Category: Vincent Joralemon

Insurance Coverage for Psychedelic Therapy

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By Vincent Joralemon

As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. For example, experts estimate MDMA-assisted therapy for PTSD will cost upwards of $12,000 per patient.

These high costs highlight the need for comprehensive insurance coverage because many of those experiencing symptoms of conditions like PTSD also frequently lack the resources to pay for such treatments. Looking at how the current system works, including presently available psychedelic therapies, can help to inform coverage policies moving forward.

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Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

The FDA Backdoor to MDMA Rescheduling

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By Vincent Joralemon

MDMA (also known as the club drug “molly” or “ecstasy”) is a Schedule I controlled substance — the most restrictive drug class with the most severe criminal consequences linked to it. But, perhaps not for long.

A recent effort to get MDMA approved by the U.S. Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. This provides a compelling model for efforts to decriminalize and destigmatize other substances moving forward.

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Sorry, You Probably Cannot Get MDMA Through Telehealth

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By Vincent Joralemon

The U.S. Food and Drug Administration’s recent acceptance of an MDMA-assisted therapy New Drug Application has experts buzzing over expanded access to the infamous substance commonly known as “ecstasy” or “molly.” 

Yet, once approved, FDA will put limits on the approved drug. If past psychedelics are any indication, this means that MDMA will probably need to be provided in a clinic under certain protocols. This means patients will need to wait for other MDMA products to complete clinical trials before we’ll see at-home, private use of the drug.

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Thank Ketamine for the Telehealth Extension

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By Vincent Joralemon

In my last post, I discussed the rise of psychedelic lobbying — how companies with vested economic interests in psychedelics have applied pressure to shape regulations that favor their business models.

One such initiative — the ketamine therapy industry’s push to extend the COVID-era telemedicine flexibilities for prescriptions of controlled substances — highlights how sophisticated these campaigns can be, and how their impact stretches beyond the psychedelic industry.

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Psychedelic Lobbying and Regulatory Capture

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By Vincent Joralemon

Psychedelic companies and advocacy groups are spending substantial resources to influence regulatory policy, shaping what the blossoming field will ultimately cohere into.

Although regulations are designed to protect the public interest, the rulemaking process is often dominated by lobbying from those with special interests in the fields meant to be regulated. When that leads to undue influence, the result is known as “regulatory capture.”

Yet, not all lobbying campaigns are necessarily problematic — the goal instead should be for regulators to leverage industry insights while maintaining independence in their ultimate decision-making.

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Ketamine Is the New Viagra

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By Vincent Joralemon

Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Johnson & Johnson’s ketamine-based formulation generated $183 million in Q3, surpassing Pfizer’s erectile dysfunction (ED) drug, which earned $110 million over the same period. Remarkably, a therapeutic made from ketamine, once dismissed as a “club drug” or “horse tranquilizer,” now sells more than one of the most notable 21st-century pharmaceuticals. 

Yet, these two drugs have more in common than meets the eye, and the path Spravato has taken looks strangely similar to that of Viagra. By looking at the journey traversed by Viagra over the past twenty years, we can predict where Spravato (and other psychedelic therapies) are headed.

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Want to Change Minds About Psychedelics? Start with PTSD

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By Vincent Joralemon

Psychedelics have a public relations problem, due in part to overzealous promoters, genuine risks, and bad science. But, recent psychedelic legislation sponsored by conservative congressperson Dan Crenshaw shows minds can be changed in this space.

Public perceptions will shape efforts to reclassify, decriminalize, and make psychedelics available for therapeutic use. The most effective way to change peoples’ opinions is to highlight the success stories of those who have tried psychedelics. And, as Crenshaw’s story shows, psychedelic-assisted therapy for post-traumatic stress disorder (PTSD) is a compelling application for precisely those who harbor the most skepticism towards these drugs.

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A Pseudo-Nonprofit Model for Psychedelic Clinical Trial Funding

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By Vincent Joralemon

A $70 million deal struck between a venture capital firm and a prominent psychedelic advocacy organization suggests that funding for psychedelic research may increasingly rely on nonprofit and commercial partnerships.

As the commercial appeal of these substances grows, this might serve as a promising model to channel the resources of for-profit entities toward this field. This funding can support clinical trials, FDA approval, and ultimately insurance coverage for these promising (but resource-intensive) therapies.

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Psychedelics Are Cheap. Psychedelic Treatment Is Not.

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By Vincent Joralemon

Psychedelics hold immense potential to address an array of conditions that are otherwise challenging to treat, but accessing these therapies can be costly, which means that potential benefits will be stratified along the lines of socioeconomic status.

This is an acute concern, because many with conditions that psychedelics may help to treat — such as post-traumatic stress disorder, postpartum depression, treatment-resistant depression, and alcohol use disorder — lack the resources to pay for effective health treatments.

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