HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-212-007
Topic:
Esketamine (Spravato)
Section:
Injections
Effective Date:
August 5, 2024
Issued Date:
August 5, 2024
Last Revision Date:
June 2024
Annual Review:
June 2024
 
 

Esketamine (SpravatoTM) is the S-isomer of racemic ketamine and is an antidepressant which is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor (an ionotropic glutamate receptor). Due to adverse events (sedation, dissociation, etc.) an individual must be monitored by a healthcare provider while administering the medication and for at least two hours after administration is complete. Due to the risk of increased blood pressure with administration, the healthcare provider should monitor the individual’s blood pressure before and after treatment. Individuals with acute suicidal ideation may benefit from hospitalization.

Policy Position

Esketamine (Spravato) may be considered medically necessary for the treatment of individuals 18 years of age and older when the following criteria are met:

Treatment Resistant Major Depressive Disorder (MDD)

  • Prescribed by or in consultation with a licensed mental health professional with prescriptive authority (e.g., psychiatrist, psychiatric or mental health nurse practitioner, etc.); and
  • Diagnosis of treatment resistant MDD based on the current DSM by a mental health professional; and
  • Individual has failed to adequately respond to at least three (3) different antidepressants which may be defined as:
  • Individual has had no response at minimal therapeutic dose for four (4) weeks of therapy resulting in therapy change; or
  • Individual has had no response or a partial response with dose limiting side effects resulting in therapy change; or
  • Individual has had a partial response at or above maximum therapeutic dose for a treatment duration of at least eight (8) weeks resulting in therapy change; and
  • At least one of these antidepressant trials must be in the current episode of depression; and
  • Individual has failed to adequately respond to at least one (1) trial of augmentation with a second agent along with one of the antidepressant trials; and
  • Esketamine (Spravato) is not to be used as monotherapy and is being prescribed in conjunction with least one oral antidepressant; and
  • Individual is not receiving esketamine (Spravato) in conjunction with transcranial magnetic stimulation (TMS); and
  • Healthcare setting and pharmacy are certified by and individual will be enrolled in the Spravato Risk Evaluation and Mitigation Strategy (REMS) program, providing the appropriate monitoring to include at least two (2) hours of observation by the healthcare provider after administration of esketamine (Spravato) by the individual in the healthcare setting

Continuation of Therapy

  • Individual has demonstrated sustained improvement from baseline in depressive symptoms as documented by standardized rating scales that reliably measure depressive symptoms; and
  • Individual will continue to receive esketamine (Spravato) in conjunction with an oral antidepressant; and
  • Dosing is in accordance with the FDA approved labeling and does not exceed 84 mg per week.

Esketamine (Spravato) not meeting the criteria as indicated in this policy is considered not medically necessary.

S0013

G2082

G2083

 

 

 

 




Esketamine (Spravato) may be considered medically necessary for the treatment of individuals 18 years of age and older when the following criteria are met:

MDD with Acute Suicidal Ideation

  • Prescribed by or in consultation with a licensed mental health professional with prescriptive authority (e.g., psychiatrist, psychiatric or mental health nurse practitioner, etc.); and
  • Diagnosis of MDD based on the current DSM by a mental health professional; and
  • Individual has suicidal ideation with intent, confirmed by individual, and may warrant potential hospitalization; and
  • Individual may not have a current DSM-5 diagnosis of bipolar (or related) disorder, obsessive-compulsive disorder (OCD), antisocial personality disorder or borderline personality disorder; and.
  • Individual may not have a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis; and
  • Individual may not have a history of moderate to severe substance or alcohol use disorder within 6 months of screening; and.
  • Individual may not have a positive urine test result for phencyclidine, cocaine or amphetamines; and
  • Esketamine (Spravato) is not to be used as monotherapy and is being prescribed in conjunction with least one oral antidepressant; and
  • Individual is not receiving esketamine (Spravato) in conjunction with transcranial magnetic stimulation (TMS); and
  • Healthcare setting and pharmacy are certified by and individual will be enrolled in the Spravato Risk Evaluation and Mitigation Strategy (REMS) program, providing the appropriate monitoring to include at least two (2) hours of observation by the healthcare provider after administration of esketamine (Spravato) by the individual in the healthcare setting; and
  • Treatment with esketamine (Spravato) does not exceed four (4) weeks.

Esketamine (Spravato) not meeting the criteria as indicated in this policy is considered not medically necessary.

S0013

G2082

G2083

 

 

 

 




NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.


F32.0

F32.1

F32.2

F32.3

F32.4

F32.8

F32.9

F33.0

F33.1

F33.2

F33.3

F33.41

F33.8

F33.9

R45.851

 

 

 

 

 

 


Place of Service: Inpatient/Outpatient

The use of esketamine (Spravato) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.



The policy position applies to all commercial lines of business



Links






This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.