Integrated Solutions for EU Joint Clinical Assessment
The EU HTA regulation marks a significant paradigm shift, especially for products in high-impact areas like oncology, rare diseases, and Advanced Therapy Medicinal Products (ATMPs). The transition from national to centralised JCAs demands early planning, strategic evidence generation, and precise, timely execution. At Kintiga, we are at the forefront of EU HTA preparedness. Our consultants possess in-depth knowledge of the EU HTA Regulation and provide comprehensive support throughout the entire process—from early strategy development and JCA dossier preparation to interpreting national implications from the final assessment report through to local reimbursement.
We specialise in:
- EU HTA Readiness Workshops to lay a strong foundation for regulatory and organisational preparedness
- PICO Simulation & Evidence Generation for targeted, data-driven evidence planning
- Joint Scientific Consultation & Early HTA Advisory for maximising the value of early stakeholder engagement
- Comprehensive EU HTA Strategy for integrated planning and seamless execution of the process
- EU HTA Business Wargaming to stress-test and refine your market access strategy and routines
- JCA Dossier Development Excellence for expert scientific writing and robust compilation
- JCA Dossier Rapid Finalisation for accelerated, deadline-driven submission support
- Delta Dossier Integration to bridge European assessments with national market access requirements
We help you stay ahead of the curve – partner with us to ensure your organisation is fully equipped to navigate the evolving EU HTA landscape with confidence and success.
Our services
Prepare your organisation for the new EU HTA process with our expertly facilitated workshop.
We provide:
- A comprehensive analysis of the general requirements and key success factors of the EU HTA process
- Joint evaluation of the strategic implications for your portfolio and corporate structure
- Facilitated self-assessment tailored to your organisation’s specific functions
- Practical guidance to raise awareness and initiate sustainable tactical measures for effective European market access alignment
We help pharmaceutical companies navigate the complexities of PICO-driven clinical evaluation, ensuring robust preparation for the European Joint Clinical Assessment (JCA) process.
We provide:
- Expert operational assessments and simulations tailored to anticipated PICO schemes (Population, Intervention, Comparator, Outcome)
- Early hypothesis development for final PICO requirements, supporting strategic decision-making for national price negotiations
- Comprehensive gap analysis of your evidence package, formally and strategically identifying areas for improvement
- Recommendations for closing evidence gaps & optimising resource allocation for further evidence generation
- Strategic support to maximise success in national downstream processes across EU member states
Our approach ensures your evidence generation strategy is both efficient and aligned with diverse regulatory expectations, helping you minimise risk and maximise value.
Early scientific and HTA advice is essential for a successful market access strategy. We help you ask the right questions and build a compelling evidence story to optimise your product’s development and reimbursement prospects.
We provide:
- Strategic assessment of the most suitable early advice pathway for your product
- Preparation of comprehensive briefing packages, including initial PICO scope proposals and tactical considerations
- Coordination and submission of JSC and parallel EMA scientific advice requests
- Expert support in preparing for and conducting meetings with HTA bodies and regulatory authorities
- Clear presentation of data and targeted questions to maximise the value of feedback received
- Post-meeting analysis and refinement of your EU market access strategy based on outcomes and recommendations
Partner with us to ensure your engagement with HTA and regulatory authorities is expertly managed, paving the way for successful product development and market entry.
Navigating the complexities of EU Health Technology Assessment (HTA) requires a forward-thinking, integrated strategy. We support you in achieving optimal reimbursement outcomes while ensuring broad patient access across Europe.
We provide:
- Comprehensive development and implementation of tailored EU HTA strategies
- Integration of national price analyses into the overall EU HTA approach
- Roadmap creation for actionable steps to maximise success before and during the EU HTA process
- Strategic scenario planning and operational support for tactical execution
- Ongoing partnership and guidance throughout every stage of the EU HTA journey up until the national price negotiations
Prepare your team for the EU HTA process with our immersive, hands-on business wargaming training. We bridge the gap between theory and practice, enabling participants to experience and master real-world decision-making before the actual Joint Clinical Assessment (JCA) procedure.
We provide:
- Realistic, scenario-based simulations tailored to the EU HTA environment
- Role-playing exercises that mirror actual stakeholder interactions and decision-making pressures
- Immediate feedback on choices and strategies to reinforce learning
- Development of effective communication and information-flow routines
- Enhanced understanding and retention of the EU HTA framework
- Practical preparation for the real JCA procedure, ensuring your team is ready to perform at its best
Delivering high-quality, strategically structured JCA dossiers within tight deadlines.
We provide a comprehensive, AI-supported & agile approach to the creation and management of European JCA dossiers, ensuring efficiency, accuracy, and compliance with all regulatory requirements.
Our services include:
- Modular, technology-supported dossier writing and quality control processes
- Semi-automated table textualisation and interpretation aligned with JCA qualitative standards
- Advanced large document handling and management using LaTeX-based text editing tools
- Expert guidance for the timely and formally correct compilation of European JCA dossiers and submission files
With extensive experience in the successful delivery of diverse (especially German) HTA dossiers, we are your ideal partner for navigating the complexities of the European JCA process.
Specialist intervention for teams under pressure to finalise their JCA dossier on time.
We provide immediate, high-impact support for late-stage JCA dossier projects, ensuring you meet regulatory requirements and submission deadlines—even when time is critically short.
Our services include:
- Intensive dossier review and gap analysis to identify and address critical issues
- Rapid data collation, integration, formatting and description in line with JCA standards
- Fast-track AI-supported writing and quality control for accelerated turnaround
- Streamlined document management for large, complex documents using LaTeX-based text editing tools
- Expert troubleshooting of methodological and technical challenges
- Direct guidance on compliance with the latest European JCA requirements
- Proven management in critical situations with a track record of delivering dossiers under tight timelines
Rely on our experience and advanced tools to bring your dossier across the finish line—on time and in full compliance.
Achieve seamless market access by expertly navigating both European and national requirements. Our local expertise ensures your value story is compelling and compliant at every level.
We provide:
- Strategic guidance to align European and national HTA and pricing strategies
- Preparation of comprehensive national dossiers tailored to local requirements on the basis of JCA pre-work
- In-line integration of cost-effectiveness analyses and additional evidence as required
- Expert advice on positioning your therapy for national appraisal and reimbursement
- Ongoing support to ensure your dossier remains the foundation for successful market entry
