Overview of the Drug Reimbursement Process
The Health Service Executive (HSE) is responsible for decisions regarding the reimbursement of new drug technologies.
- The Corporate Pharmaceutical Unit (CPU) of the HSE is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications and the operation of the national pricing framework agreements
- The HSE Drugs Group makes recommendations regarding drug reimbursement.
- The HSE leadership group considers these recommendations and make decisions regarding drug reimbursement.
The HSE asks us to advise on whether or not a medicine is good value for money. We give advice to help the HSE provide the most effective, safe and cost-effective (value for money) treatments for patients.
The CPU commissions the NCPE to assess medicines following receipt of an application for reimbursement. The NCPE are commissioned to review the following classes of medicines:
- New active substances seeking reimbursement in Ireland, including those with an orphan designation from the European Medicines Agency
- New indications for currently reimbursed drugs
- Drugs which are already reimbursed by the HSE, and are associated with high expenditure or uncertain clinical benefit.
The NCPE employs a two-step process to make our recommendations in the most efficient manner and minimise time to market access for new treatments.
All medicines are subjected to a preliminary Rapid Review. Products with a high cost relative to potential comparators and/or those with a net impact on the drugs budget will be subjected to a full health technology assessment (HTA). Similarly, products where there is a query in relation to the comparative clinical efficacy and/or value for money will also be selected for full HTA.
Full Health Technology Assessment
Following full HTA, an assessment report outlining NCPE conclusions and recommendations is sent to the HSE CPU to support evidence-based decision-making on reimbursement. In the case of oncology drugs a report is also sent to the National Cancer Control Programme (NCCP).
Decisions on drug reimbursement are taken by the HSE.
The criteria which the HSE must consider when reaching reimbursement decisions on drugs are described in Schedule 3, Part 3 of the Health (Pricing and Supply of Medical Goods) Act 2013.
The NCPE’s recommendations address three of nine criteria, including the
- Efficacy, effectiveness and added therapeutic benefit,
- Cost-effectiveness, and
- Budget impact.
Other additional criteria considered by the HSE when making reimbursement decisions include:
- Health needs of the public,
- Proposed costs, benefits and risks of the item or listed item relative to therapeutically similar items and the level of certainty in relation to the evidence of those costs, benefits and risks,
- Availability and suitability of the drug for supply and reimbursement under the current schemes,
- Clinical need for the drug,
- Availability of the appropriate level of clinical supervision to ensure patient safety, and
- Resources available to the HSE.
A Rapid Review is the first step in the drug reimbursement process. All medicines undergo Rapid Review as part of the drug reimbursement process. The NCPE endeavour to complete Rapid Reviews in approximately four weeks. The Rapid Review assessment report consists of the following information:
- An overview of current clinical practice and treatment options for the disease
- An overview of how well the drug works compared to current clinical practice
- An overview of the drug cost and likely budget impact
- Information on cost-effectiveness assessments in other countries.
The outcome of a Rapid Review is a recommendation to the HSE on reimbursement, or the need for a full health technology assessment (HTA). Products with a high cost relative to potential comparators and/or those with a net impact on the drugs budget will be subjected to a full HTA. Similarly, products where there is a query in relation to the comparative clinical efficacy and/or value for money will also be selected for formal HTA.
Applicant companies can submit a Rapid Review application at any point following receipt of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). For more information on how to submit a Rapid Review, please click here.
A full health technology assessment (HTA) is a systematic assessment of the clinical and cost-effectiveness of a medicine. Only a selection of medicines are required to undergo a full HTA as part of the drug reimbursement process. The NCPE full HTA assessment 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). The full HTA report consists of the following information:
- Disease background and epidemiology
- Detailed description of current clinical practice and treatment options
- Detailed description of the intervention (drug) under assessment
- Detailed review of the clinical and comparative efficacy of the drug under assessment
- Detailed review of the safety and comparative safety of the drug under assessment
- Detailed review of the cost-effectiveness of the drug under assessment
- Detailed review of the budget impact of the drug under assessment.
The outcome of a full HTA is a recommendation to the HSE on reimbursement. An overview of our HTA recommendations is provided here. For more information on how to submit a full HTA, please click here.
Applicant companies can submit a full HTA dossier, following commissioning of a full HTA by the CPU and attendance at a pre-submission meeting with the NCPE. For more information on how to submit a full HTA, please click here.
The NCPE considers that patients can make a valuable contribution to the Health Technology Assessment of new drug technologies, and to this end have created the Patient Organisation Submission Process. The NCPE actively seeks input from Patient Organisations. Submissions from Patient Organisations are passed to the HSE to consider as part of their decision making process.
The NCPE actively seeks advice and input from clinicians throughout the Rapid Review and full HTA process. This advice contributes to our understanding of current clinical practice, to the potential place in therapy of a new treatment, to the selection of appropriate comparators and outcomes for our HTA assessments. For more information on how to contribute to our assessments, please click here.