Question 1

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

Accepted Answer

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

Question 2

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

Accepted Answer

• Deliverable D3.1: Guidelines for cost definitions and harmonization of cost accounting methodologies for economic evaluation [PDF](undefined)
 • 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](undefined)
 • User Manual [PDF](undefined)
 • List of standard unit costs [XLSX](undefined)
 • Work Package Overall Results – Poster [PDF](undefined)
 • European Healthcare and Social Cost Database [LINK](https://www.easp.es/Impact-Hta/Default)

Question 3

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

Accepted Answer

• Deliverable D4.1: Revising the methodological aspects applied to the identification, measurement and valuation of social costs in economic evaluations [PDF](undefined)
 • Deliverable D4.2: How relevant is the societal perspective in economic evaluations? Evidence from five case studies [PDF](undefined)
 • 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](undefined)
 • Work Package Overall Results [Poster PDF](undefined)
 • European Healthcare and Social Cost Database [LINK](https://www.easp.es/Impact-Hta/Default)

Question 4

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

Accepted Answer

• 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) [PDF](https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_98d54dc6ba7046bfa89d11f59b96dad2.pdf)
 • Deliverable D5.2: Comparison of EQ-5D-5L value sets from different disease areas in 2 countries (Germany and Spain) [PDF](undefined)
 • Work Package Overall Results – Poster [PDF](undefined)
 • Dataset on adult preferences toward EQ-5D-Y health states in Slovenia [PDF] (https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_17fa419d7b0f4578ba34482d6547fbb9.csv)
 • Dataset on adolescent preferences toward EQ-5D-Y in Slovenia [PDF] (https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_634cbf1f49534ccab6213890eee2a6c7.csv)
 • Dataset on adult preferences toward EQ-5D-Y health states in Germany [PDF] (https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_e357aded6fd447a38a8a2df393bdca14.xlsx)
 • Dataset on adolescent preferences toward EQ-5D-Yin Germany [PDF] (https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_a411ee28ae644610880c2ee13bb682ee.xls)
 • Dataset on preferences of diabetic patients toward EQ-5D5L health states in Germany [PDF] (https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_f9313dce40774c44a0c6f8f43d5ac544.xlsx)
 • Dataset on preferences of rheumatic patients toward EQ5D-5L health states in Germany [PDF] (https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_ba5c74ffc7494feca66a3a30ccbbeadc.xlsx)
 • Dataset on adult preferences toward EQ-5D-Y health states in Spain [PDF] (https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_4f8a8e52d4d7468e95702c67ee221838.xlsx)
 • Dataset on adolescent preferences toward EQ-5D-Yin Spain [PDF] (https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_66511a3016764a30ba1e660ebbb212d3.xlsx)
 • Dataset on preferences of diabetic patients toward EQ-5D5L health states in Spain [PDF] (https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_9e691190f161417b93b1a733469d5f3f.xlsx)
 • Dataset on preferences of rheumatic patients toward EQ5D-5L health states in Spain [PDF] (https://e1a359c7-7583-4e55-8088-a1c763d8c9d1.usrfiles.com/ugd/e1a359_cdecfa6e26b54e9aa32e90e68979cbb2.xlsx)

Question 5

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

Accepted Answer

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

Question 6

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

Accepted Answer

• 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](undefined)
 • 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](undefined)
 • 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](undefined)
 • 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)

Question 7

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

Accepted Answer

• Deliverable D8.1: Toolkit including a list of relevant indicators to capture hospital performance variability and Toolkit to assess the transferability of evidence produced in other jurisdictions and decision-making levels [PDF](undefined)
 • Analysis of economic evaluation methods for hospital-based assessment – Questionnaire [excel document](undefined)
 • List of Indicators [PDF](undefined)
 • Toolkit to capture hospital performance variability [excel document](undefined)
 • Toolkit to assess transferability of evidence produced in other jurisdictions [https://altems.unicatt.it/altems-ricerca-a-toolkit-to-assess-the-transferability-of-evidence-produced-in-other-jurisdictions](https://altems.unicatt.it/altems-ricerca-a-toolkit-to-assess-the-transferability-of-evidence-produced-in-other-jurisdictions)
 • Deliverable D8.2: Toolkit of instruments to identify the clinical variability and its impact on the use of health technology [PDF](undefined)
 • Efficiency evaluation model for the assessment of clinical variation – Hip replacement [xslm document zip](undefined)
 • Efficiency evaluation model for the assessment of clinical variation – Knee replacement [xslm document zip](undefined)

Question 8

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

Accepted Answer

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

Question 9

WP10: Appraisal of Orphan Medicinal Products (OMPs)

Accepted Answer

• Deliverable D10.1: HTA Appraisal Framework Suitable for Rare Disease Treatments (Orphan Medicinal Products) [PDF](undefined)
 • Deliverable D10.2: Guidance on Use of Patient Reported Outcome Measures in HTA Appraisals of Rare Disease Treatments [PDF](undefined)
 • Deliverable D10.3: Guidance on Use and Implementation of Outcome-Based Managed Entry Agreements for Rare Disease Treatments [PDF](undefined)
 • 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](javascript:void(0))
 • 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](undefined)
    • Template for public documentation of an OBMEA data collection agreement [WORD DOC](undefined)
    • Terms of reference template for a monitoring committee responsible for overseeing implementation of an OBMEA [WORD DOC](undefined)
    • Patient group submissions template for re-appraisal after an OBMEA [WORD DOC](undefined)
 • 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](https://doi.org/10.5281/zenodo.5040265)

Question 10

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

Accepted Answer

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

Question 11

WP12: Synthesis, dissemination and communication"

Accepted Answer

D12.2: An exposé of lessons learned and policy recommendations [PDF].(undefined)
Summary of Project results [PDF](https://8c3e11d9-5f36-452f-abe3-c95befd6e85d.filesusr.com/ugd/f4f92f_7780fcdc4f0f48daba7431b8536d87ac.pdf)

PROJECT OUTPUTS