review outcome but succeeded in a confidential price negotiation with the HSE, the average time to reimbursement following a rapid review submission is 229 days. However, if the drug went through a full HTA process and received a negative recommendation, the average time to reimbursement following the initial rapid review submission is 1196 days.

The MAP Online team is doing a wider study for all the NCPE appraisals completed between 2018 and 2021 and will publish the research on MAP Online in due course. If you are interested in this topic, make sure to log into MAP Online to see the latest update.

As we can see from our pilot study of the 12 drugs, an HTA application in Ireland is very likely to receive a negative outcome. If an applicant does receive a negative recommendation, what are the possible actions that it can take to achieve reimbursement?

From MAP’s experience, it is important to understand the reason for the NCPE’s decision – is it due to lack of or uncertainty regarding the clinical evidence supporting the drug or is it related to price and budget impact? Such information can be obtained from the NCPE’s appraisal report or through discussions with the HSE Corporate Pharmaceutical Unit (CPU).

In most cases, the reason for a drug to not be recommended for reimbursement is the price or budget impact. This will require the applicant to engage with the CPU in pricing negotiations to reach a confidential agreement.

Another effective option is to engage with key stakeholders to get them to lobby the Minister of Health or HSE to reimburse the relevant medicine. This would include briefing interested politicians and asking them to submit questions or motions calling on the Minister of Health to encourage the HSE to make the medicine available to the patients who will benefit from it.

There is no official template or explicit process for such post-appraisal negotiations with the CPU. MAP has experience of numerous instances where a negotiation with the CPU has resulted in HSE Drugs Group support and positive decisions by HSE. For more insights regarding this topic, please see the ‘What are the possible actions following a negative NCPE recommendation?’ page on MAP Online.


We have recently completed our first MAP Online Country Focus month. MAP Online Ireland has recently been fully audited, validated and updated by the MAP Online team with redesigned images throughout. Please contact our Member Support team with any questions you have, including if you would like to book a navigational tour.

If you aren’t a MAP Online member and would like to find out more about the benefits of membership please get in touch at enquiries@mapbiopharma.com.

Xingyao Liu

MAP Online Associate Consultant
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