Ketamine for Depression: Understanding FDA Approval, Pricing, and Administration

As of 2020, the scenario regarding ketamine prescriptions and its use for treating depression has evolved significantly. Initially introduced for anesthesia, ketamine has now been approved by the FDA as an intranasal (nasal spray) formulation under the brand name Spravato (esketamine) for specific conditions. This article will delve into the details of obtaining a prescription for ketamine, its approved indications, pricing, and the intricacies of administration. We will also explore the different aspects of this treatment and address common concerns related to its deployment.

Is Ketamine FDA Approved for Depression?

Yes, ketamine, specifically the nasal spray formulation esketamine under the brand name Spravato, is FDA approved for the treatment of certain cases of depression. It is approved for use in adult patients with treatment-resistant depression (TRD) as part of a combination therapy. Treatment-resistant depression is defined as depression that has not responded adequately to two or more different pharmacological treatments, including antidepressants administered at clinically significant doses for an adequate period of time.

Understanding the FDA Approval Process

The FDA's approval for esketamine as a nasal spray for treatment-refractory depression and later for depression with suicidal ideation and planning reflects its rigorous assessment of safety and efficacy. This approval came after years of clinical trials and regulatory scrutiny. Key aspects include:

1. Authorized Clinics or Pharmacies: Patients should seek treatment from authorized clinics or pharmacies where they can receive esketamine under the supervision of a healthcare provider experienced in its administration. These providers must adhere to the Risk Evaluation and Mitigation Strategy (REMS) program.

2. Administration and Observation Period: Ketamine nasal spray administration typically occurs in a clinic setting due to the need for close observation. The first session may take about 2.5 hours, as post-administration monitoring is required to manage potential side effects. Subsequent visits may be shorter but still necessitate observation.

Prescription and Administration Process

Treatment Intervals: The treatment protocol involves an initial dose regimen followed by a maintenance schedule. The first month typically involves two dosing sessions per week, then one session per week in the second month, and finally, one session every two weeks until remission or as advised by the healthcare provider.

Cost Considerations: The cost per treatment session ranges from $550 to $850, which can add up over the course of treatment. Payment options may vary, and healthcare insurance coverage is essential. Currently, it is unclear whether Medicare will fully cover the costs, as coverage under Part B or D may depend on the specific circumstances.

Billing and Coverage: The extended observation period required after each administered dose must be billed as a separate procedure. Determining whether the spray administration and observation are considered a medical or pharmacy benefit can influence which Medicare part (B or D) covers the cost. As of now, Blue Cross has stated that they will cover the treatment if it is part of the plan.

Important Precautions and Considerations

IIV Administration: Ketamine is not suitable for at-home use and must be administered intravenously (IV) in a clinical setting. Misuse of ketamine can lead to severe adverse effects, including respiratory depression and suicidal ideation, as it can heighten such thoughts in some individuals.

Comprehensive Knowledge: Extensive research and instruction provided by the company selling Spravato align with FDA guidelines. It is important to understand that Spravato is specifically approved for use in patients with treatment-resistant depression, and its use for other conditions remains undefined.

Patient Information: Patients with a history of bipolar disorder may face additional challenges in obtaining this treatment, as the FDA guidelines are primarily geared towards patients with major depressive disorder.

Neurobiological evidence and clinical trials emphasize the importance of proper medical administration and thorough patient screening. While esketamine offers a promising avenue for treating depression, careful and informed decision-making is crucial. Always consult with a healthcare professional before starting any new treatment regimen.