Subject: Specialty Quantity Limit Rinvoq 3175-H P2024a
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RINVOQ
(upadacitinib tablets; oral solution)
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Policy:
I. 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.
II. COVERED QUANTITIES
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Medication
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Standard Limit
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Exception Limit*
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FDA-recommended dosing
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Rinvoq (upadacitinib) 15 mg
extended-release tablet
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30 tablets per 30 days
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N/A
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RA, AS, nr-axSpA: 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
pJIA
• Pediatric patients 2 years of age and older weighing 30 kg
and greater: 15 mg once 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
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Rinvoq (upadacitinib) 30 mg
extended-release tablet
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30 tablets per 30 days
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N/A
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Rinvoq (upadacitinib) 45 mg
extended-release tablet
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No standard limit - only
used for induction dosing
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84 tablets per 84 days
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Rinvoq (upadacitinib) LQ
1 mg/mL oral solution
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360 mL (2 bottles)
per 30 days
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N/A
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PsA/pJIA
• Pediatric patients 2 years 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
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Abbreviations: RA = rheumatoid arthritis; PsA = psoriatic arthritis; AS = ankylosing spondylitis; nr-axSpA = non-radiographic axial spondyloarthritis, pJIA: polyarticular juvenile idiopathic arthritis
*Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.
Place of Service:
Outpatient
The above policy is based on the following references:
- Rinvoq [package insert]. North Chicago, IL: AbbVie Inc.; April 2024.
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.
June 30, 2024
