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HealthPartners

Coverage criteria policies

Ibalizumab-uiyk (Trogarzo™)

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. 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

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. Prescribed by an HIV-treatment specialist; and,
  2. Patient is 18 years of age or older; and,
  3. Patient has heavily treatment-experienced multidrug resistant HIV-1 infection, defined as trial and failure of at least one drug from each the following classes:
    1. NRTI
    2. NNRTI
    3. Protease Inhibitor
    4. INSTI (Integrase Strand Transfer Inhibitor); and,
  4. Viral load is >1,000 copies/mL, with medical chart documentation; and,
  5. Patient has been treated for HIV for a duration of at least 6 months, with current or recent therapeutic failure (in the last 8 weeks); and,
  6. The prescribed regimen is within the FDA approved dosing regimen.
  7. 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.

Initial authorizations will be provided for 6 months.

Reauthorizations:

  1. Prescribed by an HIV-treatment specialist; and,
  2. Patient is 18 years of age or older; and,
  3. Patient has been compliant to therapy; and ,
  4. Demonstrated positive effect from treatment, defined as a viral load reduction of >50%, or viral load of <200 copies/mL.

Reauthorizations will be provided for 12 months.

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.

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.

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. Trogarzo (Prescribing Information). Montreal, Quebec Canada. Theratechnologies Inc., March 2018.

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Policy activity

  • 08/13/2018 - Date of origin
  • 01/01/2019 - Effective date
Revision date
  • 11/05/2018

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