CurrentCignaPolicy N/A

Inflammatory Conditions - Simponi Subcutaneous Drug Quantity Management Policy - Per Days

Defines retail and home-delivery maximum quantity limits per time period for Simponi SC (50 mg and 100 mg formulations) and one-time override rules for induction/additional dosing for ulcerative colitis. Applies to Cigna-administered health benefit plans subject to plan terms.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Simponi Subcutaneous Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeClarified; Revised

Effective Date

Next Review Date

Key ActionIf a patient is initiating or needs additional ulcerative colitis induction dosing with no Simponi claims in the past 130 days, approve a one-time override (retail = 3 syringes or home delivery = 5 syringes) for 30 days; otherwise ensure claims follow retail (1 per 28 days) or home delivery (3 per 84 days) quantity limits.

POLICY UPDATE CHANGES

Policy Statement updated to clarify that 'One-time' overrides are provided for 30 days in duration.

Policy updated to reflect existing quantity limits when product is obtained via home delivery.

2Formulation strengths covered

1Retail max syringes per 28 days

3Home delivery max syringes per 84 days

130 daysLookback period for initiation override

Coverage Summary

Coverage stance: covered_with_criteria for Simponi SC (golimumab) products. Scope: Defines retail and home-delivery maximum quantity limits per time period for Simponi SC 50 mg/0.5 mL and 100 mg/mL formulations (prefilled syringes and SmartJect autoinjectors). Coverage is contingent on meeting the Drug Quantity Management rule and specified quantity limits; exceptions require approved overrides or will be considered not medically necessary. Effective / Last review date: Last review: 2025-02-10.

General Drug Quantity Management

Simponi SC products are covered as medically necessary when the Drug Quantity Management rule is met. Any other exception is considered not medically necessary.

Coverage requires adherence to the specified retail and home delivery maximum quantities per time period for the specific strength and form.

Initial Therapy / Induction Rules

Simponi SC 100 mg/mL (prefilled syringe or SmartJect autoinjector)

Drug Quantity Limits and Overrides for Ulcerative Colitis induction/additional dosing

Retail maximum quantity per 28 days = 1 syringe/autoinjector

Home Delivery maximum quantity per 84 days = 3 syringes/autoinjectors

Ulcerative colitis initiation or additional induction dosing

One-time retail override = 3 syringes/autoinjectors
Retail override allows for initiation dosing at Week 0 and Week 2
One-time home delivery override = 5 syringes
Home delivery override allows for Week 0 and Week 2 and then 100 mg once every 4 weeks at Week 6 and Week 10

Prior Authorization

One-time override for Ulcerative Colitis induction

If patient is initiating or requires additional induction dosing for ulcerative colitis and has no Simponi claims in past 130 days, approve one-time override: retail = 3 syringes or home delivery = 5 syringes; one-time approvals are 30 days in duration.

One-time retail override: 3 syringes/autoinjectors (30-day approval)
One-time home delivery override: 5 syringes (30-day approval)

Continuation Therapy Criteria

Simponi SC 50 mg/0.5 mL (prefilled syringe or SmartJect autoinjector)

Drug Quantity Limits

Retail maximum quantity per 28 days = 1 syringe/autoinjector

Home Delivery maximum quantity per 84 days = 3 syringes/autoinjectors

Billing Rule

Adhere to quantity limits

Submit claims consistent with the retail and home delivery maximum quantities (retail per 28 days = 1; home delivery per 84 days = 3); claims exceeding these limits require an approved override or will be considered not medically necessary.

Retail maximum: 1 syringe/autoinjector per 28 days
Home delivery maximum: 3 syringes/autoinjectors per 84 days

Provider Actions & Documentation

Documentation Required

Verification of claim history for override

Document absence of Simponi claims in past 130 days to support approval of the one-time induction/additional dosing override.

Required lookback period: 130 days
Absence of Simponi claims in that period must be documented to support the one-time override

Billing Rule

Claims handling / denial risk for excess quantity

Claims exceeding retail/home delivery maximums require an approved override or will be considered not medically necessary.

One-time overrides are provided for 30 days
Retail one-time override quantity: 3 syringes/autoinjectors

Applicable Codes

NDC / product descriptions (formulary/product-level)NDC|mixed

50 mg/0.5 mL	Simponi SC prefilled syringe
50 mg/0.5 mL SmartJect	Simponi SC prefilled SmartJect autoinjector
100 mg/mL	Simponi SC prefilled syringe
100 mg/mL SmartJect	Simponi SC prefilled SmartJect autoinjector

Background and Clinical Evidence

Simponi SC (golimumab) is a tumor necrosis factor (TNF) inhibitor indicated for ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Dosing varies by indication: for ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis the recommended dose is 50 mg once monthly, while ulcerative colitis induction requires a higher initial dosing regimen (200 mg at Week 0, then 100 mg at Week 2, then 100 mg every 4 weeks). Simponi SC is available as 50 mg/0.5 mL and 100 mg/mL prefilled syringes and SmartJect autoinjectors.

Evidence: Simponi subcutaneous injection prescribing information, Janssen; November 2023.

Definitions: One-time override — A single approval for additional quantity provided for 30 days duration to allow induction dosing as specified.

Quantity Limits & Thresholds

Quantity limits and initiation-lookback

No prior Simponi claims lookback for overrideabsence of claims for Simponi in the past 130 days

Retail maximum quantity per 28 days1 syringe/autoinjector

Home delivery maximum quantity per 84 days3 syringes/autoinjectors

Revision History

2025-02-10clarifiedLatest

Policy Statement updated to clarify that 'One-time' overrides are provided for 30 days in duration.

2025-02-10revised

Policy updated to reflect existing quantity limits when product is obtained via home delivery.