IQVIA EU HTA SOLUTIONS

JCA success with one partner. EU‑wide.

Let’s build your custom solution, for EU HTA success at global, regional and national level.

JCA success with one partner. EU-wide.

The implementation of the EU HTA Regulation represents a turning point for health technology assessments (HTA), impacting market access strategies and launch preparations at global, regional and national level.

Tap into IQVIA’s unparalleled combination of expertise and skills, to maximise the benefits of the new Joint Clinical Assessments (JCA) process for your assets. With IQVIA EU HTA Solutions you have one partner by your side to support you on your JCA journey – end-to-end, and EU-wide.

IQVIA EU HTA Solutions

Our experience
480+

European HTA dossiers developed since 2020

Our experience
25+

PICO simulations conducted

Our experience
5+

JCA dossiers underway

Our team
290+

Local on-the-ground market access experts across 17 European countries

OUR TEAM
60+

HTA epidemiologists, statisticians, ITC and health economics specialists

Our publications
25+

Thought Leadership publications on EU HTA since 2024

Download our IQVIA EU HTA Solutions factsheet to learn more
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Case studies

Getting ready for EU HTA at global, regional and local level - with IQVIA EU HTA Solutions

JCA readiness at global, regional, and local level

Client need: Guidance to optimize teams, resources, and internal processes ahead of their first Joint Clinical Assessment (JCA) submission in 2025

Solution: Conducted EU HTA readiness assessment and peer benchmarking to identify existing gaps, and co-created comprehensive guidance for the operationalization of JCA together with cross-functional client teams

Results: Established new ways of working at global, regional, and local level, to meet JCA requirements and successfully execute their first Joint Clinical Assessment (JCA) submission

Early scientific advice strategy and execution

Client need: (i) Tool to define optimal approach for early HTA scientific advice (ESA), considering Joint Scientific Consultation (JSC), parallel EMA-JSC advice, and local ESA opportunities; (ii) end-to-end ESA support for pipeline asset

Solution: (i) Developed a decision-making tool based on uncertainty in HTA approach, risk associated with joint/parallel engagement, importance of markets, and timing requirements vs. asset approval timeline; (ii) Used the tool to assess ESA opportunity for target pipeline asset, and supported application, briefing book development, strategic review of advice, and developed recommendations

Results: (i) Playbook to facilitate ESA preparations; (ii) recommendations to refine the pipeline asset’s trial protocol

PICO simulation and evidence strategy

Client need: PICO prediction for two oncology pipeline assets, and strategic recommendations to optimize evidence generation

Solution: Assessed analogues and simulated the scoping process in line with the latest JCA guidance documents to predict likely PICOs; mapped planned evidence generation activities against PICOs to identify any gaps

Results: Asset-specific recommendations for evidence generation strategy, to optimise data package based on the anticipated PICOs

Evidence generation, JCA strategy and dossier

Client need: Development of JCA strategy, JCA dossiers and objection handler for two oncology assets, in addition to indirect treatment comparison (ITC) feasibility assessment and analyses

Solution: Define JCA strategy based on predicted PICOs, evidence package and anticipated label, and draft JCA dossier; assess ITC feasibility, define strategy, and conduct ITC analyses in line with the published JCA guidance; following JCA scope confirmation, finalise the dossiers in line with refined JCA strategy; provide post-submission support and finalise objection handler to aid local HTA communication and submissions

Results: Support currently ongoing

German 'delta' dossier and strategy

Client need: National dossier development for the client’s first two assets eligible for Joint Clinical Assessment (JCA), including strategic advice on relevant analyses for local HTA success and mitigation strategies; recommendation on best practices to incorporate local needs into regional and global JCA preparations

Solution: Planning and development of the ‘delta’ dossiers; strategic recommendations to shape new internal JCA processes to ensure local evidence requirements and dossier preparations are optimally aligned

Results: Support currently ongoing

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