Marplan (isocarboxazid)

POLICY NUMBER

L.5.01.451

Marplan (isocarboxazid)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Isocarboxazid is a monoamine oxidase inhibitor (MAOI). Isocarboxazidis indicated for the treatment of depression. Because of its potentially serious side effects, isocarboxazid is not an antidepressant of first choice in the treatment of newly diagnosed depressed patients. The effectiveness of isocarboxazid in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials, therefore periodic evaluation is necessary regarding the long-term usefulness of the drug for the individual patient.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 

Initial Criteria

Marplan (isocarboxazid) may be considered medically necessary for individuals who meet the following criteria:

1. The individual is ≥16 years of age;

2. The individual has a documented diagnosis of major depressive disorder;

3. The individual is intolerant to or has failed at least two antidepressants (see Failure in Policy Guidelines);

4. The requested agent will not be taken in combination with any of the following:

   1. Other MAOI or dibenzazepine-related entities;

   2. Tricyclic antidepressants;

   3. Bupropion;

   4. Selective serotonin re-uptake inhibitors (SSRIs);

   5. Buspirone;

   6. Amphetamines;

   7. Meperidine;

   8. Dextromethorphan;

   9. Cheese or other foods with a high tyramine content;

   10. Anesthetic agents;

   11. Antihypertensives;

   12. CNS depressants; OR

   13. Thiazide diuretics;

5. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

6. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval:  6 months

Renewal Criteria

Marplan (isocarboxazid) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has previously been approved for therapy through the BCBSMS PA process;

2. The individual has documented clinical improvement;

3. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

4. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 1 year

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medication failure is defined as disease progression despite maximally tolerated dose (>4 weeks use) as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

01/01/2014: New policy added.

07/31/2015: Code Reference section updated for ICD-10.

02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Policy guidelines updated to add medically necessary and investigative definitions.

05/27/2016: Policy number L.5.01.451 added.

02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug name to the top of the policy. Policy statement updated with minor edits. Sources section updated. Effective 04/01/2019.

11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding beneficial effects in some patients. Policy section updated with the following statements: 1) Prior authorization is required. 2) The use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Medically necessary criteria updated. Added renewal criteria. Policy Exceptions updated to remove FEP and State Health Plan members. Policy Guidelines updated to define medication failure and to change "Nervous/Mental Conditions" to "Mental Health Disorders." Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

06/27/2024: Policy updated to extend Length of Approval to 6 months.

03/31/2025: Effective 06/01/2025 - Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for isocarboxazid. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Policy statement criteria updated regarding combination therapy, contraindications to therapy, and dose requirements. Policy Guidelines updated regarding medication failure. Sources updated. Policy update effective 06/01/2025.

SOURCE(S)

Marplan prescribing information. Validus Pharmaceuticals, LLC. October 2020. Last accessed January 2025. 

CODE REFERENCE

None