CurrentCignaPolicy N/A

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

Defines quantity limits, one-time override rules, and coverage criteria for Skyrizi subcutaneous formulations for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySkyrizi Subcutaneous Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeQuantity limits and override criteria updated

Effective DateN/A

Next Review DateN/A

Key ActionApprove a one-time 300 mg override for 150 mg pens/syringes when initiating therapy or needing induction dosing if no Skyrizi claims in past 130 days; approval quantity = mg received in past 84 days plus 300 mg.

SourceLink

POLICY UPDATE CHANGES

A new quantity limit was added for one 180 mg/1.2 mL prefilled cartridge per 56 days.

Policy statement clarified that 'One-time' overrides are provided for 30 days.

Override criteria for 150 mg pens/syringes updated to specify override amount in mg and clarify approval quantity calculation (previous mg removed for obsolete 75 mg syringes).

150 mgmax per 84 days (150 mg pen/syringe)

1.2 mLmax per 56 days (180 mg cartridge)

2.4 mLmax per 56 days (360 mg cartridge)

30 days

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Coverage Criteria and Drug Quantity Management

Skyrizi SC quantity limits and one-time override criteria

Product(s) covered as medically necessary when the Drug Quantity Management rule and criteria are met. Any other exception is considered not medically necessary.

Quantity limits (per formulation)

150 mg prefilled syringe/pen: Maximum quantity = 150 mg (1 syringe/pen) per 84 days.
180 mg/1.2 mL prefilled cartridge: Maximum quantity = 1.2 mL (180 mg) (1 prefilled cartridge) per 56 days.
360 mg/2.4 mL prefilled cartridge: Maximum quantity = 2.4 mL (360 mg) (1 prefilled cartridge) per 56 days.

One-time override for 150 mg pens/syringes: If the patient is initiating treatment for plaque psoriasis or psoriatic arthritis or requires additional induction dosing for plaque psoriasis or psoriatic arthritis, as verified by absence of claims for Skyrizi in the past 130 days, approve a one-time override for 300 mg (2 pens or syringes). Approval quantity equals the mg of Skyrizi the patient has received in the past 84 days plus 300 mg.no claims in past 130 days

One-time overrides provided for 30 days.

No overrides for cartridges: No overrides recommended for 180 mg/1.2 mL or 360 mg/2.4 mL prefilled cartridges.

Coverage determination on rule failure: If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the criteria below; exceptions are considered not medically necessary unless criteria are met.

Product(s) are covered as medically necessary only when the Drug Quantity Management rule and the specific criteria in this policy are met. Any exception to the listed criteria and quantity limits is considered not medically necessary unless the stated criteria and override conditions are satisfied.

Requests that exceed the product-specific maximum quantities per the stated timeframes (for example, > 150 mg per 84 days for 150 mg pens/syringes, or > the cartridge limits per 56 days for 180 mg and 360 mg cartridges) and that do not meet the documented one-time override criteria are considered not medically necessary.

Coding, Lookbacks, and Claims History

Coding guidancemixed

No codes listed

No prior Skyrizi claims timeframe for override

RequirementNo claims for Skyrizi in the past 130 days

PurposeVerifies eligibility for one-time 300 mg override when initiating or needing induction dosing for plaque psoriasis or psoriatic arthritis

Applies to150 mg prefilled pens and prefilled syringes only

Lookback window for mg calculation

Lookback windowPast 84 days (used to calculate mg previously received)

Used forApproval quantity calculation: mg received in past 84 days plus override amount

Provider Actions, Prior Authorization, and Denial Risk

Prior Authorization

Quantity overrides and prior authorization overview

Quantity overrides and prior authorization: This Drug Quantity Management program allows one-time quantity overrides when criteria are met. If a patient is initiating treatment for plaque psoriasis or psoriatic arthritis (or requires additional induction dosing) and there are no claims for Skyrizi in the past 130 days, a one-time override for 300 mg (two 150 mg pens/syringes) may be approved for retail or home delivery. The approved quantity equals the mg of Skyrizi received in the past 84 days plus 300 mg. Overrides for Skyrizi 180 mg and 360 mg cartridges are not recommended. One-time overrides are provided for 30 days.

Applies when no Skyrizi claim in prior 130 days.
One-time override quantity = prior 84-day mg total + 300 mg.
Override available for retail and home delivery.
Overrides valid for 30 days.

Step Therapy

Step therapy (none specified)

Step therapy: No explicit step therapy requirements are specified in this policy. Providers should follow plan-specific step therapy rules if present in the member's benefit document; absence of an explicit step requirement in this policy does not waive any plan-level step edits.

Background — Drug and Indications

Skyrizi (risankizumab-rzaa) is an interleukin‑23 (IL‑23) blocker provided as subcutaneous formulations including 150 mg prefilled syringes and pens, 180 mg/1.2 mL prefilled cartridges, and 360 mg/2.4 mL prefilled cartridges. Dosing and quantity management in this policy apply to Retail and Home Delivery settings and specify maximum quantities per product formulation and allowable one-time overrides for initiation or induction when criteria are met.

Dosing Definitions and Terms

Induction and maintenance dosing

Induction dosing (plaque psoriasis/psoriatic arthritis)150 mg SC at Week 0 and Week 4 (plaque psoriasis/psoriatic arthritis induction described as Week 0 and Week 4)

Induction dosing (Crohn’s disease)600 mg IV at Week 0, Week 4, and Week 8

Maintenance dosingSC 150 mg every 12 weeks (plaque psoriasis/psoriatic arthritis) or SC 180 mg or 360 mg every 8 weeks (Crohn’s disease and ulcerative colitis)

Policy noteOne-time 300 mg override may be approved for initiating or induction dosing for plaque psoriasis/psoriatic arthritis when no Skyrizi claims in past 130 days

Initial Therapy and Induction-Specific Overrides

INITIAL THERAPY CRITERIA

Induction dosing and initiation-specific override rule

Induction dosing consideration for authorization: When initiating treatment for plaque psoriasis or psoriatic arthritis, absence of Skyrizi claims in the past 130 days permits a one-time override of 300 mg (2 pens/syringes) for initiation or additional induction dosing; the approval quantity equals mg received in the past 84 days plus 300 mg. For Crohn's disease and ulcerative colitis, IV induction dosing is described in the prescribing information but IV formulations are not targeted by this SC quantity management policy.

Step Therapy Requirements

Step	Requirement
1	No step therapy requirements specified in this quantity management policy.

Product-Specific Quantity Limits

Skyrizi 150 mg/mL prefilled syringe

Strength & formSkyrizi 150 mg/mL prefilled syringe

Standard fill150 mg (1 syringe)

Quantity limit periodPer 84 days

Skyrizi 150 mg/mL prefilled pen

Strength & formSkyrizi 150 mg/mL prefilled pen

Standard fill150 mg (1 pen)

Quantity limit periodPer 84 days

Site of Care Applicability

Note

Limits apply to Retail and Home Delivery

Quantity limits and any one-time overrides apply to both Retail and Home Delivery dispensing settings.

Retail and Home Delivery maximum quantities and override rules are specified in the criteria and Drug Quantity Limits.