ph-0481
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Spravato (esketamine)

Policy Number: PH-0481

 

(Nasal)

 

Last Review Date: 02/04/2020

Date of Origin: 05/13/2019

Dates Reviewed: 05/2019, 07/2019, 02/2020

  1. Length of Authorization
  • Initial: 4 weeks
  • Renewal: 4 weeks for first renewal; 3 months for subsequent renewals
  1. Dosing Limits

A.  Quantity Limit (max daily dose) [Pharmacy Benefit]:

  • Induction (weeks 1 to 4): 2 kits/week (56 mg or 84 mg kit); (one 56 mg kit Day 1)
  • Maintenance (weeks 5 to 8): 1 kit/week (56 mg or 84 mg kit)

B.  Max Units (per dose and over time) [Medical Benefit]:

  • Induction (weeks 1 to 4): 84 mg twice weekly (56 mg Day 1)
  • Maintenance (weeks 5 to 8): 84 mg weekly
  1. Initial Approval Criteria
  • Patient is at least 18 years old; AND
  • Patient must NOT be pregnant; AND
  • Patient has a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of major depressive disorder (MDD); AND
  • Patient has failed a trial of at least 2 antidepressants of different classes for a duration of at least 6 weeks each at generally accepted doses in the current depressive episode, unless contraindicated or clinically significant adverse effects are experienced (‘Failed trial’ is defined as less than 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 at least 6  weeks in the current depressive episode with at least 1 of the following, unless contraindicated or clinically significant adverse effects are experienced (see ‘failed trial’ as defined above):
    • An antidepressant from a different class; OR
    • An atypical antipsychotic; OR
    • Lithium; AND
  • Patient has tried psychotherapy alone or in combination with oral antidepressants, if psychotherapy resource available; AND
  • Patient must NOT have failed prior ketamine treatment for MDD; AND
  • If patient has previously tried one of the following, then patient must NOT have failed a previous trial of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or deep brain stimulation (DBS); AND
  • Patient is NOT receiving concomitant ECT, VNS, TMS, or DBS; AND
  • Patient must NOT have intellectual disability; AND
  • Patient must NOT have a current or prior DSM-5 diagnosis of any of the following:
    • Concomitant psychotic disorder; OR
    • MDD with psychosis; OR
    • Bipolar or related disorders; OR
    • Obsessive compulsive disorder (OCD); OR
    • History of moderate to severe substance or alcohol use disorder; OR
    • Personality 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 (greater than 140/90 mmHg in patients less than 65 years old or greater than 150/90 mmHg in patients 65 or older); AND
  • Patient must NOT have known hypersensitivity to any component of the product; AND
  • Patient must NOT have homicidal ideation/intent or suicidal ideation with some intent to act; AND
  • Patient must have a baseline 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
  • Patient must be maintained on an antidepressant medication in conjunction with esketamine (esketamine is not to be used as monotherapy); AND
  • Patient is NOT receiving concomitant ketamine therapy; AND
  • Patient has a history of adherence with oral therapy (compliant with at least 80% of their doses as evident by refill history or prescriber attestation during current depressive episode); AND
  • Esketamine is prescribed by or in consultation with a psychiatrist or psychiatric mental health nurse practitioner (PMHNP); AND
  • Prescriber attestation that he/she has reviewed the dosing schedule with the patient; 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
  • Attestation that prescriber’s healthcare setting is certified in the Spravato Risk Evaluation and Mitigation Strategies (REMS) program; AND
  • Attestation that the prescriber will check blood pressure prior to each visit AND is capable of monitoring patient as directed following administration, ensuring patient has been stable for at least 2 hours, with baseline or decreasing blood pressure, prior to cessation of monitoring.
  1. Renewal Criteria
  • Patient must continue to meet the above criteria; AND
  • Patient has not experienced unacceptable toxicity (dissociation, cognitive impairment, etc.); AND
  • Prescriber attestation that patient has committed to receiving all scheduled doses thus far in treatment and will continue to do so; 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 any validated depression rating scale.
  1. Dosage/Administration

Indication

Dose

Treatment-resistant depression (TRD)

Induction (administer twice per week):

  • Day 1: 56 mg
  • Weeks 1 to 4 subsequent doses: 56 mg or 84 mg

Maintenance:

  • Weeks 5 to 8: 56 mg or 84 mg once weekly
  • Weeks 9 and after: 56 mg or 84 mg once every 2 weeks or once weekly
  1. Billing Code/Availability Information

HCPCS:

  • J3490 – Unclassified drugs

NDC:

  • 56 mg Dose Kit: Unit-dose carton containing two 28 mg nasal spray devices (56 mg total dose): 50458-0028-xx
  • 84 mg Dose Kit: Unit-dose carton containing three 28 mg nasal spray devices (84 mg total dose): 50458-0028-xx
  1. References
  1. Spravato [dossier]. Titusville, NJ; Janssen; March 2019.
  2. Papakostas GI. Incidence, impact, and current management strategies for treatment-resistant major depressive disorder. Medscape. Available at: https://www.medscape.org/viewarticle/574817_1. Accessed May 3, 2019.
  3. American Psychiatric Association Work Group on Major Depressive Disorder. Practice guideline for the treatment of patients with major depressive disorder. 3rd ed. October 2010. Available at: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf. Accessed May 3, 2019.
  4. Major Depression. National Institute of Mental Health. Available at: https://www.nimh.nih.gov/health/statistics/major-depression.shtml. Accessed May 3, 2019.
  5. Johnston KM, Powell LC, Anderson IM, et al. The burden of treatment-resistant depression: a systematic review of the economic and quality of life literature. J Affect Disord. 2019; 242: 195-210. DOI: 10.1016/j.jad.2018.06.045.
  6. American Psychiatric Association Work Group on Major Depressive Disorder. Practice guideline for the treatment of patients with major depressive disorder. 3rd ed. October 2010. Available at: https://www.psychiatry.org/psychiatrists/practice/clinical-practice-guidelines.  Accessed May 3, 2019.
  7. Socci C, Medda P, Toni C, et al. Electroconvulsive therapy and age: age-related clinical features and effectiveness in treatment resistant major depressive episode. J Affect Disord. 2018; 227:627-632.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

F32.0

Major depressive disorder, single episode, mild

F32.1

Major depressive disorder, single episode, moderate

F32.2

Major depressive disorder, single episode, severe without psychotic features

F32.3

Major depressive disorder, single episode, severe with psychotic features

F32.4

Major depressive disorder, single episode, in partial remission

F32.5

Major depressive disorder, single episode, in full remission

F32.81

Premenstrual dysphoric disorder

F32.89

Other specified depressive episodes

F32.9

Major depressive disorder, single episode, unspecified

F33.0

Major depressive disorder, recurrent, mild

F33.1

Major depressive disorder, recurrent, moderate

F33.2

Major depressive disorder, recurrent severe without psychotic features

F33.3

Major depressive disorder, recurrent, severe with psychotic symptoms

F33.40

Major depressive disorder, recurrent, in remission, unspecified

F33.41

Major depressive disorder, recurrent, in partial remission

F33.42

Major depressive disorder, recurrent, in full remission

F33.8

Other recurrent depressive disorders

F33.9

Major depressive disorder, recurrent, unspecified

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Articles may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/Article): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

SPRAVATO™ (esketamine) Prior Auth Criteria
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