The Oireachtas has put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, to give full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. These include the clinical and cost effectiveness of the product, the opportunity cost, the potential or actual budget impact, and the impact on resources that are available to the HSE.
The NCPE are commissioned to conduct a health technology assessment (HTA) by the HSE’s drugs group to inform its decision-making process. The NCPE’s recommendations address three of nine criteria outlined in the 2013 Act including the:
- Efficacy, effectiveness and added therapeutic benefit;
- Cost-effectiveness, and
- Budget impact.
The NCPE initiate patient input by inviting patient organisations to give input to the HTA process through the use of their Patient Organisations Submission of Evidence Template and supporting guide. This enables patient organisations to provide suitable patient and carer input to the assessment of a particular medicine. This information is passed to HSE Drugs Group as part of the HTA report.
A separate expert body that feeds into the HSE’s decision making process, specifically for rare diseases, is the Rare Disease Technology Review Committee (RDTRC). This body meets after the completion of the NCPE’s HTA and is responsible for:
- reviewing proposals received from industry or expert groups in Ireland for funding of new products for rare diseases or expanded indications for existing products for rare diseases; and
- providing contributions to the development of clinical guidelines for relevant Orphan Medicinal Products (OMPs) and supporting the implementation of guidelines in conjunction with the National Drugs Management Programme Office where applicable.
As part of its assessment process the RDTRC provides a platform for patients, families and clinicians to give an input to HSE’s decision making process similarly to the patient input to the HTA process.
Both these independent bodies submit reports to the HSE Drugs Group which helps to inform the HSE’s deliberations on reimbursement decisions inline with the 2013 Act.