FDA-approved, for example:

• Infections (site and location vary by indication for requested agent)

Non-FDA-approved, for example:

• Infections (site and location vary by indication for requested agent)

Note: The above lists may not include all FDA-approved and non-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.

artesunate for the treatment of malaria

• Documentation of the following is required:
  • appropriate diagnosis; and
  • appropriate dose and frequency.

Avycaz, Fetroja, Recarbrio, and Zerbaxa for the treatment of hospital-acquired (nosocomial) bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) infections caused by susceptible Gram-negative organisms

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response or adverse reaction to two or contraindication (e.g., culture is not susceptible) to all of the following:
    • aminoglycosides (gentamicin, amikacin, tobramycin); or
    • aztreonam; or
    • cefepime; or
    • ceftazidime; or
    • ciprofloxacin or levofloxacin; or
    • imipenem/cilastatin; or
    • meropenem; or
    • piperacillin/tazobactam.

Avycaz, Fetroja, Recarbrio, and Vabomere for the treatment of carbapenem-resistant enterobacterales

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • culture is resistant to ertapenem and meropenem (if cultures can be obtained); or
    • suspected resistance to ertapenem and meropenem and susceptibility testing is not able to be performed.

Avycaz, Recarbrio, tigecycline, Xerava, and Zerbaxa for the treatment of complicated intra-abdominal infections (cIAI)

• Documentation of the following is required:
  • appropriate diagnosis; and
  • for tigecycline or Zerbaxa, member is ≥ 18 years of age; and
  • inadequate response or adverse reaction to two or contraindication (e.g., culture is not susceptible) to all of the following:
    • combination therapy with aztreonam and metronidazole and vancomycin; or
    • combination therapy with metronidazole and cefepime; or
    • combination therapy with metronidazole and cefotaxime; or 
    • combination therapy with metronidazole and ceftazidime; or
    • combination therapy with metronidazole and ceftriaxone; or 
    • combination therapy with metronidazole and ciprofloxacin; or
    • combination therapy with metronidazole and levofloxacin; or
    • doripenem; or
    • ertapenem; or
    • imipenem/cilastatin; or
    • meropenem; or
    • moxifloxacin; or
    • piperacillin/tazobactam; and
  • for Avycaz or Zerbaxa, the requested agent is being utilized concurrently with metronidazole.

Avycaz, Fetroja, Recarbrio, Vabomere, Zemdri, and Zerbaxa for the treatment of complicated urinary tract infections (cUTI)

• Documentation of the following is required:
  • appropriate diagnosis; and
  • for Vabomere, Zemdri, or Zerbaxa, member is ≥ 18 years of age; and
  • inadequate response or adverse reaction to two or contraindication (e.g., culture is not susceptible) to all of the following:
    • amikacin; or
    • ampicillin/sulbactam; or
    • aztreonam; or
    • cefepime; or
    • ceftazidime; or
    • ceftriaxone; or
    • ciprofloxacin or levofloxacin; or
    • ertapenem; or
    • gentamicin; or
    • imipenem/cilastatin; or
    • meropenem; or
    • piperacillin/tazobactam. 

Baxdela injection and Nuzyra injection for the treatment of non-MRSA community acquired bacterial pneumonia (CABP) infections

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response, adverse reaction, or contraindication to Teflaro; and
  • inadequate response or adverse reaction to a regimen containing one or contraindication to all of the following: 
    • amoxicillin; or
    • amoxicillin/clavulanate; or
    • ampicillin/sulbactam; or
    • azithromycin; or
    • cefotaxime; or
    • cefpodoxime; or
    • ceftriaxone; or
    • cefuroxime; or
    • clarithromycin; or
    • doxycycline; or
    • levofloxacin; or
    • moxifloxacin.

Baxdela injection and Nuzyra injection for the treatment of non-MRSA skin and soft tissue infections (SSTIs)

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response, adverse reaction, or contraindication to Teflaro; and
  • one of the following:
    • organism susceptibility to the requested agent; or
    • culture cannot be obtained due to the nature of the infection; and
  • one of the following:
    • inadequate response to one regimen available without PA; or
    • adverse reaction, contraindication, or culture is resistant to all regimens available without PA.

Baxdela injection, Dalvance, Kimyrsa, linezolid injection, Nuzyra injection, Orbactiv, Sivextro injection, Synercid, tigecycline, and Vibativ for the treatment of MRSA SSTIs

• Documentation of the following is required: 
  • appropriate diagnosis; and
  • for Baxdela, Kimyrsa, Nuzyra, Orbactiv, Sivextro, Synercid, or Vibativ, member is ≥ 18 years of age; and
  • inadequate response, adverse reaction, or contraindication (e.g., culture not susceptible) to all of the following: ceftaroline, daptomycin, vancomycin; and
  • for Synercid or tigecycline, one of the following:
    • inadequate response, adverse reaction, or contraindication to all other available agents that treat MRSA SSTIs; or
    • culture is resistant to all other available agents that treat MRSA SSTIs (if cultures can be obtained); and
  • for Kimyrsa, medical necessity for use instead of Orbactiv.

Please note: Adverse events caused by vancomycin, such as red-man syndrome (rate-related infusion reaction) or renal (kidney) adverse events, such as increased serum creatinine or microalbuminuria, are also associated with Vibativ, and renal events in particular are higher with Vibativ. Thus, these specific adverse reactions are not appropriate clinical rationale for selecting Vibativ over vancomycin.

Dalvance, linezolid injection, Sivextro injection, Synercid, tigecycline, and Vibativ for the treatment of non-MRSA/non-VRE infections

• Documentation of the following is required:
  • appropriate diagnosis; and
  • for Sivextro, Synercid, or Vibativ, member is ≥ 18 years of age; and
  • one of the following:
    • organism susceptibility to the requested agent; or
    • culture cannot be obtained due to the nature of the infection; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to vancomycin; or
    • culture is resistant to vancomycin (if cultures can be obtained).

Please note: Adverse events caused by vancomycin, such as red-man syndrome (rate-related infusion reaction) or renal (kidney) adverse events, such as increased serum creatinine or microalbuminuria, are also associated with Vibativ, and renal events in particular are higher with Vibativ. Thus, these specific adverse reactions are not appropriate clinical rationale for selecting Vibativ over vancomycin.

Dalvance or Vibativ for VRE infection or suspected VRE infection

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to linezolid; or
    • culture is resistant to linezolid (if cultures can be obtained).

linezolid injection for the treatment of MRSA bone/joint infections

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to vancomycin; or
    • culture is resistant to vancomycin (if cultures can be obtained); or
    • member has a history of MRSA infections that have not responded to vancomycin in the past.

linezolid injection, Sivextro injection, Synercid, and tigecycline for the treatment of VRE infections

• Documentation of the following is required:
  • appropriate diagnosis; and
  • for Sivextro or Synercid, member is is ≥ 18 years of age; and
  • for Sivextro, Synercid, or tigecycline, one of the following:
    • inadequate response, adverse reaction, or contraindication to linezolid; or
    • culture is resistant to linezolid (if cultures can be obtained).

linezolid injection for the treatment of MRSA central nervous system (CNS) infections 

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to vancomycin; or
    • culture is resistant to vancomycin (if cultures can be obtained); or 
    • member has a history of MRSA infections that have not responded to vancomycin in the past.

linezolid injection and Vibativ for the treatment of HABP infections caused by MRSA or suspected MRSA

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to vancomycin; or
    • culture is resistant to vancomycin (if cultures can be obtained); or 
    • member has a history of MRSA infections that have not responded to vancomycin in the past; and
  • if the request is for Vibativ, both of the following:
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to linezolid; or
      • culture is resistant to linezolid (if cultures can be obtained); or 
      • member has a history of MRSA infections that have not responded to linezolid in the past.

Please note: Adverse events caused by vancomycin, such as red-man syndrome (rate-related infusion reaction) or renal (kidney) adverse events, such as increased serum creatinine or microalbuminuria, are also associated with Vibativ, and renal events in particular are higher with Vibativ. Thus, these specific adverse reactions are not appropriate clinical rationale for selecting Vibativ over vancomycin.

Vibativ for the treatment of VABP infections caused by MRSA or suspected MRSA

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is is ≥ 18 years of age; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to vancomycin; or
    • culture is resistant to vancomycin (if cultures can be obtained); or
    • member has a history of MRSA infections that have not responded to vancomycin in the past; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to linezolid; or
    • culture is resistant to linezolid (if cultures can be obtained); or
    • member has a history of MRSA infections that have not responded to linezolid in the past.

Please note: Adverse events caused by vancomycin, such as red-man syndrome (rate-related infusion reaction) or renal (kidney) adverse events, such as increased serum creatinine or microalbuminuria, are also associated with Vibativ, and renal events in particular are higher with Vibativ. Thus, these specific adverse reactions are not appropriate clinical rationale for selecting Vibativ over vancomycin.