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Drug - Spravato™ (esketamine nasal spray) [Janssen Pharmaceuticals Inc.]

September 2019

Therapeutic Area - Antidepressants, Other

Approval criteria

  • Patient is at least 18 years old AND
  • Patient has a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of major depressive disorder (MDD) AND
  • Patient must have a baseline depression assessment using any validated depression rating scale (e.g., Montgomery-Asberg Depression Rating Scale [MADRS], Hamilton Depression Rating Scale [HAM-D], Patient Health Questionnaire Depression Scale [PHQ-9], Beck Depression Inventory [BDI]) AND
  • Spravato is prescribed by or in consultation with a psychiatrist or psychiatric mental health nurse practitioner (PMHNP) AND
  • Patient must NOT have a current DSM-5 diagnosis of any of the following:
    • Concomitant psychotic disorder OR
    • MDD with psychosis OR
    • Bipolar or related disorders OR
    • Active moderate to severe substance or alcohol use disorder AND
  • Patient must NOT have any of the following conditions:
    • Aneurysmal vascular disease OR
    • Arteriovenous malformation OR
    • History of intracerebral hemorrhage OR
    • Uncontrolled hypertension (> 140/90 mmHg in patients < 65 years old or > 150/90 mmHg in patients ≥ 65 years) AND
  • Patient must NOT be pregnant OR
  • Patient must NOT be breast-feeding AND
  • Patient must have demonstrated ability to self-administer Spravato.  Request for replacement doses for any reason will not be accepted AND
  • Patient must NOT have known hypersensitivity to any component of the product AND
  • Patient has failed a trial of ≥ 2 antidepressants of different classes for a duration of ≥ 6 weeks each at generally accepted doses in the current depressive episode, unless contraindicated or clinically significant adverse effects are experienced (failed trial defined as < 50% reduction in symptom severity using any validated depression rating scale) AND
  • Patient has failed a trial of antidepressant augmentation therapy for a duration of ≥ 6 weeks in the current depressive episode with ≥ 1 of the following, unless contraindicated or clinically significant adverse effects are experienced (failed trial as defined above):
    • An atypical antipsychotic OR
    • Liothyronine OR
    • Lithium OR
    • An antidepressant from a different class AND
  • Patient has tried psychotherapy alone or in combination with oral antidepressants, if psychotherapy resource is available AND
  • Patient must NOT have failed prior ketamine treatment for MDD AND
  • Patient is NOT receiving concomitant electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or deep brain stimulation (DBS) AND
  • Patient is NOT receiving concomitant ketamine therapy AND
  • Patient must be taking Spravato in conjunction with an antidepressant medication (Spravato is not to be used as monotherapy) AND
  • Patient has a history of adherence with oral therapy (compliant with ≥ 80% of their doses as demonstrated by refill history or prescriber attestation during current depressive episode) AND
  • Attestation that the prescriber has conducted a comprehensive review of patient’s current medications and the risks and benefits of the following concomitant medications have been carefully evaluated:
    • CNS depressants (e.g, benzodiazepines, opioids, alcohol)
    • Psychostimulants (e.g., amphetamines, methylphenidate, modafanil, armodafanil)
    • MAO inhibitors AND
  • Attestation that prescriber’s healthcare setting is certified in the Spravato Risk Evaluation and Mitigation Strategies (REMS) program AND
  • Prescriber attestation that patient understands and is committed to receiving scheduled doses AND has the capability of being available twice a week with adequate transportation to and from treatment facility AND
  • All appointments for doses administered during the initial 4 weeks are scheduled and documented in patient chart notes AND
  • Prescriber attestation that he/she has reviewed the dosing schedule with the patient AND
  • The following documentation must be provided at time of request:
    • Healthcare facility’s written processes and procedures to ensure that administration of Spravato is by the patient and under the direct observation by a healthcare provider; and the patient is monitored by a healthcare provider for at least 2 hours post-administration (e.g., a facility-specific treatment protocol for Spravato)
    • Healthcare facility’s written procedures to ensure that product dispensed for a specific named-patient that is consistent with Federal and State regulations (e.g., product dispensed for a specific named-patient must be administered within 14 days after receipt by healthcare facility)
    • Healthcare facility’s written policy regarding the disposal of unused, partially used, and completely used Spravato that is compliant with Federal and State regulations.  Participation in the Janssen’s Spravato disposal program alone is not sufficient as the program does not address the disposal of completely used Spravato
  • Initial approval is for 4 weeks

Renewal criteria

  • Patient must continue to meet the above criteria AND
  • Patient must demonstrate disease improvement and/or stabilization as a result of the medication, as documented by a 50% reduction in symptom severity using a validated depression rating scale AND
  • Patient has not experienced unacceptable toxicity (e.g., dissociation, cognitive impairment) AND
  • Patient has not missed any doses scheduled during the initial 4 weeks OR
  • Patient’s missed doses are due to clinical reasons (e.g., therapy is delayed due to elevated blood pressure) AND
  • Prescriber provides, at time of request, encounter summaries of scheduled doses or missed doses during the initial 4 weeks
  • First renewal approval is for 4 weeks; subsequent renewal approval is for 3 months

Quantity limits

  • Weeks 1 to 4 (“Induction Phase”): 2 kits/week (56 mg or 84 mg kit) 
  • Week 5 and thereafter (“Maintenance Phase”): 1 kit/week (56 mg or 84 mg kit)

Billing for Spravato

Spravato must be billed as a medical claim.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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