The FDA recently approved a very old drug, Spravato (esketamine) from Janssen Pharmaceuticals, for a very new indication. Esketamine was originally approved by the FDA in 1970, a mere 35 years ago!
Spravato is indicated for the treatment of:
• Treatment-resistant depression (TRD) in adults, as monotherapy or in conjunction with an oral antidepressant.
• Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.
Spravato (56mg or 84mg) is administered intranasally and only under the supervision of a healthcare provider. It was approved with a Black Box Warning and an associated REMS program. Dosing is twice weekly in weeks 1-4, once weekly in weeks 5-8, and once every two weeks in weeks 9 and after.
The cost of Spravato ranges between $700 and $1200 per dose.
Year 1 cost will range between $23,800 (56mg) and $40,800 (84mg).
Janssen also announced specialty pharmacy distribution options as follows;
“The specialty pharmacy pathway is the process of acquiring Spravato through a REMS-certified specialty pharmacy. This pathway allows treatment centers to treat patients who are covered under the pharmacy benefit. The pharmacy pathway does not require your treatment center to purchase Spravato but does require shipment coordination before each treatment session. Using the specialty pharmacy pathway, your treatment center receives patient-assigned product from a REMS-certified pharmacy and bills only for associated healthcare services.”
The following SPs are REMS certified and were included because of their geographic coverage, health plan coverage, and fulfillment capabilities.
- AllianceRX — (Walgreens/Prime)
- CVS Specialty — (CVS Caremark)
- Humana Specialty — (Humana)
- AcariaHealth — (Centene)
CLICK HERE to access the J&J brochure detailing specialty pharmacy access
