CurrentCignaPolicy N/A

Inflammatory Conditions - Etanercept Products Drug Quantity Management Policy

Defines Cigna's drug quantity limits and authorization criteria for etanercept (Enbrel) subcutaneous products, including retail and home delivery maximums and special induction dosing for plaque psoriasis. Applies to benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyEtanercept (Enbrel) drug quantity management — Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 3, 2025

Key ActionWhen initiating treatment for plaque psoriasis, request induction dosing approval to allow one-time higher quantity (e.g., 16 syringes/28 days for 25 mg or 8 syringes/28 days for 50 mg) per criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8/28dRetail max (25 mg)

4/28dRetail max (50 mg)

24/84dHome delivery (25 mg)

16/28dInduction (25 mg)

8/28dInduction (50 mg)

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Coverage Criteria for Etanercept (Enbrel)

Induction dosing criteria

Covered when ALL of the following are met for induction dosing in plaque psoriasis:

Plaque psoriasis induction (25 mg forms): Patient is initiating treatment for plaque psoriasis or requires additional induction dosing for plaque psoriasis, verified by absence of claims for Enbrel in the past 130 daysabsence of claims for Enbrel in past 130 days

If met, approve 16 syringes/vials per 28 days for a total of 84 days at retail or a one-time override for 48 syringes/vials at home delivery

Plaque psoriasis induction (50 mg forms): Patient is initiating treatment for plaque psoriasis or requires additional induction dosing for plaque psoriasis, verified by absence of claims for Enbrel in the past 130 daysabsence of claims for Enbrel in past 130 days

If met, approve 8 syringes/autoinjectors/mini cartridges per 28 days for a total of 84 days at retail or a one-time override of 24 syringes/autoinjectors/mini cartridges at home delivery

Standard quantity limits

Standard Drug Quantity Limits (apply unless induction criteria met):

25 mg forms quantity limits: Retail maximum per 28 days = 8 prefilled syringes/vials (4 mL); Home Delivery maximum per 84 days = 24 syringes/vials (12 mL)per product/form described

Includes single-dose and multi-dose vials (obsolete multi-dose listed)

50 mg forms quantity limits: Retail maximum per 28 days = 4 syringes/auto-injectors/cartridges (4 mL) (document also lists 8 syringes per 28 days for some 50 mg presentations); Home Delivery maximum per 84 days = 12 syringes/auto-injectors/cartridges (12 mL)per product/form described

Document lists consistent home delivery limits and multiple 50 mg presentations; follow the specific form's stated limit

Requests for quantities of etanercept that do not meet the stated Drug Quantity Management criteria are considered not medically necessary.

Any exception request that does not meet the published Drug Quantity Management criteria for etanercept is considered not medically necessary.

Coding and Billing Instructions

Coding instructionsmixed

No codes listed

Provider Actions, Billing, and Denial Triggers

Billing Rule

Drug Quantity Limits

Drug Quantity Limits and induction overrides: Enbrel (etanercept) quantity limits differ by strength/form and fill channel. Retail maximums per 28 days: 25 mg/0.5 mL prefilled syringes or single‑use vials — 8 syringes/vials (4 mL); 25 mg multi‑dose vials (obsolete) — 8 vials; 50 mg/mL prefilled syringes/auto‑injectors/cartridges — 4 syringes/auto‑injectors/cartridges (4 mL). Home Delivery maximums per 84 days: corresponding multiples (24 for 25 mg forms; 12 for 50 mg/mL forms).

Retail max per 28 days — 25 mg forms: 8 syringes/vials (4 mL)
Home Delivery max per 84 days — 25 mg forms: 24 syringes/vials (12 mL)
Retail max per 28 days — 50 mg/mL forms: 4 syringes/auto‑injectors/cartridges (4 mL)
Home Delivery max per 84 days — 50 mg/mL forms: 12 syringes/auto‑injectors/cartridges (12 mL)

Definitions

Induction dosing (plaque psoriasis) — initial higher-frequency dosing and transition to maintenance

Induction regimen (adult plaque psoriasis)50 mg subcutaneous twice weekly for 3 months (then maintenance 50 mg once weekly)

Induction approval (50 mg forms - quantity)Approve up to 8 syringes/auto-injectors/mini cartridges per 28 days for a total 84-day induction period (retail) or one-time home delivery override as specified

Induction approval (25 mg forms - quantity)If initiating on 25 mg presentation, approve up to 16 syringes/vials per 28 days for a total 84-day induction period (retail) or one-time home delivery override as specified

Eligibility check for inductionPatient is initiating treatment for plaque psoriasis or requires additional induction dosing, verified by absence of Enbrel claims in the past 130 days

Transition to maintenanceAfter the 3-month induction period, change dosing to maintenance 50 mg subcutaneous once weekly

Background

Etanercept (Enbrel) is a tumor necrosis factor inhibitor (TNFi) administered by subcutaneous injection and is approved for multiple inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and juvenile forms of arthritis. Typical adult dosing for many indications is 50 mg subcutaneously once weekly, while plaque psoriasis may require a higher-frequency induction regimen prior to maintenance therapy.

For plaque psoriasis induction, adult patients may receive 50 mg subcutaneously twice weekly for up to 3 months followed by maintenance dosing of 50 mg once weekly; pediatric dosing varies by weight. Etanercept products are available in 25 mg and 50 mg prefilled syringe/auto-injector presentations and in mini cartridges for certain devices.

Policy Summary

PayerCigna

PolicyEtanercept (Enbrel) drug quantity management — Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 3, 2025

SourceLink

On This Page

Denial Risk

Denial Trigger for Quantity Rule

Quantity‑limit denial trigger and coverage determination: If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the policy Criteria. All approvals are provided for the duration specified in the Criteria. One‑time overrides are available and provided for 30 days unless the Criteria specify otherwise.

Noncompliance with quantity rule at POS → adjudicate per Criteria below
Approvals follow durations in Criteria; one‑time overrides default to 30 days unless otherwise noted

Prior Authorization

Quantity Limits and Induction Overrides

Provider action — induction and one‑time override details: For patients initiating therapy or needing additional induction dosing for plaque psoriasis (no Enbrel claim in past 130 days), approve induction quantities as follows: Enbrel 25 mg (prefilled syringes, single‑dose vials, multi‑dose vials) — approve 16 syringes/vials per 28 days for 84 days at retail, or one‑time override for 48 syringes/vials at home delivery. Enbrel 50 mg/mL (prefilled syringes, autoinjectors, mini cartridges) — approve 8 syringes/autoinjectors/mini cartridges per 28 days for 84 days at retail, or one‑time override of 24 syringes/autoinjectors/mini cartridges at home delivery.

Induction verified by absence of Enbrel claims in past 130 days
25 mg induction: 16 per 28 days × 84 days (retail) or one‑time override 48 at home delivery
50 mg/mL induction: 8 per 28 days × 84 days (retail) or one‑time override 24 at home delivery