Review of Relative effectiveness assessments (REAs) of pharmaceuticals at the European network for health technology assessment (EUnetHTA): A first step towards a consolidated European perspective on comparative effectiveness &amp; safety?

Chassagnol, Frédéric; Marcelli, G; Wagle, Julia Annabel; Giuliani, Giovanni; Traub, D; Schaub, V.; Ruof, Jörg

doi:10.1016/j.healthpol.2020.06.013

Cited by 8 publications

(13 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The previous comparison of Chassagnol et al of EU JCA and national CAs with different focuses found, that EU JCA has a more inclusive approach to evidence than the German CA [ 4 ]. The analysis revealed a high heterogeneity across the HTA appraisals of the four countries (France, Italy, Germany and UK).…”

Section: Discussionmentioning

confidence: 99%

“…Differences in HTA methodologies across European countries are well known [2][3][4][5] and may lead to delayed and unequal access by patients to medicines in Europe [6,7]. Since 2006 and until 2021, the European network for Health Technology Assessment (EUnetHTA) developed and piloted methods and processes for cross-border collaboration on HTA in Europe, including > 20 joint clinical assessments (JCA) for pharmaceuticals and > 30 for medical devices, on a EU-funded project basis [8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

“…During the last years, several analyses evaluated guidelines, methods and outcomes of HTAs on national versus European level, focusing on selected countries, indications or on specific products [1,4,[19][20][21][22]. To our knowledge, the question of transferability of EU JCA to German CA has so far not been investigated in detail.…”

Section: Introductionmentioning

confidence: 99%

“…Three analyses focused on the HTA Core Model as basis for JCA which was considered as useful and flexible framework for standardized evidence generation [ 19 , 20 , 22 ]. Three publications compared EU JCA to national reports [ 2 , 4 , 21 ]. Thereby, two analyses focused on specific products (pazopanib [ 1 ] or alectinib, midostaurin and regorafenib [ 21 ]) in selected countries.…”

Section: Introductionmentioning

confidence: 99%

“…As it is published as abstract only, there is not enough detailed information to evaluate the impact of differences seen between the EU JCA and German CA and to answer our question of interest. The comprehensive analysis by Chassagnol et al [ 4 ] includes 12 JCA from JA1 to JA3 and national assessments of France, Italy, Germany and UK. Since the comparison comprises four countries, methodological aspects are reported rather high level and provided information is considered as not sufficiently detailed to answer our question of interest.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective

et al. 2021

View full text Add to dashboard Cite

Objective The transferability of the EU joint clinical assessment (JCA) reports for pharmaceuticals for the German benefit assessment was evaluated by systematically comparing EU JCA and German clinical assessments (CA) based on established assessment elements for HTA and assessing the potential impact of differences on Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) ability to derive the therapeutic added value. Methods Identification of all pharmaceuticals undergoing both, EU JCA and German CA between January 2016–June 2020. Qualitative review and data extraction from the assessments, assessment of methodological differences using a hierarchical model. Recommendations for harmonisation were developed and consented with pharmaceutical industry stakeholders. Results Differences with potentially major impact: (1) View on differing treatment algorithms and definition of corresponding subpopulations/respective comparators. (2) Clinical relevance of surrogate/intermediate endpoints. Inclusion of different/surrogate morbidity endpoints resulting in different relative effectiveness conclusions. (3) Tolerance of study interventions not used according to marketing authorisation. (4) Different operationalisation and/or weighting of individual safety endpoints leading to differing relative safety conclusions. Differences with potentially minor impact: (1) Disagreement in risk of bias assessment for overall survival and its robustness against study limitations. (2) Use of patient-reported outcome symptom scales as measurements for health-related quality of life instruments. Conclusion While many synergies between EU JCA and German CA exist, we identified several aspects in HTA methodology that would benefit of harmonisation and ensure the transferability of future EU JCA to the German HTA process without duplicated evaluation requirements. For those, a set of recommendations was developed.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective

et al. 2021

View full text Add to dashboard Cite

show abstract

Agreement about Availability of Alternative Treatments for Innovative Drugs Assessed by the EMA and HTA Organizations

Madrid Paredes,

Versteeg,

Vreman

et al. 2024

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

The European Medicines Agency (EMA) and European national/regional health technology assessment (HTA) organizations consider the availability of existing treatments when evaluating a new drug. Since disagreement about the availability of alternative treatments may impact patient access to new drugs, this study aimed to investigate whether the EMA and HTA organizations agreed on the availability of alternative treatments and whether a lack of alternative treatments was associated with HTA organizations' added benefit assessment outcomes. For 97 innovative drugs authorized in 2019–2021 (excluding vaccines and diagnostic tools), assessments by the EMA and AEMPS (Spain), AIFA (Italy), HAS (France), IQWiG/G‐BA (Germany), NICE (England and Wales), and ZIN (the Netherlands) were identified. Until 1 June 2022, 429 HTA drug‐indication combinations were identified for these 97 drugs, of which 205 exactly matched the EMA's indication. For those, the overall agreement between the EMA and HTA organizations on whether alternative treatments were available was 87%. The agreement of HTA organizations with the EMA on whether available treatments were either pharmacological on‐label, pharmacological off‐label, or non‐pharmacological was 87%, 21%, and 57%, respectively. For all 429 HTA drug‐indication combinations, absence of alternative treatments as considered by HTA organizations was associated with a higher chance to provide added benefit: risk ratio 1.8 (95%‐CI 1.4–2.3). In conclusion, although there was high overall agreement between the EMA and HTA organizations about whether alternative treatments exist, there were differences in the types of treatment considered. Parallel joint scientific consultations could inform drug developers about relevant alternative treatments to facilitate patient access to innovative drugs.

show abstract

Guiding Principles for Evaluating Vaccines in Joint Health Technology Assessment in the European Union: Preparing for the European Union’s Regulation on Health Technology Assessment for Vaccines

Largeron,

D’Agostino,

Chapman

et al. 2024

Value in Health

View full text Add to dashboard Cite

Review of Relative effectiveness assessments (REAs) of pharmaceuticals at the European network for health technology assessment (EUnetHTA): A first step towards a consolidated European perspective on comparative effectiveness & safety?

Cited by 8 publications

References 11 publications

Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective

Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective

Agreement about Availability of Alternative Treatments for Innovative Drugs Assessed by the EMA and HTA Organizations

Guiding Principles for Evaluating Vaccines in Joint Health Technology Assessment in the European Union: Preparing for the European Union’s Regulation on Health Technology Assessment for Vaccines

Contact Info

Product

Resources

About