FDA-approved, for example:

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

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

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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

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
  • medical necessity for use of the combination product instead of the commercially available separate agents as defined by one of the following:
    • significant psychiatric diagnosis leading to documented difficulty with adherence; or
    • homeless members who may have difficulty storing larger amounts of medications; or
    • difficulty with adherence leading to complications; or
    • child/adolescent member or a member with developmental issues without adequate supports to properly manage their own HIV regimen; 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
  • medical necessity for use of the combination product instead of the commercially available separate agents as defined by one of the following:
    • significant psychiatric diagnosis leading to documented difficulty with adherence; or
    • homeless members who may have difficulty storing larger amounts of medications; or
    • difficulty with adherence leading to complications; or
    • child/adolescent member or a member with developmental issues without adequate supports to properly manage their own HIV regimen; 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
  • medical necessity for use of the combination product instead of the commercially available separate agents as defined by one of the following:
    • significant psychiatric diagnosis leading to documented difficulty with adherence; or
    • homeless members who may have difficulty storing larger amounts of medications; or
    • difficulty with adherence leading to complications; or
    • child/adolescent member or a member with developmental issues without adequate supports to properly manage their own HIV regimen; 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
  • antiretroviral therapy for ≥ 60 days 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.

fosamprenavir

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to an antiretroviral regimen containing one of the following protease inhibitors: atazanavir, darunavir, ritonavir; and
  • concurrent antiretroviral therapy with at least one other antiretroviral; and
  • appropriate dosing.

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 and Sunlenca 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
  • appropriate dosing; and
  • for Rukobia, 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
  • medical necessity 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; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: Rukobia, Sunlenca.

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.