top of page
< Back

202203-147246

2022

Healthfirst Inc.

Medicaid

Digestive System/ Gastrointestinal

Pharmacy/ Prescription Drugs

Medical necessity

Upheld

Case Summary

Diagnosis: Digestive System/Gastrointestinal.
Treatment: Pharmacy/Prescription Drugs.
The insurer denied Xeljanz.
The denial is upheld.

The patient is a male with ulcerative colitis (pancolitis), psoriasis, and iron-deficiency anemia. He has failed mesalamine, Uceris foam, Remicade, and Entyvio. He has had improvement on Xeljanz 10 milligrams (mg) twice daily. Colonoscopy showed no disease activity. The subject under review is the medical necessity of Xeljanz for the treatment of Ulcerative Colitis.

the request for Xeljanz 10 mg is not supported as medically necessary by the submitted documentation in the case. Xeljanz has proven effective in a double-blind, placebo-controlled trial of patients with moderate-severe ulcerative colitis [1-5]. American Gastroenterological Association guidelines for the treatment of ulcerative colitis recommend Xeljanz to attain remission after failure of anti-tumor necrosis factor agents [6]. However, the requested dose is not supported.

According to the Food and Drug Administration (FDA)-approved prescribing information for Xeljanz, the dose of Xeljanz 10 mg twice daily is supported for 8 weeks; if needed, Xeljanz 10 mg twice daily or Xeljanz XR 22 mg once daily is supported for a maximum of 16 weeks, followed by maintenance with Xeljanz 5 mg twice daily or Xeljanz XR 11 mg once daily; for patients with loss of response during maintenance treatment, Xeljanz 10 mg twice daily or Xeljanz XR 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 [5]. Per the FDA-approved prescribing information, "For patients with loss of response during maintenance treatment, Xeljanz 10 mg twice daily or Xeljanz XR 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"; Xeljanz has adverse effects, and use of the minimal effective dose is advisable [5]. In this case, the failure of the standard dose of 5 mg twice daily or 11 mg daily (of Xeljanz XR) is not documented. For this reason, the request to continue Xeljanz 10 mg is not supported.

bottom of page