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Joint Clinical Assessment

Pan-European clinical assessment process for drugs and medical devices.

joint clinical assessment

Purpose

What is the Joint Clinical Assessment?

  • The JCA is an HTA process that aims to harmonise the clinical assessment of medicines and devices across the EU.
  • The JCA provides a single point for the submission and compilation of clinical and safety evidence, which is then shared with the EU individual countries.
  • EU countries utilise the JCA outputs to make decisions on price, reimbursement and funding in their market.
  • The JCA will run in parallel alongside the European Medicines Agency’s marketing authorisation application process.

Insights

Why is the JCA important?

  • It is the evidence base that each country will use to set the price, reimbursement and market access
  • The JCA applies to all new medical products and devices approved by the European Medicines Agency from:
    • 2025: Oncology products, ATMPs and medical devices
    • 2028: Orphan designation products
    • 2030: All central authorised medicinal products

 

Preparation

How to prepare for the JCA

  • Prioritizing early scientific advice is a crucial component of a strong strategy, providing companies with a way to minimize the risk of unforeseen negative outcomes.
  • Despite the uncertainty surrounding data requirements for joint clinical assessments, it is imperative for organizations to establish a robust rationale for trial design, create compelling justifications for surrogate endpoints, and include outcomes relevant to patients.
  • Remap’s multidisciplinary teams possess extensive knowledge of European market access challenges, maintaining the highest scientific standards in our research to effectively communicate a product’s value.
  • Our expertise in joint clinical assessments positions us to assist pharmaceutical companies in adeptly navigating the complexities and opportunities associated with the anticipated implementation of EU HTA.

Process

Writing the JCA dossier and supporting the process

  • Remap Consulting possess significant expertise in joint EU HTA/EMA dossier witing, and liaising with stakeholders, ensuring seamless coordination and alignment throughout the process.
  • We excel in understanding the specific PICOs needed for the JCA process, leveraging our experienced team members who have successfully compiled such dossiers previously.
  • Our team is dedicated to facilitating information gathering, writing, and strategic thinking to ensure the development of high-quality dossiers that meet regulatory standards and client expectations.
  • Furthermore, we have a proven track record in managing multi-HTA assessment processes, including the EUnetHTA relative assessment processes.
  • Our learnings and insights from these experiences enable us to help companies navigate the complexities and uncertainties of the new JCA process effectively.

Literature

Learn more about the JCA

Read our in-depth article for more information on:

  • JCA process including scoping and PICO consolidation
  • Dossier development phase and submission process
  • Current progress and future developments

 

Read now

Webinars

Check out our video series for the latest insights on EU HTA

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Our EU HTA team

Paul Craddy, PhD
Managing Director & Founder

Paul Craddy founded Remap Consulting in January 2014 to help clients optimise their pricing, health economics and market access outcomes.

Prior to that, Paul was Head of Diabetes for Pricing, Market Access and Health Economics for EUCAN within Takeda Pharmaceuticals. In this role, Paul was responsible for leading the franchise including managing the launch of a new diabetes therapy, providing input into R&D for pipeline products and optimising in-market products. Paul was also a member of the PMAHE management team, helping set the strategic direction of the PMAHE department.

During his time in Nycomed, Paul led the strategic pricing team responsible for global pricing decisions for Nycomed’s global brands. He was also a core member of the PMAHE integration team during the Takeda takeover, helping to design and implement the new PMAHE organisation within Takeda.

Preceding Nycomed, Paul was a PMA consultant with IMS Consulting based in Cambridge, UK. Here, he managed numerous global PMA projects across a variety of international clients, developing launch pricing strategies, creating payer value propositions & communications and managing market access reorganisations.

Paul holds a PhD in molecular biology from Edinburgh University and has a BSc Biology from Manchester University.

Graham Foxon, PhD, MBA
Managing Director & Founder

With over 20 years pharmaceutical experience, within both consultancy and pharmaceutical companies, Graham brings expertise in embedding market access drivers into clinical development programme; developing global product launch pricing strategies and producing HTA submissions to address payers’ pricing and reimbursement requirements.

Graham’s industry experience includes GSK, start-up biotech companies and Ferring pharmaceuticals. During his time at Ferring Graham was Global Head of Market Access and Pricing taking responsibility for all market access activities from incorporation of payer value into clinical development programs through to development and implementation of the market access and pricing strategy for global product launches.

Graham’s consultancy experience was obtained within both IMS consulting (previously Cambridge Pharma) and Adelphi Values whereby he was responsible for global pricing and reimbursement projects ranging from strategic insights to global pharmaceutical companies; market access training to senior management and affiliates; development of biosimilar access strategies and EU pricing and reimbursement submissions.

Graham has worked across many therapeutic areas including Oncology, Gastroenterology, Urology, Fertility, Obstetrics and Endocrinology.

Graham has a Ph.D. in neuropharmacology from Durham University and an MBA from Aston University. He currently lives in near Manchester, UK.

Janice Haigh
Practice Lead

With over 25 years’ experience, Janice stands as a seasoned problem-solver, having honed her expertise in both consultancy and the pharmaceutical industry. Throughout her career, she has deftly navigated across disciplines, seamlessly bridging the gap between global departments and country affiliates to ensure the effective implementation of strategies.

Prior to joining Remap in 2023, Janice held the position of Vice President within Parexel’s global pricing and market access team, managing a team of 50 consultants, and delivered a wide range of global projects in market access strategy, evidence optimization and value communications.

Among her distinguished roles, Janice served as the Senior Director of pricing and market access at Astellas Pharma Europe. During her tenure, she designed and delivered a parallel trade management system which restored revenues in the EEA. Additionally, she was responsible for developing pricing and market access strategies for new products, collaborating with multi-disciplinary brand teams and country affiliates to optimize launch.

Janice’s expertise further shone in her role as the Practice Lead at Quintiles Advisory Services where she seamlessly integrated market access thinking with technical disciplines such as health economics modelling and biostatistics, paving the way for holistic pricing and market access strategies. She fostered relationships across a range of functions including clinical, RWE, and commercial, culminating in the development of integrated solutions tailored to address intricate client inquiries involving both strategy and implementation.

In her first market access role as Principal for IMS/Cambridge Pharma Consultancy, she delivered client solutions in distribution strategy, “supply chain integrity”, the impact of EU enlargement and pricing and market access across multiple therapy areas, geographies, therapy areas and at all stages of development and commercialization.

Janice has a bachelor’s degree in mathematics from Royal Holloway College and a master’s in management science from Imperial College London.

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Remap Consulting have significant experience working with pharmaceutical and biotech companies in helping them navigate global market access.​

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