Discussion on Esketamine - Dr. Katzman
The FDA approval of esketamine last week was big news for the therapeutic ketamine community, and we have been asked by many for our thoughts and comments.
Thanks to the lovely hosts at Psychedelics Today, who reached out to Dr. Katzman for her opinion, and read her statement on their most recent podcast discussing this news (21:00 - 30:00 minutes).
Copied below is her statement:
The approval of esketamine by the FDA is highly controversial in the community of current ketamine providers for several reasons:
Route of Administration:
Esketamine is delivered as a nasal spray, while most of us in the therapeutic ketamine community work with intravenous (IV), intramuscular (IM), and sublingual administrations (SL). A potential complication of nasal administrations is that the bioavailability (how much of the drug gets absorbed) is widely variable, with some estimates between 8-50% (vs. 100% IV, 93% IM, 30% SL). This range can make targeted dosing strategies challenging. However, delivering this drug as a simple nasal spray may reduce medical equipment and monitoring needs (as do sublingual lozenges).
The high prices (estimated between $590 and $885 per dose) for esketamine being quoted in the media are apparently wholesale, which does not include pharmacy markup or administration fees. It would be entirely dependent on a patient's plan to determine if this medicine is covered with only a standard co-pay, or what portion of the retail price they might be responsible for. (This means that even with insurance coverage, one could end up paying quite a bit out of pocket, as plan coverage varies widely.)
(For example, Blue Cross/Blue Shield just released a statement that esketamine is currently under clinical review, and it will be considered experimental until they make a determination if it should be a covered service under their medical benefits.)
I want to emphasize that it was never the medicine itself that led to higher costs of treatment, as generic ketamine is incredibly cheap at a few dollars per dose. What patients pay for is the provider's time (4 hours spent with a co-therapy team, such as in our practice) and facility costs (nursing staff and medical equipment, as is offered in IV infusion centers).
If the medicine is covered by insurance as an FDA approved treatment for mental health concerns, does that mean provider and facility costs will be paid, as well? It remains to be seen how this might look in our practices.
This is also an area where we lack clarity. Esketamine is just the left-handed half of the ketamine molecule. This allowed Janssen Pharmaceuticals to run clinical trials seeking a patent and FDA approval, whereas no company was willing to spend the money testing generic, off-patent ketamine, despite years of successful clinical application and smaller-scale studies. There have been some mixed results about the true efficacy of esketamine; there is a proposal for a study that compares esketamine with generic ketamine happening in Japan, so we all anticipate those results. Without that research, it is hard to reliably say what the functional differences might be.
As for whether this medicine could also be a valuable adjunct to psychotherapy, that is also still an unknown, as few of us have worked with it in any capacity. There are conflicting reports about the dissociative and/or psychedelic features (or "adverse effects," as they are called in the medical research paradigm) of esketamine.
In general, many in the community have a optimistic view of the larger picture, as FDA approval for the use of a ketamine product for mental health diagnoses brings this treatment back into the realm of psychiatry, legitimizes our work, and potentially makes it more broadly accessible to more people. (And there is some hope that insurance plans might perform a cost analysis, and conclude that it is WAY more cost-effective and equally clinically beneficial to cover generic ketamine!) All the challenges mentioned above speak more to the nature of our fragmented and profit-driven health care and medical research system than anything else.
We would additionally mention two other concerns: (1) the mandate that patients be entered into a national registry, which can often create barriers via fear of stigma for traditionally oppressed and disenfranchised populations, and (2) the requirement that patients also be prescribed an oral medication along with esketamine, given that many come to ketamine treatment when traditional oral medication has not proved successful and/or have struggled with adverse effects of such interventions.
We welcome open dialogue and discussion with our community, so please feel free to share your thoughts! (Dr. Grant is planning to write his own comparison of outcomes for esketamine vs racemic ketamine, so keep your eye out for that coming soon!)