Effective Date:
a) This policy will apply to all services performed on or after the above revision date which will become the new effective date.
b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.
1) Entyvio (Vedolizumab) requires prior authorization.
2) Entyvio is used to treat Ulcerative Colitis and Crohn’s Disease.
Entyvio (Vedolizumab) is considered medically necessary for patients with moderate to severely active Ulcerative Colitis or moderate to severely active Crohn’s Disease (K50.00 - K50.919) AND the following:
1) For Ulcerative Colitis, inadequate response with, or lost response to or was not able to tolerate a) either Stelara, or Simponi AND b) Xeljanz/XR
2) For Crohn’s Disease, inadequate response with, or lost response to or was not able to tolerate two (2) of Humira, Cimzia, and Stelara.
3) For both UC and Crohn’s Disease, inadequate response with, or lost response to or demonstrated dependence on corticosteroids AND
Reauthorization requires documentation that patient is responding positively to therapy.
Codes Used In This BI:
C9026 – Injection, Vedolizumab, 1mg (deleted 12/31/2015)
J3380 – Injection, Vedolizumab, 1mg (Entyvio) effective 1/1/2016
1) Entyvio Prescribing Information. Takeda Pharmaceuticals. May 2014.
2) Clinical Pharmacology. Accessed online 3/2/2015.
3) Sands, B, Peyrin-Biroulet L, Loftus, Jr. E, et al. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med 2019; 381:1215-1226. September 2019.