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Coverage criteria policies

Ibalizumab-uiyk (Trogarzo™) – 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

Trogarzo requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

Trogarzo is generally covered subject to the indications listed below when all of the following criteria are met, and per member plan documents.

Initial Authorizations:
  1. Patient is at least 18 years old; and,
  2. Patient has heavily treated multidrug resistant disease (including failure of at least one NRTI, NNRTI, and PI); and,
  3. Used in combination with antiretroviral therapy (ART); and,
  4. Patient is currently failing on their current antiretroviral regimen.

Initial authorizations will be provided for 6 months.

Reauthorizations:

  1. Patient continues to meet initial criteria; and,
  2. Disease response as indicated by a decrease in viral load; and,
  3. Absence of unacceptable toxicity from the drug.

Reauthorizations will be provided for 6 months.

Quantity Limits:

Loading dose: 2,000 mg (10 vials or 13.3ml)

Maintenance dose: 800 mg (4 vials or 5.32 ml) every 2 weeks

Definitions

Trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.

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

C9399

Unclassified drugs or biologicals (This code should only be used for drugs and biologicals that are approved by the FDA on or after January 1, 2004) (Hospital Outpatient Use ONLY)

J1746

Injection, ibalizumab-uiyk, 10 mg (use effective 1/1/2019)

J3590

Unclassified biologics (use before 1/1/2019)

NDC

Codes

Description

62064012201

Trogarzo 200 MG/1.33ML SOLN

62064012202

Trogarzo 200 MG/1.33ML 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/trogarzo.jsp

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Policy activity

  • 08/13/2018 - Date of origin
  • 01/01/2019 - Effective date

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