Many clinicians have
publicly expressed cautious optimism about the FDA’s recent approval of a nasal
spray for major depressive disorder in adults who have been resistant to
multiple other treatments. But payer issues abound for Spravato (esketamine),
partly because the FDA is imposing strict parameters on its use due to safety
concerns.
Esketamine is derived
from ketamine, a general anesthetic first approved by the FDA in 1970. Similar
to ketamine, Spravato is designated as a Schedule III controlled substance that
may carry the risk of illicit use or diversion. In approving Spravato on March
5, The FDA said that the nasal spray cannot be taken at home. Instead, the
patient must self-administer it under the supervision of a health care provider
in a doctor’s office or clinic certified by the drug’s manufacturer — a
distribution model that will further add to the cost of an already expensive
treatment.
Typically, the cost of
generics for antidepressants is “really inexpensive, less than $50 a month,”
notes Dea Belazi, Pharm.D., president and CEO of AscellaHealth, a Berwyn,
Pa.-based PBM. By comparison, the cost would mushroom into thousands of dollars
monthly for Spravato.
Janssen’s nasal spray can
work faster than other treatment options, with some antidepressants requiring
four to six weeks of use to become effective, Belazi notes. “Some
psychotherapists I’ve talked to see esketamine as a bridge while
antidepressants kick in,” he says. However, “because of the price point, I’d
guess 99% of payers will limit this to a treatment-resistant population.”
The bottom line is,
“there’s a significant cost implication here for the payers,” Belazi says, “and
most payers will want to calculate what the patient population could look like
to estimate costs. At the end of the day, it’s a debilitating disease. But if
it’s high cost, you’d likely be looking at other options.”
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