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Areas of Collaboration

We are laser-focused on advancing market access and reimbursement for psychedelic therapies. Our collaboration targets include:

• Reimbursement Pathway Evaluation: Engage with system stakeholders to assess country-specific pathways.
• Framework Design & Validation: Develop outcomes-based reimbursement frameworks and agreements.
• Health Economic Analysis: Quantify the direct and indirect benefits of therapies for key conditions.
• Stakeholder Alignment: Coordinate evidence generation needs and offer strategic guidance to developers.
• HTA & Payer Engagement: Optimize HTA processes and methodologies through active payer collaboration.
• Multi-disciplinary Forums: Participate in projects and forums dedicated to psychedelic access.
• Funding & Billing Frameworks: Innovate funding strategies and billing systems for multi-component therapy delivery.

Below is our detailed external roadmap for advancing access to psychedelic therapies in Europe. This strategic vision outlines seven essential workstreams that support both immediate action and long-term planning. Each workstream includes an introduction that explains its purpose, along with clear details on our offerings, priorities, key stakeholder groups, and timelines. While we are prepared to drive several initiatives, we recognise that some steps will require active collaboration with developers, research experts, and policy makers.

Targeted Strategic Consulting for Developers

We offer direct, client-focused advisory services to help developers navigate Europe’s complex market access landscape. Our deep regulatory insights and market expertise empower companies to prepare for successful product launches and regulatory engagements.

What We Offer:

• Bespoke advisory on market entry strategies and regulatory navigation.
• Development of country launch strategy memos, HTA preparedness workshops, evidence generation planning, and competitive analysis.

Immediate Priorities:

• Deliver actionable strategies that integrate market access planning with reimbursement insights.
• Bundle consulting with pathway mapping and framework development for a comprehensive support package.

Key Stakeholders: Developers, clinical research organisations, and medical affairs teams expanding into Europe.

Timeline: Available immediately through short-term, intensive engagements (typically 2–4 months).

Health Economic Analysis (Health System)

Our analytical approach to building robust, evidence-based economic models forms the backbone of this initiative. By collaborating with leading research groups, we generate data-driven insights that inform policy decisions and stimulate investment in psychedelic therapies.

What We Offer:

• Co-development of economic modelling frameworks for conditions such as treatment-resistant depression and PTSD.
• Joint workshops and open-source model platforms to encourage collaborative analysis.

Immediate Priorities:

• Establish a pipeline of health economic analyses to guide policy makers and funding bodies.
• Engage priority research teams and academic experts across Europe.

Key Stakeholders: Health economists, academic experts, philanthropic organisations, and policy makers.

Timeline: This initiative can commence immediately, laying a foundation that will be refined as more clinical data becomes available.

Country Pathway Deep Dives & Pilot Pathways

Mapping out practical reimbursement routes, this initiative identifies key pilot projects and reimbursement pathways in priority European markets. It aims to provide actionable insights and early strategic direction to ease the transition from clinical research to market access.

What We Offer:

• Tailored pathway reports and policy intelligence briefings on early access opportunities.
• Strategy memos for piloting projects supported by philanthropic initiatives.

Immediate Priorities:

• Deliver actionable, country-specific insights over a 10–12 week period.
• Initiate early discussions with regional health authorities and public payers.

Key Stakeholders: Developers, ecosystem actors, philanthropic organisations, and regional health authorities.

Timeline: Ready to launch immediately, independent of Phase III outcomes.

Alliance Building & Capacity Development

Uniting diverse stakeholders, our goal is to forge a coordinated European alliance that streamlines collaboration and advocacy across the psychedelic therapy ecosystem. This initiative will facilitate shared best practices and strengthen collective impact.

What We Offer:

• Organisation of regular stakeholder meetings and creation of shared workstreams (e.g., economic modelling, training standards, and policy briefs).
• Development of governance frameworks to support ongoing collaboration.

Immediate Priorities:

• Establish a clear alliance identity and mission to align diverse interests.
• Mobilise stakeholder support through in-kind contributions and part-time coordination.

Key Stakeholders: Non-profit organisations, policy think tanks, patient advocacy groups, and philanthropic funders.

Timeline: Coordination and initial alliance formation should begin immediately to build strategic momentum.

Reimbursement Frameworks & Models

In anticipation of market authorisation, we are focused on designing adaptable reimbursement frameworks that meet the needs of diverse European healthcare systems. This approach ensures that economic evaluations are robust, evidence-based, and fit for purpose.

What We Offer:

• Facilitated workshops and whiteboard sessions to design innovative reimbursement models, including staged and outcomes-based approaches.
• Draft framework development with country-specific adaptations validated through stakeholder engagement.

Immediate Priorities:

• Initiate framework discussions once robust clinical data from Phase III studies is available.
• Collaborate with HTA experts and economic think tanks for technical rigour.

Key Stakeholders: Market access leaders, policy experts, philanthropic organisations, and healthcare innovation think tanks.

Timeline: Work is ideally timed to begin after Phase III studies provide a robust evidence base.

Funding & Billing Infrastructure Design

This initiative lays the groundwork for real-world reimbursement by developing practical billing and funding standards that align with existing healthcare systems. It focuses on creating an infrastructure that supports the implementation of psychedelic therapies.

What We Offer:

• Drafting of billing standards, including proposals for procedure codes and diagnosis-related group mappings.
• Stakeholder interviews with clinics, digital therapy providers, and public payers to inform pilot proposals.

Immediate Priorities:

• Begin preliminary design work in insurance-based markets.
• Develop pilot templates adaptable to evolving clinical evidence.

Key Stakeholders: Hospital systems, public payers, clinics, and digital health providers.

Timeline: Preliminary groundwork can commence immediately, with full-scale design following robust Phase III evidence.

HTA Innovation & Policy Engagement

We are committed to transforming health technology assessment processes to ensure that psychedelic therapies are evaluated fairly and comprehensively. Our efforts aim to shape policy frameworks and evaluation methods that reflect the unique value of these therapies.

What We Offer:

• Contributions to HTA reform consultations and co-branded policy memos.
• Organisation of HTA methodology workshops to engage academic experts and policy makers.

Immediate Priorities:

• Initiate early dialogues with HTA bodies and policy experts to explore necessary reforms.
• Develop collaborative responses to ensure evaluation methods are fit for purpose.

Key Stakeholders: Regulatory bodies, academic experts, umbrella organisations, and policy advisory groups.

Timeline: Early groundwork should start now, with more intensive engagement following Phase III studies.