How can we make psychedelics accessible and do it quickly?

That is what is covered in the most recent BrainFutures Report.

Here are the key insights on 1) access, 2) affordability, and 3) quality.

1. To provide broad access, the FDA REMS requirements need to be reasonable

REMS – Risk Evaluation & Mitigation Strategies – means that for some medications – like psychedelics – the FDA has requirements when prescribing

They need to be there – to manage risk, but …

BrainFutures urges the FDA to consider its own perspective that the REMS should “not unduly impede patient access to the drug, and minimize the burden on the health care delivery system to the extent practicable”

I.e. don’t strangle it with regulations

2. To increase affordability, have a strategy for reimbursement

Psychedelics will be more expensive than prescription medicines.

Treatments will cost between $5-8k for therapy alone.

3 strategies can help make them affordable:

• Build psychedelic treatments into current coverage
• Have a uniform coding strategy (provided in the report)
• Work with the current statutory & regulatory framework

Or, in other words, snug them within the current medical (especially Medicare) framework

A quick sidestep:

This is what has currently gone wrong with Esketamine (besides being 100x more expensive than (r/s)ketamine), there is no uniform coding strategy.

If this was the case, it might have been prescribed more often.

3. Ensure high quality by making standards of care

raining is currently done by many different parties & per molecule

Training can cost from $6-22k or $18-143 if you include lost income

BrainFutures argues that “if unaddressed, the current approach to training will remain disjointed, time-consuming, and expensive for providers, potentially threatening the supply of clinicians willing to administer PAT and thus patient access.”

Two strategies for training are:

1. Program Accreditation: Design a body that offers independent accreditation

2. Provider Certification: Have a certification board evaluate & certify care providers

To make psychedelic therapy accessible, affordable & high-quality BrainFutures recommends starting with:

• Making standards of care
• Accreditation of educational programs
• Give certification to providers
• Unify reimbursement coding

Check out the full report here.