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, nevirapine extended-release, Symfi, Symfi Lo, Symtuza, 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.
• 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).

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.
• For recertification, documentation of a decrease in waist circumference from baseline is required.

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.

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.

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.