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Medicines approval and reimbursement in Ireland

Medicines approval and reimbursement in Ireland content

Once a medicine has been approved at a European level, the pharmaceutical company will make separate applications for reimbursement at a national level in different EU or EEA countries. In Ireland these applications are made to the HSE Corporate Pharmaceutical Unit (CPU) who then commission the National Centre for Pharmacoeconomics (NCPE) to carry out an assessment on that medicine.

National Centre for Pharmacoeconomics (NCPE)

There are two steps in the NCPE assessment process. All medicines first undergo a Rapid Review which takes approximately four weeks. Medicines that are considered to have a high cost compared to existing medicines or a significant budget impact will then be required to undergo the second step which is a full pharmacoeconomic assessment, called a Health Technology Assessment (HTA). Medicines will also be referred for a full HTA if there is any query over the effectiveness or value for money or the drug.

A full HTA should take approximately 90 working days. However, this 90 day clock will stop and recommence any time the NCPE request additional information from the pharmaceutical company. Therefore, the actual timeframe from when a HTA begins to when a recommendation is made is usually much longer. All of the steps and timelines for assessment of a medicine are published on the NCPE website where all medicines can be searched for by name.

Following a Rapid Review or a HTA, the NCPE will make a recommendation based on the assessment it has carried out. The terminology used in these recommendations and what this means for the medicine in question is explained on the NCPE website.

Health Service Executive (HSE)

The NCPE publishes all recommendations on its website and communicates this with the HSE Corporate Pharmaceutical Unit (CPU). The CPU then presents the NCPE appraisal to the HSE Drugs Group. The HSE Drugs Group will decide whether or not the Irish Government will fund the medicine through the public health system. This decision will go to HSE Leadership for approval. There may also be input from the Department of Health at this point. If there is a negative decision about reimbursement, the pharmaceutical company may enter into negotiations with the HSE to come to an arrangement on price.

There is no specified timeframe for any of the steps involved in the HSE processes and the time taken to reach and publish a decision can vary hugely between medicines. This lack of transparency and consistency is a significant concern for Fighting Blindness and many other patient groups, who have come together to advocate for reform in this area. You can read more about advocacy and access to therapies here.