Dáil Éireann Debate, Wednesday - 17 January 2024
1507. Deputy Sean Sherlock asked the Minister for Health the criteria for which reimbursement applications may be eligible for a rapid review assessment only; and the criteria for referring medicines to carry out a full health technology assessment. [56570/23]
View answerThe Rapid Review process has been a core component of the NCPE’s assessment pathway for 14 years. It facilitates the identification of drugs which require additional assessment in the form of a full Health Technology Assessment (HTA), while maintaining a robust appraisal of the relevant clinical and economic evidence for drugs which do not require further assessment. It allows for appropriate resource prioritization within a national HTA agency and is considered to be an efficient way of determining the requirement for a full HTA and targeting resources for those drugs where there is most value in conducting a HTA.
The objective of the Rapid Review is to provide a recommendation to the HSE on the need for a full HTA and, in some cases, on reimbursement. Following the Rapid Review, a full HTA will subsequently be required for those drugs for which additional information and/or analysis is required to inform a reimbursement recommendation. Where a full HTA is not required, a reimbursement recommendation may be made to the decision-maker at this stage. Reimbursement decisions in Ireland are made by the HSE on the basis of decision-making criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013, which includes additional criteria to those assessed by the NCPE.
Factors which are evaluated during Rapid Review and thus inform the requirement for a full HTA include: the cost of the drug relative to potential comparators; uncertainty in relation to comparative clinical effectiveness; uncertainty in relation to cost effectiveness; and the potential drug budget impact. Further details in relation to Rapid Review recommendations and interpretation are outlined in a recent journal article authored by NCPE staff which is available here: doi.org/10.1007/s40273-021-01093-8 .
The Framework Agreement on the Supply and Pricing of Medicines (2021-2025) outlines that the NCPE endeavour to complete the Rapid Review within a 4-week timeframe. The NCPE review process involves critical appraisal of the Applicant submission using standard formal criteria, independent targeted literature review, validation of inputs and assumptions and independent clinical opinion. In summary, the formal criteria assessed by the NCPE Review Group include:
• The disease epidemiology and the eligible population.
• The licensed indication and the proposed place in therapy of the pharmaceutical within relevant treatment guidelines and clinical pathways.
• Potential comparators (defined as current standard of care treatments). Clinical opinion may be sought to establish clinical pathways and current standard of care for patients in Ireland.
• The robustness of the clinical and safety evidence, in particular whether there is direct clinical trial evidence versus current standard of care to determine comparative effectiveness and safety.
• Economic considerations, including the cost of the drug relative to potential comparators, and net and gross drug budget impact estimates.
• Other indications for which the drug is being investigated or for which a license is sought.
• The outcomes of HTAs from other jurisdictions, if available at the time of assessment.
• The critical appraisal of the Rapid Review submission determines the requirement for a full HTA. The criteria that may deem a full HTA unnecessary in order for reimbursement to be recommended at this stage are:
• Robust clinical efficacy data indicating that the drug is non-inferior or is superior relative to the standard-of-care comparator(s) while being equal or lower in cost;
• A small eligible population with an unmet need and a low estimated net drug budget impact.
• A low estimated net drug budget impact, along with the potential for a system to allow usage to be restricted to particular subgroups or indications (e.g. via the High Tech Hub or a Managed Access Programme). This may facilitate a positive recommendation. Here, the NCPE will recommend reimbursement if a process may be introduced to ensure that the appropriate place in therapy / net drug budget impact may be realised as outlined in the Applicant submission.
• Similarly, where there is no evidence of therapeutic advantage associated with a drug that is considerably more expensive than the appropriate comparator(s), a full HTA may be deemed unnecessary in order to make a recommendation against reimbursement.
• Where the clinical efficacy and safety is similar to current standard of the care, the NCPE may advise a price reduction (so that the drug is equal or lower in cost relative to the comparator) in order to recommend reimbursement.
• Therefore, there are multiple criteria involved in the determination of the Rapid Review recommendation and this is made by careful consideration of the evidence and the experience and judgement of the NCPE Review Group.
