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
Health technology assessment (HTA) is a multidisciplinary process that evaluates the clinical effectiveness, safety, economic viability, and broader impact of health technologies. Health technologies refer to any intervention, such as medicines, vaccines, medical devices, procedures, and systems, used to prevent, diagnose, or treat a disease or condition that affects human health. HTAs are essential to ensure that technologies being considered for adoption are safe, effective, and can deliver the desired outcomes at a reasonable cost. By assessing the technological properties of health technologies, HTA also help healthcare systems identify promising innovations that can improve health outcomes and enhance patient care.
In a rapidly evolving healthcare landscape, HTA evaluation plays a crucial role in informing policy decision-makers, healthcare providers, and patients about the most effective and cost-efficient technologies to adopt. HTAs must be conducted in a structured and thorough manner. Therefore, the HTA process involves several steps, including systematic reviews, a review of the clinical evidence, economic evaluation, and budget impact estimation. This information should be unbiased and evidence based.
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines in accordance with the 2013 Health Act. As part of this statutory assessment process the HSE must consider the affordability of each individual decision against overall resources as allocated. In line with the 2013 Health Act, if a Company would like a medicine to be reimbursed by the HSE the Company must first submit an application to the HSE.
In reaching its decision on the whether to include a new medicine on the reimbursement list, Part 3 of the 2013 Health Act requires the HSE to have regard to the following criteria:
Three of the above criteria are included in a HTA: comparative clinical effectiveness (4), cost effectiveness (2) and budget impact (5).
In submitting an application for reimbursement, a Company will propose a price for reimbursement having regard, as applicable, to this Framework Agreement 2021 (an agreement between the Irish Pharmaceutical Healthcare Association (IPHA) and the HSE regarding the pricing and supply of medicines.
The term ‘health technology’ encompasses a wide range of health interventions. ‘Technology’ includes any intervention that may be used to promote health; to prevent, diagnose or treat a disease; or in rehabilitation or long-term care.
Technologies include, but are not limited to:
A health technology does not have to be a medical intervention given directly to a patient. It may be as broad as a restructuring of how an aspect of the health service is organised and delivered, such as the transfer of a service from secondary to primary care settings. The technology does not need to be new, and a HTA can look at changing existing services through reallocation of resources or through standardising current services. A HTA can also be used to inform decisions about discontinuing ineffective technologies and, thereby, support the best use of available resources.
HTAs are carried out by a range of public bodies and research groups.
The content of a HTA will vary depending on the decision being supported. For example, a full HTA to support a national decision will typically collect and summarise evidence under a number of headings. These headings include:
There are recommended guidelines around the evidence required under these particular headings. Each of these areas is important. For ease of use, the national guidelines have been developed as stand-alone documents.
The guidelines are intended to be applicable to all healthcare technologies, including pharmaceuticals, procedures, medical devices, broader public health interventions and service delivery models. It is important to refer to the most up-to-date version of these guidelines.
A summary of the HTA process from the NCPE website is outlined in Fig. 1 and the text below. The formal reimbursement process begins once the applicant company receives a positive decision from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and they have certainty around the reimbursement price for which they intend to apply.
Summary of the health technology assessment process in Ireland, HSE–CPU – Health Service Executive Corporate Pharmaceutical Unit, HTA – health technology assessment, NCPE – National Centre for Pharmacoeconomics,
The HTA process, following CHMP opinion, consists of several steps:
Salutem Insights have created a short video to summarise the reimbursement process here : Understanding the Irish Reimbursement Process for Medicines
It is important to note that the HTA process in Ireland is continually evolving, and the specific steps and bodies involved may vary depending on the specific intervention and circumstances. However, the overall aim remains to ensure that healthcare technologies are evaluated in a rigorous, transparent, evidence-based and equitable manner to facilitate informed decision-making and optimise healthcare resource allocation in Ireland.
From the Salutem Insights database the timeframe between RR submission and reimbursement has varied over time for new medicines that have undergone a HTA (see Fig. 2). For example, in 2010, the average time between RR submission and reimbursement was 290 days compared to 829 days in 2022. These timelines do not take into account the NCPE stop-clock process and the time it takes to submit a HTA to the NCPE following the outcome from the RR.
Salutem Insights have been conducting HTAs in Ireland since 2007. They have conducted HTAs on vaccines, orphan medicines, oncology medicines, orphan medicines and gene therapies. Salutem Insights can help you navigate the reimbursement process in Ireland with ease.
If you’re a pharmaceutical company looking to introduce a new medicine to the Irish market, navigating the reimbursement process can be complex and time-consuming.
In this video you’ll gain a better understanding of the two routes to reimbursement in Ireland: Rapid Review and Health Technology Assessment (HTA).
The reimbursement process is officially triggered by submitting an application to the Corporate Pharmaceutical Unit (CPU). This application includes a Rapid Review submission, which determines whether a HTA is required or not based on the relative clinical benefit and relative cost of the new medicine. If a HTA is required, it is assessed by the National Centre for Pharmacoeconomics (NCPE). Timelines to reimbursement vary between the two routes. For example, it takes 357 and 914 days for medicines to be reimbursed following a Rapid Review and HTA respectively. The long timelines are due to price negotiations that are required post submissions to secure reimbursement.
Salutem Insights offers a comprehensive solution to help pharmaceutical companies navigate the Irish reimbursement process with ease. Their services include HTAs, Rapid Reviews, systematic literature reviews, expert elicitation, and burden of illness studies. By partnering with Salutem Insights, you can ensure that your reimbursement application is handled efficiently and effectively, allowing you to focus on bringing your medicine to patients in need.
Don’t let the reimbursement process be a roadblock to introducing your medicine in Ireland. Contact Salutem Insights today to learn more about how they can help you succeed.
In the rapidly evolving healthcare industry, market access is crucial for the successful launch of new products and services. Market access consultancy services play a pivotal role in helping organisations navigate the complexities of market entry, providing valuable local insights and strategies to maximise success. In this blog, we will explore the benefits of access consultancy services and how they can accelerate the launch of your healthcare product.
Market access consultancy services encompass a range of disciplines, including health economics and outcomes research (HEOR), economic modelling, and medical writing. By combining these fields, access consultancy firms can provide a comprehensive understanding of the market landscape and develop tailored strategies to achieve market access.
1 Healthcare providers: Ensuring that patients have access to the best treatments available
2 Payers and insurers: Making informed decisions on coverage and reimbursement
3 Pharmaceutical and medical device manufacturers: Successfully launching their products and maximising market potential
Market access consultancy services can help you identify key trends in market access. This information is vital for developing a successful market access strategy and finding the fastest route to reimbursement.
Market access consultancy services can also help you evaluate the clinical and cost-effectiveness of your product. By conducting a thorough Health Technology Assessment (HTA), access consultants can guide you in determining appropriate pricing and reimbursement strategies to ensure market access.
Economic modelling is another essential aspect of market access consultancy services. Consultants can help you develop budget impact models and cost-effectiveness analyses to support your market access strategy.
Market access consultants can also assist with the preparation of the clinical component of reimbursement submissions to ensure that the clinical value of your product is well understood.
When selecting a market access consultancy firm, consider the following criteria:
1 Expertise in health economics and outcomes research
2 Experience with economic modelling and medical writing
3 Proven success in market access
4 Insights into market access trends
Before partnering with a market access consultancy firm, ask the following questions:
1 What experience do they have with similar products and markets?
2 How well do they understand current market trends and challenges?
3 Are they committed to your organisation’s success? Will they reduce your workload?
In conclusion, market access consultancy services, like those offered by Salutem Insights, can provide invaluable support in the successful launch of your product. By leveraging their expertise in health economics, economic modelling, medical writing and latest market access insights, Salutem Insights can help you develop a comprehensive market access strategy that maximises your product’s potential. If you’re considering partnering with a market access consultancy firm, we encourage you to reach out to Salutem Insights for a consultation or further information to see how their team of experts can help your organisation succeed. Don’t miss this opportunity to unlock your product’s market potential – contact Salutem Insights today!
This must-attend event welcomes all healthcare stakeholders and is directly relevant to researchers and academicians, assessors and regulators, payers and policymakers, the life sciences industry, healthcare providers, and patient engagement organizations. This global scientific event will cover key HEOR topics, including:
The National Enterprise Awards were set up to celebrate the achievements of Ireland’s micro-enterprise sector and commend the businesses that continue to demonstrate excellence in their day-to-day operations and prove that the Republic of Ireland is home to some of the most innovative and diverse enterprises, businesses, and initiatives throughout Europe.
We are delighted to be shortlisted for the National Enterprise Awards 2022.