CurrentBlue Cross Blue Shield - IowaPolicy 05.01.62

Antidepressant Drug Coverage (Khedezla, Desvenlafaxine ER, Viibryd, Fetzima, Luvox CR, Trintellix)

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 Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAntidepressant Drug Coverage (Khedezla, Desvenlafaxine ER, Viibryd, Fetzima, Luvox CR, Trintellix)

Policy CodePolicy 05.01.62

Change TypeRevision (Oct 2023)

Effective DateSeptember 29, 2022

Next Review Date

Key ActionObtain prior authorization showing therapeutic failure to required SSRI/SNRI and alternative trials (each ≥2 months at maximally tolerated doses) before coverage of listed agents.

SourceLink

POLICY UPDATE CHANGES

Policy revised in October 2023 (document lists a revision date).

24 monthsapproval duration

30/moquantity limit

2 monthsmin trial duration

05.01.62internal id

Coverage Criteria for Listed Antidepressants

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Initial Approval — Khedezla / Desvenlafaxine ER

Covered when ALL of the following are met:

Khedezla/Desvenlafaxine ER initial approval: Patient has a diagnosis of major depressive disorder (MDD); patient must have had therapeutic failure to ALL of the following unless currently receiving a positive therapeutic outcome on the requested medication through health insurance (excludes samples or manufacturer patient assistance): (i) extended-release venlafaxine at a maximally tolerated therapeutic dose for a minimum duration of 2 months; (ii) one generic SSRI at a maximally tolerated therapeutic dose for a minimum duration of 2 months OR same intolerable side effect with more than one SSRI trial (class effect); (iii) one alternative treatment strategy (bupropion, mirtazapine, trazodone, lithium, or another augmentation agent) at a maximally tolerated therapeutic dose for a minimum duration of 2 months.durations: 2 months per trial

Quantity request must not exceed 30 tablets per month

Initial Approval — Viibryd / Fetzima

Covered when ALL of the following are met:

Viibryd/Fetzima initial approval: Patient has a diagnosis of major depressive disorder (MDD); patient must have had therapeutic failure to ALL of the following unless currently receiving a positive therapeutic outcome on the requested medication through health insurance (excludes samples or manufacturer patient assistance): (i) one generic SSRI at a maximally tolerated therapeutic dose for a minimum duration of 2 months OR same intolerable side effect with more than one SSRI trial (class effect); (ii) one generic SNRI at a maximally tolerated therapeutic dose for a minimum duration of 2 months OR intolerable side effect with more than one SNRI trial; (iii) one alternative treatment strategy (bupropion, mirtazapine, trazodone, lithium, or another augmentation agent) at a maximally tolerated therapeutic dose for a minimum duration of 2 months.durations: 2 months per trial

Approval will be for 24 months

Initial Approval — Luvox CR for OCD

Covered when ALL of the following are met:

Luvox CR initial approval for OCD: Member has a diagnosis of obsessive-compulsive disorder (OCD); member must have tried and failed TWO generic SSRIs, one of which was immediate-release fluvoxamine (Luvox) at maximally tolerated therapeutic doses for a minimum duration of 2 months each unless currently receiving a positive therapeutic outcome on the requested medication through health insurance (excludes samples or manufacturer patient assistance).2 months per SSRI trial

Approval will be for 24 months

Initial Approval — Trintellix

Covered when ALL of the following are met:

Trintellix initial approval: Patient has a diagnosis of major depressive disorder (MDD); patient must have had therapeutic failure to ALL of the following unless currently receiving a positive therapeutic outcome on Trintellix through health insurance (excludes samples or manufacturer patient assistance): (i) two generic SSRIs at maximally tolerated therapeutic doses for a minimum duration of 2 months each OR same intolerable side effect with more than one SSRI trial (class effect); (ii) one generic SNRI at a maximally tolerated therapeutic dose for a minimum duration of 2 months OR intolerable side effect with more than one SNRI trial; (iii) one alternative treatment strategy (bupropion, mirtazapine, trazodone, lithium, or another augmentation agent) at a maximally tolerated therapeutic dose for a minimum duration of 2 months.2 months per trial

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.

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

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)

Denial Risk

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

Denial Risk

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)

Documentation Required

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

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)

OpenPayer

Antidepressant Drug Coverage (Khedezla, Desvenlafaxine ER, Viibryd, Fetzima, Luvox CR, Trintellix)

Coverage Criteria for Listed Antidepressants

Billing Codes and Dosing Information

Prior Authorization, Step Therapy, and Documentation Requirements

Clinical Background

Key Definitions

Pharmacotherapy (Antidepressants)