Stakeholder Consultation

This appendix documents the structured consultation process undertaken between September 2024 and February 2025 to gather insights from key stakeholders across the European healthcare landscape regarding reimbursement pathways for psychedelic therapies.

The process involved in‑depth interviews with over 25 stakeholders representing diverse perspectives within the healthcare ecosystem.

The consultation followed a dual‑track approach, combining standardised discussion topics applicable across all stakeholder groups with targeted questions tailored to specific stakeholder expertise. This methodology enabled broad coverage of systemic issues and deep exploration of domain‑specific challenges and opportunities.

Initial written consultations with 15 stakeholders helped shape the research questions and identify key focus areas, while subsequent interviews provided detailed insights into specific aspects of reimbursement pathways and implementation challenges.

This appendix is organised into three main sections:

• General Discussion Guide: Presents the core questions and themes explored with all stakeholders, focusing on fundamental challenges and opportunities in psychedelic therapy reimbursement.
• Stakeholder‑Specific Guides: These guides detail the specialised question sets developed for different stakeholder groups, including payers, drug developers, healthcare providers, and patient advocates.
• Stakeholder Overview: Provides an anonymised summary of the consulted stakeholders, their roles, and their geographical distribution while maintaining confidentiality commitments.

The insights gathered through these consultations have been instrumental in developing the recommendations presented in this report and understanding the practical challenges of implementing psychedelic therapies within European healthcare systems.

14.2.1 General Discussion Guide

The general discussion guide was structured to explore key aspects of psychedelic therapy reimbursement across European healthcare systems. This standardised component ensured consistent coverage of fundamental topics while allowing flexibility to accommodate different stakeholder perspectives and country‑specific contexts.

Core Discussion Areas:

Reimbursement Pathways

• Exploration of potential routes for reimbursement within national healthcare systems
• Comparison of drug versus psychotherapy reimbursement mechanisms
• Analysis of hybrid models for combined drug‑therapy interventions
• Investigation of private insurance opportunities and alternative funding routes

Value Assessment

• Clinical value for patients and healthcare systems
• Broader societal benefits, including economic and social impacts
• Quality of life improvements and functional outcomes
• Cost‑effectiveness considerations and resource utilisation

Evidence Requirements

• Clinical trial design and endpoint selection
• Health economic evidence needs
• Real‑world evidence expectations
• Comparative effectiveness requirements

Implementation Considerations

• Infrastructure requirements and funding mechanisms
• Healthcare professional training needs
• Quality assurance and safety monitoring
• Integration with existing mental health services

Access and Equity

• Barriers to equitable access
• Solutions for underserved populations
• Geographic and socioeconomic considerations
• Patient selection criteria and treatment protocols

Stakeholder Engagement

• Role of patient advocacy groups
• Professional association involvement
• Political and regulatory influences
• Healthcare provider perspectives

Interview Structure

The discussion guide was designed to be adaptable while maintaining a focus on core themes. Each interview began with an introduction explaining the project's objectives and confidentiality provisions, followed by targeted questions drawn from the guide based on the stakeholder's expertise and role. Key discussion points were prioritised to ensure critical topics were covered within time constraints. Follow‑up questions were used to explore emerging themes and country‑specific considerations. The guide provided a framework for semi‑structured discussions, allowing for both systematic data collection and the emergence of unexpected insights. This approach enabled comprehensive coverage of reimbursement challenges while remaining responsive to stakeholder expertise and local context.

14.2.2 Stakeholder‑Specific Guides

The general discussion guide was adapted to create specialised question sets tailored to different stakeholder groups and geographical contexts. This customisation ensured relevant, in‑depth exploration of issues specific to each stakeholder's expertise while maintaining consistency in core themes across interviews.

Stakeholder Categories and Adaptations

Payers and HTA Bodies

• Detailed exploration of evaluation frameworks and evidence requirements
• Focus on cost‑effectiveness methodologies and budget impact considerations
• Questions about innovative payment models and risk‑sharing agreements
• Country‑specific reimbursement processes and decision‑making criteria

Drug Developers and Industry

• Clinical trial design and evidence generation strategies
• Regulatory pathway considerations
• Market access planning and pricing strategies
• Infrastructure development and implementation challenges

Healthcare Providers and Clinics

• Practical implementation considerations
• Training and certification requirements
• Patient selection and treatment protocols
• Reimbursement processes at the clinic level
• Infrastructure and resource needs

Patient Advocacy Groups

• Access and equity considerations
• Patient needs and preferences
• Barriers to treatment
• Social and cultural considerations

Geographic Customisation

Questions were further tailored to reflect specific national contexts:

• Germany: G‑BA and IQWiG requirements; AMNOG process considerations; sickness fund perspectives; regional implementation variations
• United Kingdom: NICE evaluation criteria; NHS integration challenges; regional differences across England, Scotland, and Wales; independent regulatory considerations
• Netherlands: ZiN requirements; insurance system dynamics; progressive drug policy implications; integration with existing mental health services
• Czech Republic: SÚKL processes; healthcare system capacity; training and certification requirements; infrastructure development needs

Additional Considerations

The stakeholder‑specific guides maintained flexibility to explore emerging themes while ensuring coverage of key topics relevant to each group. Cross‑cutting issues were approached from different angles depending on the stakeholder's perspective and role in the healthcare system. The interview and question selection duration were adjusted based on the stakeholders' availability and expertise, with priority given to areas where participants could provide unique insights or decision‑making authority.

14.2.3 Stakeholders Consulted

Czech Republic

We extend special thanks to Viktor Chvátal and Sumudu Gouri Boyinova from PsychedelicsEUROPE for their invaluable assistance in conducting stakeholder interviews and providing expert insights into the Czech healthcare landscape.

• Clinical Practice and Implementation: Senior leadership of a pioneering psychedelic therapy clinic, with extensive experience delivering ketamine therapy within existing regulatory frameworks, provided a unique perspective on practical implementation challenges and successful clinic operation models.
• Payer and Regulatory Perspective: A senior expert with extensive experience in both governmental drug control and the insurance sector offered unique perspectives on pricing mechanisms, reimbursement pathways, and regulatory requirements within the Czech healthcare system.
• Investment and Philanthropy: A senior representative from a philanthropic investment group focused on mental health innovations provided expertise in funding and scaling healthcare initiatives along with strategic perspectives on market development and implementation challenges.
• Market Access Expertise: Two senior market access consultants with over 20 years of combined experience, possessing extensive knowledge of bringing novel treatments to market in the Czech Republic and direct experience with both payers and psychedelic therapy providers, provided deep insight into VZP processes and requirements.

This diverse group of Czech stakeholders provided comprehensive insights into the practical, financial, and policy‑related aspects of implementing psychedelic therapy within the Czech healthcare system. Their combined expertise spans clinical practice, healthcare policy, reimbursement mechanisms, and market access strategies.

The Netherlands

• Non‑profit and Education Sector: Three leaders from a prominent Dutch non‑profit organisation dedicated to psychedelic research and clinical education brought together diverse expertise spanning two decades of pharmaceutical industry experience, digital mental healthcare innovation, and academic research, providing comprehensive insights into implementation pathways within the Dutch healthcare system.
• Market Access and Healthcare Policy: A senior market access consultant with two decades of experience working with major European pharmaceutical companies offered detailed perspectives on market access strategies and health technology assessment challenges specific to psychedelic therapies in the Netherlands.
• Payer and Mental Health Services: A former payer representative with thirty years of experience in healthcare procurement and mental health service commissioning provided valuable insights into value‑based payment systems and reimbursement mechanisms in the Dutch healthcare landscape.
• Mental Health Network Leadership: The founder of a nationwide mental health professional network comprising hundreds of practitioners shared expertise on mental healthcare delivery systems, reimbursement processes, and ongoing research into psychedelic therapy implementation.
• Clinical Implementation: Special acknowledgement to Ingmar de Gooijer, founder of Magnolia Health, who provided practical insights from operating both reimbursed ketamine therapy services and legal psilocybin truffle treatments in clinical settings, as well as expertise in healthcare communications and public affairs.
• Healthcare Authority Perspective: A representative from the National Health Care Institute (Zorginstituut Nederland) with specific experience in the health economics of psychedelics offered crucial insights into basic healthcare package inclusion criteria and evaluation processes.
• Academic and Clinical Research: A senior academic leader combining expertise in psychiatry and epidemiology, with active involvement in multiple psychedelic trials and governmental advisory roles, provided perspective on the scientific and policy aspects of psychedelic therapy implementation.

This comprehensive group of Dutch stakeholders offered multi‑faceted insights into the implementation and reimbursement pathways for psychedelic therapies within the Netherlands. Their combined expertise encompasses regulatory frameworks, clinical practice, research, and healthcare policy, providing a thorough understanding of the opportunities and challenges within the Dutch healthcare system.

Germany

• Academic and Clinical Leadership: A senior professor of psychiatry at a major German university, combining expertise in neurology, psychiatry, psychotherapy, and sleep medicine, provided comprehensive insights into mental healthcare delivery, reimbursement pathways, and the practical implementation of ketamine therapy within the German healthcare system.
• Clinical Practice and Non‑profit Sector: A former executive of Germany's pioneering psychedelic medicine clinic, a non‑profit organisation leader with an extensive background in healthcare, offered valuable perspectives on the practical implementation of innovative treatments within existing regulatory frameworks.
• Research and Development Expertise: A senior researcher with extensive experience across pharmaceutical development, clinical trials, and regulatory affairs provided perspectives on innovation pathways, equity considerations, and regulatory requirements for novel therapies in the German context.
• Market Access and Reimbursement Expertise: A senior consultant from a leading German market access consultancy specialising in AMNOG processes and pharmaceutical reimbursement offered detailed insights into benefit assessment procedures, price negotiations with statutory health insurance funds, and strategic approaches to securing optimal reimbursement for innovative therapies.

This select group of German stakeholders provided deep insights into the academic, clinical, regulatory, and market access aspects of implementing psychedelic therapies within Germany. Their combined expertise spans clinical practice, research and development, healthcare system implementation, and reimbursement pathways.

United Kingdom

• Healthcare Policy and Procurement: A former senior executive at NHS England with two decades of global pharmaceutical experience brought unique insights from their role in pharmaceutical industry negotiation.
• Patient Advocacy: The co‑founder of a psychedelic patient advocacy organisation, combining lived experience from clinical trials with active community building and advocacy work, provided crucial perspectives on patient needs and engagement within the UK healthcare system.
• Industry Analysis: Special acknowledgement to Josh Hardman, founder of Psychedelic Alpha, who contributed valuable market intelligence and industry insights through his extensive work in psychedelic sector analysis, commentary, and advisory roles with venture funds.
• Commercial Leadership: A former Chief Commercial Officer and current board‑level advisor to multiple life sciences companies offered strategic insights into connecting traditional pharmaceutical approaches with emerging psychedelic therapeutics.
• Clinical Practice and Facilitation: Two experienced psychedelic facilitators and guides—one with an extensive background in mental health nursing and ceremonial contexts, and another with over three decades of psychotherapy practice—offered valuable perspectives on the practical implementation and therapeutic aspects of psychedelic therapy within clinical settings.

This group of UK stakeholders provided comprehensive perspectives on the implementation pathways for psychedelic therapies within the British healthcare system. Their combined expertise spans healthcare policy, patient advocacy, market analysis, commercial strategy, and clinical practice.

Europe

• Health Technology Assessment: A senior European Medicines Agency expert with extensive experience in health economic modelling and evidence assessment, bringing insights from multiple European institutions—including NICE, the European Commission's Joint Research Centre, and national HTA bodies—offered valuable perspectives on evaluation frameworks for novel therapies across EU member states.
• Policy and Advocacy: Special acknowledgement to Tadeusz Hawrot, founder and Executive Director of the Psychedelic Access and Research European Alliance (PAREA), who contributed fifteen years of EU‑level policy experience and expertise in establishing healthcare advocacy coalitions.
• Public Affairs and Strategic Communications: Special thanks to Viktor Chvátal and Sumudu Gouri Boyinova of PsychedelicsEUROPE, who provided crucial insights into EU policy frameworks and stakeholder engagement strategies.

This group of EU‑level stakeholders offered strategic insights into the broader European implementation landscape for psychedelic therapies. Their combined expertise in health technology assessment, policy advocacy, and public affairs provides a valuable understanding of the opportunities and challenges in harmonising approaches across EU member states.