PROJECT OUTPUTS

WP2: Development and application of a tool to combine and use RCT and observational/registry data in economic evaluation


  • Deliverable D2.1: A review of parametric model choice used to extrapolate RCT outcomes [PDF]
  • Deliverable D2.2: Validation of the DICE modelling technique against existing methods and speeding up execution of the simulation engine [PDF]
  • Deliverable D2.3: Training modules and manuals for HTA staff, reviewers, and modelers (available on the DICE Platform)
  • DICE platform based on Discretely Integrated Condition Event simulation to model health benefits and treatment costs during CEA modelling [LINK]




WP3: Developing a costing methodology and a database of unit costs


  • Deliverable D3.1: Guidelines for cost definitions and harmonization of cost accounting methodologies for economic evaluation [PDF]
  • Deliverable D3.2: Database (final version) with the initial core dataset of costs and the User Manual; Final version of the Guidelines; List of standard unit costs with country values [PDF]
  • User Manual [PDF]
  • List of standard unit costs [XLSX]
  • Work Package Overall Results – Poster [PDF]
  • European Healthcare and Social Cost Database [LINK]




WP4: The role of social costs in economic evaluations of health care decisions in Europe


  • Deliverable D4.1: Revising the methodological aspects applied to the identification, measurement and valuation of social costs in economic evaluations [PDF]
  • Deliverable D4.2: How relevant is the societal perspective in economic evaluations? Evidence from five case studies [PDF]
  • Deliverable D4.3: Core dataset of social costs. Creating a database on unit costs in Europe of lost work time and the value of informal and formal care time of unit costs of health services [PDF]
  • Work Package Overall Results [Poster PDF]
  • European Healthcare and Social Cost Database [LINK]




WP5: Exploring health preferences on different subpopulation groups using EQ-5D


  • Deliverable D5.1: Value sets for the EQ-5D-Y in Germany, Slovenia and Spain and comparison of EQ-5D-Y value sets across countries (Germany, Slovenia and Spain) (available in 2022)
  • Deliverable D5.2: Comparison of EQ-5D-5L value sets from different disease areas in 2 countries (Germany and Spain) [PDF]
  • Work Package Overall Results – Poster [PDF]
  • Dataset on adolescent preferences toward EQ-5D-Y in Slovenia (available July 2022)
  • Dataset on adult preferences toward EQ-5D-Y health states in Slovenia (available July 2022)
  • Dataset on preferences of diabetic patients toward EQ-5D5L health states in Germany (available July 2022)
  • Dataset on preferences of rheumatic patients toward EQ5D-5L health states in Germany (available July 2022)
  • Dataset on preferences of diabetic patients toward EQ-5D5L health states in Spain (available July 2022)
  • Dataset on preferences of rheumatic patients toward EQ5D-5L health states in Spain (available July 2022)
  • Dataset on adult preferences toward EQ-5D-Y health states in Germany (available July 2022)
  • Dataset on adolescent preferences toward EQ-5D-Yin Germany (available July 2022)
  • Dataset on adult preferences toward EQ-5D-Y health states in Spain (available July 2022)
  • Dataset on adolescent preferences toward EQ-5D-Yin Spain (available July 2022)




WP6: Methodological guidance on the analysis and interpretation of non-randomised studies to inform health economic evaluation


  • Deliverable D6.1: Meta-epidemiological comparison of effect sizes in matched studies (available in 2022)
  • Deliverable D6.2: Recommendations on how to analyse and interpret non-randomised studies [PDF]
  • Dataset: Effect estimates obtained from randomised and nonrandomised studies (available December 2022)




WP7: Methodological tools using multi-criteria value methods for HTA decision-making


  • Deliverable D7.1: An analytical framework outlining the determinants of HTA recommendations across settings based on primary data collection and primary analysis of secondary data (available January 2023). D7.1 Executive summary [PDF]
  • Deliverable D7.2: Advancing knowledge and MCDA tools to assist HTA agencies in evaluating medicines on a common basis (available January 2023). D7.2 Executive summary [PDF]
  • Deliverable D7.3: Testing the IMPACT-HTA Value Framework in collaboration with HTA agencies: Case studies on Non-Small Cell Lung Cancer and Spinal Muscular Atrophy (available January 2023). D7.3 Executive summary [PDF]
  • Dataset on determinants of HTA recommendations (available January 2023)
  • Dataset from the 1st Delphi process to HTA stakeholders, organized into 6 parallel panels (2 rounds), about “This aspect should be considered in the evaluation of new medicines on a common basis” (2019) (available January 2023)
  • Dataset from the 2nd Delphi process to HTA stakeholders, organized in a single panel (2 rounds), question “This aspect should be considered in the evaluation of new medicines on a common basis” (2019) (available January 2023)
  • Dataset from the Web-Delphi process to INAMI stakeholders (three rounds), about “The relevance of the following value aspects for the evaluation of new medicines in this disease context is” (2020) (available January 2023)
  • Dataset from the Web-Delphi process to TLV stakeholders (three rounds), about “The relevance of the following value aspects for the evaluation of new medicines in this disease context is” (2020) (available January 2023)




WP8: Analysis of economic evaluation methods for hospital-based assessment





WP9: Expanding economic analysis for HTA: methods for measuring fiscal impact of new healthcare intervention


  • Deliverable D9.1: Algorithm for the estimation of the fiscal impact of new technologies [PDF] and [Excel doc]
  • Deliverable D9.2: Evidence from pilot application from selected therapeutic areas [PDF]




WP10: Appraisal of Orphan Medicinal Products (OMPs)


  • Deliverable D10.1: HTA Appraisal Framework Suitable for Rare Disease Treatments (Orphan Medicinal Products) [PDF]
  • Deliverable D10.2: Guidance on Use of Patient Reported Outcome Measures in HTA Appraisals of Rare Disease Treatments [PDF]
  • Deliverable D10.3: Guidance on Use and Implementation of Outcome-Based Managed Entry Agreements for Rare Disease Treatments [PDF]
  • Country vignettes: HTA appraisal/reimbursement processes for rare disease treatments in most EU and EEA Member States, Canada and New Zealand have been documented [LINK]
  • Outcomes-Based Managed Entry Agreements (OBMEA) Tools to support use and implementation with a rare disease treatment:
    • Checklist to determine if an OBMEA is appropriate [PDF]
    • Template for public documentation of an OBMEA data collection agreement [WORD DOC]
    • Terms of reference template for a monitoring committee responsible for overseeing implementation of an OBMEA [WORD DOC]
    • Patient group submissions template for re-appraisal after an OBMEA [WORD DOC]
  • Dataset of the characteristics of AIFA registries up to 2019: Xoxi, Entela. (2021). Characteristics of AIFA registries up to 2019 [Data set]. Zenodo. [https://doi.org/10.5281/zenodo.5040265]




WP11: From HTA results to guidance implementation: paving the way


  • Deliverable D11.1: Systematic review of decrementally cost-effective interventions [PDF]
  • Deliverable D11.2: Stakeholders’ perspective: a political economy report [PDF]
  • Deliverable D11.3: A toolbox on candidate cost-effective technologies for HTA producers and users [PDF]
  • Work Package Overall Results [Poster PDF]




WP12: Synthesis, dissemination and communication


D12.2: An exposé of lessons learned and policy recommendations (available January 2023).

Summary of Project results [PDF]