CurrentCignaPolicy N/A

Rinvoq (upadacitinib) — Drug Quantity Management Policy

Defines drug quantity management rules and permitted supply quantities for Rinvoq (tablets and oral solution) for Cigna-administered health benefit plans; affects providers prescribing and pharmacies dispensing Rinvoq for covered members.

Policy Summary

PayerCigna

PolicyRinvoq (upadacitinib) — Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeQuantity limits addedoverride criteria clarified

Effective DateN/A

Next Review DateDec 18, 2024

Key ActionVerify absence of Rinvoq claims in the past 130 days to approve induction overrides for 45 mg tablets and calculate approval quantity as prior 365-day amount plus specified additional tablets.

SourceLink

POLICY UPDATE CHANGES

Rinvoq 1 mg/mL oral solution: new quantity limit allowing 360 mL (2 bottles) per 30 days at retail or 1,080 mL (6 bottles) per 90 days for home delivery.

Rinvoq 45 mg tablet override criteria clarified: approve an additional 84 tablets for Crohn's disease and an additional 56 tablets for ulcerative colitis; approval quantity equals prior 365-day amount plus the additional tablets.

3015 mg retail max

9015 mg home delivery max

3030 mg retail max

5645 mg annual max

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Coverage Criteria for Rinvoq

Drug Quantity Limits and Override Criteria

Rinvoq products are covered as medically necessary when quantity limits are met; overrides are addressed as follows:

Rinvoq 15 mg and 30 mg tablets: Covered when dispensed at or below the listed maximum quantities: 15 mg and 30 mg tablets — Retail maximum 30 tablets per 30 days; Home delivery maximum 90 tablets per 90 days.see product limits

No overrides recommended for 15 mg and 30 mg formulations.

Rinvoq 45 mg tablets - Crohn's disease induction: If initiating treatment for Crohn's disease or requiring additional induction dosing, and absence of Rinvoq claims in the past 130 days is verified, approve an override for an additional 84 tablets (84 days).no Rinvoq claims in past 130 days

Approval quantity = number of Rinvoq 45 mg tablets the patient received in the past 365 days plus 84 tablets.

Rinvoq 45 mg tablets - Ulcerative colitis induction: If requiring additional induction dosing for ulcerative colitis, and absence of Rinvoq claims in the past 130 days is verified, approve an override for an additional 56 tablets (56 days).no Rinvoq claims in past 130 days

Approval quantity = number of Rinvoq 45 mg tablets the patient received in the past 365 days plus 56 tablets.

Rinvoq LQ oral solution: Covered when dispensed at or below the listed maximum quantities: Rinvoq LQ (1 mg/mL, 180 mL bottle) — Retail maximum 360 mL (2 bottles) per 30 days; Home delivery maximum 1,080 mL (6 bottles) per 90 days.see product limits

No overrides recommended; oral solution is a separate formulation.

Requests for quantities of Rinvoq that exceed the stated Drug Quantity Limits are considered not medically necessary unless the specific override criteria described for the product and indication are met. If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the criteria in this policy.

Exceptions other than the stated override criteria in this policy are considered not medically necessary. Approvals are limited to the conditions and quantities specified in the criteria; any request outside those provisions does not meet medical necessity.

Provider Actions and Override Processes

Billing Rule

Quantity limit enforcement and override conditions

Rinvoq quantity limits are enforced at point of sale; if the quantity rule is not met coverage will be determined by the criteria below and documented overrides where applicable.

Drug Quantity Limits: 15 mg & 30 mg tablets — retail max 30 tablets/30 days; home delivery max 90 tablets/90 days.
45 mg tablets — retail and home delivery maximum 56 tablets per 365 days.
Oral solution (1 mg/mL, 180 mL bottle) — retail max 360 mL (2 bottles)/30 days; home delivery max 1,080 mL (6 bottles)/90 days.

Prior Authorization

15 mg and 30 mg tablets - overrides

No overrides are recommended for the 15 mg and 30 mg tablet strengths. Prescriptions exceeding standard quantity limits for these strengths should follow normal coverage determination processes; anticipate denial risk when the quantity rule is not met.

Key Definitions

inv-09: Rinvoq LQ — definition

FormulationRinvoq LQ is the 1 mg/mL oral solution formulation of upadacitinib supplied in a 180 mL bottle.

Bottle size180 mL per bottle (oral solution).

Substitution noteRinvoq LQ is not substitutable with Rinvoq extended‑release tablets; changes between formulations should be made by the provider.

Step Therapy Notes

Product	Step therapy / override recommendation
{"text":"Rinvoq 15 mg tablets","status":""},{"text":"No overrides recommended","status":"covered"}
{"text":"Rinvoq 30 mg tablets","status":""},{"text":"No overrides recommended","status":"covered"}

Quantity Limits by Formulation

inv-11: Rinvoq 15 mg tablets — quantity limits

Retail quantity limit30 tablets per 30 days (15 mg tablets).

Home delivery quantity limit90 tablets per 90 days (15 mg tablets).

Packaging15 mg tablets supplied in bottles of 30 tablets each.

inv-12: Rinvoq 30 mg tablets — quantity limits

Retail quantity limit30 tablets per 30 days (30 mg tablets).

Home delivery quantity limit90 tablets per 90 days (30 mg tablets).

Packaging

Background

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor indicated for multiple inflammatory conditions including ankylosing spondylitis, atopic dermatitis, Crohn's disease, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. It is available as extended-release tablets (15 mg, 30 mg, 45 mg) and as an oral solution formulation (Rinvoq LQ, 1 mg/mL). Dosing varies by indication and may include induction regimens (for example, 45 mg once daily for Crohn's disease or ulcerative colitis induction) and weight-based pediatric dosing for the oral solution.

Documentation Required

Override documentation for 45 mg tablets

For 45 mg tablets, document the absence of Rinvoq claims in the prior 130 days to verify initiation of Crohn's disease or need for additional induction dosing. Calculate approval quantity as the number of Rinvoq 45 mg tablets the patient has received in the past 365 days plus the applicable induction allowance: +84 tablets for Crohn's disease induction dosing, or +56 tablets for ulcerative colitis induction dosing. Approvals granted under this override are limited to the stated additional tablets and duration (84 days for Crohn's disease; 56 days for ulcerative colitis).

Crohn's disease induction or additional induction dosing: verify no Rinvoq claims in past 130 days → approve override for additional 84 tablets (84 days).
Ulcerative colitis additional induction dosing: verify no Rinvoq claims in past 130 days → approve override for additional 56 tablets (56 days).
Approval quantity = prior 365-day 45 mg tablet total + induction allowance (84 or 56 tablets as applicable).
Retail and home delivery override quantities follow the same calculation and limits.