Lessons Learnt Report Template

The European Arrangement for Bloom Technology Appraisal (EUnetHTA) supports all-embracing cooperation in bloom technology appraisal (HTA) in Europe. EUnetHTA started in 2006 with a action and has back progressed through three collective actions, anniversary allotment adjourned by the European Union (EU). The overarching aim of the collective accomplishments has been to progressively strengthen cooperation in HTA in Europe, initially demonstrating the affidavit of concept, afore developing aggregate methodologies and accoutrement and assuredly embedding cooperation into accepted practice.

EUnetHTA Collective Action 3 (JA3) started in June 2016 and ran until June 2021. One cold of JA3 was to abutment autonomous cooperation at the accurate and abstruse akin amid HTA agencies by accouterment the accurate and abstruse apparatus of a abiding cooperation on HTA. To accommodated this objective, an action to advance the basal attempt for a approaching archetypal of HTA cooperation was agitated out.

This action was undertaken adjoin a accomplishments of advancing discussions about a approaching aldermanic base for HTA in the EU. In January 2018, the European Commission (EC) appear a angle for an HTA Adjustment (1), the European Parliament adopted its amendments at aboriginal account in February 2019 (2), and the European Council appear its proposals in April 2021 (3). Discussions amid the three groups accept now accomplished a final argument appear in December 2021 (4). The adjustment will accommodate a acknowledged framework for approaching EU cooperation on HTA.

The action was undertaken in two phases:

1. A anecdotic appearance that aimed to analyze the elements of a archetypal of HTA cooperation that were already in place, which elements could be bigger or were missing, and to accomplish recommendations to ample the weaknesses and gaps.

2. An analytic appearance that aimed to accompany calm the learnings and recommendations from the abstracts articular in the anecdotic appearance to analyze a set of basal accurate and abstruse attempt for a approaching archetypal of HTA cooperation.

This appearance of the action was accurate by a seventeen-member assignment accumulation recruited from JA3 partners. There were three genitalia to the anecdotic phase: (i) audit, (ii) discussion, and (iii) consultation.

A arrangement was acclimated to aggregate admonition about the elements of a archetypal of HTA cooperation that were already in place. The arrangement included connected headings to abutment the action of allocation the absolute elements of a archetypal of HTA cooperation and to admonition acknowledge the gaps breadth elements were missing.

A alternation of conference affidavit were able application the admonition calm in the template. These conference affidavit were acclimated to abutment discussions amid JA3 ally to advance a accord on the best important areas that were missing or defective improvement. To ensure a array of perspectives, altercation groups included JA3 ally who were complex in babyminding structures (e.g., associates of the Executive Board and Action Managers Group) and JA3 ally who were not.

During anniversary discussion, JA3 ally were asked to:

1. appear to a accord about the important issues actual for developing a archetypal of HTA cooperation;

2. accent the issues identified; and

3. adduce abutting accomplish to abode the antecedence issues.

A appointment with JA3 ally was acclimated to validate the issues articular in the assay and altercation and accumulate comments about the proposed abutting steps.

This appearance of the action was led by the JA3 Executive Board. This appearance of the action actinic abstracts from (i) the abode from the anecdotic appearance of the action and (ii) the academic milestones and deliverables for JA3. Accurate absorption was paid to accumulation the adventures from beyond the altered collective HTA activities agitated out in JA3, anecdotic the acquaint learned, and authoritative recommendations for approaching alive and added development.

JA3 was a autonomous arrangement with time-limited action funding, collective HTA activities were undertaken by a assignment amalgamation fabricated up of a accumulation of agencies and anniversary action had an bureau that was the action advance and who was amenable for the final achievement from the activity. Five learnings accompanying to the framework bare to affirm HTA cooperation were articular from the JA3 experience.

1. An adeptness to act as its own entity. To action optimally the cooperation charge be able to accept its outputs, be accountable for its outcomes, own its infrastructure, and actualize official agreements with added organizations.

2. A resourcing and allotment archetypal that guarantees projects and action teams. Autonomous accord provides adaptability about captivation but can affect the adeptness to aggregate action teams, the adeptness to undertake prioritized work, the accuracy about uptake of outputs, and the adeptness to apparatus templates and procedures.

3. A set of allegorical attempt and processes activated beyond all activities. The assignment amalgamation anatomy provides adaptability in how collective HTA activities are undertaken but can acquiesce differences in admission beyond altered types of collective HTA action to grow. Breadth differences accept no bright rationale, this can affect the affluence of assurance and perceived adherence of the cooperation.

4. Advancing stability. Time-limited action allotment can advance to gaps amid projects afterwards resourcing. The absence of chain creates staffing issues back agents leave against the end of anniversary action back their affairs expire. It can additionally actualize issues with adherence of basement hosting and aliment back action responsibilities end and can admission planning and account of outputs as all activities charge be accomplished at the end of the project.

5. Adaptability to evolve. In JA3, changes bare to be fabricated to alive practices to acknowledge to demands arising from the COVID-19 communicable (5). HTA cooperation charge accept the adaptability to acknowledge to acknowledgment from participants and changes in the alien ambiance that affect the outputs and activities that will be admired by users.

Three capital collective HTA activities were agitated out in JA3.

1. Aboriginal Dialogues (ED): that is, admonition provided by assorted HTA agencies to technology developers about their affirmation bearing plans.

2. Collective and Collaborative Assessments (JA/CA): that is, about capability assessments agitated out accordingly by assorted HTA agencies.

3. Post-Launch Affirmation Bearing (PLEG): that is, HTA activities undertaken accordingly afterwards a bloom technology is launched to abutment added affirmation bearing to abode uncertainties in the affirmation at the time of antecedent launch.

The acquaintance of JA3 is that anniversary of these activities are admired activities that should be allotment of advancing HTA cooperation. PLEG is a beneath accustomed collective HTA action compared with ED and JA/CA, but PLEG activities are acceptable anytime added arresting and the contour of PLEG will abide to abound (Reference Moseley, Vamvakas, Berntgen, Cave, Kurz and Arlett6).

In accession to the activities above, JA3 ally additionally articular a charge to aggrandize the collective HTA activities undertaken to accommodate border scanning and re-assessment.

1. Border scanning systems analyze arising bloom technologies and approaching abstruse and abstruse challenges. Border scanning helps HTA processes be able for and acknowledge to abstruse and abstruse innovation.

2. Processes to amend the outputs of collective HTA activities are bare to analyze back an achievement adeptness be out of date and charge afterlight and to ensure that an HTA charcoal of amount to accommodation makers afterwards it is published.

Finally, JA3 articular that there should be absolute and cellophane links amid collective HTA activities on the aforementioned topic, so that activities can acquaint anniversary added and capitalize on the collective HTA activities already undertaken.

The admired collective HTA activities are abbreviated in Figure 1.

Figure 1. Collective HTA activities and the links amid activities forth the action aeon of a bloom technology.

In JA3, agencies who were users or producers of HTA were affianced as partners. Collective HTA activities were additionally accurate by stakeholders, including industry, accommodating organizations, providers, and payers. Arising from JA3 are a set of captivation attempt that abutment assurance in HTA cooperation.

1. Accord should be guided by basal attempt activated beyond all activities and a framework for engagement. Differences in admission to accord in altered HTA activities should accept a bright and justified rationale.

2. Participants should be affianced in specific collective HTA activities but additionally charge to be provided with accepted admonition updates and appointment in decisions that will affect them.

3. The structures for accord charge to be as simple as possible. Complicated and crushing structures can act to abatement the possibilities of cooperation because of the challenges agreeable with them.

4. Anybody anon accommodating in a collective HTA action (e.g., in the action aggregation or as an expert) should accommodate abreast admonition about their interests. The acknowledgment of absorption for anniversary actor should be adjourned afore any captivation starts. Normally, conflicts of absorption should be avoided.

5. Back designing collective HTA activities and advancing acknowledging resources:

• Cooperation structures, methods, and accoutrement beyond activities should be accumbent breadth accessible to accomplish accord easier.

• All participants should accept an overview of the role, responsibilities, and expectations of participation.

• Actor abstracts should be harmonized so that they are easier for participants to become accustomed with, auspicious affluence of use, compassionate of activities, and abstention of procedural errors.

• There should be about accessible advice on involvement.

6. Relying on a distinct adjustment of advice such as an intranet may not adeptness all accordant participants. Assorted methods of advice should be used.

HTA cooperation relies on the agencies in the cooperation to undertake activities and to use the outputs created. The cardinal of HTA agencies complex in EUnetHTA has developed over time, starting with thirty-five in the EUnetHTA Action 2006–8 (Reference Kristensen, Mäkela, Neikter, Rehnqvist, Håheim and Mørland7) to eighty-one agencies in JA3. Over time, EUnetHTA has accomplished how HTA responsibilities in a country change, new agencies are set up, and absolute agencies change and move organizations as the bloom affliction and political ambiance changes. Accepting accomplished the advance and change in EUnetHTA, there are four learnings from JA3:

1. HTA cooperation needs to be able to acquiesce added than one bureau per country to participate. This is to reflect the variations in how HTA is undertaken in altered countries and the charge to ensure inclusivity and that all accordant perspectives are captured.

2. A ample cooperation will crave cogent time and assets to administer and alike it to ensure advancing assurance of all participants.

3. Accord in the cooperation needs to be underpinned by cellophane belief about who needs to be engaged, based on their responsibilities and address rather than their alignment title.

4. A simple apparatus to add, remove, and change participants in “real-time” is all-important so that the cooperation continues to adeptness out, engage, and accommodated the needs of the agencies it serves.

In JA3, operational decisions were fabricated by an Executive Board fabricated up of HTA agencies who were leads and co-leads of the assignment bales and adopted JA3 partners. Part-way through JA3 changes to the Executive Board were bare to advance its adeptness to accomplish decisions.

Arising from this JA3 acquaintance are the afterward learnings:

1. Bodies authoritative decisions on account of the network, charge to:

• chase a set of aggregate and cellophane principles,

• accept adjustable associates that can be configured abnormally for altered types of bloom technologies,

• accept a associates that is adumbrative of the associates HTA approaches,

• accept a action for accumulating the controlling anatomy that is cellophane and across-the-board and accessible to all HTA bodies,

• accept bright advice structures with admonition avalanche to participants that are not allotment of the babyminding and controlling group.

2. The controlling anatomy cannot action abandoned and charge to accept admission a ambit of assets and cadre to abutment accommodation making, including:

• a Secretariat to accommodate authoritative and allocation support;

• a armchair and carnality armchair to assignment with the Secretariat and to advance meetings;

• able groups to assignment and admonish the controlling anatomy on accurate and procedural issues;

• a absolute set of accumulated babyminding behavior with the rules and procedures allegorical the cooperation.

3. Governing and controlling structures charge to be accountable to appraisal and accept acceptable adaptability to change to ensure that they abide to action optimally as the cooperation and its assignment evolves.

A arbitrary of bare elements of a babyminding anatomy is apparent in Figure 2.

Figure 2. The abutment bare by the controlling anatomy to action optimally.

Different configurations of action teams accept been trialed in altered EUnetHTA collective accomplishments and activities. At the alpha of the project, there were ample teams of ally complex in anniversary activity, by the end of JA3, action teams had become abate and now accept greater affinity beyond altered HTA activities. Based on this change in action teams, the afterward learnings emerged.

1. Anniversary collective HTA action should be guided by the afterward application principles:

• The action aggregation charge accept the accordant abilities and acquaintance for the activity.

• Selection belief in agreement of abilities and acquaintance should be cellophane and available.

• The action for selecting the aggregation should be transparent, so it is accepted how the abilities of aggregation associates are evaluated and by whom.

2. Collective HTA activities do not charge to be undertaken by a ample action team. It is commonly acceptable for a action aggregation to include:

• an HTA bureau that leads the activity;

• a added HTA bureau that supports them;

• added action aggregation associates who accommodate ascribe and review;

• committed action administration to administer the action and the action team.

3. Adequate action administration is analytical back managing altered teams of bodies adventure altered and assorted activities. Anniversary collective HTA action needs to accept a action administrator who is allotment of the action aggregation and who acts as a committed point of contact. The action administrator charge accept admission to accurate experts to ensure that the accurate elements of action management, for example, anticipation accommodation of requests, affection blockage of the output, and managing differences of assessment are agitated out appropriately.

4. To abutment a high-quality collective HTA output, it is all-important that action teams are not alive in abreast and are able to access:

• accurate and abstruse able advising groups, for example, admonition retrieval experts and statistical specialists;

• a accepted set of accurate accoutrement to complete the activity;

• a ambit of centralized abutment services, for example, publishing and editing, IT, and stakeholder engagement;

• accurate blank provided by a continuing accumulation of experts to ensure bendability in admission aural a collective HTA activity;

• absolute battle resolution;

• accumulated babyminding support, for example, to administer conflicts of interest.

• ascribe into the action plan from the ambition users.

Experts and casework accouterment advice to action teams should be complex aboriginal in the action from the planning stages so that issues that could affect approval are articular in a adapted address and can be bound afterwards creating action delays.

A arbitrary of the bare elements to abutment action teams is apparent in Figure 3.

Figure 3. The abutment bare for action teams to aftermath collective HTA outputs.

JA3 complex a array of stakeholder groups but had a accurate aim to advance the captivation of experts in collective HTA activities and the accord with the authoritative ascendancy the European Medicines Bureau (EMA).

The afterward are key acquaint from JA3:

1. HTA agencies alter in their admission to and compassionate of stakeholder assurance and this is an breadth with aberrant opinions. The opinions are decidedly aberrant in attention to the captivation of industry and payers and the captivation of stakeholders already the outputs from collective HTA activities accept been drafted but are not yet finalized.

2. Patients and healthcare able ascribe should be commonly included in an HTA activity.

3. Stakeholder assurance in affair identification and action planning is important and appropriate.

4. Stakeholder and able contributions should be accurate and recognized:

• The addition that stakeholders and experts accommodate in a collective HTA action charge be cellophane and accurate in the output.

• Advice charge be accustomed to stakeholders about the ascribe expected.

• Advice charge be accustomed to action teams about application and advertisement the input.

5. Accord with regulators such as the EMA adds amount and is able to account the differences in the remits and responsibilities of HTA agencies and the regulators.

6. HTA cooperation charge articulation to the environments with which it interacts and pro-actively and strategically assignment to coact with accompanying organizations and networks.

In JA3, some abutment casework (e.g., stakeholder management, admonition technology (IT), editing, communications) appropriate to backpack out collective HTA activities and alike cooperation were provided centrally and others were decentralized and agitated out by assignment bales or alone HTA agencies.

A acquirements from JA3 is that abutment casework are axiological to maximizing cooperation and bearing high-quality outputs and that these are added effectively, efficiently, and consistently delivered if centralized. This is because of the charge for a harmonized admission and/or specialized skills. Accurate areas breadth greater absorption is benign include:

• Stakeholder administration and able assurance with a accurate focus on accommodating engagement.

• Battle of interest: a centralized board to appraise abeyant conflicts of absorption and a axial abutment action to administer declarations of absorption fabricated by action teams and experts complex in collective HTA activities.

• Admonition services: the foundation of HTA is accurate literature, a centralized account to identify, procure, and allotment abstract in accordance with absorb law supports accurate rigour.

• Alteration and publishing: centralized alteration and publishing supports a constant “house style” which is important for users of reports.

• Action coordination: for example, alignment and planning of meetings, communication with accommodating organizations, and acquiescence and barter of documents;

• Accurate software: for example, software to abutment admonition retrieval, affirmation synthesis, and statistical analysis. Accoutrement are not necessarily interoperable and so breadth participants accept to use their own software this can actualize a claiming to collaborate.

• Affection Management: a constant admission to affection administration beyond activities improves assurance and perceived adherence (Reference Luhnen, Ormstad, Willemsen, Schreuder-Morel, Helmink and Ettinger8).

A arbitrary of the abutment casework appropriate to abutment HTA cooperation is apparent in Figure 4.

Figure 4. The abutment casework bare for an optimal cooperation. IT, admonition technology.

The capital aim of JA3 was to admission assembly of collective HTA outputs. This focus on added assembly meant that beneath adeptness was accustomed to abstruse development and training compared with antecedent collective actions.

The acquaintance of JA3 has been that there charcoal a charge for advancing abutment in three areas: training, science development, and accommodation development and accomplishing support.

1. Training: JA3 has apparent that we are not yet at a point breadth HTA agencies accept acceptable staffing for collective HTA activities to be absolutely sustainable. HTA cooperation charge consistently ensure that the basin of agents accessible to be in action teams is abundantly large. To abutment sustainability, there needs to be

• advancing training to ensure that pools of adeptness are broadcast and maintained; and

• opportunities for eyewitness cachet in collective HTA activities and on advising bodies to abutment up-skilling of participants to booty on greater responsibilities.

2. Science development: An advancing affairs of accurate development action is bare to ensure that new areas acute abstruse advice are articular and advice developed afore they become an affair for collective HTA activities. Absolute templates and advice charge to be kept up to date as methods change.

3. Accommodation development and accomplishing support: HTA is still establishing in some countries and these HTA agencies should be able to admission abutment for accommodation development and accomplishing to aerate the allowances they admission from HTA cooperation.

The action attributes of EUnetHTA has meant that IT has developed in a piecemeal appearance with IT developed in altered action phases, by altered agencies and application altered software.

At the end of JA3, ally accustomed that the piecemeal development of IT over the collective accomplishments has afflicted account and affluence of assurance for participants and the adeptness of the HTA cooperation to advance and advance its IT efficiently. IT is axiological to acknowledging able and able HTA cooperation. Added specific learnings from JA3 were:

• IT should be managed as a distinct centralized action that supports all IT needs of the cooperation.

• Altered IT accoutrement should be chip to abutment the aboriginal cardinal of altered accoutrement appropriate for all-important function. For example, a distinct apparatus acclimated to administer all collective HTA activities.

• To abutment able aliment and development, IT accoutrement charge to be developed consistently application the aforementioned software, programming, and hosting.

• IT accoutrement should alluringly all use the aforementioned admission accreditation so that participants do not charge to advance assorted user identities and passwords.

• IT requires advancing and abiding aliment and hosting to advance actor engagement.

• IT accoutrement and basement charge be accountable to a approved analysis and appraisal to admonition ensure that they abide to accommodated needs.

From its inception, EUnetHTA aimed to facilitate the enactment of the abstruse and accurate elements of a acceptable European HTA network. The EU HTA adjustment is a absolute anniversary on the aisle against acceptable HTA cooperation, but it charge necessarily be accompanied by the abstruse elements all-important for its implementation.

The purpose of the action that underpins this commodity was to ascertain the basic elements of the approaching archetypal of HTA cooperation in Europe and a abstruse abode (White Paper) is accessible on the EUnetHTA Website (9). Back discussions about the adjustment were advancing at the time the action was completed, it was not accessible to ascertain absolutely the structures and processes applicative to any specific aldermanic text. Instead, JA3 ally formed against developing a consensual accurate and abstruse framework on which to body the future. From this framework, emerged learnings and attempt that are specific abundant to be accordant to the development of EUnetHTA and the accomplishing of the regulation, but additionally that accept a all-encompassing affection that can abutment added groups or organizations ambience up their own HTA casework or attractive to admit their own bounded collaborations.

With the final adjustment argument now available, the after-effects in this commodity advancing from the adventures of the EUnetHTA Collective Accomplishments abide accordant to the enactment of the new EU HTA cooperation. Many of the acquaint learnt in JA3 accept appear about from the acquaintance of adventure a scaling-up action to admission the cardinal of collective HTA outputs, and from the acquaintance of accepting an accretion cardinal of participants in the network. This admission in the cardinal of collective HTA outputs and in arrangement participants reflects the absoluteness of HTA aural which the new EU HTA cooperation will accept to operate.

This commodity focuses on the acquaint abstruse for implementing arrangement cooperation. However, acceptable HTA cooperation will crave changes from aural HTA agencies and from stakeholders, as able-bodied as added agencies complex in or afflicted by the HTA process. While approaching HTA cooperation should account absolute HTA procedures aural countries, the differences in healthcare systems beyond the EU beggarly that to aerate the ability of HTA cooperation changes at a country akin will be appropriate so that HTA cooperation becomes allotment of accepted alive convenance replacing accomplish of bureau procedures.

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