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Coverage criteria policies

Avelumab (Bavencio®) – Minnesota Health Care Programs

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

Avelumab (Bavencio) requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

All requests for doses exceeding the FDA-approved regimen will not be covered.

Initial authorization criteria:

Merkel cell carcinoma (MCC):

  1. Patient must be at least 12 years of age; and,
  2. Patient must have a diagnosis of metastatic MCC; and,
  3. Patient has tried and failed guideline recommended chemotherapy treatment regimen(s); and,
  4. Patient is not currently participating in a clinical trial; and,
  5. Prescriber must attest that patient will be provided reproductive health instructions during therapy and for at least 1 month after stopping therapy

Initial authorization is for 3 months.

Urothelial carcinoma (UC):

  1. Patient must be at least 18 years of age; and,
  2. Patient must have a diagnosis of metastatic UC; and,
  3. Patient is not currently participating in a clinical trial; and,
  4. One of the following:
    1. Patient has had disease progression during or following platinum-containing chemotherapy; or,
    2. Patient has had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; and
  5. Prescriber must attest that patient will be provided reproductive health instructions during therapy and for at least 1 month after stopping therapy

Initial authorization is for 3 months.

Reauthorization criteria:

  1. Documentation that patient has no disease progression; and,
  2. Absence of any one of the following unacceptable toxicities from the drug:
    1. Grade 3 or 4 pneumonitis or recurrent Grade 2 pneumonitis
    2. AST/ALT more than 5 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal
    3. Grade 4 diarrhea or colitis or recurrent Grade 3 diarrhea or colitis
    4. Serum creatinine more than 1.5 and up to 6 times the upper limit of normal
    5. Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks
    6. Persistent Grade 2 or 3 immune-mediate adverse reactions lasting more than 12 weeks

Reauthorization is for 6 months.

Quantity limit:

10 mg/kg every 2 weeks, weight must be submitted at time of request

Definitions:

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.

The services associated with these codes require prior authorization:
HCPCS

Codes

Description

J9023

Injection, avelumab, 10 mg

NDC

Codes

Description

44087353501

Bavencio 200 MG/10ML SOLN

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. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/bavencio.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date

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