Esketamine Faces FDA Next Week
As the drug company Johnson and Johnson move forward with their FDA approval of Spravato (esketamine nasal spray), we are watching closely.
Although, FDA approval smooths the way for insurance coverage, there are still many hurdles to overcome.
First is cost, which is expected to be steep. Prior authorizations will likely be required by most insurance companies and strict rules will likely be in place for approval. And even with approval for esketamine nasal spray, there will be out of pocket expenses to the patient.
The second hurdle we are anticipating at the Injection and Infusion Clinic of ABQ are the hurdles around administration. This is referred to as REMS (Risk Evaluation and Mitigation Strategies). According the linked article above, it is anticipated that administration of the nasal spray will require two hours of monitoring and there will be no distribution of the drug...meaning you can't pick it up from the pharmacy and take it home. The clinic will have to stock the medication, administer it and then monitor you for two hours. There is no comment about activity restrictions after administration (ie driving)
It is difficult to determine if or how insurance will cover the two hours of monitoring in addition to the cost of the drug.
Currently patients at the Injection and Infusion Clinic of ABQ spend about 1.5-2hours receiving a ketamine infusion and recovery. The clear advantage of infusions is absorption and peak level.
We will continue to monitor the advantages and disadvantages of esketamine nasal spray (Spravato) as it comes to market so we can advice our patients on best practices.