About our speakers

Richard Smale (Director of System Coordination, NHSE South West)

Richard has worked for the NHS for over 30 years in a broad range of roles including as an accountant, general manager, head of IT services, and as Executive Director of Strategy and Transformation. These roles have involved working for community, mental health, and acute providers, as well as a Commissioning Support Unit, Clinical Commissioning Group, and ICB. His current role is with NHSE South West where he works to coordinate the relationship with local integrated care systems.

Following the recent announcements of the integration of NHSE with the DHSC, and the required reduction in the size of ICBs, Richard will be the Programme Director for the transition programme in the South West. In this context, Richard will bring relevant insights into the changes in the structure of the NHS that are expected to emerge over the coming months.

Gail Fortes Mayer (Associate Director of Strategic Commissioning, NHS Arden and Greater East Midlands Commissioning Support Unit)

Gail has 20 years’ experience in the NHS in commissioning and performance improvement roles. Her past and current roles have involved overseeing commissioning for specialised services, elective and diagnostic pathways, long-term conditions, and cancer. As such, she is ideally placed to comment on the practical implications of the changes we are witnessing in NHSE and DHSC, and the budgetary challenges facing ICBs.

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About our speakers

Tim Goodson (Executive Officer, Dorset General Practice Alliance and former Integrated Care System [ICS] system leader)

Tim Goodson spent his career working within the NHS helping to improve services for patients. Most recently Tim was the ICS lead for Dorset as well as being the Chief Executive for Dorset Clinical Commissioning Group (CCG) for 9 years. These roles enabled him to take a leadership role both locally and nationally, enabling Dorset to be at the forefront of promoting an integrated approach across health and social care.

Under Tim’s stewardship, Dorset undertook a comprehensive Clinical Service Review that set out the roadmap for how Dorset wanted to transform health services to improve patient care, whilst at the same time offering a sustainable solution for the NHS in Dorset. During Tim’s career he has held a broad range of executive responsibilities including the post of Director of Finance for three Primary Care Trusts also spanning 9 years. Tim now runs his own company providing consultancy services and hands on support to boards, and is also a Trustee of a local hospice.

Ashleigh Boreham (Deputy Director Partnerships, Research and Innovation, NHS Dorset and formerly Deputy Chief Officer Strategy and Transformation, NHS Dorset)

Ashleigh is a highly experienced healthcare leader with a career spanning over two decades. In addition to his role as Deputy Director Partnerships, Research and Innovation, his current portfolio also includes his role as Programme Director for Oral Health and the Medical School, in addition to leading on Creative Health and on Health for the Armed Forces Community.

He previously served for 27 years in the Regular Army, deploying to the Balkans, Sierra Leone, Kenya and Oman before joining the NHS in 2020. He was Head of Medical Operations in Germany and Afghanistan, and commanded two Field Hospitals, deploying to Iraq and Kosovo in this role. He was awarded the Order of St John in 2001. Previous appointments included Corps Colonel and Head of Career Management for the Army Medical Services, leading strategic workforce planning and medical training.

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This article was updated in November 2024, with reflections on the latest information about the EU JCA and how industry is responding.

Jump to:

• What is the EU JCA?
• When will the JCA be a requirement?
• Will the JCA replace local HTA?
• JCA methods and guidelines
• Who conducts and assesses the JCA?
• The JCA scoping process
• Four key considerations for Pharma and Medtech
• How can Mtech Access & Petauri™ provide support?

What is the EU JCA?

In January 2022, the European Parliament enacted a new EU Health Technology Assessment Regulation (HTAR), with the main aims being to:

• Standardise clinical assessment of medicines and high-risk medical devices across the EU
• Avoid duplication of work
• Improve access to innovative health technologies to patients across Europe
• Strengthen the quality of health technology assessments (HTAs)

Currently, Pharma and Medtech manufacturers have to submit evidence individually in each of the 27 EU markets; the intention of the JCA is that at least some of the assessment can be done centrally.

The JCA will provide an assessment report, which acts as a universal information source for relative treatment effects, safety, and other clinical parameters agreed in the scoping process. The report will also cover the clinical area addressed by the technology and its technical characteristics. A summary report will be developed. Both reports will be based on scientific, clinical, patient, industry, and HTA body expertise.

The introduction of the JCA should benefit smaller markets, which may not have the required capacity or expertise to conduct assessments independently.

When will the JCA be a requirement?

The JCA will be rolled out in stages. New cancer medicines and advanced therapy medicinal products (ATMPs) will require a JCA from 12th January 2025. Orphan medicines will require assessment at EU level from 13th January 2028. Finally, all other new medicines launching in the EU will need a JCA from 13th January 2030.

Will the JCA replace local HTA?

The JCA is not a full HTA and is focused only on clinical evidence. It is not an appraisal, and local agencies reserve the right to draw their own conclusions on relative efficacy and safety.

Whilst all member states will be required to give each JCA “due consideration”, each state will be able to request additional information relevant to their market. Cost-effectiveness and reimbursement decisions will be made at national level.

JCA methods and guidelines

The voluntary EU HTA cooperation, EUnetHTA21, a consortium of 12 European HTA bodies, were contracted to develop guidance documents to support the EU HTAR.

EUnetHTA21 developed HTA methodological guidelines, including guidance on scoping, evidence synthesis, endpoints, validity of studies, etc. Whilst these guidelines are written for the assessors and co-assessors, Pharmaceutical and Medtech companies can also learn from the information provided.

JCA guidelines published by EUnetHTA21 include::

• JCA submission dossier guidance and template
• JCA assessment report guidance and template
• JCA procedural guideline for appointing assessors and co-assessors
• Production of JCA on medical products and medical devices

In September 2023, the Member State Coordination Group on Health Technology Assessment (HTACG) was established to oversee future joint EU HTA work. HTACG have published the following two pieces of guidance:

• Guidance on outcomes for joint clinical assessments
• Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments

The guidance on outcomes for JCAs will help member state authorities define the scope of the JCAs and help assessors report all elements that member states need for the national appraisal of the clinical added value of health technology.

The guidance on reporting requirements for multiplicity issues and subgroup, sensitivity, and post hoc analyses in joint clinical assessments describes how assessors should deal in practice with multiplicity issues and complementary analyses in JCA reports.

Who conducts and assesses the JCA?

The JCA process will be conducted by the HTACG. The HTACG comprises four subgroups, with two (Joint Clinical Assessment and Joint Scientific Consultation) directly responsible for the delivery of JCA reports. One subgroup will be responsible for the identification of emerging health technologies, and another will focus on methodology.

The JCA will be conducted by representatives from the designated subgroups who will be responsible for all JCA activities and timelines, as well as collecting input from regulatory agencies, clinicians, and patients.

For each technology requiring assessment, the JCA group will appoint two member states, one leading and one supporting, who will be responsible for assessing the manufacturer’s dossier and producing the JCA report. The appointed member states will liaise with the other member states as required.

The JCA scoping process

To inform development of the assessment scope, the manufacturer will submit elements of their European Medicines Agency (EMA) application, namely the summary of product characteristics and clinical overview. Based on this information, assessors will prepare a proposal for the assessment scope in terms of population, intervention, comparators, outcomes (PICO), which has the aim of specifying the framework for assessment and the evidence requirements the manufacturer will need to satisfy.

Each of the 27 EU member states will be required to fill out a PICO survey, to allow them to identify national needs. Following the survey, the JCA assessor and co-assessor will consolidate all PICOs, which will be validated by EU patients and clinical experts, as well as the Committee for Scientific Consistency and Quality (CSCQ).

The finalised assessment scope will be communicated to Pharmaceutical and Medtech manufacturers, from which point they have 90 days to develop and submit the JCA dossier. Submission of the dossier is required at least 45 days prior to publication of the Committee for Medicinal Products for Human Use (CHMP) opinion.

Four key considerations for Pharma and Medtech

Manufacturers can expect to face various challenges throughout the JCA process, including:

1. Different national requirements

EU member states will be able to request additional information, such as cost-effectiveness evidence, during the JCA process. Yet, additional clinical information will still be required at national level and this is where reimbursement decisions will be made. Additionally, there may be differences in accepted methods for evidence synthesis between the EU member states. Presumably, individual member states will still be able to request the same evidence as at EU level, but analysed differently.

2. Risk of needing to repeat submission following CHMP opinion

The JCA dossier submission needs to be made prior to CHMP opinion (at least 45 days prior to publication of the opinion). Since aspects of PICOs may change following CHMP opinion, there is a risk that the whole JCA process will need to be repeated.

3. Potential for an unmanageable number of PICOs

Even though PICOs at national level will be consolidated, there is no cap on the number of consolidated final PICOs. The definition of standard of care and patient populations are likely to vary across member states and so there is a risk of an unmanageable workload for manufacturers.

4. Limited contact with assessors

Manufacturers will have limited input into the JCA process. As the JCA is not an appraisal, and reimbursement decisions won’t be made, it is understood that the EU assessor and co-assessor’s contact with manufacturers will be limited to requesting clinical evidence if missing from the JCA submission dossier.

Despite the intention to avoid duplication of efforts, the four challenges above are likely to increase the workload for manufacturers.

How can Mtech Access & Petauri™ provide support?

We can help Pharma and Medtech companies with strategic considerations, evidence synthesis, and dossier development for their JCA submissions.

We are HTA experts and our team have collectively completed more than 170 HTA submissions, with a 100% success rate in oncology and rare diseases. We work closely with our clients, becoming an extension of their teams, to ensure the value of their products is appropriately communicated. We provide continuous strategic support throughout to maximise the chances of successful reimbursement, whilst project timelines are closely monitored for timely delivery.

At Mtech Access – Powered by Petauri, we have specialist teams of Systematic Reviewers and Statisticians who consistently deliver evidence synthesis according to the most robust standards, across all disease areas. Several of our Evidence Team were previously members of an Evidence Assessment Group for the National Institute for Health and Care Excellence (NICE) and use this experience to ensure that our systematic reviews adhere to HTA requirements and are of the highest quality. In addition, our large in-house team of specialist Medical Writers are experienced in writing reimbursement and HTA submission dossiers. All of our submissions undergo a thorough proofing process by our Editorial Team, who offer quality assurance.

Please email info@mtechaccess.co.uk to discuss how we can support you with your JCA dossier.

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What led you to pursue a career in market access?

Over time, as I went along my career pathway, I picked up lots of skills and experience that eventually led me to a career in market access. Initially, I completed a 4-year MSci (Hons) in Chemistry at The University of Nottingham. I knew I wanted to continue with science, but was unsure of continuing down a pure chemistry path. So, I did a gap year in South America, undertaking volunteer work with Raleigh International in Chile and further travel across the continent.

On returning, I worked in business development for an environmental laboratory. I enjoyed the work but quickly realised I’d like to explore healthcare as a career option. I gained a place on the NHS graduate scheme in Clinical Biochemistry. After completing my initial training, I returned to university to complete a PhD in Personalised Medicine, investigating cancer signalling pathways. This offered lots of opportunities with several industry sponsors, as well as training in laboratory techniques and computational skills (e.g. mathematical model building, AI, advanced statistical techniques). Additionally, I spent some time in Berlin as part of a collaboration with Charité Hospital.

After completing my PhD, I successfully secured my own funding to continue my research as a Doctoral Prize Fellow. Alongside my studies, I joined the Oxbridge Biotech Roundtable, where I worked on several consultancy projects, including technology transfer policy and diagnostics market assessment for a large pharmaceutical company.

I really liked the variety that consultancy offered, so I decided to switch from academia to a full-time role in consultancy, eventually specialising in market access. In my last role, I branched out into digital transformation and explored how AI, data, and analytics could be used to improve processes across pharmaceutical functions.

What motivated you to join Mtech Access?

I was attracted to Mtech Access as they offered opportunities for providing innovative solutions to clients compared with larger multinational companies. Additionally, I had been working on digital transformation for pharmaceutical clients and wanted to return to a role focused solely on market access.

What have you been involved with in your first few months at Mtech Access?

I completed a comprehensive induction and got to know people from across the different services; everyone has been very friendly.

I’ve also written several thought leadership pieces, such as our article, Top 10 HEOR trends – A detailed look at ISPOR’s 2024–2025, in response to ISPOR’s trends. Recently, I’ve been engaging with clients and developing a lunch and learn presentation on Medtech reimbursement pathways, as well as developing proposals and contributing to project work.

Overall, the company has been really welcoming. Before joining, the company invited me to the company-wide Christmas party and a smaller office gathering in Manchester.

What have you learnt from your first interactions with the team?

Everyone that I have come across has been friendly and eager to help – a great collaborative and supportive working culture. There is a theme of excellence that runs through the company in everything the team does, both internally and externally. It is great to be here in such a people-first environment.

What has surprised you most about Mtech Access?

The quantity of work that the business is undertaking in Medtech. Especially since it’s such an exciting time, with new regulations in the EU (e.g. the AI act) and ever-changing reimbursement pathways. Additionally, there are opportunities to work on interesting and innovative technological advancements, such as digital and AI.

If you could swap your expertise and role with a colleague from another team, who would you swap with?

I would probably swap with the Health Economics Modelling Team, as their work is similar to the mathematical component of my PhD, but with a difference – modelling cost effectiveness rather than modelling cancer signalling pathways.

When you are not at work, what do you like to do?

I love getting out to the mountains, be it hiking, climbing, swimming, or kayaking. I am currently focused on completing all 282 Munros, the highest mountains in Scotland. I also love live music and going to gigs.

To learn more about our expertise in market access strategy and pricing, please email info@mtechaccess.co.uk.

If you are interested in joining our team at Mtech Access, please visit our careers page for details of our current vacancies.

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Who’s attending from Mtech Access?

David Niziol

MD & Founder

Anthony Bentley

Director – Health Economics

Clare Foy

Director – Global Market Access

Adam Brown

Director – Consulting Services

Hannah Palin

Director – Market Access

Lydia Crowe

Director – Commercial

Key reads and insights ahead of ISPOR

What role does ICER play in US market access?

We delve into ICER’s influence on drug pricing and access in the US. We also explore the importance of maximising engagement with ICER for favourable pricing and access outcomes…

Top 10 HEOR trends – A detailed look at ISPOR’s 2024–2025 topics

We bring together specialists from across Mtech Access to look at each of ISPOR’s top 10 HEOR trends for 2024-25. Jump in, as our experts give their hot-take on each trend, sharing their perspectives on what’s happening in these areas…

EThe role of economic evaluation in US healthcare

Hannah Palin (Director – Market Access) and Calum Jones (Associate Director – Health Economics) explore the landscape for economic evaluation in the US and highlight important considerations for companies seeking to infiltrate this key market….

Free guide to market access and reimbursement in key European markets

Request your copy of our popular introductory guide: ‘Market access and reimbursement in key European markets’…

AMCP dossier planning for US market access and reimbursement

What is an AMCP dossier and how are they used in US market access? Drawing on their extensive experience compiling AMCP dossiers, here, our global market access experts explain when, why and how…

EU Joint Clinical Assessment (JCA) – implications for Pharma and Medtech

What is the EU Joint Clinical Assessment (JCA) and what does it mean for market access and reimbursment in Euorpe?…

6 questions to ask when adapting global market access materials for local markets

How can you ensure that the market access materials, value proposition and evidence developed by global teams, will resonate for your local audience?…

Setting your product up for success – commercialisation strategy for the US market

How can you ensure your product is set up for success from early clinical trials right through to launch and commercialisation? In this Global Whispers webinar we explore best practice…

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