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EU HTA Solutions

Expert EU HTA Regulation Services

A Strategic Partner with Hands-on Experience

The European Commission is implementing the Regulation on Health Technology Assessment (HTA) to be applied from 2025 onward. The rules are meant to “facilitate better access to evidence-based healthcare and innovative technologies to patients across Europe.” 

To achieve the benefits promised by the new regulation, health technology developers (HTDs) need a flexible and knowledgeable strategic partner that is well versed in the expectations of EU HTA authority and national/regional HTA bodies.  

As an industry leader, Certara’s global HTA and market access experts provided guidance and support to clients in the context of programs such as EMA-HTA Parallel Scientific Advice and EUnetHTA Joint Assessments, both of which functioned as pilot programs for the new EU Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC) starting in 2025.  

Comprehensive Services to Support JCA and JSC Planning, Preparation and Submission

For nearly 30 years, Certara’s global team has supported our clients with integrated solutions market access strategy, reimbursement scenario planning, regulatory and reimbursement dossiers, health economic modeling, evidence synthesis, comparative effectiveness research, real-world evidence generation, and more. The team brings a wealth of hands-on experience, including the development of local pricing and reimbursement submissions to HTA bodies worldwide, and liaises routinely with a strong external European expert network that includes former payers and key opinion leaders in the clinical and public health domains.  

Certara can provide strategic support for:

  • Workshops and training on EU HTA regulation (JCA and JSC) 
  • PICO scenario planning
  • Data review and evidence synthesis to identify and fill data gaps 
  • Comparative effectiveness research (NMA, MAIC, STC, and other complex methods as needed)  
  • Complete JCA support including: 
    • Guidance and development of submission strategy 
    • Project management to ensure critical deadlines are met 
    • Writing and compilation of the JCA EU HTA submission dossier 
  • Development of complementary national dossiers 
  • Participation in HTA/regulatory discussion meetings  
  • Discussion of strategic implications on advice received 

Rigorous Data Review and Gap Analysis 

As a starting point for any JCA submission, Certara determines if available evidence fulfills EU JCA submission requirements. This includes product information, comparative evidence versus the appropriate comparators in the anticipated indication, and statistical analyses required by the EU HTA regulation. The JCA submission dossier will focus on characteristics of the treatment, its comparative efficacy and safety, the health problem including burden of illness, current comparative landscape, comparators and intended target population or subpopulations.

Strategy Workshop and PICO Scenario Planning

The 100-day timeline from PICO (patient population, interventions, comparators and health outcomes) information communicated to the HTD requires a flexible and agile approach that accounts for multiple scenarios. Before or during the scoping phase, Certara experts work closely with HTDs to define the research question and potential data requirements including indirect comparisons. Careful, long-term planning during initial strategy sessions paired with an agile adoption of workstreams, draft dossiers and ad hoc work is the best possible recipe for timely readiness when the PICO(s) is finally established.

Evidence Synthesis and Indirect Treatment Comparison (ITC/NMA)

Certara is a leading expert in the methodologies for HTA submissions, including systematic literature reviews according to specified requirements, quantitative techniques such as network meta-analysis and model-based meta-analysis (MBMA) and other established, advanced indirect treatment comparison (ITC) methods (MAIC, STC, NMR, ML-NMR). Our experts specialize in combining patient-level and aggregate data, randomized control trials and real-world studies as well as generation of external control arms to define patient control groups who are not part of the same trial. The integrated team of HTA, market access and biostatistical experts works as a single unit, facilitating dialogue, strategic planning/design and efficient project execution to optimize resources and budget.

Writing and Compilation of High Quality JCA Submission Dossiers

In accordance with the submission dossier template and guidance provided by the European Commission (building on EUnetHTA 21 draft template), Certara develops a complete and high-quality submission dossier as evidence evolves to present a compelling case for the new medical product under assessment. Experts in global HTA requirements, dossier development and biostatistics are part of the dossier development team ensuring that EU HTA requirements are met. Submission dossiers are developed in an iterative, staggered manner, leveraging a flexible yet structured process resulting in an evidence-based but strategic document referencing the most compelling and recent evidence. Quality control is supported by the regulatory document quality group to assure compliance with rigorous standards. The Certara team has long standing experience in reimbursement submissions to HTA bodies (including German AMNOG dossiers) and additionally gained expertise through prior development of submission documents as part of the EUnetHTA Joint Action initiative.

Support for post-JCA National Activities

While common scientific and clinical aspects of the JCA will factor into national HTA processes, member states maintain autonomy in decision-making related to the value a new medicinal product holds for their respective health systems. Certara can advise on national and regional strategies post-JCA to resolve discrepancies that may arise and support the development of complementary national dossiers.

Joint Scientific Consultation (JSC)

Expert JSC guidance and/or national early advice with HTA/regulatory bodies to generate appropriate evidence for market access in Europe

The EU offer of JSC either as multi-HTA or as multi-HTA/EMA parallel scientific consultation is an opportunity for HTDs to seek advice in early clinical development phases which is critical for planning purposes, and future assessments, prior to the start of pivotal trials. Certara offers comprehensive JSC services:

Strategic guidance:

  • Determining whether JSC is appropriate for a specific product and stage of development
  • Appropriate timing of a JSC application within the context of an overall clinical development plan
  • Compelling rationale for selection based on JSC qualifying criteria
  • Expert guidance on JSC strategy, questions and company position, submission documents, and follow up on implications of advice received

Application and submission preparation:

  • Support completion of JSC application form
  • Development of briefing documents including key questions for regulators / HTA bodies and company position underpinned by respective evidence
  • Review and compilation of all materials into a submission package

Preparation for and participation in advice meetings Scientific and regulatory expertise:

  • Providing insights on HTA requirements across EU markets
  • Alignment of evidence generation plans with anticipated HTA/payer needs
  • Weighing in on clinical development plans, trial designs, endpoints, etc., from a broad range of scientific disciplines

EU HTA Regulation Services Leadership 

Elvira Müller, PhD, MPH

VP, HTA Strategy and Access

Elvira Müller is Vice President within Certara’s Evidence & Access group, responsible for HTA and Evidence Development while managing Certara’s consulting team based in Germany. Besides numerous HTA engagements, she has substantial expertise in EUnetHTA collaboration as well as in European Joint Clinical Assessments (JCA) and Joint Scientific Consultation (JSC). She has 20+ years of experience in global market access, applying her senior expertise in providing high-quality scientific advice to optimize the value of pharmaceuticals and medical technologies. Elvira holds an MSc and PhD in Biology and Toxicology from Würzburg University and an MPH from Ulm University.

Roman Casciano, PhD, MEng

SVP, Evidence & Access

Roman Casciano is a Senior Vice President within Certara’s Evidence and Access group. As an applied health economist and market access strategist, Roman has personally led hundreds of engagements in the global market access, HEOR and real-world evidence context related to product value demonstration and has deep experience in both formal and informal exchanges with payers and HTA bodies. 

Ananth Kadambi, PhD

VP, Real World Evidence & Modeling Solutions

Ananth Kadambi is Vice President of RWE & Modeling Solutions within Certara’s Evidence and Access group. Dr. Kadambi has more than 20 years’ experience in pharmaceutical consulting across a variety of disciplines, including quantitative systems pharmacology modeling, health economic modeling, systemic literature reviews, indirect treatment comparisons, and complex statistical analyses of clinical and real-world databases required to support regulatory, payer and HTA submissions worldwide. Ananth completed his PhD in biomedical engineering at the University of Virginia.

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