The conference organisers have curated an exceptional programme featuring thought-provoking presentations and dynamic panel sessions led by industry leaders driving market access strategy and practice. Following the opening keynote sessions, the conference will split into nine topic tracks and main plenary sessions each day. Here, we outline our top recommendations for sessions from each topic track.

Jump to your favourite topic to see our recommendations and some suggested pre-reading:

• Real-World Evidence & Data (in G102)
• Market Access (in the Auditorium)
• Pricing (in the Exhibition Hall)
• Pre-Launch Success (in G103)
• Reimbursement (in G104)
• Rare Diseases (in G105)
• Digital Transformation (in G106)
• Health Technology Assessment (in the Exhibition Hall)
• Health Economics & Outcomes Research (in G107)

Or consult the full agenda here.

Real World Evidence & Data

A key theme in the Real World Evidence & Data presentations is the use of artificial intelligence (AI). AI has the potential to expedite the generation, synthesis, and analysis of real-world evidence (RWE). The Wednesday afternoon panel at 14:30 will focus on this topic, featuring speakers from top Pharma companies such as Boehringer Ingelheim, Takeda, Sanofi, and Novartis, along with independent experts.

We are eager to hear what Lianne Barnieh (Associate Director, HEOR – BeiGene) will discuss in the last session on Wednesday at 17:45. Earlier in the afternoon, Trine Pilgaard (Director, Head of Market Access, Denmark and Iceland – Pfizer) will review the landscape and use of RWE across Denmark at 16:15. There is another dive into a local market on Thursday afternoon at 15:50, where Eva Susanne Dietrich (Professor, Departments for Clinical Pharmacy and Regulatory Affairs – University of Bonn) will explore RWE in Germany.

Thursday lunchtime features interesting sessions on using real-world data (RWD) for market access and value communication. Frederico Calado (Real-World Data Strategic Partnership Lead – Sanofi) will cover ‘Value based approaches to searching, screening and developing RWD strategic partnerships’ at 12:00. Elena Panitti (Global Director, Evidence Valuation and Enablement – Novartis) will present ‘Digitizing the integrated evidence plan, benefits and learnings’ at 12:40.

The afternoon panel at 14:45 continues this theme, bringing leaders from Sanofi, GSK, Johnson & Johnson Innovation, Dr Reddy’s Laboratories Ltd, Chiesi, and Takeda together to explore ‘From data to decisions: harnessing evidence for seamless product launches’.

Prepare for the conference with:

• On-demand webinar: Best practice RWE approaches to support economic modelling for HTA
• On-demand webinar: Engage NHS healthcare decision-makers with RWD

Market Access

The market access track offers a variety of sessions. We are particularly excited about Matt Slabbert’s (Vice President, Global Head of Public Affairs – Astellas) session: ‘Novel medicines platform: what does this mean for EU access policy’ on Wednesday at 12:25. We look forward to his insights on the long-term impact of this platform, which aims to foster collaboration and improve access to high-cost novel medicines.

The theme of multi-national collaboration continues in the Wednesday afternoon panel session. Independent experts and policy advisers will join leaders from Novartis and UCB to discuss ‘Anticipated impacts of the European Union (EU) health technology assessment (HTA) on market access’. With the roll-out of the EU Joint Clinical Assessment (JCA) this year for new cancer medicines and advanced therapy medicinal products (ATMPs), it is no surprise that this remains a hot topic.

A more surprising (and welcome) addition to the programme is Iroda Jurabekova’s (Global Director, Oncology Pricing and Market Access – Boehringer Ingelheim) session: ‘Leading an innovative culture in access teams’ on Wednesday at 15:35.

Prepare for the conference with:

• Summary and frequently asked questions (FAQs): EU Joint Clinical Assessment (JCA) – Implications for Pharma and MedTech

Pricing

The pricing agenda explores the challenges of developing fair and commercially appropriate pricing strategies from various standpoints.

For example, Malik Ait-Yahia’s (Director, Head of Market Access, Pricing and Governmental Affairs – Biogen) session approaches the topic from the perspective of emerging markets and rare disease. Join his talk, ‘Developing fair pricing to increase rare disease access in emerging countries’, at 15:35 on Wednesday in the Exhibition Hall.

On Thursday at 12:40, independent global market access expert, Neil Grubert, will cover: ‘Implications of crossborder collaborations for pricing and procurement’. Neil is an excellent speaker and very knowledgeable about the market access landscape and policy changes across key markets. His presentation is sure to be informative!

The pricing panel on Thursday at 14:45 will explore ‘Value based healthcare in theory and practice: challenges for pricing’. With panellists from Menarini, Abbott Laboratories, Novartis, BeiGene, and Dutch health insurer trade association, Zorgverzekeraars Nederland, this is set to be a thought-provoking discussion that will address real-world challenges in developing pricing strategies.

For a local, Spanish perspective on pricing, join José Luis Sánchez (Director, Market Access, Spain and Portugal – Jazz Pharmaceuticals) on Thursday afternoon at 15:50 as he explores ‘Price negotiation evolution in Spain’.

Prepare for the conference with:

• Read: What is willingness to pay? – Comparing price testing methodologies

Pre-Launch Success

Pre-launch success may seem a little ambiguous, but here, many of the presenters interpret it as “preparations and strategy for a successful launch”. For example, Olga Diachenko (Director Market Access, EMENA – Accord Healthcare) will present ‘Subnational reimbursement strategies for successful launches’ at 16:15 on Wednesday. Similarly, one of the day’s final sessions will feature Najib Slassi (Commercial Director, Gene Therapies – Novartis) presenting ‘Elevating market access to enable successful launches’. It will be interesting to see common themes between these sessions. Both sessions seem likely to discuss how global teams can best support local affiliates by providing the right evidence, resources, and propositions for local market launches and reimbursement success.

On Thursday, Tina Fischer (Head of Health Technology Assessments, Oncology – Daiichi-Sankyo) will discuss incorporating early local HTA agency feedback into strategies for wider international launches. Catch her session: ‘Incorporating early advice from HTA bodies and local levels to ensure successful international launches’ at 15:50.

Prepare for the conference with:

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

Reimbursement

Day 1 of the reimbursement sessions focuses on antimicrobials. At 14:30 on Wednesday, a panel will explore ‘The UK subscription model for antimicrobials: what’s next internationally?’. Later, at 15:35, Jennifer Quinn (Head of Global Value and Access – Debiopharm International) will discuss ‘Leveraging current reimbursement pathways to enable more equitable access for antibiotics’.

Thursday features sessions on innovation, sustainability, and affordability. At 12:00, Ad Antonisse (Director, Market Access & Corporate Affairs – AstraZeneca) will present ‘Innovative reimbursement schemes: uncertainties and performance indicators’. The afternoon panel at 14:45 is a must-see. Leaders from Novartis, UCB, Sanofi, Viatris, and Zorgverzekeraars Nederland will join Mary Lynne van Poelgeest-Pomfret (President of the World Federation for Incontinence and Pelvic Problems [WFIPP]) to explore ‘Sustainability of healthcare: reimbursement driven by affordability constraints’.

We’re also excited about Ankita Kaushik’s (Senior Director, HEOR, Global Value and Access – Gilead Sciences) session at 12:40 on Thursday, ‘Evidence generated from clinical trials to maximise reimbursement’.

Prepare for the conference with:

• On-demand webinar: Maximising NHS impact on a budget: assessing value in healthcare

Rare Diseases

Be sure to attend the sessions on rare diseases. Orphan and ultra-orphan medicines face unique market access and reimbursement challenges. Experts will share insights on launching innovative treatments in this field.

We’re excited about Ning Lu’s (Director, International Market Access and Pricing – Blueprint Medicines) session, ‘International access needs for orphan drugs: improving evidence and pricing strategies’, at 11:45 on Wednesday. Her global perspectives on evidence and pricing in the rare disease space will be fascinating.

On Thursday at 15:50, Sebastian Kessel (Senior Director, Head of Market Access & Public Affairs, Germany – UCB) will discuss the challenges and opportunities of launching multiple assets in one indication. An interesting strategic challenge!

Prepare for the conference with:

• On-demand webinar: Rare disease market access – Launching orphan drugs in secondary markets: the Nordic and MENA regions
• Four-part in-depth read: Challenges for orphan medicines entering the European market
• On-demand webinar: Rare disease market access: Strategic and tactical challenges facing orphan medicines entering Europe

Digital Transformation

Wednesday’s digital transformation sessions will focus on AI and RWD in market access and HEOR. Don’t miss Bill Malcolm’s (Executive Director, Global HEOR Economic & Predictive Modelling – BMS) session on ‘Generative AI applications in market access and HEOR’ at 11:45.

Thursday’s agenda, chaired by Health Innovation Network CEO, Rishi Das-Gupta, shifts the focus towards digital innovation in healthcare. It begins with a session on HTA for digital health technologies and the EDiHTA project at 11:55.

At 12:40, Aodan Tynan (Vice President, Global Market Access – Astellas) will present ‘Omni channel approaches to improve customer interactions through digital and other pathways’. It’s encouraging to see omni channel customer engagement being discussed.

Prepare for the conference with:

• On-demand webinar: Digital payer value communication tools – How to meet the needs of your internal stakeholders and customers
• Read: Digital options to enhance your local market access materials
• Read: Evolving market access pathways for AI-enabled Medtech in Europe

Health Technology Assessment

As expected, the EU JCA is a key topic in the HTA sessions. Wednesday’s panel at 14:30, titled ‘HTA Panel – Challenges for the implementation of the EU HTA’, will feature panellists from the French Authority for Health (Haute Autorité de Santé [HAS]), Consortium of Health and Social Care of Catalonia, and European Commission & National Agency for Regional Care Services, Italy. Eelko Den Breejen (Sr Director, Global Access Strategy & Pricing Oncology Team Lead, Portfolio & Market Engagement – Pfizer) will provide the industry perspective. This is a must-attend session!

On Thursday at 12:40, Helen Knight (Director of Medicines Evaluation – National Institute for Health and Care Excellence [NICE]) will present ‘Balancing cost-effectiveness and affordability: Developing methodological approaches to implement complex and high-volume products in the NHS’. Her insights on balancing these elements in healthcare systems will be intriguing.

The Thursday afternoon panel will revisit the topic of AI, focusing on its value in HTA. Panellists include leaders from HTA bodies, such as Dalia Dawoud (Associate Director, Research – NICE), Rosa Maria Vivanco Hidalgo (Head of HTA – AQuAS Gencat), and Oresta Piniazhko (Director, HTA Department – Ministry of Health, Ukraine). Leaders from BMS and GSK, along with Rishi Das-Gupta (CEO – Health Innovation Network) and Meindert Boysen (Independent HTA Expert & Chair – Health Technology Assessment International [HTAi] Global Policy Forum), will also participate.

Prepare for the conference with:

• Summary and FAQs: EU Joint Clinical Assessment (JCA) – Implications for Pharma and Medtech
• On-demand webinar: Artificial intelligence (AI) in clinical trials: implications for evidence synthesis and market access
• On-demand webinar: Maximising NHS impact on a budget: assessing value in healthcare

Health Economics and Outcomes Research

The HEOR agenda is varied, as expected. We’re particularly excited about Matthias Bischof’s (Senior Director, International Health Economics – Novartis) session at 16:15 on Wednesday, titled ‘Societal perspectives in cost effectiveness analyses: a comprehensive assessment’.

On Thursday at 12:40, Christina Vandorou (Director, Macroeconomics and Health Policy, EMEA –Johnson & Johnson Innovative Medicine) will explore ‘The value of investing in healthcare systems for the future’. This broad but enticing topic promises to offer valuable insights.

Prepare for the conference with:

• Quick read: What does HEOR really mean in 2025?
• On-demand webinar: De-mystifying health economic model classifications and structures

Learn more about our plans for World EPA Congress and connect with our team here.

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But HEOR is evolving. The methodologies that underpin it are diversifying as Pharma and Medtech companies experiment with new ways to generate, synthesise, and evaluate evidence. In this changing landscape, we ask: what does HEOR really mean in 2025?

The HEOR evolution

20 years ago, ‘outcomes research’ was a catch-all phrase for studies not directly related to clinical trials. Today, systematic literature review (SLR) and network meta-analysis (NMA) have become distinct specialisms in their own right, and the term real-world evidence (RWE) has grown to encompass a broad and sometimes confusing range of activities. Likewise, where once the range of health economic model structures could be counted on one hand, now economists use a range of advanced modelling techniques from partitioned survival modelling (now commonly used to show the value of some of the most innovative cancer treatments) to regression-based modelling (where real-world data can be incorporated to better estimate relationships between variables).

Whilst these innovations have added depth to the field, they have also contributed to a dilution of the once-clear term: HEOR.

The healthcare landscape is undeniably growing in complexity, with rising life expectancies, ageing, rare, and complex populations (e.g. with genetic mutations), and increasing pressures on systems pushing decision-makers to look for solutions that address cost, value, and outcomes. HEOR is often positioned as the answer to these challenges. However, its broad scope may obscure the concrete deliverables decision-makers need.

So, what does HEOR really mean in 2025? Is it a term that's still relevant, or has it become just another buzzword?

The continued relevance of HEOR

Despite the confusion, HEOR remains a significant term in Pharmaceutical and Medtech industries. Many professionals still hold HEOR-related job titles, and the term is embedded in the vocabulary of health research.

HEOR has expanded its remit to include emerging methodologies, such as big data analytics and artificial intelligence (AI), positioning itself as a modern, data-driven discipline (we presented research on the accuracy and efficiency of automated or AI tools in SLRs at ISPOR Europe).

Even as some of its components evolve into separate disciplines, HEOR continues to capture the essence of evaluating the economic and human impact of medical treatments.

The ongoing need for HEOR outputs

The traditional outputs of HEOR, such as health economic models, NMA, and synthesised evidence, are indispensable for successful market access. These outputs directly align with the goals of Pharmaceutical and Medtech professionals: securing positive health technology assessment (HTA) recommendations, optimising pricing and reimbursement decisions, and addressing payer concerns around clinical and economic uncertainty.

For instance, in European markets, HEOR insights might focus on cost-effectiveness thresholds and health system affordability, whereas in the US, robust real-world data and patient preference studies can differentiate products for commercial payers seeking value-based care solutions. In Asia–Pacific markets, evidence often needs to address healthcare access disparities and demonstrate cost efficiency for treatments within resource-limited settings. Meanwhile, in emerging markets, HEOR may be critical in supporting priority-setting frameworks to optimise scarce healthcare budgets.

HEOR’s role in payer engagement

For Pharma and Medtech professionals, the growing importance of payer engagement makes HEOR outputs more critical than ever. Health economic models, real-world evidence, and patient-centred outcomes provide the robust evidence that payers need to make funding decisions.

Whilst HTA markets rely on systematic comparisons of clinical and economic data, payers in less formalised systems still value strong evidence that demonstrates cost effectiveness, patient impact, and affordability. Aligning HEOR deliverables to payer priorities ensures its outputs remain relevant and actionable across markets.

Our approach: Defining HEOR for today’s challenges

HEOR is often positioned as a global framework for evaluating healthcare value, even in resource-limited markets. However, such broad claims about HEOR’s global applicability may overlook the need for more specific outputs, such as context-driven analyses, priority-setting frameworks, or data synthesis tailored to local realities.

Across Petauri™, we embrace the breadth and adaptability of HEOR, recognising that its meaning can vary depending on the context. Our strength lies in the diverse range of specialisms within our team, enabling us to support clients across the entire HEOR spectrum.

Whether it’s strategically advising clients on the most relevant methods and tools, helping them cut through the noise to identify the deliverables they truly need, or producing technical outputs to the highest standard, we ensure HEOR works for today’s challenges. The challenge isn’t that HEOR is meaningless; rather, it’s that it means different things to different people – and we’re equipped to meet those varied needs.

Conclusion: HEOR as a flexible, useful framework

In 2025, HEOR may no longer be a neatly defined discipline, but its relevance is clear. For Pharma and Medtech professionals tasked with evidence generation, HEOR offers a flexible, multidisciplinary framework to tackle specific challenges, whether it’s generating economic models for HTA submissions, delivering robust real-world evidence for payers, or creating outcome frameworks that matter to patients.

Rather than focusing on what HEOR ‘is,’ the key is to align its outputs with decision-makers’ priorities. By breaking HEOR into tangible deliverables, we can demonstrate value and support impactful market access decisions.

To speak to our evidence experts about your global HEOR requirements, contact us today.

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Looking back a few weeks to ISPOR Europe, Will Battershill and Hollie Wheat, Analysts from Delta Hat – Powered by Petauri™, share their key takeaways from the conference, relating to health technology assessment (HTA) decision-making. Will begins with insights on the hot topic of incorporating patient and carer perspectives, whilst Hollie dives into the use of surrogate endpoint evaluation.

Incorporating societal impacts into HTA decision-making

Will Battershill explores a key them from ISPOR Europe: the benefits of incorporating societal impacts into HTA decision-making.

Expanding HTA perspectives beyond the payer

ISPOR Europe featured some thought-provoking discussions on expanding the perspective taken in HTA beyond that of the payer, which typically focuses on costs to the health system and health-related benefits to patients. Speaker panels at the conference explored how incorporating societal impacts, such as bereavement or productivity, could provide a more holistic picture of the disease burden on individuals and their families. These broader perspectives pose practical and conceptual challenges, however, which could complicate decision-making.

Bereavement disutility debate

One hot topic was whether to include bereavement disutility in HTA models. This refers to the negative impact on the health-related quality of life of those close to a deceased patient. The idea is to address the “carer quality-adjusted life year (QALY) trap”, where extending life for a patient with informal carers is considered less valuable than for a patient without carers. Including bereavement disutility introduces a large negative effect after death, which, due to discounting, could shift cost-effectiveness outcomes.

Challenges in incorporating bereavement effects

Becky Pennington (Senior Research Fellow, University of Sheffield) presented evidence from UK household surveys. She showed that both carers and non-carers experience substantial disutility from bereavement, lasting 1–2 years. Dr Tara Lavelle (Assistant Professor of Medicine, Tufts University School of Medicine) presented research demonstrating increased carer productivity after bereavement over time.

Incorporating bereavement effects is not straightforward, however Dr Saskia Knies (Erasmus School of Health Policy & Management), representing the Dutch HTA body, highlighted challenges, such as determining the appropriate time horizon for models. She also pointed out the need to adjust willingness-to-pay thresholds to match a broader perspective. Pennington’s findings suggest that bereavement effects are similar for carers and non-carers. This raises the question of whether these effects should apply universally in survival-related HTAs, potentially diluting their impact on cost-effectiveness outcomes.

Risk of unintended consequences: Productivity gains versus survival

Lavelle’s work also raised an important issue: if post-bereavement productivity gains outweigh caregiving losses, could this unintentionally favour death over survival in societal cost-effectiveness analyses?

Incorporating broader support structures in HTA: A patient perspective

In an educational symposium on adopting a societal perspective for HTA in breast cancer, a patient representative stressed the importance of recognising broader support structures in patients’ lives. The discussions highlighted the complexity of integrating these factors into HTA frameworks, as there is no clear method to do so alongside clinical outcomes.

Complexities of expanding HTA perspectives

Expanding HTA perspectives beyond payer-centric views has prompted insightful research and facilitates a more comprehensive understanding of disease impact. However, these approaches also revealed marked methodological and ethical complexities. I felt that, without clearer frameworks for implementation, broadening HTA perspective might inadvertently introduce ambiguity rather than actionable insights.

Mtech Access presented a poster that looked at this issue as it relates to orphan disease: The Use of Patient and Carer Perspectives and Real-World Evidence in Orphan Disease Health Technology Assessment Submissions.

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Surrogate endpoint evaluation in HTA decision-making

Hollie Wheat shares her insights from the session on ‘borrowing information from diverse sources to enhance the evidence base for surrogate endpoint evaluation in HTA decision-making’.

Surrogate endpoints: Filling evidence gaps in HTA

One of the most thought-provoking and applicable sessions was on the use of surrogate endpoint evaluation in HTA decision-making, as led by Sylwia Bujkiewicz (Professor of Biostatistics, University of Leicester), with discussants Anastasios Papanikos (Principal Statistician, GSK), Janharpreet Singh (Professor of Biostatistics, University of Leicester), and Georgios Nikolaidis (Associate Director, IQVIA). Surrogate endpoint analyses help fill evidence gaps in HTA, often relevant where there is uncertainty in short-term data, for example in the context of small clinical trial data set and/or limited numbers of events observed within the period of trial follow-up. The use of surrogate endpoint analysis in HTA is ever increasing – 18 of 47 National Institute for Health and Care Excellence (NICE) technology appraisals between January 2022 and May 2023 included some type of surrogacy analysis.

That being said, existing surrogacy analysis methodology assumes that the relationship between endpoints remains the same for each arm. That is, one surrogate relationship may be applied to more than one treatment group.

Innovations in surrogate endpoint methodology

As surrogacy methodology evolves, however, new models are constantly being developed. These include Bayesian hierarchical models with treatment class as a covariate, mixture models that give more weight to studies with similar information to the study with missing data, and approaches that borrow from real-world evidence to inform surrogate relationships.

Key insights: Reducing uncertainty in surrogate endpoint predictions

One surprising insight from the session was that, with mixture models, sharing information at the progression-free survival level before predicting overall survival reduces uncertainty around the prediction.

Applying surrogate endpoint analysis to my work

I am currently working on a project involving the use of a surrogacy analysis. Since it’s my first experience with these methods, the session helped me gain a deeper understanding of how surrogate endpoints can aid HTA.

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4 FAQs about systematic literature reviews for Pharma and Medtech market access

What is the difference between a systematic literature review and a meta-analysis?

A systematic literature review seeks to gather and synthesise all relevant data, whether clinical or non-clinical, pertaining to a research question. This can be achieved through either narrative synthesis or a meta-analysis. A meta-analysis is a statistical method used to combine clinical outcome data from various sources, such as clinical trials, into a single analysis to compare interventions. Researchers often conduct meta-analyses after a systematic review has identified all relevant clinical data.

What is the difference between a targeted literature review and a systematic literature review?

A systematic literature review follows robust pre-specified methodology. It is good practice to pre-register protocols for a systematic review on a public database. These protocols will clearly outline the research question(s) to address, along with systematic literature review methods, search strategy, and any pre-planned analyses. This helps ensure transparency of the systematic literature review processes. Researchers should register protocols before extracting any data.

A targeted literature review focuses its scope and employs restricted methods compared with systematic literature reviews. A targeted review may only look at a single database and may have a restricted search strategy to reduce the number of results for a more focused analysis. In addition, single reviewers may be employed. As such, a targeted review will not be as robust, as there is an increased likelihood of missing studies of relevance or introducing bias.

Are systematic literature reviews qualitative or quantitative?

Systematic literature reviews can be qualitative, quantitative, or a bit of both. This will depend on your research question(s) and the evidence/data available. The best approach depends on what the reviewers discover while designing the review protocol and scoping the literature initially. Reviewers should clearly document the planned evidence synthesis in the review protocol and note any changes during the review.

How long should a systematic literature review take?

This depends on the research question(s) posed and the outputs required. As an example, take a systematic literature review that has 3,000 search results, with 200 results that requiring full-text screening. Of these, 35 are included for data extraction. We would expect a systematic literature review of this size to take between 12–18 weeks to complete from protocol development through to reporting.

11 FAQs about meta-analyses for Pharma and Medtech reimbursement

What is meta-analysis in healthcare?

A meta-analysis is a statistical method of ‘pooling’ data from multiple studies that have addressed a similar research question to provide a combined effect estimate for a clinical outcome(s) (e.g. complete response) from multiple data sources. Hence providing more power and confidence in the observed effect. Meta-analyses in healthcare combine clinical evidence from studies to ensure comprehensive assessment of treatment effectiveness across multiple interventions, most notably for health technology assessment (HTA).

Meta-analyses can include data from various types of studies (e.g. randomised controlled trials [RCTs], observational studies, single-arm studies). The study design determines the type of analysis required.

What is the difference between conventional meta-analysis and network meta-analysis?

A conventional meta-analysis compares two trial arms (e.g. drug versus placebo) from multiple studies in a pairwise manner. It aims to determine which treatment is most effective. In contrast, a network meta-analysis can compare multiple trial arms, even if they have not been directly compared in a head-to-head trial. Its goal is to determine the most effective treatment option.

When would you use a meta-analysis?

Researchers utilise meta-analysis when they plan to include multiple studies addressing the same research question. These studies typically involve similar populations, interventions, and outcomes. Homogeneity or similarity of the trial characteristics should be proven prior to including within a meta-analysis. Meta-analysis helps to synthesise and analyse data from these studies to draw robust conclusions.

Can you conduct a systematic literature review without a meta-analysis?

Yes, a meta-analysis is not always necessary. After conducting a systematic literature review, researchers synthesise all included data, whether that be statistically or narratively. The data can be used to support evidence generation requirements in various ways, such as incorporating these into HTA submissions.

If good head-to-head clinical trial data are available, it may not be necessary to conduct a network meta-analysis for the purpose of HTA. However, if other studies are available that consider interventions of interest, a network meta-analysis would be favourable to ensure all relevant data on the interventions of interest are captured. An economic model submitted to an HTA agency can then explore scenarios including all available data or just the data from the key clinical trial.

In some cases, data may not be homogenous meaning a robust meta-analysis, or network meta-analysis, is not possible.

What is the major advantage of a meta-analysis?

Meta-analyses provide greater statistical power by combining several studies into what is effectively one larger study. As a result, we can be more confident in the data. Some meta-analyses, such as indirect treatment comparisons (ITCs), enable comparisons between interventions where no direct comparison exists, for example, via an RCT.

What do you write/include in a pharmaceutical meta-analysis?

When conducting a meta-analysis of clinical trials, the aim is to identify how effective one treatment is in comparison with another. Statistical analyses are conducted on the data to estimate treatment effect. In general, the results you would expect to see include:

• Effect estimate: overall pooled estimate based on multiple studies included in the meta-analysis showing whether studies generally favour an intervention or comparator. Can be derived in many forms including, but not limited to, odds ratio, risk ratio, rate ratio mean difference, standardised mean difference
• Confidence intervals (e.g. 95%): highlights the variation associated with the effect estimate derived from multiple studies to see how much confidence should be applied to the observed effect
• p-value for effect estimate: indicates the statistical significance (i.e. p<0.05=reject null hypothesis; p≥0.05=failure to reject the null hypothesis) associated with the pooled effect estimate
• Heterogeneity (e.g. I2): provides insight on whether studies included in the pooled analyses differ in terms of the direction of effect observed (i.e. one study significantly favours the intervention, whereas another significantly favours the comparator)

What are the assumptions for meta-analyses and network meta-analyses?

For meta-analyses, homogeneity is a key assumption in being able to draw robust conclusions from pairwise comparisons. In the context of network meta-analysis, homogeneity is a key assumption to check there is no imbalance in the distribution of effect modifiers across the different types of direct treatment comparisons. Another important assumption to take into account for a network meta-analysis is coherence.

How many studies are needed for a meta-analysis?

Performing a meta-analysis requires a minimum of two studies. Yet, if the studies contain small sample sizes with wide confidence intervals, experts will warn against performing a meta-analysis with just two studies. This is mainly because of the imprecision observed in the effect estimate, which makes the analysis redundant for making clinical decisions about the statistically compared drugs. Many will often report two studies qualitatively and only perform a meta-analysis if they have at least three studies included.

Can a meta-analysis be qualitative?

Yes, albeit these are rare and often used in the discipline of psychology to assess key themes developing from qualitative data. These are often referred to as meta-syntheses.

What is an ITC?

An indirect treatment comparison involves conducting a meta-analysis to compare two treatments that have not been directly compared in head-to-head trials (e.g. through an RCT). Indirect treatment comparisons are conducted when a common comparator exists. Two trials may have different treatments but the same comparators, allowing that common comparator to act as an anchor. For example, where direct evidence is available for treatment A versus treatment B and for treatment A versus treatment C, the ITC allows a comparison of treatment B versus treatment C.

What are the assumptions for indirect treatment comparisons?

Homogeneity (i.e. similarity) across included trials is a key assumption for indirect treatment comparisons. In addition to homogeneity, transitivity (i.e. the ‘anchor’ comparator is similar across trials) and consistency (i.e. direct and indirect evidence are in agreement) are also important assumptions when performing indirect treatment comparisons. If these assumptions are not met, the results of the indirect treatment comparison are likely to be misleading. In the case of transitivity, if the ‘anchor’ comparator is not similar between trials, then you are introducing indirectness into the direct comparison, which is used as the platform to calculate your indirect comparison.

Do you have a different question for our experts? Send your question to info@mtechaccess.co.uk.

Our experts are here to support all your evidence synthesis, generation, and communication requirements, including all aspects of systematic literature review and network meta-analysis. We also offer education and training on key principles of evidence synthesis. To learn more, email info@mtechaccess.co.uk.

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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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In Europe, there have recently been several legislative changes. For example, the European Union (EU) AI Act, and the introduction of reimbursement pathways at the national level to support access to digital health technology. In this article, Louise Maddison (Senior Consultant – Global Market Access, Mtech Access) explores the evolving market access landscape for AI-enabled Medtech, with a particular focus on the key European markets of France, Germany, and the UK.

The path to market access involves multiple stakeholders, each playing a crucial role. Patients represent the basis of unmet need, and physicians want to use the technology and their data to address this unmet need. Payers need to be convinced of the clinical and economic evidence supporting the new technology. Additionally, medical societies and coding agencies are essential to the process. Regulators are responsible for granting clearance and marketing authorisation. Currently, many are revising their frameworks to adequately address the unique challenges posed by AI.

EU AI Act

From August 2024, the AI Act came into force across the EU, which has additional implications for digital health manufacturers beyond the Medical Device Regulation (MDR) (1-3). The AI Act provides a framework for AI systems based on a risk-based approach and applies to all industries, to ensure AI systems used in the EU are safe, transparent, traceable, non-discriminatory, and environmentally friendly.

‘High-risk AI systems’, such as AI-based medical software, must comply with strict requirements, including systems for risk mitigation, robust datasets, and clear user guidance. Many of which overlap with the current rigorous requirements of conformity assessment under the MDR. It is important to note that the risk levels between the MDR and AI Act are not equivalent. Indeed, AI-enabled technology, which requires conformity assessment by a notified body and includes devices classed as ‘medium risk’ under MDR, would automatically be ‘high risk’ under the AI act.

The AI Act will become fully applicable from August 2026, but high-risk AI systems, such as medical devices, will have an extra year to comply. Medical device manufacturers will need to act now to ensure that their regulatory plans meet the AI Act requirements.

Additionally, the transition from Medical Device Directive (MDD) to MDR within the EU means that there is increased evidence demonstration of device performance and safety prior to medical device approval and post-market follow-up, as well as improving transparency and traceability of data (4). From May 2024, devices may only be marketed under MDR certification and next year devices with MDD certification may no longer be sold.

AI-enabled medical devices in the UK

As part of the UK’s medical technology strategy, a 5–10 year plan, the Medicines and Healthcare products Regulatory Agency (MHRA) have been establishing a streamlined pathway for Medtech innovation (5). Recently, there have been several initiatives with a focus on AI to set the UK apart from other markets as the place for development and commercialisation of healthcare technologies.

AI Airlock

A regulatory sandbox aimed at understanding and mitigating risks associated with Software as a Medical Device/Artificial Intelligence as a Medical Device (SaMD/AIaMD) prior to placing on the market (6). The objective is to identify challenges and share findings to aid regulatory and funding efforts for AI as a medical device. Creating sandboxes enables AI innovations to be explored within a contained space outside of the existing regulatory framework and allows regulators to collect important insights before deciding on further regulatory action. As part of a pilot project involving the National Health Service (NHS) and Team UK Approved Bodies (AB), 4–6 projects will be selected to test regulatory issues in clinical settings.

AI low-risk products

Similar to the EU, the UK uses a risk-based classification system for medical devices, and the higher the risk class, the greater the scrutiny required (7). However, many AI-enabled healthcare products currently in the lowest risk classification, where an independent conformity assessment is not required, will be up-classified. It is expected that this will provide users and patients with additional protection through greater scrutiny during the product’s lifecycle.

Additionally, the MHRA has published 10 guiding principles jointly with the US Food and Drug Administration (FDA) and Health Canada, Good Machine Learning Practice for Medical Device Development: Guiding Principles, to promote good practice for all medical devices.

International recognition of medical devices in the UK

The MHRA has also announced plans to incorporate approvals from outside the UK alongside United Kingdom Conformity Assessment (UKCA) marking until June 2030 (8). A comparable regulator countries framework would recognise approvals from the FDA, EU member states, Health Canada, and the Australian Therapeutic Goods Administration (TGA). Reliance on other regulators will enable faster approvals by the MHRA. The operational aspects are under development with industry and designated approved bodies, for AIaMD there will be a review of pre-market data. It is expected that the final version of the framework will come into force in 2025.

Government recognition of the benefits of AI to healthcare

Governments are increasingly recognising the benefits that AI can bring to drive efficiency in healthcare. In Germany, the national lung cancer early detection programme will be implemented with AI used to assist radiologists in reviewing low-dose computed tomography images (9). AI can support such large volume screening programmes with workflow, diagnostics, and data analysis. The UK government is also exploring how the NHS can use AI to transform the health and social care settings, as well as improvements to regulatory processes, e.g. use of machine learning to streamline document assessments by the MHRA (7, 10).

Reimbursement for digital healthcare

Medtech manufacturers targeting different markets must evaluate the current market access pathways in each country to achieve reimbursement, as pathways are evolving to support AI-based healthcare innovations.

AI reimbursement in Germany

In Germany, there are fast-track options to support patient access to new technologies. The Digital Healthcare Act in 2019 introduced Digital Health Applications/Digital Nursing Applications (DiGA/DiPA) fast-track pathways, which provide expedited regulatory approval and reimbursement by statuary health insurance (11, 12). Applications to the DiGA/DiPA fast track have included psychological interventions, bones and joint health, and cardiology.

Building on this, the German government passed the Digital Act (DigiG) last year, which aimed to support the use of digital solutions and improve access to health data, including the expansion of the DiGA to higher risk medical technology, with the overall aim of improving everyday care in Germany (13).

AI reimbursement in France

In France, similar to the German DiGA, the Early Access to Reimbursement for Digital Devices (PECAN) fast-track scheme was established in 2023 to enable the temporary reimbursement (1 year) of digital health technologies prior to permanent reimbursement (14). This allows time for manufacturers to collect additional clinical data and finalise the submission dossier for permanent reimbursement.

AI reimbursement in England

Ongoing change and innovation are providing opportunities for accelerated access and reimbursement in England. One such approach is the Early Value Assessment (EVA) for digital products, devices, and diagnostics, which aims to support rapid access to technologies that address national unmet needs (e.g. early cancer detection) (15). The EVA is open to digital health technologies or other medical technologies that are European Conformity (CE) or UKCA marked, which require further data collection before recommendation; digital technologies must also have Digital Technology Assessment Criteria (DTAC) approval. The EVA supports manufacturers with the production of evidence required for a full National Institute for Health and Care Excellence (NICE) appraisal, as well as recommendation on future use in the NHS.

To learn more about reimbursement pathways for medical technology, we offer a free guide for US and key European markets.

Changing market access landscape

To bring AI-enabled medical technology to market it is essential to understand:

• The various approval and reimbursement routes relevant to your product
• The evidence required to demonstrate both clinical and economic value
• Where it will be positioned in the treatment pathway

We can offer support to bring your healthcare innovation to market and throughout the product lifecycle by providing commercialisation strategy, evidence synthesis and analysis, as well as payer value communications. To understand more about how we add value to your digital health pipeline, read this case study or drop us an email at info@mtechaccess.co.uk.

References

1. European Commission. AI Act enters into force. 2024. Available from: https://commission.europa.eu/news/ai-act-enters-force-2024-08-01_en. Accessed on: 20th August 2024.
2. European Parliament. EU AI Act: first regulation on artificial intelligence. 2024. Available from: https://www.europarl.europa.eu/topics/en/article/20230601STO93804/eu-ai-act-first-regulation-on-artificial-intelligence. Accessed on: 20th August 2024.
3. European Commmission. Artificial Intelligence – Questions and Answers. 2024. Available from: https://ec.europa.eu/commission/presscorner/detail/en/QANDA_21_1683. Accessed on: 20th August 2024.
4. European Commission. Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation. Available from: https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_24. Accessed on: 20th August 2024.
5. Department of Health & Social Care. Medical technology strategy. 2024. Available from: https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy#priority-3-enabling-infrastructure-1. Accessed on: 20th August 2024.
6. MHRA. AI Airlock: the regulatory sandbox for AIaMD. 2024. Available from: https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy#priority-3-enabling-infrastructure-1. Accessed on: 20th August 2024.
7. MHRA. Impact of AI on the regulation of medical products. 2024. Available from: https://www.gov.uk/government/publications/impact-of-ai-on-the-regulation-of-medical-products/impact-of-ai-on-the-regulation-of-medical-products. Accessed on: 20th August 2024.
8. MHRA. 2024. Statement of policy intent: international recognition of medical devices. Available from: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices. Accessed on: 20th August 2024.
9. Ward P. Lung cancer screening arrives across Germany. 2024. Available from: https://www.auntminnieeurope.com/clinical-news/ct/article/15678766/lung-cancer-screening-arrives-across-germany. Accessed on: 20th August 2024.
10. NHS England. The NHS AI Lab. 2024. Available from: https://transform.england.nhs.uk/ai-lab/. Accessed on: 20th August 2024.
11. Federal Ministry of Health. Driving the digital transformation of Germany’s healthcare system for the good of patients. 2019. Available from: https://www.bundesgesundheitsministerium.de/en/digital-healthcare-act. Accessed on: 20th August 2024.
12. Federal Institute for Drugs and Medical Devices. DiGA and DiPA. 2024. Available from: https://www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Health-Applications/_node.html. Accessed on: 20th August 2024.
13. Federal Ministry of Health. Law to accelerate the digitization of the healthcare system (Digital Law – DigiG). 2023. Available from: https://www.bundesgesundheitsministerium.de/ministerium/gesetze-und-verordnungen/guv-20-lp/digig. Accessed on: 20th August 2024.
14. Digital Early Support (PECAN). Available from: https://gnius.esante.gouv.fr/fr/financements/fiches-remboursement/prise-en-charge-anticipee-numerique-pecan#:~:text=Le%20dispositif%20cible%20les%20dispositifs,un%20remboursement%20de%20droit%20commun. Accessed on: 21st August 2024.
15. NICE. Early Value Assessment (EVA) for Medtech. Available from: https://www.nice.org.uk/about/what-we-do/eva-for-medtech. Accessed on: 21st August 2024.

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About our panel

Dan Howard (Associate Director – Health Economics, Mtech Access)

Dan has 10 years’ experience as a technical, hands-on health economist in both consulting and industry. He has specialised in oncology and rare disease modelling across a breadth of indications, and has led or contributed to over 20 HTA submissions. Dan is also experienced in the development of indirect treatment comparisons in the context of single-armed oncology trials, which are becoming all the more common with accelerated regulatory pathways and corresponding earlier reimbursement timelines. Dan has an MSc in Health Economics and Decision Modelling from the University of Sheffield and an MPhil in Neuroscience from the University of Manchester.

Joseph O’Reilly (Principal Medical Statistician, Arcturis)

As a member of the RWE team at Arcturis, Joe is responsible for the development and implementation of statistical solutions for clients and the advancement of internal research programmes to devise novel methods for observational clinical research. He has led projects developing external control arms from RWD, which have been used to support NICE HTA submissions. Prior to joining Arcturis, Joe was a post-doctoral Biostatistician and Epidemiologist in The Institute of Genetics and Cancer at the University of Edinburgh. Joe obtained his PhD in Bayesian method development from the University of Bristol.

Nick Latimer (Analyst, Delta Hat; Professor of Health Economics, University of Sheffield; former NICE Appraisal Committee member)

Nick is a former National Institute for Health and Care Excellence (NICE) Appraisal Committee member, who has authored five NICE Decision Support Unit (DSU) technical support documents related to survival analysis, treatment switching, and partitioned survival models.

In addition to his role at Delta Hat, Nick is a Professor of Health Economics at the University of Sheffield. His current work involves investigating the use of cancer registry datasets to estimate the comparative effectiveness of treatments.

Samantha Gillard (Director – HTA, Mtech Access)

Sam has 21 years’ experience within market access and health economics, and leads the Mtech Access HTA Team. Having worked with the majority of the top 25 pharma companies and numerous medical device companies, Sam understands the varied challenges in getting a product to market and can offer strategic advice across the product life cycle. Sam has worked across a wide range of disease areas, with particular expertise in oncology, diabetes, cardiology, wound care, hip replacement, transplantation, and psoriasis. Sam has a PhD in neuropharmacology from the University of London.

Arcturis use RWD and specialise in applying innovative RWE techniques to support the discovery and development of new medicines.

Delta Hat specialise in the technical aspects of evidence-based medicine and modelling, as well as acting as external reviewers for NICE and the Scottish Medicines Consortium (SMC).

Mtech Access are experts in preparing all aspects of HTA submission dossiers and health economic models.

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