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In this webinar, Juliet Wallace (Senior Partnerships Coordinator) delves deep with our expert panel into the pivotal role of health economic evaluation in supporting market access for medical devices. Juliet puts audience questions to Hannah Palin (Director, Local Market Access), Calum Jones (Associate Director, Health Economics), and Evelyne Priestman (Consultant, Health Economics).

Hannah Palin

Director, Local Market Access

Hannah Palin specialises in the launch and commercialisation of new healthcare interventions. She is an expert in developing materials that communicate the clinical and economic value that products deliver within the care pathway. Hannah will draw on her experiences creating local launch strategies for a wide range of Medtech products.

Calum Jones

Associate Director, Health Economics

Calum Jones has deep expertise with early economics models to support strategic decision making, reimbursement and HTA. These types of models are a staple of Pharma market access, but are often overlooked by Medical Device teams. Calum will help us understand the value early modelling and evaluation can add for Medtech.

Evelyne Priestman

Consultant, Health Economics

Evelyne Priestman’s expertise lies in leveraging health economic modelling for the commercialisation and launch of medical devices. Evelyne will discuss the common obstacles that launch teams encounter when introducing new devices to local markets, and how health economics can generate the evidence needed to navigate these challenges successfully.

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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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The symposium featured the following guest speakers and facilitators:

• Professor Hilary Garratt CBE (ICB NHS Non-Executive Director, Accredited Senior Executive Coach and Mentor)
• Dr Raj Patel MBE (Former Senior Medical Director in NHS England, NHS Transformation Consultant)
• Patrick McGinley (Head of Costing and Service Line Reporting, NHS Trust)
• Gail Fortes Mayer (Associate Director of Strategic Commissioning, ICB)

The symposium brought National Health Service (NHS) leaders and life sciences experts together to discuss the future of healthcare, focusing on innovation, collaboration, and transformation. The event launched with an energising discussion on the life sciences sector’s crucial role in advancing patient care. This discussion identified several surmountable barriers to partnership, which highlighted the need for new ways of working from both the NHS and industry. The ambition to make real change was evident throughout.

NHS–industry collaboration

The symposium stressed the critical importance of NHS–industry synergy to drive access, innovation, and transformation. Whilst the NHS’s complexity and constant evolution pose challenges, these partnerships can greatly improve patient outcomes and care quality. Mtech Access offer training solutions specifically designed to help industry partners navigate and understand these complexities, paving the way for more effective collaborations.

Stakeholder engagement

Understanding key stakeholders and funding models emerged as essential to building successful partnerships and optimising patient outcomes. The symposium offered a valuable platform for NHS leaders and industry representatives to connect, share insights, and strengthen partnerships for the future.

Policy and leadership

Attendees highlighted the need for strong leadership to navigate volatile, uncertain, complex, and ambiguous (VUCA) environments. Public dialogue and promoting integrated care promotion were emphasised as essential strategies for navigating the complexities of the healthcare system.

Digital transformation and workforce expansion

Other central themes included digital transformation, balancing finances, workforce expansion, and nurturing talent. The discussion emphasised the need for reform in social care and action to meet the needs of an ageing population.

Integrated care

Integrated Care Partnerships, Integrated Care Boards (ICBs), and provider collaboratives were explored as mechanisms to improve patient outcomes, enhance productivity, reduce inequalities, and drive broader economic and social growth. These new structures present a unique opportunity for the life sciences industry to engage at scale and support the development of a more efficient, cohesive healthcare system.

Evidence-driven approach

The symposium emphasised the value of an evidence-driven approach to address population health needs and deliver proactive care. Leveraging data to improve planning and care delivery can help the NHS tackle its most pressing challenges. As an evidence-driven approach is at the heart of what we do at Mtech Access, it was encouraging to hear this advocated by both NHS and industry. We look forward to exploring how data can be best leveraged by our industry partners and the NHS to aid improved relationships and better outcomes for patients.

Challenges and opportunities

Our guest speakers also examined workforce shortages and the rise of artificial intelligence (AI) in healthcare. Industry partners were urged to drive rapid innovation and secure funding to support these advancements.

Partnering with NHS Integrated Care Systems

Successful engagement with NHS Integrated Care Systems (ICSs) requires a strategic, collaborative approach. Key takeaways for industry partners included:

Understanding ICS structures

Each ICS has its own unique priorities and challenges. Partners who spend time learning more about the local context and specific needs of the ICS they engage with will be better positioned to collaborate effectively.

Mtech Access’s training programmes help partners develop this understanding, making the ICS landscape easier to navigate.

Building strong relationships

Establishing relationships with key ICS stakeholders, including clinical leaders, commissioners, and decision-makers, is crucial. Building trust and showing a commitment to improving patient outcomes will set a strong foundation for success.

Aligning with NHS priorities

Tailoring your initiatives to the priorities of the NHS, such as improving outcomes, enhancing productivity, tackling inequalities, and supporting economic and social growth is essential. Customised proposals aligned with each ICS’s goals can make a meaningful impact.

Demonstrating value

Clearly communicating the value that your solutions offer, including clinical, economic, and operational benefits, is key. Evidence of successful implementations and measurable outcomes can reinforce your case for partnership.

Mtech Access experts in value communication and evidence can help you communicate your proposition in a way that will resonate with NHS decision-makers.

Collaborating on evidence-driven projects

Engaging in projects that use data to identify population needs and deliver proactive care is beneficial. An evidence-driven approach can help partners address NHS complexities and improve planning and care delivery.

Being flexible and adaptable

Given the rapidly evolving healthcare landscape, flexibility is essential. Industry partners should remain open to feedback and adapt to changing circumstances, including co-designing solutions with the ICS and other stakeholders.

Focusing on integrated care

Supporting initiatives that promote integrated care across all settings, fostering collaboration with various sectors and providers beyond the NHS.

The ‘triple win’

A ‘triple win’ approach emerged as a powerful framework for partnership. Focusing on solutions that deliver value across these three areas ensures initiatives are sustainable and impactful. This holistic approach not only improves patient care but also aligns with NHS goals and drives innovation within the life sciences sector.

In conclusion, the transforming healthcare symposium provided invaluable insights into the future of healthcare, emphasising the need for collaboration, innovation, and evidence-based strategies to enhance patient care and outcomes. With strong partnerships and Mtech Access’s support in understanding the structure and priorities of the NHS, both the NHS and life sciences sector can work together to overcome challenges and build a more effective, efficient healthcare system.

To fully capitalise on the insights and strategies from the transforming healthcare symposium, explore how Mtech Access can support your organisation’s journey through the NHS landscape. With services designed to make sense of policy shifts, navigate complex funding systems, and deepen your understanding of evolving healthcare structures, we can help you align your strategy with NHS priorities.

From interpreting key policy changes to understanding the financial systems that drive the NHS, our tailored solutions provide essential insights for effective engagement. Whether you’re looking to grasp the structures and decision-makers within ICBs and Primary Care Networks (PCNs), learn about prescribing pathways and budgets, or drive impactful service redesign, Mtech Access offer expert guidance every step of the way.

Connect with us to unlock opportunities for meaningful partnership with the NHS, support sustainable transformation, and advance patient care together. Email info@mtechaccess.co.uk to discuss our training and strategic consulting services.

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On 23rd September, the ABPI released an updated Code of Practice. Their last release was in 2021, and this latest update has been much anticipated. There are no track changes of what has been updated and so you will need to be proactive to learn what has changed, how it impacts your materials, and how fast you need to react.

We knew an update was coming, but we didn’t know precisely when. With >3,000 comments on their initial consultation (including from me!), the Prescription Medicines Code of Practice Authority (PMCPA) have done well to consider the views, publish the update this year, and end the uncertainty.

As far as timescales go, failure to comply with new requirements will not constitute a breach between 1st October 2024 (when the new code comes into effect) and the end of the year. However, from 1st January 2025, it will.

Updates to prescribing information (Clause 12)

As with previous iterations, prescribing information must be part of and easily accessible from promotional material. It can be challenging, however, to find a place for prescribing information and links or buttons to it within visually engaging materials. We have always found creative and compliant solutions for prescribing information placement in digital tools. The new code aims to provide new clarity and further options.

The PMCPA have communicated that Clause 12 has been completely re-written and, after the first sentence of 12.1 (which is identical), changes start emerging.

It is interesting that the sentence “The prescribing information must form part of the promotional material and must not be separate from it” is omitted in the new version of the code. Indeed, the new code goes as far as to say that digital material used for in-person meetings could have the prescribing information made available as a printed document (with the digital material referring directly to this). In the new version of the code, prescribing information can be separated from the material in certain circumstances.

Clause 12.1 sets out 3 scenarios in relation to promotional materials being used in the following contexts:

1. Printed material
2. Digital material accessed by a recipient on their own device
3. Digital material shown to a recipient in person on a company device

Focusing on digital materials, for those accessed by a recipient on their own device, the code allows companies to include prescribing information as text, by way of a clear and prominent, direct, single-click link.

For digital materials shown to a recipient in person on a company device, the code now allows for two further options. The first option is for a clear and prominent ‘quick response’ (QR) code with instructions to scan it for the prescribing information. The second option is to provide prescribing information in a printed document, which must be referred to in the digital material.

Using a QR code for prescribing information

The QR code was invented 30 years’ ago, and, in its most basic form, enables your smart device camera to detect a URL to which you can then navigate. QR codes are commonly used across marketing and promotion for many industries.

What seems to change with this QR option is onus of responsibility. If your audience doesn’t have a smart device (or they left it in another room, or their camera doesn’t work, or their battery life is low!) then there won’t be a way to access the prescribing information.

Will this constitute a breach? Will the QR code approach carry an additional risk, and will signatories embrace or reject this change? Ultimately, might your audience wish to access prescribing information but not be able to? If you think the QR option brings an answer of ‘maybe’, then perhaps consider another method in addition, such as a paper copy that is referred to in the digital material. On the positive side, the QR code enables the prescribing information to be hosted centrally, away from the promotional material, enabling updates to it that don’t necessarily mean an update to the promotional material itself. This is a useful change in the new code.

Wider ABPI Code changes and opportunities to learn more

Do note, there are many changes across the code. The changes to Clause 12 that I have highlighted are just one aspect of the update. You can read more about the new code here.

During October, there will be three ABPI-run on-demand webinars explaining the changes to the code: check the ABPI website for details.

To explore the impact of these changes on your promotional materials and the new options for placement of prescribing information, email info@mtechcaccess.co.uk.

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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.
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The power of real-world data

Real-world data offer a wealth of information that can significantly inform decision-making within healthcare systems. The right data, presented in the right way, can allow healthcare professionals to analyse performance trends, spot outliers, and identify areas for improvement. Whilst relevant datasets are sometimes publicly available or easily sourced through collaborative partnerships, these raw data are often in a format that is difficult to present or analyse. By transforming raw data into visual, easy-to-use dashboards, we can help field teams present compelling cases for change, ultimately strengthening partnerships with NHS customers.

The role of data visualisation

One of the key takeaways from the webinar was the critical role of data visualisation in making real-world data more accessible and impactful. Iain highlighted the advantages of using visual tools, such as Connected Insights dashboards, over traditional methods, such as Excel® spreadsheets or static data tables. Visuals not only capture attention more effectively but also aid in quicker decision-making by presenting complex data in a more digestible format.

For instance, heat maps/choropleth maps can illustrate variations in health outcomes across different regions, making it easier to identify areas that need attention.

Flexible tools for varied use cases

We can design Connected Insights dashboards to suit a wide range of use cases. Whether for promotional use by field teams, pre-call planning in business intelligence, or non-promotional roles by Medical Science Liaisons (MSLs) for example, these dashboards can be tailored to meet your specific needs and therapy area.

Iain emphasised that these tools are not just about presenting data but telling a story. We develop the narrative in collaboration with clients, ensuring the content aligns with their objectives and resonates with their audience. This narrative-driven approach helps to make the data more relevant and the interactions more meaningful.

Overcoming challenges with data integration

One of the challenges of working with real-world data is their disparate nature. Data can come from various sources, appear in different formats, or be available at varying levels of granularity. We have developed strategies to overcome these challenges, such as aggregating data from multiple sources into a cohesive view and testing the dashboard’s effectiveness with NHS Associates before full deployment.

Iain also addressed the importance of understanding the regulatory landscape and navigating compliance challenges. By engaging with NHS Associates and incorporating their feedback, we can ensure that the tools that we develop not only meet technical requirements but also resonate well with NHS stakeholders.

Explore how you can use real-world data and data visualisation

Iain and I concluded the webinar with an open invitation to healthcare organisations, to collaborate with us to explore how real-world data can enhance their market access strategies. Iain emphasised the positive feedback that we’d received from clients who had already implemented these tools, and encouraged attendees to start a conversation about how we can help them leverage real-world data in their interactions with NHS customers.

In an era where face time with healthcare professionals is limited, making the most of every interaction is essential. With the right tools and data-driven insights, organisations can engage more effectively, drive change, and ultimately improve patient outcomes.

For those interested in exploring these possibilities further, we offer a wealth of expertise and are ready to collaborate on developing solutions tailored to your needs. Whether you have a clear idea or just the seed of one, now is the time to start the conversation. Email info@mtechaccess.co.uk to explore this further with Iain and myself.

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