tofacitinib
Marketed as XELJANZ, XELJANZ XR.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| NDA213082 | XELJANZ | 2020-09-25 | PFIZER |
| NDA208246 | XELJANZ XR | 2016-02-23 | PFIZER |
| NDA203214 | XELJANZ | 2012-11-06 | PF PRISM CV |
Manufacturers
PFIZER, PF PRISM CV
Common denial patterns
- Boxed warning step therapy — TNF-inhibitor required first (FDA 2021 ORAL Surveillance trial)
- Age restriction (≥50 with CV risk factors excluded)
- Indication restriction (RA vs PsA vs UC vs JIA)
Specific notes
Brand: Xeljanz. JAK1/3 inhibitor. FDA boxed warning (September 2021) for increased risk of MACE, malignancy, thrombosis, mortality vs TNF inhibitors — based on ORAL Surveillance trial. Plans now uniformly require TNF-inhibitor failure first.
Pfizer XELSOURCE: https://www.xeljanz.com
Frequently asked questions
Why does insurance commonly deny tofacitinib?
Boxed warning step therapy — TNF-inhibitor required first (FDA 2021 ORAL Surveillance trial); Age restriction (≥50 with CV risk factors excluded); Indication restriction (RA vs PsA vs UC vs JIA).
When was tofacitinib FDA approved?
Earliest FDA approval on record: 2012-11-06.
What brand names are sold as tofacitinib?
XELJANZ, XELJANZ XR.
Is there a patient assistance program for tofacitinib?
Yes — Pfizer XELSOURCE at https://www.xeljanz.com.
What's specific to tofacitinib?
Brand: Xeljanz. JAK1/3 inhibitor. FDA boxed warning (September 2021) for increased risk of MACE, malignancy, thrombosis, mortality vs TNF inhibitors — based on ORAL Surveillance trial. Plans now uniformly require TNF-inhibitor failure first.
Sources
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