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| Medical Policy: | I-129-007 |
| Topic: | Vedolizumab (Entyvio®) |
| Section: | Injections |
| Effective Date: | May 28, 2018 |
| Issue Date: | May 28, 2018 |
| Last Reviewed: | February 2018 |
Vedolizumab (Entyvio) is a monoclonal antibody and integrin receptor antagonist used for the treatment of moderately to serverly active Crohn’s disease (CD) and ulcerative colitis (UC) in adult patients. Vedolizumab reduces chronically inflamed gastrointestinal tissue associated with UC/CD by binding to the α4β7 integrin receptor and inhibiting its interaction with mucosal addressin cell adhesion molecule-1 (MAdCAM-1). This results in the inhibition of memory T-lymphocyte movement across the endothelium of the inflamed gastrointestinal tissues. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Primary Non-responders to adalimumab (Humira) or infliximab (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis), or infliximab-qbtx (Ixifi).
Vedolizumab (Entyvio) may be considered medically necessary when ANY ONE of the following criteria is met:
- Treatment with infliximab (Remicade) or an infliximab biosimilar for at least fourteen weeks was ineffective, not tolerated, or is contraindicated in patients with moderate to severe disease activity of UC or CD; or
- Treatment with adalimumab (Humira) for at least eight weeks was ineffective, not tolerated, or is contraindicated in patients with moderate to severe disease activity of UC; or
- Treatment with adalimumab (Humira) for at least twelve weeks was ineffective, not tolerated, or is contraindicated in patients with moderate to severe disease activity of CD.
Primary Responders to adalimumab (Humira) now relapsing
Vedolizumab (Entyvio) may be considered medically necessary for UC or CD in patients who initially achieved remission in their disease with adalimumab (Humira) AND have lost response to adalimumab (Humira) as evidenced by a relapse in disease activity during treatment, for the following indication:
- Treatment with infliximab (Remicade) or an infliximab biosimilar for at least fourteen weeks was ineffective, not tolerated, or is contraindicated.
An exception to the requirement for infliximab (Remicade) or an infliximab biosimilar failure in order to receive approval for vedolizumab (Entyvio) for this group of “primary responders to adalimumab (Humira) now relapsing” may be considered if the treating physician chooses to independently obtain therapeutic drug monitoring and the tests show strong levels of adalimumab with no antibodies.
Note: Therapeutic monitoring of drug levels for infliximab (Anser IFX) and adalimumab (Anser ADA) are considered experimental/investigational and therefore non-covered.
Primary Responders to infliximab (Remicade) now relapsing
Vedolizumab (Entyvio) may be considered medically necessary for moderate to severe disease activity of UC or CD in patients who initially achieved remission in their disease with infliximab (Remicade) or an infliximab biosimilar AND have lost response as evidenced by a relapse in their symptoms during treatment.
Contraindications for adalimumab (Humira) or infliximab (Remicade)
Vedolizumab (Entyvio) may be considered medically necessary as an initial therapy for moderate to severe disease activity of UC or CD in patients for whom a tumor necrosis factor (TNF) is contraindicated. TNF’s are contraindicated in patients with:
- Moderate to severe Class III or IV heart failure (HF). (Remicade dose should not exceed 5mg/kg); or
- Previous severe hypersensitivity to inactive components of (Remicade) or an infliximab biosimilar or to any murine proteins; or
- Patients in which the risks of treatment with a TNF inhibitor may outweigh the benefits of treatment:
- Current malignancy; or
- Lupus or lupus-like syndrome with a TNF inhibitor that required discontinuation of TNF inhibitor therapy; or
- Demyelinating disorder with a TNF inhibitor therapy that required discontinuation of TNF inhibitor therapy; or
- New onset or worsening of heart failure that required discontinuation of TNF inhibitor therapy.
Vedolizumab (Entyvio) is considered not medically necessary for an individual with ANY of the following:
- In combination with a tumor necrosis factor (TNF) antagonist [e.g., adalimumab (Humira), golimumab (Simponi]; or
- In combination with an immunomodulatory drug, such as natalizumab (Tysabri); or
- Uncontrolled active, severe infections including but not limited to: sepsis, tuberculosis, cytomegaloviral colitis, giardiasis, listeria meningitis, salmonella sepsis, anal abscess etc.; or
- Individual has not had a tuberculin skin test (TST) or Centers for Disease Control (CDC) recommended equivalent to evaluate for latent tuberculosis prior to initiating vedolizumab; or
- New or worsening neurological signs or symptoms of John Cunningham virus (JCV) infection or risk of progressive multifocal leukoencephalopathy (PML).
Vedolizumab (Entyvio) for any other indication is considered experimental/investigational and therefore non-covered.
Non-Preferred Intravenous Injectable Product(s)
In order for a request for the non-preferred product, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis) to be approved for Crohn's disease, Fistulizing Crohn's disease or Ulcerative colitis, the individual must have had an adequate therapeutic trial and experienced a documented drug therapy failure or intolerance to infliximab, cA2 (Remicade).
NOTE: Dosage recommendations per the FDA label. |
| Place of Service: Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Intravenous Vedolizumab (Entyvio) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
12/2017, Criteria Revised for Vedolizumab (Entyvio)
03/2018, Coverage Criteria Revised for Vedolizumab (Entyvio)
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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