Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Initial Criteria
Vedolizumab (Entyvio) may be considered medically necessary when the following criteria are met:
- The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
- ONE of the following:
- If a diagnosis of Crohn's Disease, then ONE of the following:
- The individual must have failed a three (3)-month trial of a TNF inhibitor [i.e., infliximab-axxq (Avsola), certolizumab pegol (Cimzia), adalimumab (Humira), infliximab-abda (Renflexis), infliximab-dyyb (Inflectra), Infliximab, or infliximab (Remicade)], as evidenced by paid claims or printouts; or
- The individual has a high risk of infection or malignancy (e.g., age greater than 55 years, history of malignancy, history of serious infection); or
- If a diagnosis of Ulcerative Colitis, then ONE of the following:
- The individual must have failed a three (3)-month trial of a TNF inhibitor [i.e., infliximab-axxq (Avsola), adalimumab (Humira), infliximab-abda (Renflexis), infliximab-dyyb (Inflectra), Infliximab, infliximab (Remicade), or golimumab (Simponi)], as evidenced by paid claims or printouts; or
- The individual has a high risk of infection or malignancy (e.g., age greater than 55 years, history of malignancy, history of serious infection).
Reauthorization Criteria
The continued use of vedolizumab (Entyvio) may be considered medically necessary when ALL of the following criteria are met:
- The individual has previously been approved for vedolizumab (Entyvio) through Blue Cross Blue Shield of North Dakota's precertification process; and
- The prescriber has provided documentation that the individual has demonstrated disease stability or beneficial response to therapy; and
- The individual must continue to meet applicable initial criteria.
The use of vedolizumab (Entyvio) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
