Antidepressant Drug Coverage (Khedezla, Desvenlafaxine ER, Viibryd, Fetzima, Luvox CR, Trintellix)
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Defines medical necessity and coverage criteria for specific antidepressant medications (Khedezla, desvenlafaxine ER, Viibryd, Fetzima, Luvox CR, Trintellix) for treatment of major depressive disorder and OCD where indicated, and applies to Wellmark Blue Cross and Blue Shield members.
Policy revised in October 2023 (document lists a revision date).
Coverage Criteria for Listed Antidepressants
Initial Approval — Khedezla / Desvenlafaxine ER
Covered when ALL of the following are met:
Quantity request must not exceed 30 tablets per month
Initial Approval — Viibryd / Fetzima
Covered when ALL of the following are met:
Approval will be for 24 months
Initial Approval — Luvox CR for OCD
Covered when ALL of the following are met:
Approval will be for 24 months
Initial Approval — Trintellix
Covered when ALL of the following are met:
This policy defines coverage for the specified antidepressant agents (Khedezla/desvenlafaxine ER, Viibryd, Fetzima, Luvox CR, and Trintellix) only when the coverage criteria specific to each agent are fully met. For Trintellix, for example, approval requires a diagnosis of major depressive disorder (MDD) and documented therapeutic failure to all required prior therapies, including two generic SSRIs (each at maximally tolerated dose for a minimum of 2 months), one generic SNRI (at maximally tolerated dose for a minimum of 2 months), and one alternative augmentation strategy (at maximally tolerated dose for a minimum of 2 months). Where noted in the criteria sets, approvals are issued for 24 months. Quantity requests must not exceed the policy limits (e.g., typical monthly supply restrictions).
Khedezla (brand and generic), desvenlafaxine ER, Viibryd, Fetzima, Luvox CR, and Trintellix are considered not medically necessary when the patient has been started on therapy using medication 'samples' (i.e., not dispensed from the pharmacy or not initiated during an inpatient mental health hospitalization) without meeting the prior therapy requirements, or when the patient does not meet the specific prior-therapy and diagnostic criteria set forth in this policy.
Billing Codes and Dosing Information
| Code(s), if applicable. | Placeholder indicating to use appropriate CPT/HCPCS/Revenue/ICD codes as applicable |
Prior Authorization, Step Therapy, and Documentation Requirements
Prior Authorization Required
Prior authorization is required for the listed antidepressants (Khedezla/brand and generic, desvenlafaxine ER, Viibryd/brand and generic, Fetzima, Luvox CR and generic, Trintellix). Requests must document diagnosis and prior therapy trials as described in the policy; quantity requests must not exceed 30 tablets per month where specified. Approval duration when criteria met: 24 months for applicable agents.
- Affected products: Khedezla (brand & generic), Desvenlafaxine ER, Viibryd (brand & generic), Fetzima, Luvox CR (and generic), Trintellix
- Quantity limit: ≤ 30 tablets per month (where specified)
- Approval period: 24 months (when criteria met)
Sample-initiated or Inpatient-initiated Therapy Does Not Meet Criteria
Therapy initiated with free samples or medications started during an inpatient mental health hospitalization is not acceptable as meeting prior therapy requirements. If the member was started on the requested agent via samples (not dispensed by a pharmacy) or inpatient initiation, the request will be considered not medically necessary unless the member subsequently meets all prior therapy criteria documented via pharmacy-dispensed medications or covered treatment history.
- Sample-initiated therapy does not satisfy prior authorization requirements
- Inpatient-initiated therapy does not satisfy prior authorization requirements
Failure to Meet Prior Therapy Criteria
Requests that do not document completion of the required prior therapy trials (or current receipt of the requested medication through health insurance with positive therapeutic outcome) will be considered not medically necessary.
- Failure to document required prior SSRI/SNRI/alternative strategy trials at maximally tolerated doses for required durations will lead to denial
- Exceptions only if member is currently receiving the requested medication with documented positive therapeutic outcome through health insurance (sample or manufacturer assistance program obtainment excluded)
Required Clinical Documentation
Required clinical documentation must include diagnosis and clear documentation of prior medication trials: agent name, dose (maximally tolerated where applicable), duration of trial (minimum 2 months per trial as specified), and reason for failure or intolerable side effects. If class-wide intolerance is asserted, documentation must show intolerable side effects with more than one agent in that class. For continuation of therapy, evidence of current receipt of the requested medication through health insurance with positive therapeutic outcome is acceptable (samples or manufacturer's patient assistance programs are excluded).
- Document diagnosis (e.g., major depressive disorder or OCD where applicable)
- Document each prior trial: medication name, maximally tolerated dose, duration (minimum 2 months unless otherwise specified), and reason for failure or intolerance
- If claiming class effect intolerance, document intolerable side effects with more than one agent in the class
- Document current receipt through health insurance and positive therapeutic outcome if using that as exception (exclude samples or manufacturer assistance)
Step Therapy Requirements
Step therapy requirements: approval is contingent on documented therapeutic failure to the specified lower-cost or class-preferred agents listed for each product. Required trials differ by agent but generally include trials of SSRIs (one or two agents as specified), an SNRI trial where specified, and one alternative strategy (bupropion, mirtazapine, trazodone, lithium, or another augmentation agent) each at maximally tolerated doses for minimum durations of 2 months.
- Khedezla/Desvenlafaxine ER: failure of extended-release venlafaxine (≥2 months), one SSRI (≥2 months) or class intolerance, and one alternative strategy (≥2 months)
- Viibryd/Fetzima: failure of one SSRI (≥2 months) and one SNRI (≥2 months) or class intolerance, and one alternative strategy (≥2 months)
- Luvox CR (OCD): failure of TWO SSRIs (one may be immediate-release fluvoxamine) each for ≥2 months
- Trintellix: failure of TWO SSRIs (each ≥2 months) and one SNRI (≥2 months), and one alternative strategy (≥2 months)
Clinical Background
Major depressive disorder (MDD) is a common indication covered by this policy. The intent of the policy is to ensure that higher-cost or brand antidepressant agents are used appropriately after demonstrated therapeutic failure or intolerance to lower-cost, class-preferred alternatives. To that end, the policy requires documented trials at maximally tolerated therapeutic doses for specified durations (typically a minimum of 2 months per trial) of SSRIs, SNRIs, venlafaxine where specified, and at least one alternative or augmentation strategy before coverage of the listed agents is approved.
Key Definitions
Pharmacotherapy (Antidepressants)
Pharmacotherapy (antidepressants)
Covered when the following pharmacotherapy criteria are met:
Minimum 2 months per trial; maximally tolerated doses required.
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