Subject: Specialty Quantity Limit Rinvoq 3175-H P2025a

Drug

RINVOQ  (upadacitinib)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If the member’s plan allows a quantity limit exception review for the requested medication, coverage of an additional quantity may be provided up to the exception limit with prior authorization.

Covered Quantities

Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

Medication	Standard Limit	Exception Limit
Rinvoq (upadacitinib) 15 mg extended-release tablet	30 tablets per 30 days	N/A
Rinvoq (upadacitinib) 30 mg extended-release tablet	30 tablets per 30 days	N/A
Rinvoq (upadacitinib) 45 mg extended-release tablet	N/A	84 tablets per 84 days
Rinvoq (upadacitinib) LQ 1 mg/mL oral solution	360 mL (2 bottles) per 30 days	N/A

FDA-recommended Dosing

Abbreviations: RA = rheumatoid arthritis; PsA = psoriatic arthritis; AS = ankylosing spondylitis; nr-axSpA = non-radiographic axial spondyloarthritis; pJIA = polyarticular juvenile idiopathic arthritis; GCA = giant cell arteritis

RA, AS, nr-axSpA, GCA

• 15 mg once daily

PsA

• Pediatric patients 2 years of age to less than 18 years of age weighing 30 kg and greater and adults:
  • 15 mg once daily
• Pediatric patients 2 years of of age to less than 18 years of age weighing:
  • 10 kg to less than 20 kg: 3 mg (3 mL oral solution) twice daily
  • 20 kg to less than 30 kg: 4 mg (4 mL oral solution) twice daily
  • 30 kg and greater: 6 mg (6 mL oral solution) twice daily

pJIA

• Pediatric patients 2 years of age and older weighing 30 kg and greater:
  • 15 mg once daily
• Pediatric patients 2 years of of age to less than 18 years of age weighing:
  • 10 kg to less than 20 kg: 3 mg (3 mL oral solution) twice daily
  • 20 kg to less than 30 kg: 4 mg (4 mL oral solution) twice daily
• 30 kg and greater: 6 mg (6 mL oral solution) twice daily

Atopic Dermatitis

• Pediatric patients 12 years of age and older weighing at least 40 kg and adults less than 65 years of age:
  • Initiate treatment with 15 mg once daily. A dosage of 30 mg once daily may be considered if an adequate response is not achieved.
• Dose adjustments: Reduce to 15 mg once daily for patients:
  • 65 years of age and older
  • With severe renal impairment (not recommended for patients with end stage renal disease)
  • Receiving strong CYP3A4 inhibitors

Ulcerative Colitis

• Induction dose of 45 mg once daily for 8 weeks.
• Maintenance dose of 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease.
• Dose adjustments: Induction dose of 30 mg once daily for 8 weeks and maintenance dose of 15 mg once daily for patients:
  • With severe renal impairment
  • With mild to moderate hepatic impairment (Child-Pugh A or B)
  • Receiving strong CYP3A4 inhibitors

Crohn’s Disease

• Induction dose of 45 mg once daily for 12 weeks.
• Maintenance dose of 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease.
• Dose adjustments: Induction dose of 30 mg once daily for 12 weeks and maintenance dose of 15 mg once daily for patients:
  • With severe renal impairment
  • With mild to moderate hepatic impairment (Child-Pugh A or B)
  • Receiving strong CYP3A4 inhibitors

Place of Service:

Outpatient

The above policy is based on the following references:

1. Rinvoq [package insert]. North Chicago, IL: AbbVie Inc.; April 2025.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 19, 2025