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Table 38: Antiretroviral/HIV Therapy


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Drug Category: Anti-infectives

Medication Class/Individual Agents: Antiretroviral/HIV Therapy

I. Prior-Authorization Requirements

 Antiretroviral/HIV Therapy – CCR5 Antagonists

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

maraviroc solution Selzentry PA  
maraviroc tablet Selzentry PA   BP, A90

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

Cabotegravir injection:

  • Cabotegravir injection is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection. Individuals must have a negative HIV-1 test prior to PrEP initiation and must be tested with each subsequent injection due to reports of drug-resistant HIV-1 variants when used by individuals with undiagnosed HIV-1 infection.

Fostemsavir:

  • Fostemsavir 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 due to resistance, intolerance, or safety considerations.

Ibalizumab-uiyk:

  • Ibalizumab-uiyk, 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.

Maraviroc Black Box Warning:

  • Hepatotoxicity has been reported with maraviroc use. Evidence of a systemic allergic reaction (e.g., pruritic rash, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur. Members with signs or symptoms of hepatitis or allergic reaction following use of maraviroc should be evaluated immediately.

Maraviroc Warnings:

  • Caution should be used when administering maraviroc to members with preexisting liver dysfunction or who are co-infected with viral hepatitis B or C.
  • More cardiovascular events including myocardial ischemia and/or infarction were observed in members who received maraviroc. Use with caution in members at increased risk of cardiovascular events.


 

 Antiretroviral/HIV Therapy – CD4-Directed Post-Attachment Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

ibalizumab-uiyk Trogarzo PA  

 Antiretroviral/HIV Therapy – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

abacavir / dolutegravir / lamivudine Triumeq PD test  
abacavir / lamivudine Epzicom test   # , A90
abacavir / lamivudine / zidovudine Trizivir test   # , A90
atazanavir / cobicistat Evotaz test  
bictegravir / emtricitabine / tenofovir alafenamide Biktarvy PD test  
cabotegravir / rilpivirine Cabenuva PD test  
darunavir / cobicistat Prezcobix PD test  
darunavir / cobicistat / emtricitabine / tenofovir alafenamide Symtuza PD test  
dolutegravir / lamivudine Dovato PD test  
dolutegravir / rilpivirine Juluca PD test  
doravirine / lamivudine / tenofovir disoproxil fumarate Delstrigo PD test  
efavirenz / emtricitabine / tenofovir Atripla test   # , A90
efavirenz 400 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg Symfi Lo PA   A90
efavirenz 600 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg Symfi PA   A90
elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide Genvoya PD test  
elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil fumarate Stribild test  
emtricitabine / rilpivirine / tenofovir alafenamide Odefsey PD test  
emtricitabine / rilpivirine / tenofovir disoproxil fumarate Complera test  
emtricitabine / tenofovir alafenamide Descovy PD test  
emtricitabine / tenofovir disoproxil fumarate Truvada test   # , A90
lamivudine / tenofovir disoproxil fumarate Cimduo PA  
lamivudine / tenofovir disoproxil fumarate Temixys PA  
lamivudine / zidovudine Combivir test   # , A90

 Antiretroviral/HIV Therapy – Fusion Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

enfuvirtide Fuzeon test  

 Antiretroviral/HIV Therapy – Integrase Strand Transfer Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

cabotegravir injection Apretude PA  
cabotegravir tablet Vocabria test  
dolutegravir tablet Tivicay PA   - > 1 unit/day
dolutegravir tablet for oral suspension Tivicay PD test  
raltegravir Isentress test  

 Antiretroviral/HIV Therapy – Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

doravirine Pifeltro PD test  
efavirenz Sustiva test   # , A90
etravirine Intelence test   BP
nevirapine Viramune test   # , A90
nevirapine extended-release Viramune XR PA   A90
rilpivirine Edurant test  

 Antiretroviral/HIV Therapy – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

cobicistat Tybost test  
tesamorelin Egrifta SV PA  

 Antiretroviral/HIV Therapy – Nucleoside Analog Reverse Transcriptase Inhibitors (NRTI)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

abacavir Ziagen test   # , A90
didanosine test   A90
emtricitabine Emtriva test   BP, A90
lamivudine 10 mg/mL solution Epivir test   # , A90
lamivudine 150 mg, 300 mg tablet Epivir test   # , A90
stavudine test   A90
zidovudine Retrovir test   # , A90

 Antiretroviral/HIV Therapy – Nucleotide Analog Reverse Transcriptase Inhibitors (NtRTI)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

tenofovir disoproxil fumarate powder Viread PA   - ≥ 13 years A90
tenofovir disoproxil fumarate tablet Viread PA   - > 1 unit/day # , A90

 Antiretroviral/HIV Therapy – Protease Inhibitors (PI)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

atazanavir Reyataz test   # , A90
darunavir Prezista PD test   BP
fosamprenavir Lexiva test   BP
lopinavir / ritonavir Kaletra test   # , A90
nelfinavir Viracept test  
ritonavir packet, solution Norvir test  
ritonavir tablet Norvir PD test   BP, A90
saquinavir Invirase test  
tipranavir Aptivus test  

 Antiretroviral/HIV Therapy – gp120 Attachment Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

fostemsavir Rukobia PD PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • HIV-associated visceral adipose tissue accumulation (VAT) lipodystrophy (Egrifta)
  • HIV infection (Cimduo, efavirenz/lamivudine/tenofovir disoproxil fumarate, maraviroc, nevirapine extended-release, Rukobia, tenofovir disoproxil fumarate, Temixys, Tivicay, Trogarzo)
  • Pre-exposure prophylaxis (Apretude)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member's condition and requested medication (see below).

 

 Apretude

  • Documentation of all of the following is required:
    • indication of pre-exposure prophylaxis; and
    • member is HIV-negative; and
    • member is considered at-risk for acquiring HIV infection; and
    • member weight is ≥ 35 kg; and
    • clinical rationale for use instead of both of the following: emtricitabine/tenofovir disproxil fumarate, Descovy; and
    • appropriate dosing.

  

 Cimduo and Temixys

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • member is ≥ 18 years of age; or
      • member is < 18 years of age and weighs ≥ 35 kg; and
    • clinical rationale for use of the combination product instead of the commercially available separate agents; and
    • concurrent antiretroviral therapy with at least one other antiretroviral; and
    • requested quantity is ≤ one unit/day.

  

efavirenz 400 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg 

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • member is ≥ 18 years of age; or
      • member is < 18 years of age and weighs ≥ 35 kg; and
    • clinical rationale for use of the combination product instead of the commercially available separate agents; and
    • requested quantity is ≤ one unit/day.

  

efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg 

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • member is ≥ 18 years of age; or
      • member is < 18 years of age and weighs ≥ 40 kg; and
    • clinical rationale for use of the combination product instead of the commercially available separate agents; and
    • requested quantity is ≤ one unit/day.

    

Egrifta SV

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • appropriate dose and frequency; and
    • member has been using antiretroviral therapy for at least two months within the last 90 days; and
    • other potential causes of VAT accumulation/central obesity have been ruled out; and
    • one of the following:
      • for male member, waist circumference is currently > 102 cm; or
      • for female member, waist circumference is currently > 88 cm; and
    • member has failed lifestyle modification with diet and exercise.
  • For recertification, documentation of a decrease in waist circumference from baseline is required.

    

maraviroc

  • Documentation of the following is required:
    • appropriate diagnosis.

SmartPA: Claims for maraviroc will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for HIV disease. 

 

nevirapine extended-release

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical records documenting an inadequate response or adverse reaction to nevirapine immediate-release formulation.

 

Rukobia for HIV-1 infection

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • ongoing detectable viremia; and
    • antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindication to antiretroviral; and
    • failing current antiretroviral regimen due to resistance, intolerance or safety considerations; and
    • concurrent antiretroviral therapy with at least one other antiretroviral; and
    • requested quantity is ≤ two units/day.

    

tenofovir disoproxil fumarate tablet > one unit/day

  • Documentation of all of the following is required:
    • diagnosis of one of the following:
      • HIV infection; or
      • Chronic Hepatitis B; and
    • clinical rationale for exceeding the quantity limit. 

  

Tivicay > one unit/day

  • For members <18 years of age, documentation of all of the following is required:
    • appropriate diagnosis; and
    • concurrent therapy with efavirenz, fosamprenavir/ritonavir, Aptivus (tipranavir)/ritonavir, rifampin, or carbamazepine.
  • For members ≥ 18 years of age, documentation of all of the following is required:   
    • appropriate diagnosis; and
    • one of the following:
      • concurrent therapy with efavirenz, fosamprenavir/ritonavir, Aptivus (tipranavir)/ritonavir, rifampin, or carbamazepine; or
      • integrase strand transfer inhibitor (INSTI)-associated resistance substitutions or clinically suspected INSTI-resistance. 

Trogarzo 

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • ongoing detectable viremia; and
    • resistance to at least one agent from each of the following three classes of antiretrovirals: NRTI, NNRTI, PI; and
    • concurrent antiretroviral therapy with at least one other antiretroviral; and
    • appropriate dosing.

 

Viread powder ≥ 13 years of age

  • Documentation of all of the following is required:
    • diagnosis of one of the following:
      • HIV infection; or
      • Chronic Hepatitis B; and
    • swallowing disorder or condition affecting ability to swallow tablets (i.e., dysphagia).

SmartPA: Claims will usually process at the pharmacy without a PA for members ≥ 13 years of age request if the member has a history of paid MassHealth pharmacy claims of the requested medication for at least 90 days out of the last 120 days.

 

† Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 09/2007

Last Revised Date: 09/2022


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Last updated 09/19/22

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