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HealthPartners

Coverage criteria policies

Vedolizumab (Entyvio®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Entyvio requires prior authorization from Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

Entyvio is generally approved for use in patients diagnosed with moderate to severe ulcerative colitis and moderate to severe Crohn’s disease when all the following criteria are met:

Initial approvals
  1. Prescribed and followed by Gastoenterology.
  2. Patient has had a trial and failure of an appropriate regimen of first-line therapy based on the indication for treatment:
    1. Moderate to Severe Ulcerative colitisUse of at least two of the systemic regimens below for at least 12 weeks:
      1. Sulfasalazine 4-6 gram daily
      2. Mesalamine 2-4.8 gram daily
      3. Balsalazide 6.75 grams
      4. Corticosteroid regimens:
        1. Prednisone 40-60 mg daily
        2. Oral budesonide 9 mg daily
        3. Budesonide rectal; or
      5. Azathioprine 1.5-2.5 mg/kg daily
      6. 6-mercaptopurine 1-1.5 mg/kg daily
    2. Moderate to Severe Crohn’s DiseaseUse of first-line therapy including one of the following:
      1. Treatment with any of the following corticosteroid regimens for two weeks has been ineffective or is contraindicated:
        1. Prednisone 40-60 mg daily
        2. Oral budesonide 9 mg daily
        3. Budesonide rectal; or
      2. Inability to taper off one of the corticosteroid regimens above; or
      3. Breakthrough disease while stabilized for at least 3 months on one of the following therapies:
        1. Azathioprine 2-3 mg/kg daily
        2. 6-mercaptopurine 1-1.5 mg/kg daily
        3. Methotrexate 20mg weekly (GI intolerance requires trial of SC/IM methotrexate at 20mg weekly)
  3. Patient has had at least a 3-month trial and failure or intolerance or a contraindication to use of Remicade.
  4. The prescribed regimen is within the FDA-approved dosing regimen of 300mg at 0, 2, and 6 weeks, then every 8 weeks thereafter.
  5. No other biologic agent will be used concurrently to treat this indication.
  6. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Authorizations will be provided for one year with the following limitations:

  • A maximum of 10 infusions will be approved during the first year and 7 infusions will be approved in subsequent years. No more than 1 vial may be billed for each infusion event.
Reauthorizations for biologic regimens of up to FDA-approved doses and frequencies

Renewals will be provided annually with provider attestation that they have seen the patient within the last fourteen months and the patient is benefiting from use of the medication.

Requests for more intense (dose or interval) biologic therapy than the FDA-approved regimen

All requests for regimens exceeding the FDA-approved regimen (including annual renewals) will require provider attestation that the off-label regimen is medically necessary.

Definitions

Vedolizumab (Entyvio®) is an integrin receptor antagonist indicated for:

Adult Ulcerative Colitis (UC)

  • Adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids:
    • inducing and maintaining clinical response
    • inducing and maintaining clinical remission
    • improving endoscopic appearance of the mucosa
    • achieving corticosteroid-free remission

Adult Crohn's Disease (CD)

  • Adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids:
    • achieving clinical response
    • achieving clinical remission
    • achieving corticosteroid-free remission

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS Codes

Codes

Description

J3380

Injection, vedolizumab, 1mg

NDC Codes

Codes

Description

64764030020

Entyvio 300mg solution

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Entyvio Prescribing Information. Deerfield, IL: Takeda Pharmaceuticals America, Inc. May 2014.
  2. Lichtenstein GR, Hanauer SB, Sandborn WJ, et al., Management of crohn’s disease in adults. Am J Gastroenterol 2009; 104:465-483.
  3. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American college of gastroenterology, practice parameters committee. Am J Gastroenterol 2010; 105-523.

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Policy activity

  • 08/25/2014 - Date of origin
  • 07/01/2017 - Effective date
Review date
  • 08/2017
Revision date
  • 10/01/2016

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