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Drug Category: Antibiotics

Medication Class/Individual Agents: Antibiotics – Injectable

I. Prior-Authorization Requirements

 Antibiotics: Injectable – Aminoglycosides

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

amikacin test  

                                                                                     

 
gentamicin injection test  
plazomicin Zemdri PA  
streptomycin test  
tobramycin injection test  

 Antibiotics: Injectable – Carbapenems

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

doripenem Doribax # test  

                                                                                                   

 
ertapenem Invanz # test  
imipenem / cilastatin Primaxin # test  
meropenem Merrem # test  
meropenem / vaborbactam Vabomere PA  

 Antibiotics: Injectable – Cephalosporins

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

cefazolin test  

Ceftaroline, ceftazidime/avibactam, and ceftolozane/tazobactam require prior authorization (PA) to ensure appropriate utilization and due to safety concerns.

 
cefepime Maxipime # test  
cefotaxime Claforan # test  
cefotetan Cefotan # test  
cefoxitin test  
ceftaroline Teflaro PA  
ceftazidime Fortaz # test  
ceftazidime / avibactam Avycaz PA  
ceftolozane / tazobactam Zerbaxa PA  
ceftriaxone test  
cefuroxime sodium test  

 Antibiotics: Injectable – Fluoroquinolones

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

ciprofloxacin Cipro # test  

                                                                                    

 
delafloxacin injection Baxdela PA  
levofloxacin Levaquin # test  
moxifloxacin injection Avelox test  

 Antibiotics: Injectable – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

azithromycin Zithromax # test  
  • Dalbavancin, dalfopristin/quinupristin, daptomycin, linezolid, oritavancin, tedizolid, telavancin, and tigecycline require PA to ensure appropriate utilization and due to safety concerns.
    • These antibiotics are approved for indications that include complicated and uncomplicated skin and skin structure infections, intra-abdominal infections, pneumonia, bacteremia, endocarditis along with vancomycin-resistant Enterococci (VRE) infections.
    • In addition, all of the agents have activity against methicillin-resistant Staphylococcus aureus (MRSA) infection.
 
aztreonam injection Azactam # test  
capreomycin Capastat test  
chloramphenicol test  
clindamycin capsule, injection, oral solution Cleocin # test  
colistimethate sodium injection Coly-Mycin M # test  
dalbavancin Dalvance PA  
dalfopristin / quinupristin Synercid PA  
daptomycin Cubicin PA  
daptomycin PA  
erythromycin injection Erythrocin test  
isoniazid test  
lincomycin Lincocin # test  
linezolid injection Zyvox PA  
metronidazole injection Metro # test  
oritavancin Orbactiv PA  
rifampin Rifadin # test  
sulfamethoxazole / trimethoprim injection test  
tedizolid injection Sivextro PA  
telavancin Vibativ PA  
tigecycline Tygacil PA  
vancomycin injection test  

 Antibiotics: Injectable – Penicillins

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

ampicillin test  

                                                                                              

 
ampicillin / sulbactam Unasyn # test  
nafcillin test  
oxacillin test  
penicillin G 0.6 million, 1.2 million, 2.4 million units Bicillin LA test  
penicillin G 5 million, 20 million units Pfizerpen # test  
penicillin G benzathine / penicillin G procaine Bicillin CR test  
piperacillin / tazobactam Zosyn # test  
ticarcillin / clavulanate Timentin test  

 Antibiotics: Injectable – Tetracyclines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

doxycycline hyclate injection test  

                                                              

 
eravacycline Xerava PA  
minocycline injection Minocin test  
omadacycline injection Nuzyra 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.
 

II. Therapeutic Uses

FDA-approved, for example:

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

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.
  • 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).

 

Avycaz 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
    • one of the following:
      • inadequate response or adverse reaction to two of the following:
        • aminoglycosides (gentamicin, amikacin, tobramycin); or
        • aztreonam; or
        • cefepime; or
        • ceftazidime; or
        • imipenem/cilastatin; or
        • levofloxacin or ciprofloxacin; or
        • meropenem; or
        • piperacillin-tazobactam; or
      • contraindication (e.g., culture is not susceptible) to all above treatment options. 

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

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

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

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response or adverse reaction to two 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; or
      • contraindication (e.g., culture is not susceptible) to all above treatment options. 

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

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • if the request is for Baxdela or Nuzyra, member is ≥ 18 years of age; and
    • if the request is for Baxdela or Nuzyra, 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 at least one less-costly, clinically appropriate regimen that does not require PA; or
      • adverse reaction, contraindication, or culture is resistant to all potential less-costly alternatives.

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

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • if the request is for Baxdela, Dalvance, Nuzyra, Orbactiv, Sivextro, Synercid, or Vibativ, member 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
    • if the request is for a drug other than Teflaro, one of the following is also required:
      • inadequate response, adverse reaction, or contraindication to Teflaro; or
      • culture is resistant to Teflaro (if cultures can be obtained); or
      • member has a history of MRSA infections that have not responded to Teflaro in the past; and
    • if the request is for Synercid or tigecycline, one of the following is also required:
      • 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).

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, daptomycin, 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
    • 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.

daptomycin for the treatment of MRSA bacteremia or endocarditis 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.

daptomycin and 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.

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

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • if the request is for a drug other than linezolid injection, one of the following is also required:
      • 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, 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.

Nuzyra 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 of the following, or contraindication to all of the following:
      • ampicillin/sulbactam; or
      • cefotaxime; or
      • ceftriaxone; or
      • ertapenem; or
      • levofloxacin; or
      • moxifloxacin.

Teflaro for the treatment of non-MRSA CABP infections

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to a regimen containing one of the following, or contraindication to all of the following:
      • ampicillin/sulbactam; or
      • cefotaxime; or
      • ceftriaxone; or
      • ertapenem; or
      • levofloxacin; or
      • moxifloxacin.

Vibativ for the treatment of VABP 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
    • 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.


Original Effective Date: 01/2013

Last Revised Date: 08/2019


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Last updated 11/18/19