Systematic reviews have long been a key component of evidence-based medicine. The use of methods to expedite systematic reviews is ever-increasing due to time and resource constraints. Systematic reviews typically take at least 12 months to conduct compared to rapid reviews, which take a number of weeks. Hence, Rapid Reviews has become a pragmatic alternative to comprehensive systematic reviews. However, it is important that Rapid Review methods remain rigorous to support good policy development and decisions.
Rapid Reviews are particularly important in the field of health technology assessment (HTA), where they are streamlined assessments of healthcare technologies, interventions, or treatments used to support informed decision-making in a timely and resource-efficient manner. Rapid Review methods are not unique to HTA, although the need for timely evidence to underpin the assessment of new technologies makes them particularly relevant in this context.
The National Centre for Pharmacoeconomics (NCPE) is the Irish organisation responsible for conducting Rapid Reviews and HTAs related to pharmaceuticals. They evaluate the clinical and cost-effectiveness of healthcare interventions to inform decision-making regarding reimbursement with the Irish healthcare system. The objective of the Rapid Review is to determine whether a HTA is required or not for a pharmaceutical.
Rapid Reviews assessed by the NCPE involves a process that is set out in their updated Rapid Review template. The template, to be completed by the applicant, is intended to provide a summary of information to facilitate the Rapid Review process. Version 2.2 of this template was published on 05 August 2022 and replaces Version 2.1. Version 2.2 – (Rapid Review Template | National Centre for Pharmacoeconomics (ncpe.ie)) includes a requirement to submit the NCPE Budget Impact Model Template for all RR submissions and contains updated instructions regarding “academic-in-confidence” data.
The Rapid Review application is comprehensive and is set out in a systematic way under the following headings:
As mentioned, every Rapid Review must now be accompanied by a Budget Impact Model Template. This is intended to guide Applicants in the calculation of Irish population estimates, patient population, drug acquisition costs, additional costs, cost offsets, results, presentation of budget impact results, and analysis of uncertainty. Version 1.8 of this template was published on 08 May 2023 and replaces Version 1.7.
Prior to starting the Rapid Review assessment, the NCPE Review Group will ensure that the Applicant submission includes:
If the submission is incomplete, the Applicant will be requested to submit the missing element(s). If errors are identified in the drug cost and/or budget impact calculations, the Applicant will be requested to correct the errors and resubmit the relevant files within three working days of the request. All electronic files must be submitted using a secure link provided by the NCPE.
Once all the information is received and the NCPE is happy to proceed the information from the applicant will be reviewed. Once this process is finished, there are 5 possible recommendations:
– A more detailed assessment i.e. HTA is required as some factors around the medication are unclear. It may be the case that it is not clear if the medicine is value for money.
-The price of the medicine is higher than other treatments used for the particular condition, and it is not clear that the medicine is value for money. A full HTA assessment may not be needed if the HSE can agree on a suitable price reduction with the applicant.
-It is recommended that the HSE consider providing the medicine. The medicine is considered to possibly work as well or better than other ways to manage the condition and it is believed that the medicine is value for money. Therefore, a full HTA is not required.
-It is recommended that the HSE not provide the medicine in question unless the HSE can agree on a suitable price reduction with the applicant. The price of the medicine is higher than other ways to manage the condition and is believed not to be value for money. Therefore, a full HTA is not recommended.
-It is believed that a full HTA should not be done because there is not enough information on how well the medicine works. The medicine will be assessed again when the applicant can provide more information.
Please note that in a small number of cases, reimbursement not recommended can be an outcome of the Rapid Review process.
The graph below shows that 60% of new pharmaceuticals result in a HTA. A key feature of the Irish system is that it is possible to avoid a HTA following a price reduction. In 2022, 28% of Rapid Reviews involved price negotiations resulting in a HTA being avoided and more timely market access.
Whatever decision you encounter it is part of an overall reimbursement process which is set out below (this NCPE flowchart can be accessed on the NCPE website).
Salutem Insights has created a short video to summarise the reimbursement process – Understanding the Irish Reimbursement Process for Medicines
If you are starting out on your reimbursement journey or have any questions about the process, please do not hesitate to contact us