Other Technologies Submission

Medical Devices, Diagnostics, and Screening Technologies:

If your company is interested in proposing a topic for a EUnetHTA assessment, please contact the team at the Austrian Institute for Health Technology Assessment (AIHTA, formerly LBI-HTA) in Vienna, Austria. AIHTA is co-lead (CoLP) of Joint Production with regard to “Other Technologies (i.e. non-pharmaceutical technologies)”.

After an initial discussion on the EUnetHTA Assessment process, the next step is to complete a Letter of Intent, in which further details about the suggested technology are described: population, intervention, comparator and outcomes. The Letter of Intent is sent upon request by WP4 CoLP AIHTA and should be submitted to AIHTA via eunethta@aihta.at.

Please note that a EUnetHTA Assessment on your suggested technology 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 EUnetHTA Assessment has started, your company might be invited to comment on the preliminary PICO and/or participate in a scoping (e-)meeting.

During the scoping phase in the Assessment process you might be requested to submit a evidence submission 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 – Other Technologies

Evidence Submission Template – Medical devices (short form)

Evidence Submission Template – Medical devices (long form)

Prior to publication of the Project Plan and/or the EUnetHTA Assessment, there is a possibility for the company to do a factual accuracy check of the draft Project Plan and/or the EUnetHTA Assessment, i.e. they can make sure that the factual information in the Project Plan and/or the EUnetHTA Assessment regarding their product(s) is correct. Each Authoring Team decides whether they want to include a factual accuracy check in their Project Plan/assessment. For direction during this process, the Fact Check Guidance has been developed.

Fact Check Guidance – Other Technologies

We are happy to explain the Other Technologies Joint or Collaborative Assessment process in further detail. As such, we have provided an extensive FAQ list for Other Technologies that we strongly recommend first checking. In addition, you can read the generic Industry Procedure Manual for more information on the Other Technologies Joint and Collaborative Assessment production process, as available below. For any further queries, the WP4 Team will be pleased to be of assistance.

Generic Industry Procedure Manual – Other Technologies

FAQs:

What are ”Other Technologies” in the context of EUnetHTA?

What is a EUnetHTA Joint Assessment in Other Technologies?

What is a EUnetHTA Collaborative Assessment in Other Technologies?

How does EUnetHTA select an assessment team?

What is a EUnetHTA submission dossier?

What methodologies are used in the EUnetHTA assessment production?

Which documents are made public?

What results can be expected from a EUnetHTA assessment?

What should I do if I see a potential error in a EUnetHTA report?

How and where are EUnetHTA assessments being used?

How can a manufacturer facilitate uptake of EUnetHTA assessments by European Member States?

How can a manufacturer suggest a topic for a EUnetHTA assessment in Other Technologies?

What can the manufacturer expect when being involved in a EUnetHTA assessment?

A manufacturer has a possible topic 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 manufacturer need to invest?

What are the benefits for a manufacturer?

What are “Other Technologies” in the context of EUnetHTA?

Other Technologies include non-pharmaceutical technologies i.e. screening technologies, medical and surgical interventions, and diagnostic technologies. The Austrian Institute for Health Technology Assessment (AIHTA) as EUnetHTA Joint Assessment (WP4) Co-Lead is responsible for coordination of EUnetHTA assessments on Other Technologies and related tasks.

What is a EUnetHTA Joint Assessment in Other Technologies?

Please see definition and general overview.

A Joint Assessment (JA) in Other Technologies is coordinated by the Austrian Institute for Health Technology Assessment (AIHTA), Joint Assessment (WP4) Co-Lead. A project manager oversees required tasks and adherence to timelines, providing support to the assessment team and relevant stakeholders. The assessment team is selected among WP4 partners that volunteer to collaborate and assess the topic. The WP4 partners are national and regional HTA agencies from 28 countries (see question regarding selection of assessment team).

The assessment team consists of an author, a co-author, and 2-5 dedicated reviewers (all EUnetHTA partners). The dedicated reviewers thoroughly review the draft project plan and the draft assessment and provide guidance and comments on these documents. Manufacturer(s) of the technology under assessment are involved in the assessment through the provision of the submission dossier, participation in scoping (e-)meeting and the possibility of a factual accuracy check of the draft project plan and the draft assessment. External experts provide comments on the draft project plan and the draft assessment and can also attend scoping (e-)meetings. Furthermore, EUnetHTA aims to include patients, patient representatives, or patient organisations in its assessments – see here.

What is a EUnetHTA Collaborative Assessment in Other Technologies?

Please see definition and general overview.

A Collaborative Assessment (CA) differs from a EUnetHTA Joint Assessment (JA) with regard to coordination, i.e. the project management is performed in a decentralised manner by the Work Package (WP) 4 Co-Lead Other Technologies (AIHTA), or by WP4 Activity Centre Department Leads (selected HTA agencies across Europe). Furthermore, in CAs, the use of the submission dossier and scoping (e-)meeting with manufacturer(s) are optional. However, the manufacturer(s) is asked to comment on the draft “population, intervention, comparator and outcomes” (PICO). Other processes are the same as those of JAs.

This should allow HTA institutes to follow tight national timelines.

How does EUnetHTA select an assessment team?

 EUnetHTA defined a set of selection criteria that are followed when an assessment team (author, co-author, dedicated reviewers) is created:

• Commitment to use the report in the national setting. Deviations from this criterion might occur if specific skills, for example for dedicated reviewers, are required.
• Expertise/knowledge of the disease area and in the drug/medical device should be available for the authoring team.
• Experience with and understanding of EUnetHTA procedures, tools, and methodology should be available for the authoring team.
• Available skills and experience from previous Joint or Collaborative assessments within the authoring team. Ideally, at least one agency within the authoring team should have experience with previous EUnetHTA assessments.
• Availability during suggested timelines.
• No conflict of interest of participating persons (following JA3 DOI procedure).
• Sufficient EUnetHTA budget for participation.
• Seek geographical spread of the authoring team throughout Europe.

A Declaration of Interest (DOI)and Confidentiality Agreement are completed and signed by all participating individuals from the HTA agencies and external stakeholders (e.g. individual patients, healthcare providers). 

What is a EUnetHTA submission dossier?

 The EUnetHTA submission dossier was created as an aggregation of the most common submission requirements from around Europe; therefore, parts of it can be re-used in national processes. In Other Technologies, the submission dossier typically follows the rapid Relative Effectiveness Assessment (REA) from the HTA Core Model® which consists of four domains:

• Description of the technology and its comparators (TEC).
• Health problem and the current use of the technology (CUR).
• Clinical effectiveness (EFF).
• Safety (SAF).

These domains consist of generic research questions, the so-called ‘assessment elements’. However, the focus of the submission dossier in Other Technologies is on the TEC and CUR domains. In addition, information on relevant ongoing and published clinical trials should be provided by manufacturers. A detailed systematic literature search (including risk of bias and GRADE assessment) is performed by the author of the EUnetHTA assessment and is not required by the manufacturer(s).

It is recommended to begin work on the EUnetHTA submission dossier as soon as a draft “population, intervention, comparator, and outcome” (PICO) is established and made available by the assessment team. In Collaborative Assessments (CA) the use of the submission dossier is optional.

Please note that EUnetHTA may also conduct the EUnetHTA assessment in Other Technologies using publicly available documents/information without the participation of the manufacturer (i.e. without having received a submission dossier from the manufacturer).

The EUnetHTA submission dossier will be published with the final assessment report on the EUnetHTA website. 

What methodologies are used in the EUnetHTA assessment production?

 EUnetHTA assessments are conducted following the HTA Core Model® and the EUnetHTA guidelines. EUnetHTA guidelines should help solve methodological challenges that are encountered by health technology assessors whilst performing (EUnetHTA) assessments. The primary aim of the EUnetHTA guidelines is lead the assessors in all steps of EUnetHTA assessment production, e.g. how available evidence/data is analysed and interpreted. The up-to-dateness of EUnetHTA guidelines is regularly verified and updated if required based on user feedback.

Which documents are made public?

 The Letter of Intent as submitted by the manufacturer will be shared with all WP4 partners that assess Other Technologies in order to form an assessment team. The Letter of Intent will not be made public. Once an assessment team is formed, the topic of the assessment and the assessment team (names of institutions only) will be published on the EUnetHTA website.

The manufacturer(s) should only provide non-confidential information that can be used for the production of the EUnetHTA assessment report. The EUnetHTA submission dossier is shared with the assessment team and will be published without redaction and alongside the final REA assessment report on the EUnetHTA website. The EUnetHTA submission requirements are available here. A confidentiality agreement is signed by all participating parties and no draft version of the EUnetHTA assessment is shared with the public.

Both the final project plan and the final assessment report are published on the EUnetHTA website together with the comments from external experts, factual accuracy check related comments from manufacturer(s) (if applicable) and the author/co-author answers to them.

What results can be expected from a EUnetHTA assessment?

 The EUnetHTA assessment analyses and discusses available evidence on relative effectiveness and safety. In most European Member States, the HTA process is divided in a technical assessment of the data and an appraisal of the available evidence. The EUnetHTA assessment does not include an appraisal. The appraisal and provision of recommendations on the added therapeutic and/or clinical benefit are left to the European Member States, since they need to be framed in a national context by the respective national HTA bodies. The same applies for health economic evaluations which are also undertaken at national level and are not included in a EUnetHTA assessment. The national HTA bodies are, however, encouraged to use the EUnetHTA assessment in their clinical assessment.

What should I do if I see a potential error in a EUnetHTA report?

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 eunethta@zinl.nl and report the potential error. In your email, please clearly:

• State your affiliation and contact details.
• Describe as specific as possible the potential error you discovered (mention the title of the report (and the project ID), state both the page number and the specific sentence, and mark the error).
• If applicable, please also submit a reference to a source where the correct information can be found.

For further details on the process steps and the error classification, you can consult the dedicated process flow here.

How and where are EUnetHTA assessments being used?

 Information about the use of EUnetHTA assessments can be found here.  As mentioned, when the assessment team is selected there is a focus on HTA institutes that indicate a commitment to use the EUnetHTA assessment on a national level (see question regarding selection of assessment team).

How can a manufacturer facilitate uptake of EUnetHTA assessments by European Member States?

 In order to facilitate national uptake, it is advised to share information on the EUnetHTA assessment and its processes with local affiliates who prepare the national submission dossiers. Communication is key! EUnetHTA has an active role in promoting the use of the EUnetHTA assessments and EUnetHTA submission dossiers among EUnetHTA partners and other stakeholders in order to facilitate the goal of broad national uptake.

INDUSTRY – HOW TO PARTICIPATE

How can a manufacturer suggest a topic for a EUnetHTA assessment in Other Technologies?

 The Austrian Institute for Health Technology Assessment (AIHTA), EUnetHTA Work Package (WP) 4 Co-Lead Other Technologies, should be contacted directly via eunethta@aihta.at if a manufacturer is interested in suggesting a topic for an assessment in Other Technologies.

The manufacturer can discuss any possible topic suggestion(s) with the AIHTA. As soon as the manufacturer and the AIHTA agree to proceed, the manufacturer is asked to complete a Letter of Intent, in which further details about the suggested topic should be outlined: population, intervention, comparator and outcomes (PICO). AIHTA will then contact EUnetHTA WP4 partners in order to identify possible assessment team members (author, co-author, dedicated reviewers). EUnetHTA aims to ensure high uptake of EUnetHTA assessments in European Member States and therefore the suggested topic will only be performed if at least 4 EUnetHTA WP4 partners (1 author, 1 co-author, 2 dedicated reviewers) are interested in working on this topic.

What can the manufacturer expect when being involved in a EUnetHTA assessment?

 In Joint Assessments (JAs), all manufacturer(s) of relevant medical technologies under assessment are contacted by the project manager and invited to participate in the assessment production process. The manufacturer(s) will be invited to a scoping (e-)meeting with author, co-author, and the project manager, where the “population, intervention, comparator, outcome” (PICO) is discussed. This meeting is an opportunity to clarify questions regarding the technical characteristics of the device(s) under assessment and to provide feedback. Furthermore, the manufacturer(s) will be asked to submit a EUnetHTA submission dossier (see question regarding “EUnetHTA submission dossier”).

In Collaborative Assessments (CA), the only difference to the involvement of manufacturer(s) in JAs is that the invitation of manufacturer(s) to the (e-) scoping meeting and the request for a EUnetHTA submission dossier are optional – this is up to the assessment team. However, the manufacturer(s) is asked to comment on the draft “population, intervention, comparator and outcomes” (PICO).

All medical technologies that are relevant for the EUnetHTA assessments (JAs and CAs) are included regardless of whether the manufacturer(s) participates in the assessment production process or not. If no EUnetHTA submission dossier is submitted, publicly available documents and information will be used. The manufacturer(s) might be asked to participate in an optional factual accuracy check of the draft project plan, as well as that of the draft EUnetHTA assessment. This means that they can make sure that the information provided regarding their product(s) is correct (even if no submission dossier is requested and/or no scoping meeting is held). The author/co-author will formally answer such factual accuracy check related comments, which are then published on the EUnetHTA website if applicable and appropriate to the factual accuracy check to allow transparency.

A manufacturer has a possible topic to suggest – when should EUnetHTA be contacted? What are the timelines?

 The manufacturer can approach the Austrian Institute for Health Technology Assessment (AIHTA), EUnetHTA Work Package (WP) 4 Co-Lead Other Technologies all year round. There are no specific deadlines for topic suggestions. Topics for assessments in Other Technologies are selected and prioritised on a regular basis.

You can contact at eunethta@aihta.at

The timelines for the production of a EUnetHTA assessment are drafted in the scoping phase when the project plan is compiled. Timelines can be adapted according to the needs of the EUnetHTA partners, i.e. when information for reimbursement decisions is due.

Please note that in non-pharmaceutical technologies, EUnetHTA generally assesses products that have a CE mark and are marketed in the EU. Exceptions are possible in certain cases.

Is there a fee for suggesting a topic or for participating in a EUnetHTA assessment?

 Manufacturers are not required to pay any fees for suggesting topics or for participating in a EUnetHTA Joint Assessment (JA) or Collaborative Assessment (CA).

What does a manufacturer need to invest?

 The main manufacturer investment is in human resources to prepare the EUnetHTA submission dossier (the request for a EUnetHTA submission dossier is mandatory in Joint Assessments (JA) and optional in Collaborative Assessments (CA)). However, a manufacturer might be able to use parts of the national submission dossiers and to add them to the EUnetHTA submission dossier, or the other way round.

If a manufacturer is invited to a face-to-face scoping meeting in which the contents of the submission dossier and the PICO are discussed with the author/co-author and the project manager, travel/accommodation costs of the manufacturer´s employees need to be covered by the manufacturer(s). Such a scoping meeting is usually held in a location in Europe with the easiest transport for all parties, but can also be held via phone/virtual meeting platforms The face-to-face or (e-)scoping meeting is mandatory in JAs and optional in CAs.

Limited time is needed for completing a factual accuracy check of the draft project plan and the draft assessment if requested by the assessment team (optional in JAs and CAs).

What are the benefits for a manufacturer?

 The benefits of participating in a EUnetHTA assessment in Other Technologies are:

• A head start:

The manufacturer has a head start on national submissions by engaging early in the process. The health technology might be reimbursed at an earlier stage because a European assessment can be used by national HTA agencies (after possible adaptation, e.g. adding an economic evaluation) for informing national decision-makers.

• Low resource costs:

Please note that EUnetHTA submission dossiers in Other Technologies focus on information regarding the technology under assessment and its current use (see question regarding “EUnetHTA submission dossier”). Therefore, the resource use is kept to a minimum on the side of the manufacturer.

• Possibility of re-use:

The material used in the EUnetHTA submission dossier can be used again in national processes, since the EUnetHTA submission template is an aggregation of the submission requirements around Europe.

• National uptake:

Provides the opportunity to improve the process of national submissions, which can be done in three ways:

1. Interested partner agencies/countries have the option to accept the EUnetHTA assessment entirely/or part of it and use it for their reimbursement decision, supplemented by the country-specific data.
2. Interested partner agencies/countries have the option to accept the EUnetHTA submission dossier augmented by the national-specific data.
3. A combination of opportunities 1 and 2.

• Get to know EUnetHTA procedures and discover the opportunity to help shape the future of European HTA.

For more information, contact eunethta@aihta.at

The next step is to complete a letter of intent, where you describe further details about your suggested topic: population, intervention, comparator and outcomes (PICO). Please note that your suggested topic 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.