Welcome to Reimbursement Pathways for Psychedelic Therapies, the podcast that investigates how psychedelics become reimbursed care.

I’m Floris Wolswijk, project manager at Delphi and founder of Blossom, and I'm on a journey to investigate how we can get psychedelics to become a part of mainstream healthcare.

Each month, I'll interview health economists, payers, drug developers, and policy architects who are shaping tomorrow's market access rules.

We'll investigate the clinical evidence, access pathways, and the healthcare systems that need to implement psychedelics.

If you research psychedelics, work in policy or reimbursement, or are just curious about this journey, then subscribe to this podcast on Spotify, Apple Podcasts, or wherever quality podcasts are found.

New episodes drop every second Wednesday.

Subscribe now and be in a room when reimbursement history is written.

Welcome to the final chapter of our series on psychedelic therapies in Europe. This episode moves beyond the regulatory and reimbursement pathways discussed in previous chapters to present critical observations from various experts.

First, Martin Gisby from Magnetar Access shares his perspective on commercial strategies and reimbursement. He highlights the importance of focusing on smaller patient populations for effective Health Technology Assessments (HTAs) and market access in Europe.

Then, Floris Wolswijk from Blossom will discuss capacity constraints in the Netherlands, emphasizing the need for a strategic plan to meet potential demand.

Josh Hardman of Psychedelic Alpha analyses the broader European context, stressing the importance of proactive engagement between stakeholders.

Tadeusz Hawrot from PAREA draws on the history of HIV/AIDS advocacy to provide future mental health advocacy strategies.

Finally, Viktor Chvátal and Sumudu Gouri Boyina from PsychedelicsEUROPE use the Czech Republic as a case study to illustrate the interaction between national and EU-level initiatives.

The episode highlights the complex landscape of integrating psychedelic therapies into European healthcare systems and the need for continued strategic collaboration among all stakeholders.

(00:00) Introduction to Psychedelic Therapies in Europe

(00:21) Critical Observations from Collaborators

(02:23) Martin Gisby on Commercial Strategy

(15:36) Future of Psychedelic Reimbursement in The Netherlands

(28:04) Market Access Challenges and Opportunities in Europe

(36:12) Lessons from the HIV Movement for Mental Health Advocacy

(43:38) Advancing Reimbursement: Focus on the Czech Republic

(50:02) Conclusion and Final Thoughts

In the penultimate episode of our series on the psychedelic therapy landscape, we explore the practical aspects of reimbursement for psychedelic therapies across Europe.

We cover nine different potential pathways, from discussing standard national reimbursement pathways and their limitations to examining modified assessment methods. These include private insurance care, out-of-pocket payments, innovative alternative access pathways, charity-based services, pre-marketing authorisation access, underground use, and cross-border healthcare.

We highlight the challenges, opportunities, and necessary adaptations within healthcare systems to make these emerging treatments widely available to patients.

(00:00) Introduction to Psychedelic Therapy Access

(02:51) Challenges in Standard Reimbursement Pathways

(09:04) Modified National Reimbursement Pathways

(17:42) Private Insurance and Out-of-Pocket Payments

(25:30) Innovative Alternative Access Pathways

(34:00) Charity and Philanthropy-Based Care Services

(39:58) Pre-Marketing Authorisation Access

(44:13) Underground and Unregulated Use

(49:50) Cross-Border Healthcare and Medical Tourism

(51:52) Conclusion and Future Directions

In Chapter 9 of our series on psychedelic therapies and reimbursement, we discuss the critical challenge of ensuring equitable access. With psychedelic therapies nearing approval in Europe, disparities in access based on income, schedule flexibility, and healthcare connections are evident.

This episode highlights the underrepresentation of ethnic minorities, immigrants, and economically disadvantaged groups in clinical trials. We explore financial, cultural, and geographical barriers, examining regulatory challenges, patient selection criteria, and the need for culturally competent care.

Practical solutions, policy recommendations, and insights from experts Sergio Perez Rosal, Monnica T. Williams, and Sonya Faber are presented to promote inclusive access and address mental health disparities among marginalised populations in Europe.

(00:00) Introduction to Equitable Access in Psychedelic Therapies

(02:12) Current Disparities in Access

(03:08) Representation Issues in Clinical Trials

(04:50) Socioeconomic Barriers to Access

(06:04) Cultural and Linguistic Barriers

(07:42) Ethical Considerations in Patient Selection

(10:41) Practical Solutions and Policy Recommendations

(14:30) Focus on Marginalised Populations

(20:50) Specific Barriers and Strategies for Improvement

(29:26) Conclusion and Future Directions

In the eighth episode, we take the opposite perspective from our discussion in the last episode on the challenges surrounding psychedelic therapies in Europe. This time, we focus on practical solutions for integrating these therapies into European healthcare systems, presented in Chapter 8: Solutions and Recommendations.

We explore strengthening clinical evidence, enhancing economic evaluations, improving regulatory processes, and building treatment infrastructure. Key recommendations are made for various stakeholders including developers, regulators, and insurers. Specific strategies for different countries such as Germany, the UK, the Netherlands, and the Czech Republic are also discussed, alongside insights from other pioneering regions like Australia, Switzerland, the United States, and Canada.

The episode emphasises the importance of collaboration and adaptive approaches for the successful integration of psychedelic therapies, aiming for their initial rollout and long-term success.

(00:00) Introduction to Psychedelic Therapies in Europe

(01:43) Clinical Evidence and Recommendations for Drug Developers

(08:10) Regulatory and Evaluator Recommendations

(10:48) Economic Evaluation Strategies

(16:55) Regulatory Pathways and Policy Reforms

(22:53) Infrastructure and Implementation Approaches

(30:31) Societal and Ethical Initiatives

(33:51) Country-Specific Recommendations

(53:18) Conclusion and Future Directions

In this episode, we explore Chapter 7: Challenges and Barriers to Reimbursement for psychedelic therapies across Europe.

We discuss the complex process of getting these treatments approved and covered by healthcare systems, focusing on the unique issues that arise from their combined use of drugs and structured psychotherapeutic support.

Key points include clinical trial design limitations, evidence challenges, economic evaluation complexities, regulatory hurdles, and societal concerns. Interviews with stakeholders highlight the diverse obstacles at each stage of the process, setting the stage for solutions to be discussed in the next chapter.

(00:00) Introduction to Reimbursement Challenges

(02:09) Clinical Evidence Challenges

(03:22) Trial Design Limitations

(09:49) Economic Evaluation Challenges

(15:44) Regulatory and Policy Barriers

(21:14) Infrastructure and Implementation Challenges

(23:31) Societal and Ethical Challenges

(25:42) Stakeholder Resistance and Misalignment

(27:05) Conclusion and Next Steps

In this episode, we move into Chapter 6: Mapping the Reimbursement Landscape in Europe.

This chapter explains how the funding systems work in various European countries, highlighting the challenges for new therapies, particularly psychedelics. We discuss the reimbursement processes in Germany, the UK, the Netherlands, and the Czech Republic, detailing how each system handles pricing, national evaluations, and implementation.

The episode also covers common elements like pricing regulations, cost-containment strategies, and cooperation at the EU level. Finally, we explore the specific hurdles psychedelic therapies face due to their unique drug-plus-therapy model and how these might be overcome to ensure patient access.

(00:00) Introduction and Overview

(00:12) Mapping the Reimbursement Landscape in Europe

(01:52) General Reimbursement Pathways for Pharmaceuticals

(03:34) Pricing Regulations and Affordability Frameworks

(05:00) Cost-Containment Strategies and Budgetary Pressures

(06:28) Time to Market Access

(09:20) Comparative Analysis of Target Countries

(09:34) Germany: Reimbursement and Implementation

(12:00) United Kingdom: Reimbursement and Implementation

(15:08) The Netherlands: Reimbursement and Implementation

(18:26) Czech Republic: Reimbursement and Implementation

(21:17) Conclusion and Next Steps

In Chapter 5, we examine the essential process of securing patient access to psychedelic therapies post-regulatory approval by working with Payer and Health Technology Assessment (HTA) bodies.

The chapter discusses the importance of demonstrating clinical efficacy through direct comparisons and indirect comparisons when head-to-head trials aren't feasible. It explains how different European countries have unique HTA processes, such as Germany, the UK, the Netherlands, and the Czech Republic, each with distinct requirements for clinical effectiveness and cost-effectiveness.

The episode also covers critical components of health economic models, including cost-effectiveness analysis (CEA), cost-utility analysis (CUA), and budget impact analyses (BIAs), and addresses the importance of early engagement with HTA bodies.

Additionally, innovative reimbursement models like outcomes-based agreements and managed entry agreements are examined as potential ways to manage the uncertainties and high upfront costs associated with psychedelic therapies.

(00:00) Introduction to Psychedelic Therapies and Regulatory Approval

(00:21) Understanding Payer and Health Technology Assessments (HTA)

(01:57) HTA and Payer Evidence Requirements

(02:02) Clinical Efficacy and Comparative Trials

(03:21) Indirect Comparisons and Their Challenges

(05:53) Subgroup Analyses in Psychedelic Therapies

(08:31) Cost-Effectiveness and Health Economic Modelling

(13:37) Country-Specific Economic Evaluations

(18:00) Budget Impact and Affordability

(20:48) Engaging with HTA Bodies

(28:28) Innovative Reimbursement Models

(30:04) Conclusion and Next Steps

In this episode about Chapter 4, we focus on the Clinical Development of Psychedelic Therapies. We'll explore the fast-evolving clinical landscape, especially in the US, and compare it with Europe where regulatory and clinical frameworks are still forming.

Key topics include designing and conducting clinical trials, addressing challenges like functional unblinding and comparator selection, and the crucial role of psychotherapy in these treatments. We also discuss regulatory considerations, patient selection, the importance of long-term efficacy, safety and tolerability, and the role of real-world evidence.

Lastly, we'll highlight the necessity of collaboration with regulators, payers, and patient advocacy groups to ensure the approval and accessibility of these therapies.

(00:00) Introduction to Clinical Development of Psychedelic Therapies

(02:01) Designing Clinical Trials for Psychedelic Therapies

(07:40) Comparator Selection in Psychedelic Trials

(14:12) Integration of Psychotherapy in Psychedelic Treatments

(20:16) Regulatory Considerations for Psychedelic Research

(21:36) Patient Selection and Inclusion Criteria

(27:15) Clinical Evidence Generation and Efficacy Outcomes

(35:02) Safety and Tolerability in Psychedelic Trials

(37:21) Real-World Evidence and Postmarketing Surveillance

(38:57) Collaboration with Stakeholders During Development

(42:21) Conclusion and Next Steps

In this episode, we explore Chapter 3 of our report on psychedelics and reimbursement, focusing on the drug development and reimbursement pathway in Europe.

We cover the journey from drug discovery and preclinical development through clinical trials, regulatory approval, and the negotiation of pricing and reimbursement. Special considerations for controlled substances and psychedelic therapies are examined in depth.

Finally, we introduce health technology assessments and strategies for achieving local market access and patient uptake.

(00:00) Introduction to Drug Development and Reimbursement

(00:37) Drug Discovery and Preclinical Development

(07:28) Clinical Trial Phases Explained

(14:15) Regulatory Approval Process

(22:45) Health Technology Assessment (HTA)

(31:41) Pricing and Reimbursement Negotiations

(41:15) Local Market Access and Uptake

(47:27) Key Stakeholders in European Psychedelic Medicine

(51:18) Conclusion and Next Steps