Mental health ecosystem
We are helping build a mental health ecosystem that supports care models of the future and promotes access and health equity over the long term.
We need a clinical and cultural shift in mental health care. Novel therapies, backed by rigorous evidence, are a first step. But new, effective care pathways that make these therapies accessible to all who can benefit can only emerge from a collaboration of mental health companies, health systems, and payers. We are joining forces with health innovators to create this ecosystem. Three areas are of particular importance to us in doing so:
- Affordability and reimbursement strategy – Our aspiration is to ensure that COMP360 psilocybin therapy, if approved, is made accessible to as many patients who might benefit as possible.
- Equitable access – We work with experts to better understand the experience socially disadvantaged populations have of mental health care and aim to ensure broad access to COMP360 if regulatory approval is obtained.
- Health systems strengthening – We work with health systems providers and innovators to accelerate research for mental health, through our own and independent research programmes, and to prepare the effective delivery of COMP360 psilocybin therapy at scale.
Affordability and reimbursement strategy
Our aspiration is to ensure that COMP360 psilocybin therapy, if approved, is made accessible to as many patients who might benefit as possible. We therefore collaborate with payers, regulatory agencies, and government bodies to work toward the approval and reimbursement of therapies that are safe, effective, and that provide a therapeutic and economic benefit over existing treatments.
Regulatory approval does not guarantee patient access to novel therapies. We actively seek advice from experts across the mental health ecosystem to attain coverage and reimbursement of our therapies.
Coalition to apply for a category III CPT tracking code through the American Medical Association (AMA)
We aspire to create a streamlined, viable coding and reimbursement framework for providers and payers in the US. We understand that the process for obtaining a new procedure reimbursement code is complex, resource intensive, and can take several years. With this in mind, we are working with manufacturers, coding experts, and not-for-profit organisations to gain approval of a new tracking code that facilitates reimbursement and captures our unique clinical approach that combines COMP360 with psychological support.
Association for Behavioral Health and Wellness (ABHW)
COMPASS is a Silver Corporate Partner of ABHW, the US national voice for payers managing behavioural health insurance benefits. We actively engage with ABHW leaders to gain an understanding of the US payer perspective through board presentations, round table discussions, policy summits, and conferences.
America’s Health Insurance Plans (AHIP)
AHIP is a US national association whose members provide health care coverage, services, and solutions to hundreds of millions of Americans. It is committed to market-based solutions and public-private partnerships that make coverage more affordable and accessible for all. We engage the AHIP network of payers and health systems to educate leaders on our clinical trial research, investigational COMP360 psilocybin therapy, and our unique clinical model through webinars, small group discussions, and conferences.
Coalition to Transform Advanced Care (C-TAC)
C-TAC is a non-profit, nonpartisan organisation that works with regulators, legislators, and payers to develop policies focused on equitable, comprehensive, and accessible care for patients and caregivers facing serious illness. Through our work with C-TAC, we seek to better understand how we can improve access to our therapies, subject to regulatory approval, for underserved and under-resourced people experiencing serious illness.
American Psychiatric Association Foundation (APAF)
We are members of APAF’s Corporate Alliance. The APAF Foundation aims to address critical mental health needs through community-based programmes, fellowships, awards, and grants.
When making decisions about the authorisation, reimbursement, pricing, and access of new medicines, healthcare payers look for the relative effectiveness of a new medicine compared with the current standard treatment. Clinical trials, focused on assessing the safety and efficacy of a new treatment, may not provide sufficient evidence of relative effectiveness. This is why we are working to generate robust and relevant real-world evidence (RWE) (i.e., clinical, economic, and patient-reported outcomes collected from routine clinical practice, rather than clinical trials) that payers need to make informed decisions about the reimbursement of our therapies, thereby seeking to ensure broad patient access.
RWE research priorities
COMPASS participates in several RWE research initiatives intended to deepen our understanding of unmet needs in mental health. In 2021, we sponsored an observational study with ICON to address knowledge gaps about treatment patterns and healthcare utilisation in real-world practice for TRD patients. The survey involved 225 healthcare providers and 1,125 patients receiving commonly utilised, currently available treatments, in Germany, France, and the United Kingdom. Learnings from this research and other ongoing RWE projects could inform the development of treatment guidelines for TRD.
COMPASS is a founding member of the GetReal Institute (GRI). The GRI brings together stakeholders to drive the adoption of tools, methods and best practices in the generation and use of RWE for better health care decision-making in Europe. The organisation seeks to reduce barriers to the use of secondary data sources and to bridge the gap between randomised clinical trials and RWE. COMPASS team members sit on steering committees of GetReal initiatives. Learn more here.
Our Patient Access and Health Systems Advisory Board is comprised of stakeholders from patient advocacy groups, healthcare providers, health systems, payors, and ethicists. The Board meets periodically to look at issues around integrating COMP360 psilocybin therapy, if approved, into health systems.
We work with experts to better understand the experience socially disadvantaged populations have of mental health care and aim to ensure broad access to COMP360 if regulatory approval is obtained.
people surveyed to understand the needs of marginalised groups
Grady Trauma Project
As part of our work to understand the context of mental health for different patient populations, we provided an unrestricted educational grant to the Grady Trauma Project in Atlanta, Georgia. This project focused on exploring the mental health care needs and attitudes towards psychedelic therapy in marginalised and underprivileged communities. 314 people were engaged through surveys. The goal was to develop culturally informed psilocybin therapy for depression and other mental health conditions. Learn more here.
Minorities tend to be underrepresented in clinical trials. A review of psychedelic literature found that 82.3% of participants in psychedelic studies were non-Hispanic White.1 This lack of diversity is a barrier to understanding the safety and efficacy of novel therapies across population subgroups, which is crucial to reducing healthcare disparities and increasing health equity. We are working to change this and increase minority representation by seeking to understand the barriers to entry to clinical trials for both patients and therapists from diverse backgrounds. We believe this will lead to better science and patient outcomes.
Our therapist training is informed by an advisory group of practitioners that have experienced and understand the realities of marginalised communities. This group has been instrumental in enhancing our psychological support model (the support patients receive in our clinical trials of COMP360 psilocybin therapy), shaping our therapist training programme, and developing cultural humility training for our therapists, trainers, and internal team. Our advisors have helped us understand our own biases, and how to be mindful of our biases while developing our therapies.
We are also focused on developing and supporting a diverse community of therapists. In our clinical trials, we communicate to the study sites that, where possible, therapists admitted to the training programme should reflect the communities where they practise, in terms of race, ethnicity, gender and other social identities.
US – COMPASS tracks US policy priorities that affect access to mental health care across various levels of government. We participate in congressional outreach and education, focused on capacity building for the mental health care workforce, mental health parity, improving the role of technology and data in decision making, and improving access to services through policies at the federal and state level.
Europe – We are an observer of the Pan-European Mental Health Coalition, a flagship initiative of the World Health Organisation (WHO) launched in response to requests to address the health disparities faced by communities across the European Region. We are involved in the mental health leadership workstream, which aims to develop leadership training and capacity building materials for policymakers from relevant sectors, mental health service providers, civil society, and self-advocacy organisations.
Health systems strengthening
We work with health systems providers and innovators to accelerate research for mental health, through our own and independent research programmes, and to prepare, subject to regulatory approval, the effective delivery of COMP360 psilocybin therapy at scale.
partnerships with health systems to conduct research and train therapists
donated to 3 independent mental health researchers through OneMind
Through these partnerships, we collaborate to advance research in mental health and build capacity to deliver our therapies at scale in the future. Upon regulatory approval, these partnerships will be key in delivering psychoeducation, continuous professional development, and training for medical professionals. The partnerships will support the continuous improvement of our care model. We have two partnerships to date:
- A Centre of Excellence with Sheppard Pratt, Baltimore, US, a leading research institute in mental health and one of the top psychiatric hospitals in the US.
- The Centre for Mental Health Research and Innovation with the South London and Maudsley NHS Foundation Trust (SLaM), the largest mental health trust in the UK National Health Service (NHS) and the Institute of Psychiatry, Psychology & Neuroscience (IoPPN)at King’s College London.
COMPASS has been instrumental in ensuring mental health is recognised as a key priority in the UK Government’s 2021 Life Sciences Vision for the next decade. Together with a group of stakeholders including the Office for Life Sciences (OLS), National Health Service (NHS), Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), universities, industry partners and patient organisations, we have worked to define the purpose, scope, and objectives of the UK Mental Health mission. The mission seeks to develop a network of research centres across multiple locations in the UK, bringing together leading universities, NHS organisations and industry partners to support the testing and trialling of novel therapies to improve outcomes for individuals with mental health disorders.
The Psychiatry Consortium is a platform that facilitates collaboration between leading biomedical research labs and pharmaceutical companies to accelerate drug discovery and development in areas of urgent, unmet medical need. Through the consortium, we also contribute to cross-sector discussions around the challenges that face the psychiatric research community. Insights and inputs generated help health systems to collectively address the issues. Learn more here.
One Mind is an NGO that accelerates collaborative research and advocacy to enable all individuals facing brain health challenges to build healthy, productive lives. Together, we created the COMPASS Rising Star Award to support early career investigators conducting cutting edge research on the underlying disease mechanisms of a range of mental illnesses. In 2022, Dr. Xin Jin, Dr. Alex Kwan, and Dr. Maryam Shanechi were the Rising Star Award winners. We will give each recipient an award of $300,000, payable in three equal annual installments. These awards will fund their scientific research, which has great potential to benefit people living with psychiatric disorders and the mental healthcare system.
British Neuroscience Association (BNA). We are a founding supporter of BNA’s inaugural Scholar’s programme, which is designed to help students from under-represented ethnic groups to thrive in neuroscience, and build a supportive community through networking opportunities, scholarships and mentorship. Learn more about the programme here. Read about the experience of scholar here.
1 Michaels, T.I., Purdon, J., Collins, A. et al. Inclusion of people of color in psychedelic-assisted psychotherapy: a review of the literature. BMC Psychiatry 18, 245 (2018). https://doi.org/10.1186/s12888-018-1824-6
Data points – Refer to data as of December 31, 2022.