Table 1.
Explanatory notes for recommendations made by the National Centre for Pharmacoeconomics for rapid reviews and health technology assessments
| Interpretation | |
|---|---|
| NCPE rapid review conclusion | |
| A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of [Drug] compared with the current standard of care | The rapid review has concluded that, on the basis of the clinical and/or economic evidence submitted, there is considerable uncertainty associated with the comparative clinical efficacy and/or value for money of the drug relative to currently available therapies, and a formal HTA is required in order to make a recommendation on reimbursement to the HSE |
| A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of [Drug] compared with the current standard of care, on the basis of the proposed price relative to currently available therapies | The rapid review has concluded that, on the basis of the price of the drug relative to currently available therapies, there is considerable uncertainty associated with the value for money of the drug. A formal HTA is required on the basis of the proposed price, in order to make a recommendation on reimbursement to the HSE |
| A full HTA is not recommended. The NCPE recommends that [Drug] be considered for reimbursement. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013 | The rapid review has concluded that, on the basis of the clinical evidence and comparative pricing of the drug, there are no major concerns regarding clinical efficacy or value for money. The HSE has been recommended to consider reimbursing the drug. The HSE’s decision on reimbursement will take into account the NCPE recommendation and the additional criteria listed in Schedule 3, Part 3 of the Health (Pricing and Supply of Medical Goods) Act 2013 |
| A full HTA is not recommended. The NCPE recommends that [Drug] not be considered for reimbursement at the submitted price. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013 | The rapid review has concluded that, on the basis of the submitted evidence, the drug is unlikely to provide additional clinical benefits and/or constitute value for money relative to currently available therapies. The HSE has been recommended to consider not reimbursing the drug on the basis of the proposed price. The HSE’s decision on reimbursement will take into account the NCPE recommendation and the additional criteria listed in Schedule 3, Part 3 of the Health (Pricing and Supply of Medical Goods) Act 2013 |
| A full HTA is not recommended until additional efficacy and/or safety data are submitted. On the basis of current evidence, the NCPE recommends that [Drug] not be considered for reimbursement, having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013 | The rapid review has concluded that the submitted evidence is unlikely to allow a robust assessment of comparative efficacy and/or value for money relative to currently available therapies. On the basis that additional evidence is expected to become available that will allow a more robust assessment, the HSE has been recommended to consider not reimbursing the drug at this time. The HSE’s decision on reimbursement will take into account the NCPE recommendation and the additional criteria listed in Schedule 3, Part 3 of the Health (Pricing and Supply of Medical Goods) Act 2013 |
| NCPE HTA recommendation | |
| The NCPE recommends that [Drug] be considered for reimbursement. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013 | The NCPE assessment has concluded that the drug represents a clinically effective, value-for-money treatment option relative to currently available therapies. The HSE has been recommended to consider reimbursing the drug. The HSE’s decision on reimbursement will take into account the NCPE recommendation and the additional criteria listed Schedule 3, Part 3 of the Health (Pricing and Supply of Medical Goods) Act 2013 |
| The NCPE recommends that [Drug] be considered for reimbursement if cost effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013 | The NCPE assessment has concluded there is robust evidence for clinical benefit of the drug, and are satisfied that the economic model presented by the company is adequate for decision making. Plausible estimates of the cost effectiveness of the drug indicate that the ICER exceeds the current WTP thresholds of €20,000 and €45,000/QALY |
| The NCPE recommends that [Drug] not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013 |
The NCPE assessment has concluded that either (i) There is robust evidence for clinical benefit of the drug, and the economic model presented by the company is adequate for decision making. Plausible estimates of the cost effectiveness of the drug indicate that the ICER far exceeds the current WTP thresholds of €20,000 and €45,000/QALY (ii) There is some evidence of comparable clinical benefit but not additional benefit, and the economic model presented by the company is adequate for decision making. Plausible estimates of the cost effectiveness of the drug indicate that the ICER exceeds the current WTP thresholds of €20,000 and €45,000/QALY |
| The NCPE recommends that [Drug] not be considered for reimbursement. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013 | The NCPE assessment has concluded that relative clinical benefit has not been demonstrated in the submission provided, or the economic evaluation presented is not sufficiently robust to estimate a plausible ICER |
HSE Health Services Executive, HTA health technology assessment, ICER incremental cost-effectiveness ratio, NCPE National Centre for Pharmacoeconomics, QALY quality-adjusted life-year, WTP willingness to pay