If your company is interested in proposing a compound for a EUnetHTA rapid REA on a pharmaceutical technology, please contact the Pharmaceutical Joint Production team via:
After an initial discussion on the Joint Assessment process, the next step is to complete a Letter of Intent, in which further details about the suggested compound are described: population, intervention, comparator and outcomes. The letter can be accessed at this link:
Letter of Intent
Finally, the Letter of Intent is submitted to the team at the same WP4_Pharmaceuticals@zinl.nl team address.
Please note that a Joint Assessment on your suggested compound will only be performed if sufficient EUnetHTA partners are interested in working on this topic, since one of the aims of EUnetHTA is to ensure high uptake of EUnetHTA assessments in European Member States.
Once the Joint Assessment has started, you are invited to submit a Scoping Document. The Scoping Document focuses on the manufacturers’ view of the PICO (+ justification).
Scoping Document – Pharmaceuticals
One month prior to CHMP opinion, you are requested to submit a dossier. To do so, please see the following links in which you can download and consult the submission requirements and templates required for the process:
Submission Requirements – Pharmaceuticals
Core Submission Dossier Template – Pharmaceuticals
Approximately three weeks prior to publication of the EUnetHTA Assessment, there is a possibility for the company to do a factual accuracy check of the draft EUnetHTA Assessment, i.e. they can make sure that the factual information in the EUnetHTA Assessment regarding their product is correct. Each Authoring Team decides whether they want to include a factual accuracy check in their assessment. For direction during this process, the Fact Check Guidance has been developed.
Fact Check Guidance – Pharmaceuticals
We are happy to explain the Pharmaceutical Joint Assessment process in further detail. As such, we have provided an extensive FAQ list for Pharmaceuticals that we strongly recommend first checking. In addition, you can read the generic Industry Procedure Manual for more information on the pharmaceutical Joint Assessment production process, as available below. For any further queries, the WP4 Team will be pleased to be of assistance.
Generic Industry Procedure Manual – Pharmaceuticals
* EUnetHTA JA3 will not be accepting any further Letters of Intent with regard to new pharma Joint Assessments through the end of Joint Action 3 on 31st May, 2021.
What is a Health Technology Assessment (HTA)?
Why a European collaboration on HTA?
Why do we strive for European collaboration on HTA?
What is the scope of EUnetHTA Assessments?
Compounds eligible for a EUnetHTA Assessment (TISP and EPL).
How do products end up in an EPL?
How and where are EUnetHTA Assessments used (uptake)?
How does EUnetHTA facilitate the uptake of EUnetHTA Assessment reports?
How can the company help to facilitate the uptake of EUnetHTA Assessment reports?
How does EUnetHTA select an assessment team?
What methodologies are used in the EUnetHTA Assessment production?
How and where are EUnetHTA Assessments being used?
Interested in participating with EUnetHTA?
How can a pharmaceutical company suggest a compound for a EUnetHTA Assessment?
What does the participation of a company in a EUnetHTA Assessment of a pharmaceutical compound look like?
A company has a possible compound to suggest – when should EUnetHTA be contacted? What are the timelines?
Is there a fee for suggesting a topic or for participating in a EUnetHTA Assessment?
What does a company need to invest?
Which documents/data are required from the manufacturer?
What information and/or documents are made public?
What should I do if I see a potential error in a EUnetHTA report?
What are the key procedural milestones in a EUnetHTA Assessment?
What is the role of a PICO question for a EUnetHTA Assessment?
HTA is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, and robust manner. HTA answers clinical questions of new, potentially innovative healthcare technologies such as: How well does a new technology work compared with existing alternative health technologies? For which population group does it work best?
EUnetHTA Assessments use the common reporting framework, namely the HTA Core Model®, to systematically search for, analyse, and integrate clinical evidence, while assessing the quality of the body of evidence. It gives national HTA bodies essential content for national appraisal procedures. Since member states have an individual legal framework for decision making, EUnetHTA Assessments refrain from providing recommendations or conclusions on the added therapeutic and/or clinical benefit. Cost-effectiveness analyses (CEA) and ethical, organisational, patient/social and legal aspects are also beyond the scope of a EUnetHTA Assessment.
The EUnetHTA Rapid Relative Effectiveness Assessments (REAs) include the following four domains:
For complete information about EUnetHTA’s definition on HTA and Rapid Relative Effectiveness Assessments, please follow this link.
The Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare was adopted in 2011 and stipulates (Article 15) that the Union shall support and facilitate cooperation between national authorities or bodies responsible for health technology assessment designated by the Member States. According to the Implementing Decision, the HTA network is to be supported by a scientific and technical cooperation to meet the objectives of the European cooperation on HTA as per Article 15 of the Directive.
EUnetHTA performs the function of the scientific and technical cooperation of the HTA network. Read more about the network here:
Health Technology Assessment Network
Health Technology Assessment Network Stakeholder Pool
For complete information about the history of EUnetHTA, please follow this link.
A European collaboration on HTA benefits pharmaceutical companies national HTA agencies and ultimately patients. By participating in EUnetHTA Assessments, companies have the opportunity to collaborate with EUnetHTA and shape the future of European HTA.
Benefits for a pharmaceutical company are:
EUnetHTA Assessments are HTA reports jointly produced by at least four EUnetHTA partners from different European countries. EUnetHTA processes, guidelines, and the HTA Core Model® are used for the production of Assessments. The HTA Core Model® is a common reporting framework to systematically search for, analyse, and integrate clinical evidence and assess the quality of the body of evidence. It gives national HTA bodies all the essential content required for national appraisal procedures.
Since Member States have an individual legal framework for decision making, EUnetHTA Assessments refrain from providing recommendations or conclusions on the added therapeutic and/or clinical benefit. Cost-effectiveness analyses (CEA) and ethical, organisational, patient/social and legal aspects are also beyond the scope of a EUnetHTA Assessment. EUnetHTA Assessments are also subject to extensive review procedures in order to ensure high quality.
Pharmaceutical EUnetHTA Assessments are centrally coordinated by the WP4 Co-Lead Partner Zorginstituut Nederland (ZIN).
All new medicines and extensions of indication that enter the market via the central procedure (i.e. via the European Medicines Agency [EMA]) are eligible for EUnetHTA Assessments. In order to actively identify compounds of specific interest for EUnetHTA partner organisations, EUnetHTA is developing a process called ‘topic identification, selection and prioritisation’ (TISP), which will result in a prioritisation list. Where the first EUnetHTA Prioritisation List (EPL) was launched as a pilot, its findings will feed into the structural and systematic approach of TISP. In addition, voluntary compound submissions by companies are much welcomed.
The EPL was based on the Innovation Observatory. The list was cross-checked with the open access Dutch Horizon Scan and the publicly available EMA list of medicines under evaluation to estimate regulatory timelines. In compiling the list, EUnetHTA partners were asked to indicate their interest, including using the Assessment at the national level. The final prioritisation was based on this feedback and combined with the anticipated feasibility of the compatibility of timelines of the EUnetHTA Assessment and estimated regulatory timelines. Therefore, prioritisation does not discriminate between pharmaceutical companies, compounds or indication. Of note, the EPL is an ad-hoc approach. In the future, this process will be replaced using the aforementioned systematic approach called ‘topic identification, selection and prioritisation’ (TISP).
As part of the implementation network, EUnetHTA collects use and uptake information by EUnetHTA partners (HTA agencies) of its jointly produced HTA information. The information is collected through surveys and interviews carried out with implementation network participants.
EUnetHTA has several processes in place to facilitate the national uptake of the EUnetHTA Assessments:
EUnetHTA also identified some steps and activities in which the company can help facilitate the national uptake of the Assessment. One of the recommendations for the company is to share information on the EUnetHTA Assessment and its processes with national affiliates who prepare the national submission dossiers. In addition, EUnetHTA recommends having each national/regional affiliate communicate to the local decision maker that they are participating in a EUnetHTA Assessment and that they should explore the options for the use of the EUnetHTA submission dossier in the national appraisal.
EUnetHTA defined a set of selection criteria that are followed when an assessment team is created (see below). EUnetHTA focusses on including relevant expertise, the commitment to use the Assessment nationally and available resources within the EUnetHTA Joint Action 3. In addition to this, EUnetHTA also seeks to build capacity by employing the following selection criteria:
A Declaration of Interest and Confidentiality Agreement (DOI) is signed by all participating individuals from the HTA agencies and external stakeholders (e.g. individual patients, healthcare providers, medical editor).
EUnetHTA Assessments are conducted following the EUnetHTA Guidelines. The primary aim of the EUnetHTA Guidelines is to guarantee consistency between Assessments and to guide the assessors in all steps of EUnetHTA Assessment production, e.g. how available evidence/data is analysed and interpreted. Existing guidelines are being revised regularly and new guidelines are being developed.
Detailed information on the use of EUnetHTA Assessments can be found here.
If your company is interested in suggesting a pharmaceutical compound for a EUnetHTA Assessment, you should submit a Letter of Intent to Zorginstituut Nederland – the Pharmaceutical Co-Lead Partner of WP4. This can be sent to WP4_Pharmaceuticals@zinl.nl. In the Letter of Intent, further details about the suggested compound are described: population, intervention, comparator and outcomes (PICO). The template for this letter can be found here.
As soon as a completed and signed Letter of Intent is received, the project manager(s) will reach out to all relevant EUnetHTA WP4 partners to identify assessment team members. Please note that, since EUnetHTA aims to ensure high national uptake of an Assessment, a EUnetHTA Assessment on a suggested compound can only be performed if there is sufficient interest from WP4 partners in (working on) this topic.
The participation of a company starts by submitting a completed and signed Letter of Intent. After a team is formed, the manufacturer is invited to submit a Scoping Document, focussing on the manufacturers’ view of the PICO (+ justification), prior to attending a scoping face-to-face meeting with the authoring team and the project manager(s). The scoping face-to-face meeting provides the possibility to discuss the PICO and the information the authoring team (author and co-author) requires in the Submission Dossier.
One month prior to CHMP opinion, the company delivers the Submission Dossier to EUnetHTA, which forms the basis for the Assessment.
Approximately three weeks prior to publication of the EUnetHTA Assessment, there is a possibility for the company to do a factual accuracy check of the draft EUnetHTA Assessment, i.e. they can make sure that the factual information in the EUnetHTA Assessment regarding their product is correct. Each Authoring Team decides whether they want to include a factual accuracy check in their assessment. The Authoring Team will formally answer fact check-related comments which are published on the EUnetHTA website in order to allow transparency. Such checks have been conducted in all Pharmaceutical Joint Assessments in JA3 so far. The factual accuracy check takes place in parallel with the medical editing of the draft assessment report and takes five calendar days.
The best time to contact Zorginstituut Nederland (WP4 pharma Co-Lead Partner) depends on the EMA submission date and the regulatory pathway (i.e. initial marked application, Type II variation or accelerated access). CHMP opinion and publication of the EPAR always form the basis of the EUnetHTA Assessment timelines. In order to publish the EUnetHTA Assessment report close after EPAR to facilitate a high national uptake, the assessment has to start immediately after CHMP opinion. This results in strict deadlines and the need for everyone to comply with the timelines set in the Project Plan.
To allow for a proper scoping phase (i.e. assembling the team, scoping face-to-face meeting) a Letter of Intent should be submitted around day 0 of EMA submission. Informal dialogue between the company and EUnetHTA on, for example, procedures, can be initiated well before EMA submission.
There is no fee for suggesting compounds or for participating in a EUnetHTA Assessment.
The main investment of companies is the time spent by their employees to prepare the EUnetHTA Submission Dossier. It is expected that the company will be able to use parts of, or the entire EUnetHTA Submission Dossier/report, for national submissions. We strongly encourage companies to get in touch with their national affiliates to make them aware of the (upcoming) EUnetHTA Submission Dossier and Assessment report to enhance the use of the EUnetHTA documents in national submissions.
The company is also invited to a face-to-face scoping meeting (see the question on “How does the participation of a company in a EUnetHTA Assessment of a pharmaceutical compound look like?”). Travel/accommodation costs of company employees cannot be reimbursed by EUnetHTA. Scoping meetings are held in Amsterdam (Netherlands) at the office of the WP4 Pharma Co-Lead Partner, Zorginstituut Nederland.
In order to proceed with a EUnetHTA Assessment the following documents are required:
Letter of Intent (LOI)
The LOI is submitted by the company will be shared with all WP4 partners that assess pharmaceuticals, in order to form an assessment team.
In the Letter of Intent, details about the suggested compound should be outlined: Population, Intervention, Comparator and Outcomes (PICO) and statistical methods available to analyse the data. The template for this letter can be found here.
In order to have an efficient and informed scoping face-to-face meeting, the manufacturer is requested to submit a Scoping Document. This document should be concise and focus on the manufacturers’ perspective (and justification) of the PICO and any statistical methods for presenting the data (e.g. Network Meta-Analysis). The template for the Scoping Document can be found here.
The Submission Dossier, provided by the company of the compound under assessment, forms the basis for the EUnetHTA Assessment. This dossier consists of:
The EUnetHTA Submission Dossier was created based on the most common submission requirements from around Europe; therefore, parts of it can be used in national processes.
In short, the Submission Dossier consists of a description of the technology and disease, provides an overview of current treatments/guidelines, proposes a scope for the assessment consisting of Population, Intervention, Comparator(s) and Outcomes (PICO), systematic literature search, and all relevant publications together with the evidence synthesis. The Submission Dossier is used as a basis in the EUnetHTA Assessment.
The Submission Dossier typically follows the rapid Relative Effectiveness Assessment (REA) model of the HTA Core Model which consists of four domains, themselves consisting of generic research questions, the so-called ‘assessment elements’:
The EUnetHTA Submission Dossier is shared with the project manager, who then shares it with the assessment team (authors, co-authors, dedicated reviewers and observers). Authors are free to cite from the Submission Dossier.
Only after publication of the EUnetHTA Assessment will the Core Submission Dossier be made public. Appendices to the Core Submission Dossier, e.g. CSRs are not published by EUnetHTA. For further information, please read EUnetHTA’s Submission Requirements Fact Sheet available here.
The following items will be made publicly available:
EUnetHTA has an error reporting and correction procedure in place. If you see a potential error in the EUnetHTA report, please contact the secretariat at email@example.com and report the potential error. In your email, please clearly:
For further details on the process steps and the error classification, you can consult the dedicated process flow here.
The exact timelines are dependent on the regulatory pathway. To give a general understanding of the timelines, please see the list below. For a thorough understanding of what the timelines may look like for a specific compound, please contact us at WP4_pharmaceuticals@zinl.nl
Key Activity & Time Expectation
Letter of Intent – Around Day 0 of EMA submission.
Scoping Document – 1 month prior to scoping face-to-face meeting.
Scoping face-to-face meeting – 2-3 months prior to CHMP opinion.
Submission Dossier – 1 month prior to CHMP opinion.
Start Assessment Phase – CHMP opinion.
Factual Accuracy Check (optional) – 3 weeks prior to publication of the Assessment Report.
Publication of the Assessment Report – 2 weeks after EPAR publication.
The starting point for an assessment of a medical intervention is the formulation of a defined research question that should be answered by the assessment. In the context of EUnetHTA the research questions to be investigated are based on policy questions from the health care systems in which a HTA report should be used. Given the diversity of health care systems in Europe, it is possible that for a given medical intervention different policy questions are formulated by different partners.
The assessment of an intervention should not be data driven, i.e. the research questions should not be deduced from the available studies (either identified via an own information retrieval by the authoring team or submitted by the MAH/manufacturer). Rather, an appropriate translation of the policy question into a research question should be performed in the planning stage of the assessment. This means that the research question (the PICO – Population, Intervention, Comparator(s), Outcomes) is pre-specified for a given assessment.
For more information on what the PICO framework is, how the PICO is used, and if EUnetHTA has a standard process for developing a PICO question, please consult the PICO FAQ.
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