The Reimbursement Case for Psychedelic Therapies Must Incorporate the Patient’s Voice

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Soldiers injured in battle. Survivors of sexual assault and domestic abuse. Communities losing everything to flood, fire or war. The list of life events that can cause post-traumatic stress disorder (PTSD), the persistent experience of debilitating anguish after a shattering experience, is long. In the US alone, PTSD is thought to affect 13 million people in a given year.???

The nature of PTSD and its impact on patients’ participation in their own healthcare and in clinical trials creates a complicated picture for this population, and many patients are undiagnosed and untreated. The economic burden of PTSD in the US is estimated to be over $232 billion. Such numbers show the limitations of existing treatments but they don’t begin to reflect the immense financial and personal costs of undertreated mental illness.

For the first time in decades, new approaches for treating PTSD and mental health conditions are coming to market, in the form of psychedelic drug therapies. Yet as discussed in the 2024 Syneos Health Trends report, the implementation pathway for novel treatments is strewn with hurdles—not least, the need to persuade payers that the therapies deliver value to patients, families, health systems and society. While all eyes are on the first regulatory approval for novel MDMA psychotherapeutics—as early as spring 2024—FDA approval without affordable access will do little to reduce the personal and societal burden of undertreated mental illness.??

Unique Reimbursement Dynamics

In November 2023, developers of psychedelic therapies and others following this space caught a glimpse of what payers may require with respect to PTSD. The Institute for Clinical and Economic Review (ICER) unveiled its plans to evaluate the health and economic outcomes of MDMA-assisted therapy (MDMA-AT) to treat the condition.??

ICER has assessed ketamine-related treatments in the past, and its value assessments often shape payers’ reimbursement decisions. The Institute’s commitment of resources to psychedelic therapies is another sign that these approaches are coming of age.??

ICER plans to release its initial value assessment on MDMA-AT for PTSD in March 2024, followed by its final Evidence Report in June 2024. Its value framework includes both quantitative and qualitative comparisons across treatments to take stock of the full range of benefits and harms in the eyes of both HCPs and patients.???

Psychedelic Economics: Putting the Puzzle Together

For innovators, success in the psychedelic space demands economic innovation. While MDMA and other chemical compounds are not expensive to manufacture, the accompanying psychotherapy can be costly. This puzzle isn’t new. Prescriptions for other mental health treatments, including those targeting substance abuse, may be paired with therapy, thus increasing the cost and complexity of care. Failure to solve the reimbursement puzzle in these and other cases underscores the need to think beyond the pharmacy shelf.??

Historically, mental health treatments have been under-reimbursed. But, working with MAPS and Compass Pathways, the American Medical Association published its first-ever CPT III codes for psychedelic-assisted therapy, which went into effect on January 1, 2024. Enabling HCPs to get reimbursed, the codes reflect how much in-person labor is required for MDMA-AT.???

According to cost-effectiveness studies in 2020 and 2022, the therapy not only provides substantial clinical benefit at a time when many patients are not helped by conventional treatments like cognitive behavioral therapy (CBT), but has also proved cost-effective, enabling payers to begin saving money in as little as three years.??

Voices of the Patient Community

In its scoping document, ICER notes that it has already “reviewed publicly available testimony from people with PTSD,” and gathered direct input from patients, families, researchers, clinicians, and manufacturers. The Institute will continue to engage with stakeholders, and it encourages encourages comments from all quarters.???

Participating in the ICER comment process presents a unique opportunity to developers, patients and advocates. The comment period is an opening for developers to show how they engaged with patients, caregivers and advocacy groups throughout the design, execution and communication of pivotal trials.???

Early in the development process, ideally before ICER announces plans to assess a treatment, developers should be building or expanding connections with representative patient communities, including mental health organizations, veterans, and groups organized around race, ethnicity and gender. This enables trial sponsors to enhance evidence dossiers with nuanced, population-specific, patient-derived insights on personal, social and cultural factors clarifying the medicine’s projected impact on daily life. We have found that patient-powered evidence supported by industry through community partnerships is more persuasive than secondary assertions and analyses by the manufacturer.???

Participating in the ICER process is a good way for companies to familiarize internal development, patient access and advocacy teams with thought processes within health systems and the reimbursement community. The process will enable companies to furnish sponsors with credible insights that can reinforce communications with payers before and after regulatory review. How well companies succeed at this task will ultimately determine if, how and when patients can benefit from the new drugs.??

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