Subject: Specialty Quantity Limit Xeljanz-Xeljanz XR 2091-H P2025a

Drug

Xeljanz-Xeljanz XR

XELJANZ  (tofacitinib)

XELJANZ XR  (tofacitinib extended-release)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Medication	Standard Limit
Xeljanz (tofacitinib) 5 mg tablet	60 tablets per 30 days
Xeljanz (tofacitinib) 10 mg tablet	60 tablets per 30 days
Xeljanz (tofacitinib) 1 mg/mL oral solution	240 mL (1 bottle) per 24 days
Xeljanz XR (tofacitinib extended-release) 11 mg tablet	30 tablets per 30 days
Xeljanz XR (tofacitinib extended-release) 22 mg tablet	30 tablets per 30 days

FDA-Recommended dosing

Abbreviations: RA = rheumatoid arthritis; PsA = psoriatic arthritis; AS = ankylosing spondylitis; pcJIA = polyarticular course juvenile idiopathic arthritis; UC = ulcerative colitis

Xeljanz tablets

RA/PsA/AS/pcJIA

• 5 mg twice daily (for pcJIA and pediatric PsA, if body weight ≥ 40 kg)
• Dose adjustment: reduce to 5 mg once daily for patients:
  • Receiving strong CYP3A4 inhibitors
  • Receiving a moderate CYP3A4 inhibitor with a strong CYP2C19 inhibitor (coadministration with strong CYP3A4 inducer is not recommended)
  • With moderate or severe renal impairment
  • With moderate hepatic impairment (not recommended for patients with severe hepatic impairment)

Ulcerative Colitis

Induction

10 mg twice daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed, continue 10 mg twice daily for a maximum of 16 weeks. Discontinue 10 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.

Maintenance

5 mg twice daily. For patients with loss of response during maintenance treatment, a dosage of 10 mg twice daily may be considered and limited to the shortest duration, with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dose needed to maintain response.

Dose Adjustments

If taking 10 mg twice daily reduce to 5 mg twice daily, and if taking 5 mg twice daily reduce to 5 mg once daily for patients:

• Receiving strong CYP3A4 inhibitors
• Receiving a moderate CYP3A4 inhibitor with a strong CYP2C19 inhibitor (coadministration with strong CYP3A4 inducer is not recommended)
• With moderate or severe renal impairment
• With moderate hepatic impairment (not recommended for patients with severe hepatic impairment)

Xeljanz oral solution

pcJIA/pediatric PsA

• 10 kg ≤ body weight < 20 kg: 3.2 mg (3.2 mL oral solution) twice daily
• 20 kg ≤ body weight < 40 kg: 4 mg (4 mL oral solution) twice daily
• Body weight ≥ 40 kg: 5 mg (5 mL oral solution) twice daily
• Dose adjustment: reduce to once daily dosing for patients:
  • Receiving strong CYP3A4 inhibitors
  • Receiving a moderate CYP3A4 inhibitor with a strong CYP2C19 inhibitor (coadministration with strong CYP3A4 inducer is not recommended)
  • With moderate or severe renal impairment
  • With moderate hepatic impairment (not recommended for patients with severe hepatic impairment)

Xeljanz XR

RA/PsA/AS

11 mg once daily

Dose adjustment

Reduce to 5 mg once daily for patients:

• Receiving strong CYP3A4 inhibitors
• Receiving a moderate CYP3A4 inhibitor with a strong CYP2C19 inhibitor (coadministration with strong CYP3A4 inducer is not recommended)
• With moderate or severe renal impairment
• With moderate hepatic impairment (not recommended for patients with severe hepatic impairment)

Ulcerative Colitis

Induction

22 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 22 mg once daily for a maximum of 16 weeks. Discontinue 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved.

Maintenance

11 mg once daily. For patients with loss of response during maintenance treatment, a dosage of 22 mg once daily may be considered and limited to the shortest duration, with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dose needed to maintain response.

Dose Adjustments

If taking 22 mg once daily, reduce to 11 mg once daily, and if taking 11 mg once daily, reduce to 5 mg once daily for patients:

• Receiving strong CYP3A4 inhibitors
• Receiving a moderate CYP3A4 inhibitor with a strong CYP2C19 inhibitor (coadministration with strong CYP3A4 inducer is not recommended)
• With moderate or severe renal impairment
• With moderate hepatic impairment (not recommended for patients with severe hepatic impairment)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xeljanz/Xeljanz XR [package insert]. New York, NY: Pfizer, Inc.; October 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.

January 01, 2026