• Ibalizumab-uiyk (Trogarzo^® ) intravenous infusion for administration by a healthcare professional

• For treatment of human immunodeficiency virus type 1 (HIV-1) infection, used in combination with other antiretroviral(s), in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of multidrug resistant human immunodeficiency virus type 1 (HIV-1) infection; AND
3. The patient has an HIV RNA viral load greater than 1,000 copies/mL [medical record documentation required]; AND
4. The patient has a history of at least 6 months of antiretroviral treatment and has current or recent treatment failure; AND
5. The patient has resistance to at least one antiretroviral medication from each of the three classes of antiretroviral medications (i.e., protease inhibitors, nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors) as measured by resistance testing [medical record documentation required]; AND
6. The patient will be taking the requested agent in combination with an optimized background antiretroviral regimen, containing at least one agent that demonstrates full viral sensitivity/susceptibility; AND
7. he requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
8.  For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: 180 days (6 months)

Continuation Criteria for Approval

1. The patient was approved through Blue Cross NC initial criteria for approval; OR
2. The patient would have met initial criteria for approval at the time they started therapy; AND 
3. The patient has had a clinically significant response to ibalizumab-uiyk (Trogarzo^® ) therapy (i.e., decreased viral load, improvement to achieve < 200 copies/mL) [medical record documentation required]; AND
4. The patient does NOT have evidence of virologic failure, defined as one of the following: 
   1. Viral load > 200 copies/mL at or beyond 24 weeks after initiating antiretroviral therapy [medical record documentation required]; OR
   2. Evidence of sustained recurrence of viremia to > 200 copies/mL (i.e., on two consecutive measurements) after initial viral suppression [medical record documentation required]; AND
5. The patient will continue taking the requested agent in combination with an optimized background antiretroviral regimen, containing at least one agent that demonstrates full viral sensitivity/susceptibility; AND
6. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
7. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: 365 days (1 year)

1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR
2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met:
   1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
   2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
   3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
   4. Re-initiation of therapy, defined as ONE of the following:
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR 
   5. Requirement of a change in the requested restricted product formulation; AND
3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

All information referenced is from FDA package insert unless otherwise noted below.

1. Emu B, Fessel, J, Schrader S, et al. Phase 3 study of ibalizumab for multidrug-resistant HIV-1. N Engl J Med. 2018;379(7):645-654. 

October 2021: Criteria change: Added Site of Care medical necessity criteria. Policy notification given 8/2/2021 for effective date 10/1/2021.

June 2021: Criteria change: Updated definition of virologic failure for clarity.

June 2021: Criteria change: Added definition of clinically significant response in continuation section; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.