CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Emsam (selegiline transdermal system) — Prior Authorization / Coverage Criteria

Defines prior authorization requirements for Emsam (selegiline transdermal system) for treating adults with major depressive disorder (MDD); applies to prescribers requesting coverage through the payer's pharmacy benefit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEmsam (selegiline transdermal system) — Prior Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document diagnosis of MDD plus prior inadequate response/intolerance/contraindication to an SNRI, SSRI, mirtazapine, or bupropion (or inability to swallow oral formulations).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

36 monthsduration of approval

Adults w/ MDDFDA-approved indication

SNRI/SSRI/mirtazapine/bupropionstep therapy alternatives

Coverage Criteria for Emsam (selegiline transdermal system)

Initial Authorization Criteria

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Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior authorization required; approval valid 36 months

Prior authorization is required for Emsam (selegiline transdermal system). If approved, authorization will be granted for a duration of 36 months.

Step Therapy

Step therapy: trial of SNRI/SSRI/mirtazapine or bupropion required

Authorization requires prior inadequate response, intolerance, or contraindication to an SNRI, an SSRI, mirtazapine, or bupropion, unless the patient is unable to swallow oral formulations.

Required prior trials: SNRI
Required prior trials: SSRI
Required prior trials: mirtazapine
Required prior trials: bupropion
Exception: no prior oral trials required if patient is unable to swallow oral formulations

Documentation Required

Document MDD diagnosis and prior treatment history or inability to swallow

Prescriber must document the diagnosis of major depressive disorder (MDD) and support one of the approval conditions with documentation of either prior inadequate response, intolerance, or contraindication to an SNRI, SSRI, mirtazapine, or bupropion, or documentation that the patient is unable to swallow oral formulations.

Denial Risk

Denial triggers: missing MDD diagnosis or unmet prior-treatment criteria

Requests may be denied if the patient does not have a diagnosis of major depressive disorder or does not meet the required prior treatment criteria.

No documented diagnosis of MDD
No documentation of inadequate response, intolerance, or contraindication to an SNRI, SSRI, mirtazapine, or bupropion, and no documented inability to swallow oral formulations

Pharmacologic Treatment Modalities

Pharmacologic (MAOI transdermal)

MAOI transdermal modality — context and authorization requirement.

MAOI use context: Emsam (selegiline transdermal system) is an MAOI indicated for adults with major depressive disorder (MDD). Prior trials of specified oral antidepressants (an SNRI, an SSRI, mirtazapine, or bupropion) demonstrating inadequate response or intolerance, or documentation of contraindication to those agents, are required for authorization unless the patient is unable to swallow oral formulations.

Prescriber must document diagnosis of MDD and supporting evidence of prior treatment failure/intolerance/contraindication or inability to swallow oral medications.

Key Definitions

inv-09: Major Depressive Disorder (MDD) — definition and relation to FDA‑approved indication

DefinitionMajor Depressive Disorder (MDD): A depressive disorder for which Emsam (selegiline transdermal system) is FDA‑approved for treatment in adults.

FDA‑approved indicationEmsam is indicated for the treatment of adults with major depressive disorder (MDD).

Relation to policy authorizationPrior authorization may be granted when Emsam is prescribed for an adult with MDD who has either failed/intolerant/contraindicated to an SNRI, SSRI, mirtazapine, or bupropion, or who cannot swallow oral formulations.

Prior therapy requirementAuthorization requires documentation of inadequate response, intolerance, or contraindication to any of: SNRI, SSRI, mirtazapine, or bupropion — unless patient cannot swallow oral medications.

Scope limitationUse of Emsam is limited to its FDA‑approved indication (adult MDD); requests for non‑MDD indications are not supported by this policy.

Background

Emsam is a monoamine oxidase inhibitor (MAOI) delivered via a transdermal system and is FDA‑approved for the treatment of adults with major depressive disorder (MDD). Because MAOIs have distinct safety profiles and drug/food interaction risks compared with other antidepressants, this policy requires either documented prior inadequate response, intolerance, or contraindication to standard oral antidepressants (an SNRI, an SSRI, mirtazapine, or bupropion) or documentation that the patient is unable to swallow oral formulations before authorization will be considered.