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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

maraviroc Selzentry PA  

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.

CCR-tropic HIV-1 Trofile Assay:

  • The Trofile co-receptor test assay is a diagnostic test that identifies CCR5-tropic HIV-1 infection.
  • A positive test result is required for the approval of maraviroc.

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. Patients 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 patients 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 patients who received maraviroc. Use with caution in patients at increased risk of cardiovascular events.
 

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

ibalizumab-uiyk Trogarzo PA  

 Antiretroviral/HIV Therapy – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

abacavir / dolutegravir / lamivudine Triumeq test  
abacavir / lamivudine Epzicom # test  
abacavir / lamivudine / zidovudine Trizivir # test  
atazanavir / cobicistat Evotaz test  
bictegravir / emtricitabine / tenofovir alafenamide Biktarvy PD test  
darunavir / cobicistat Prezcobix test  
darunavir / cobicistat / emtricitabine / tenofovir alafenamide Symtuza PA  
dolutegravir / rilpivirine Juluca PA  
doravirine / lamivudine / tenofovir disoproxil fumarate Delstrigo test  
efavirenz / emtricitabine / tenofovir Atripla test  
efavirenz / lamivudine / tenofovir disoproxil fumarate Symfi PA  
efavirenz / lamivudine / tenofovir disoproxil fumarate Symfi Lo PA  
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  
lamivudine / tenofovir disoproxil fumarate Cimduo PA  
lamivudine / zidovudine Combivir # test  

 Antiretroviral/HIV Therapy – Fusion Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

enfuvirtide Fuzeon test  

 Antiretroviral/HIV Therapy – Integrase Strand Transfer Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

dolutegravir Tivicay PA   - > 30 units/month
elvitegravir Vitekta test  
raltegravir Isentress test  

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

delavirdine Rescriptor test  
doravirine Pifeltro test  
efavirenz Sustiva BP test  
etravirine Intelence test  
nevirapine Viramune # test  
nevirapine extended-release Viramune XR PA  
rilpivirine Edurant test  

 Antiretroviral/HIV Therapy – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

cobicistat Tybost test  
tesamorelin Egrifta PA  

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

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

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

tenofovir disoproxil fumarate powder Viread PA   - ≥ 13 years
tenofovir disoproxil fumarate tablet Viread # PA   - > 30 units/month

 Antiretroviral/HIV Therapy – Protease Inhibitors (PI)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

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

II. Therapeutic Uses

FDA-approved, for example:

  • CCR5-tropic HIV-1 diagnosed through trofile assay (Selzentry)
  • HIV-associated visceral adipose tissue accumulation (VAT) lipodystrophy (Egrifta)
  • HIV infection (Cimduo, Juluca, nevirapine extended-release, Symfi, Symfi Lo, Symtuza, tenofovir disoproxil fumarate, Tivicay, Trogarzo)

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.
  • 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.
  • Additional criteria may apply, depending upon the member's condition and requested medication (see below).

 

Cimduo 

  • 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 over the commercially available separate agents; and
    • concurrent antiretroviral therapy with at least one other antiretroviral; and
    • requested quantity is ≤ 30 units/30 days.

  

Egrifta 

  • 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.

    

Juluca and Symtuza

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • clinical rationale for use of the combination product over the commercially available separate agents; and
    • requested quantity is ≤ 30 units/30 days.

  

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.

  

Selzentry  

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • trofile assay result documenting CCR5 tropism; and
    • member is ≥ two years of age; and
    • one of the following:
      • concurrent antiretroviral therapy with at least two other single entity HIV antiretrovirals; or
      • concurrent antiretroviral therapy with at least one combination product; and
    • one of the following:
      • resistance to or virologic/treatment failure while receiving combination antiretroviral therapy with at least one agent from three of the five antiretroviral drug classes (NRTI, NNRTI, PI, INSTI, enfuvirtide); or
      • intolerance to at least one agent from three of the five antiretroviral classes listed above.

  

Symfi 

  • 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 over the commercially available separate agents; and
    • requested quantity is ≤ 30 units/30 days.

  

Symfi Lo

  • 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 over the commercially available separate agents; and
    • requested quantity is ≤ 30 units/30 days.

  

tenofovir disoproxil fumarate tablet > 30 units/month

  • 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 > 30 units/month

  • 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 (e.g., > 200 copies/mL); 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 for at least 90 days in the past 120 days of the respective medication.

 

† 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: 07/2019


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Last updated 07/15/19