Spravato – NC Standard

Restricted Product(s):

• Spravato® (esketamine) nasal spray

FDA Approved Use:

• As monotherapy or in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression in adults (TRD).
• In conjunction with an oral antidepressant, for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
• Limitations of Use:
  • The effectiveness of Spravato in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of Spravato does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of Spravato.
  • Spravato is not approved as an anesthetic agent. The safety and effectiveness of Spravato as an anesthetic agent have not been established.

Criteria for Approval of Restricted Product(s):

Initial Coverage Criteria:

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of treatment-resistant depression (TRD); AND
   1. The patient has a confirmed diagnosis of major depressive disorder (MDD); AND
      1. If a single episode of MDD, the duration has been ≥ 2 years; OR
      2. If recurrent MDD, episodes are without psychotic features; AND
   2. In the current depressive episode, the patient has had an inadequate response (≤ 25% improvement) to at least two antidepressants from at least two different classes (different mechanisms of action) (e.g., selective serotonin reuptake inhibitor [SSRI], serotonin-norepinephrine reuptake inhibitor [SNRI], tricyclic antidepressant [TCA], bupropion, mirtazapine) of adequate dose and duration (typically 6 weeks); OR
3. The patient has been diagnosed with major depressive disorder (MDD) with suicidal ideation or behavior; AND
   1. The suicidal ideation and intent are imminent and warrant potential hospitalization; AND
   2. The patient will use esketamine nasal spray concomitantly with an oral antidepressant agent (i.e. esketamine will not be used as monotherapy); AND
4. At initiation of esketamine nasal spray, the patient has a depression symptom severity of ≥ 28 on the Montgomery-Asberg Depression Rating Scale (MADRS), or as scored by a comparable standardized rating scale that reliably measures depressive symptoms; AND
5. The patient does not have clinical contraindications to esketamine therapy (i.e. aneurysmal vascular disease or intracerebral hemorrhage); AND
6. The prescribed dose of esketamine nasal spray will be administered under direct supervision of a healthcare professional at a treatment facility that is certified through the Spravato (esketamine) REMS program; AND
7. The patient will NOT receive esketamine nasal spray in combination with ketamine of any formulation or route of administration used for the same indication; AND
8. The patient is being managed by or in consultation with a psychiatrist; AND
9. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 90 days (3 months)

Continuation Coverage Criteria:

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. The patient has experienced clinical benefit since initiation of therapy as indicated by at least a 50% reduction in depressive symptoms compared to baseline using the MADRS scale or a comparable standardized rating scale that reliably measures depressive symptoms; AND
3. If patient has been diagnosed with major depressive disorder (MDD) with suicidal ideation or behavior:
   1. The patient will continue therapy with an oral antidepressant agent in conjunction with esketamine nasal spray; AND
4. The patient continues to NOT have clinical contraindications to esketamine therapy (i.e. aneurysmal vascular disease or intracerebral hemorrhage); AND
5. The prescribed dose of esketamine nasal spray will continue to be administered under direct supervision of a healthcare professional at a treatment facility that is certified through the Spravato (esketamine) REMS program; AND
6. The patient will NOT receive esketamine nasal spray in combination with ketamine of any formulation or route of administration used for the same indication; AND
7. The patient continues to be managed by or in consultation with a psychiatrist.

Duration of Approval: 180 days (6 months)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90-day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval:

90 days (3 months) for initial

180 days (6 months) for continuation

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

January 2025: Criteria change: Updated to align with expanded FDA indication that requested product can be used as monotherapy for treatment-resistant depression (TRD).

October 2024: Criteria change: Clarified that previous antidepressant use is from at least two different classes (different mechanisms of action). Added limitations of use section.

October 2023: Criteria change: Addition of quantity limitations and quantity limit exception criteria. Added patient cannot receive esketamine nasal spray in combination with ketamine of any formulation or route of administration used for the same indication.

February 2023: Criteria update: Criteria review and formatting changes.

October 2020: Original utilization management criteria issued.