Reflections on the FDA Advisory Committee Review of MDMA
In this update
Opinion: Reflections on the Recent FDA Advisory Committee Review of MDMA-Assisted Therapy for PTSD
by Amil Patel
The recent meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) to review Lykos Therapeutics’ MDMA-assisted therapy for PTSD brought forth expected outcomes and highlighted several key concerns. As someone committed to enhancing equitable access to safe and supportive psychedelic therapies, I’d like to share my insights and reactions to the proceedings. The themes of concern raised during the meeting are crucial as they reflect both the challenges and opportunities inherent in this new frontier of healthcare.
Key Concerns Related to the Therapy Component
One of the primary concerns discussed was understanding the role of psychological support in the efficacy of MDMA-assisted therapy (MDMA-AT) and how this can be standardized. The FDA has consistently maintained that it lacks the authority to oversee psychological support, which isn’t surprising—they're oversight is specifically around the safety and efficacy of the medication. What Lykos is committed to pursuing is entirely new—using a medication as a tool to enhance psychological support—and the complexity of regulating such an integrated approach is evident.
The role of psychological support in the durability of MDMA-AT’s effects remains unclear. This is straightforward and unsurprising, and although the FDA has worked in collaboration with Lykos on the structure of the clinical trials, there remain valid questions on how to discern if the psychological support impacts treatment durability, as well as if the type of psychological support has a material impact. In this context, Lykos has maintained that the psychological support component is included specifically for patient safety, and it will be interesting to see how the FDA navigates oversight of this aspect. Untangling medication administration from psychological support seems unlikely, given the established context of safety.
Typical Costs of Ketamine Therapy
The costs below are gathered from a 2024 sampling of over 500 clinics found in Meeko Health’s clinic directory.?
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Intravenous (IV) and Intramuscular (IM) Ketamine Administration
IV Ketamine and IM Ketamine are the most common and effective forms of ketamine therapy. The cost per infusion or injection is between $375-$500 for treatment of mental health conditions like depression, anxiety, and PTSD. Treatments for chronic pain typically range from $675-$1200 per session because the infusion times are longer.
How many sessions do you need?
A full course of treatment for mental health conditions involves a series of 6 infusions or injections over 2 to 3 weeks, typically costing between $2250-$3000. Combined with preparation and integration therapy (KAT/KAP) the cost is typically between $3500-$5000 depending on the number of therapy sessions.
Insurance and Financing Options
Currently, most insurance companies do not cover ketamine therapy for mental health conditions, as it is considered an off-label use. However, some clinics offer financing options and payment plans to make the treatment more accessible.
Insurance companies will often cover the evaluation, intake, preparation, and integration sessions because they can usually be classified as covered therapy under healthcare plans. Each clinic providing KAT/KAP should be able to tell you if and what plans they take. This can help keep the cost of KAT/KAP to just the cost of the infusions.
Employers paying for care
Employers are starting to add benefits like the Meeko Health benefit alongside their current health plan to pay for Ketamine therapy for their employees. Individuals can check if their employer covers Ketamine Therapy.
Interested to learn more about how you can offer employees access to fast access mental health care? Visit https://www.meekohealth.com/ to learn more.
Principal & Consulting Actuary at Milliman | Healthcare Finance & Analytics
9 个月Thanks, Amil, for this informative article. It is great to see some momentum getting behind this treatment.