WORK Packages

WP1

Project management and coordination (EUR)

This WP will provide management, coordination, and communication support. Emphasis will be on innovation management and dissemination plan, continuous assessment, and monitoring of compliance with ethics requirements. Partners from academia and industry will engage in WP1 to ensure a smooth and productive workflow in the consortium.

WP2

Data management, privacy and ethics (Chino)

The objectives of WP2 are to ensure that partners can share and analyse the data according to the latest EU Ethics and Data Protection guidelines and specific requirements set up by Data Protection and Cybersecurity Officers within the data providers’ organizations.

WP3

Developing the ASCERTAIN framework (EUR)

The objective of this WP to analyse the input in support to WP4, WP5, and WP6. The theoretical underpinning of the elements of ASCERTAIN framework will be incorporated into the new models. In addition, this WP will monitor the evolving environment in the pharmaceutical and medical device sector and possible impact of changes to the ASCERTAIN framework throughout the project.

WP4

Pricing methods for IHTs (GOEG)

This work package focuses on developing new approaches for pricing innovative technologies (elements, principles and algorithms of novel pricing policies that take the value and cost perspective into account). Crucial in these models is finding a balance between improving patient access and stimulating entrepreneurship. Partners from academia, patients, professional organisations, industry, and payers will engage to ensure a broad perspective on the pricing policies.

WP5

(Cost-)effectiveness and budget impact models for IHTs (UIO)

This WP focuses on developing clinical and cost-effectiveness models and budget impact models. We aim for openaccess and dynamic models incorporating the entire life cycle of a health technology. Partners from academia, professional organisations, patients, industry and payers will engage to ensure a broad perspective on these models.

WP6

Reimbursement for IHTs (EUR)

This WP focuses on the development of dynamic and cyclic reimbursement procedures. These procedures will incorporate new appropriate reimbursement models and payment schemes for expensive health technologies and new methods to define thresholds. The WP will evaluate the impact of these procedures on equitable access, payer risk and values and preferences of EU patients and citizens. Partners from academia, patients, professional organisations, industry, and payers will engage to ensure a broad perspective on these reimbursement procedures.

WP7

Web-based platform for ASCERTAIN models as policy support tool (NURO)

The objective of this WP is to develop and validate a web-based publicly accessible ASCERTAIN policy support tool. It will cover the aspects of requirements analysis, iterative frontend and backend development, evaluation of the tools and the underlying models as well as consecutive refinement based on the user feedback. In particular, the goal is to provide the capabilities to:

Data storage, preparation, and modelling

Visual representation of the data

Interactive navigation through the portal and the underlying analysis of the data

Analytics and analysis based on user selected features and parameters

In addition, this WP will review and quality-check the comprehensive ASCERTAIN model toolbox consisting of the models developed and tested in WPs 4, 5, and 6 in task 7.2

WP8

Dissemination and exploitation (OM)

To develop the patient engagement, dissemination and communication plan (see Ch 2.2.1 and 2.2.3) and implement it. Raising awareness of the project to prepare for their exploitation by participating and organising outreach activities, events (e.g., conferences, seminars, workshops, fairs, exhibitions etc.). Promote synergies between the public and private sectors around the project, building a network of stakeholders of the scientific and industrial community, end-users/beneficiaries, policymakers, and other relevant stakeholders. Design a long-term sustainability plan to define an effective business model and business take-up, paying attention duly to IPR protection in the innovation management and knowledge transfer phases. Develop and maintain the project’s visual identity, including conventional information material, tools (project website, social media) and audio-visual material (e.g., videos, posters, brochures).