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Joint Scientific Consultation

Strategic guidance for engaging with HTA bodies under the EU HTA Regulation

The launch of the EU HTA regulation in January 2025 marks a significant shift in how pharmaceutical and biotech companies will interact with Health Technology Assessment (HTA) bodies across Europe. One of the cornerstones of this regulation is the Joint Scientific Consultation (JSC), a collaborative process that allows manufacturers to receive critical early advice from multiple HTA bodies. This guidance ensures that clinical and economic evidence generation strategies align with the requirements of these HTA bodies, helping to mitigate risks and enhance the likelihood of successful market access.

What is Joint Scientific Consultation (JSC)?

Joint Scientific Consultations (JSC) are an integral part of the EU HTA Regulation, enabling developers to seek advice from multiple HTA bodies early in the development process. Through JSC, companies can gain clarity on the data and evidence needed to meet HTA requirements, improving the likelihood of favourable assessments during the Joint Clinical Assessment (JCA)

  • Engage early with HTA bodies
  • Ensure alignment of your evidence generation strategy
  • Obtain tailored advice on your clinical development plans

We’re your partner for JSC’s

With extensive experience in market access and HTA strategies, our team at Remap Consulting is uniquely positioned to help you navigate the complexities of JSC. We provide strategic guidance and actionable insights to ensure your product development aligns with HTA expectations, ultimately enhancing your chances of success in the European market.

  • Expertise in HTA processes across Europe
  • Proven track record of guiding clients through JSCs
  • Deep understanding of the evolving EU HTA landscape
  • Customised strategies to meet the specific needs of your product and target markets

Joint Scientific Consultations tailored to you

Strategic preparation for JSCs

  • Preparing for a JSC requires careful planning and an understanding of what HTA bodies are looking for
  • We help you craft a compelling, well-organised submission that addresses the key areas of concern for HTA bodies, including clinical trial design, economic modelling, and evidence generation plans

Stakeholder communication and coordination

  • Engaging with multiple HTA bodies can be complex, but our team ensures that communication is clear, timely, and aligned with your strategic objectives
  • We manage the logistical aspects of coordinating interactions with HTA bodies, so you can focus on the substantive elements of the consultation

Tailored evidence generation advice

  • Our consultants have deep expertise in evidence generation and can provide tailored advice on how to design your clinical trials, economic models, and other evidence-generation activities to meet the expectations of HTA bodies
  • We help you anticipate potential challenges and align your evidence generation strategy with HTA requirements

Post-JSC action plan

  • Following a JSC, it’s crucial to incorporate the feedback into your product development and evidence generation plans
  • We work with you to translate the insights gained from the consultation into a clear, actionable plan, ensuring that your clinical and economic evidence meets the requirements for later HTA submissions

Why is early HTA advice critical to market access success?

Engaging in a JSC is an essential step in reducing uncertainty and ensuring the success of your product in the European market. By obtaining early advice from HTA bodies, manufacturers can adjust their development plans to meet the diverse requirements of multiple HTA authorities, reducing the risk of delays or negative outcomes during the Joint Clinical Assessment (JCA) phase.

  • Risk mitigation: engaging with HTA bodies early in the process allows you to anticipate potential challenges and adjust your strategy accordingly, reducing the risk of negative outcomes later in the process
  • Evidence alignment: by aligning your evidence generation strategy with the expectations of HTA bodies, you increase the likelihood of a successful HTA assessment and ultimately, faster patient access
  • Market readiness: with the right insights and advice from HTA bodies, you can ensure that your product is ready for the European market, supported by the evidence needed to demonstrate its clinical and economic value

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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.