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Drug Category: Infectious Disease Agents

Medication Class/Individual Agents: Antibiotics and Anti-Infectives

I. Prior-Authorization Requirements

 Anti-Infectives: Oral and Inhaled – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

albendazole Albenza # test  
  • Metronidazole is available generically in 250 mg and 500 mg tablets, and 375 mg capsules. Due to a considerable cost difference, metronidazole 375 mg capsules require prior authorization (PA).
  • Linezolid is FDA-approved for the treatment of gram-positive coccal infections including methicillin-resistant Staphylococcus aureus (MRSA). The Centers for Disease Control and Prevention (CDC) recommends that clinicians reserve linezolid for more severe infections after consultation with an infectious disease specialist or for those patients who have not responded to other antibiotics. Community-acquired MRSA has responded to a number of other antibiotics including doxycycline, clindamycin, minocycline, and TMP/sulfamethoxazole. Vancomycin continues to be first line treatment for hospital-acquired MRSA infections. Therefore, linezolid suspension and tablet require PA.
 
artemether / lumefantrine Coartem PA   - > 24 units/365 days
atovaquone Mepron # test  
benznidazole test  
clindamycin capsule, injection, oral solution Cleocin # test  
dapsone tablet test  
fidaxomicin Dificid PA  
fosfomycin Monurol test  
ivermectin tablet Stromectol # test  
linezolid suspension, tablet Zyvox PA  
mebendazole PA  
methenamine Hiprex # test  
metronidazole 250 mg, 500 mg tablet Flagyl # test  
metronidazole 375 mg capsule Flagyl PA  
nitrofurantoin Furadantin # test  
nitrofurantoin macrocrystals Macrodantin # test  
nitrofurantoin monohydrate / macrocrystals Macrobid # test  
praziquantel Biltricide BP test  
pyrantel pamoate Pin-X test  
pyrantel pamoate Reese's Pinworm test  
pyrimethamine Daraprim PA  
quinine Qualaquin PA  
rifaximin 200 mg Xifaxan test  
rifaximin 550 mg Xifaxan PA  
secnidazole Solosec PA  
tedizolid tablet Sivextro PA  
tinidazole Tindamax PA  
trimethoprim tablet test  
vancomycin capsule Vancocin # test  
vancomycin oral solution Firvanq test  

 Antibiotics: Oral and Inhaled – Aminoglycosides

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

amikacin liposome inhalation Arikayce PA  

  

 
neomycin * test  
paromomycin test  
tobramycin inhalation powder Tobi Podhaler PA  
tobramycin inhalation solution-Bethkis Bethkis PA  
tobramycin inhalation solution-Kitabis Pak Kitabis Pak # test  
tobramycin inhalation solution-Tobi Tobi # test  

 Antibiotics: Oral and Inhaled – Antitubercular Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

aminosalicylic acid Paser test  

  

 
bedaquiline Sirturo PA  
cycloserine Seromycin test  
ethambutol Myambutol # test  
ethionamide Trecator test  
pyrazinamide test  
rifabutin Mycobutin test  
rifampin Rifadin # test  
rifampin / isoniazid test  
rifampin / isoniazid / pyrazinamide Rifater test  
rifapentine Priftin test  

 Antibiotics: Oral and Inhaled – Cephalosporins

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

cefaclor test  
  • Cephalexin capsules are available in 250, 333, 500, and 750 mg strengths. The 250 mg and 500 mg capsules are significantly less costly. PA is required for cephalexin 333 mg and 750 mg capsules.
  • Cefadroxil tablet requires PA. Cefadroxil capsule and suspension are less costly alternatives and are available without PA.
  • Cefaclor is available as extended-release and immediate-release formulations. The immediate-release formulation is available without PA.
 
cefaclor extended-release PA  
cefadroxil capsule, suspension test  
cefadroxil tablet PA  
cefdinir test  
cefixime Suprax PA  
cefpodoxime test  
cefprozil test  
cefuroxime axetil test  
cephalexin 250 mg, 500 mg capsule, suspension Keflex # test  
cephalexin 333 mg capsule PA  
cephalexin 750 mg capsule Keflex PA  

 Antibiotics: Oral and Inhaled – Fluoroquinolones

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

ciprofloxacin Cipro # test  
  • Ciprofloxacin extended-release tablet is a once-a-day formulation that is FDA-approved for the treatment of urinary tract infections. Studies show safety and efficacy to be similar to immediate-release ciprofloxacin. Likewise, half-life, AUC, and time-to-peak plasma concentration were similar between equivalent daily doses of ciprofloxacin extended-release and immediate-release products. PA is required for ciprofloxacin extended-release tablets.
 
ciprofloxacin extended-release Cipro XR PA  
delafloxacin tablet Baxdela PA  
levofloxacin Levaquin # test  
levofloxacin powder PA  
moxifloxacin tablet Avelox PA  
ofloxacin tablet PA  

 Antibiotics: Oral and Inhaled – Macrolides

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

azithromycin Zithromax # test  
  • Clarithromycin is available in extended-release and immediate-release formulations. The immediate-release formulation is available without PA.
  • Telithromycin requires PA and there are clinically appropriate alternatives available without PA.
 
clarithromycin Biaxin # test  
clarithromycin extended-release PA  
erythromycin delayed-release capsule, tablet test  
erythromycin delayed-release tablet-PCE PCE test  
erythromycin ethylsuccinate suspension Eryped # test  
erythromycin tablet test  
telithromycin Ketek PA  

 Antibiotics: Oral and Inhaled – Penicillins

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

amoxicillin test  
  • Amoxicillin/clavulanate is available as immediate-release and extended-release formulations. The extended-release formulation requires PA. In addition, amoxicillin/clavulanate 125/31.25 mg/5 mL suspension requires PA. The immediate-release tablets, chewable tablets, and select strengths of suspension are available without PA.
 
amoxicillin / clavulanate 125/31.25 mg/5 mL suspension Augmentin PA  
amoxicillin / clavulanate chewable tablet, 200/28.5, 250/62.5, 400/57, 600/42.9 mg/5 mL suspension, tablet Augmentin # test  
amoxicillin / clavulanate extended-release Augmentin XR PA  
ampicillin test  
dicloxacillin test  
penicillin V test  

 Antibiotics: Oral and Inhaled – Sulfonamides

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

sulfadiazine test  

  

 
sulfamethoxazole / trimethoprim suspension Sulfatrim # test  
sulfamethoxazole / trimethoprim tablet Bactrim # test  

 Antibiotics: Oral and Inhaled – Tetracyclines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

demeclocycline test  

Oral antibiotics for the treatment of acne or rosacea:

  • Moderate acne can be managed with topical retinoids in combination with oral antibiotics and/or benzoyl peroxide.
  • Oral tetracyclines may be used for the management of papulopustular rosacea.
    • These agents are most useful for improving inflammatory papules and pustules, and may also reduce erythema.
 
doxycycline calcium syrup Vibramycin test  
doxycycline hyclate 100 mg capsule Vibramycin # test  
doxycycline hyclate 20 mg, 100 mg tablet test  
doxycycline hyclate 50 mg capsule test  
doxycycline hyclate 75 mg, 150 mg tablet PA  
doxycycline hyclate delayed-release 50 mg, 120 mg, 200 mg tablet Doryx PA  
doxycycline hyclate delayed-release 75 mg, 100 mg, 150 mg tablet PA  
doxycycline monohydrate 150 mg capsule PA  
doxycycline monohydrate 150 mg tablet PA  
doxycycline monohydrate 40 mg capsule Oracea PA  
doxycycline monohydrate 50 mg, 100 mg capsule test  
doxycycline monohydrate 50 mg, 75 mg, 100 mg tablet test  
doxycycline monohydrate 75 mg capsule PA  
doxycycline monohydrate suspension Vibramycin # test  
minocycline capsule test  
minocycline extended-release 45 mg, 90 mg, 135 mg tablet PA  
minocycline extended-release 55 mg, 65 mg, 80 mg, 105 mg, 115 mg tablet Solodyn BP test  
minocycline extended-release capsule Ximino PA  
minocycline tablet PA  
omadacycline tablet Nuzyra PA  
tetracycline 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.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 

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).

 

amoxicillin/clavulanate extended-release, cefaclor extended-release, cefadroxil tablet, cephalexin 333 mg capsule, cephalexin 750 mg capsule, clarithromycin extended-release, ciprofloxacin extended-release, and metronidazole 375 mg capsule

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to one other clinically appropriate, less-costly antibiotic; and
    • clinical rationale why requested formulation is preferred over covered formulations.

  

Arikayce

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • member is ≥ 18 years of age; and
    • member has completed a minimum of six consecutive months of a multidrug background regimen therapy; and
    • requested agent will be used as part of a combination antibacterial drug regimen to treat nontuberculous mycobacteria (Mycobacterium avium complex) lung disease; and
    • prescriber is a specialist (e.g., pulmonologist, infectious disease); or
    • consultation notes from a specialist (e.g., pulmonologist, infectious disease) regarding use of the agent.

 

Augmentin 125/31.25 mg/5mL suspension

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • one of the following:
      • member is < 12 weeks of age; or
      • medical necessity for the 125/31.25 mg/5 mL formulation over the 250/62.5 mg/5 mL formulation.

  

Baxdela tablet and Nuzyra tablet for suspected or confirmed MRSA acute bacterial skin and skin structure infection (ABSSSI) or suspected or confirmed mixed pathogen (including MRSA) ABSSSI

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • member is ≥ 18 years of age; and
    • one of the following:
      • culture is positive for MRSA and one of the following:
        • inadequate response to sulfamethoxazole-trimethoprim, clindamycin, vancomycin IV, doxycycline, or minocycline; or
        • culture is resistant to sulfamethoxazole-trimethoprim, clindamycin, doxycycline, and minocycline; or
      • member has a history of past MRSA infection and has not responded to at least two of the following: sulfamethoxazole-trimethoprim, clindamycin, vancomycin IV, doxycycline or minocycline; or
      • member has an adverse reaction or contraindication to sulfamethoxazole-trimethoprim, clindamycin, doxycycline, and minocycline; and
    • inadequate response, adverse reaction, or contraindication to linezolid; and
    • for suspected or confirmed mixed pathogen infections (including MRSA), an inadequate response, adverse reaction, or contraindication to at least one other antibiotic with gram negative coverage that does not require PA.

 

Baxdela tablet and Nuzyra tablet for suspected or confirmed mixed pathogen non-MRSA ABSSSI

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • member is ≥ 18 years of age; and 
    • inadequate response, adverse reaction, or contraindication to at least two antibiotics with appropriate coverage for pathogens that does not currently require a PA.

   

Bethkis

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to tobramycin inhalation solution. 

 

cefixime

  • Documentation of all of the following is required: 
    • appropriate diagnosis (e.g., genitourinary tract infections, respiratory tract infections, skin and skin structure infections); and
    • if the request is for suspension or chewable tablet, then one of the following:
      • age < 13 years old; or
      • medical necessity for use of chewable tablet or suspension formulations over the capsule formulation of the same product; and
    • if the request is for capsules, quantity limit of 1 unit/day; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication (e.g., culture not susceptible) to cefdinir OR cefpodoxime; or
      • member is completing a course of therapy which was initiated while a hospital inpatient.

SmartPA: Claims for cefixime capsule will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for a diagnosis of genitourinary tract infections, respiratory tract infections, or skin and skin structure infections, there is a history of at least one paid MassHealth pharmacy claim for cefdinir or cefpodoxime in the last 90 days and the current claim plus history ≤ 1 unit/day.

SmartPA: Claims for cefixime suspension will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for a diagnosis of genitourinary tract infections, respiratory tract infections, or skin and skin structure infections, member’s age < 13 years old, and there is a history of at least one paid MassHealth pharmacy claim for cefdinir or cefpodoxime in the last 90 days.

SmartPA: Claims for cefixime chewable tablet will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for a diagnosis of genitourinary tract infections, respiratory tract infections, or skin and skin structure infections, member’s age < 13 years old, there is a history of at least one paid MassHealth pharmacy claim for cefdinir or cefpodoxime in the last 90 days, and the current claim plus history ≤ 1 tablet/day.

  

Coartem > 24 units/365 days

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • medical necessity for the requested agent above quantity limits.

   

Daraprim

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

   

Dificid

  • Documentation of all of the following is required:
    • diagnosis of clostridium difficile-associated diarrhea (CDAD); and
    • inadequate response, adverse reaction, or contraindication to oral vancomycin.

  

Doryx (doxycycline hyclate delayed-release 120 mg tablet), doxycycline hyclate 75 mg and 150 mg tablet, doxycycline hyclate delayed-release 50 mg, 75 mg, 100 mg, 150 mg, and 200 mg tablet, doxycycline monohydrate 40 mg and 75 mg capsule, and doxycycline monohydrate 150 mg capsule and tablet

  • Documentation of all of the following is required:  
    • appropriate diagnosis; and
    • inadequate response to one doxycycline hyclate or monohydrate formulation covered without PA; and
    • clinical rationale as to why the requested formulation is preferred over doxycycline formulations covered without PA. 

  

Ketek

  • Documentation of all of the following is required:  
    • appropriate diagnosis; and 
    • one of the following: 
      • inadequate response or contraindication to all other clinically appropriate alternatives; or 
      • sensitivity results providing medical necessity for using this agent over all other clinically appropriate alternatives.

  

levofloxacin powder

  • Documentation of all of the following is required:  
    • appropriate diagnosis; and 
    • clinical rationale why other commercially available alternatives cannot be used.

 

linezolid suspension and tablet, and Sivextro

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • vancomycin-resistant enterococcus (VRE) infection or suspected VRE infection and one of the following:
        • the request is for Sivextro 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
        • the request is for linezolid; or
      • culture is positive for methicillin-resistant Staphylococcus aureus (MRSA) and one of the following:
        • member did not respond to at least one less-costly antibiotic (i.e. sulfamethoxazole/trimethoprim, clindamycin, vancomycin IV, doxycycline, minocycline); or
        • culture is resistant to all less-costly antibiotics (listed above, excluding vancomycin IV); or
        • member has a contraindication or adverse reaction to all less-costly antibiotics (listed above, excluding vancomycin IV); or
      • member has a history of past MRSA infection and one of the following:
        • member has not responded to at least two less-costly antibiotics (listed above); or
        • member has a contraindication or adverse reaction to all less-costly antibiotics (listed above, excluding vancomycin IV).

   

mebendazole

  • Documentation of all of the following is required for a diagnosis of pinworm or roundworm: 
    • appropriate diagnosis; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: albendazole, pyrantel pamoate.
  • Documentation of all of the following is required for a diagnosis of whipworm or hookworm:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to albendazole.

   

minocycline extended-release 45 mg, 90 mg, 135 mg tablet, minocycline tablet, and Ximino

  • Documentation of all of the following is required:  
    • appropriate diagnosis; and 
    • inadequate response to minocycline capsule; and 
    • clinical rationale as to why the requested formulation is preferred over minocycline capsules. 

  

moxifloxacin tablet and ofloxacin

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to ciprofloxacin or levofloxacin. 

 

Nuzyra tablet for non-MRSA community acquired bacterial pneumonia (CABP)

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response or adverse reaction to a regimen containing one or contraindication all of the following: ampicillin-sulbactam, cefotaxime, ceftriaxone, Invanz, levofloxacin, moxifloxacin.

 

quinine

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

   

Sirturo

  • Documentation of all of the following is required:  
    • appropriate diagnosis; and
    • the agent will be used along with at least four other antitubercular agents; and
    • clinical rationale as to why the requested agent is needed over other antitubercular agents.

    

Solosec

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • member is ≥ 18 years of age; and 
    • appropriate dosing; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: oral or vaginal metronidazole, oral or vaginal clindamycin, oral tinidazole.

   

tinidazole

  • Documentation of all of the following is required:
    • appropriate diagnosis and age; and
    • inadequate response, adverse reaction, or contraindication to oral metronidazole.

  

Tobi Podhaler

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response or adverse reaction to tobramycin inhalation solution; or
      • medical necessity for the use of the Podhaler formulation. 

 

Xifaxan 550 mg for irritable bowel syndrome with diarrhea

  • Documentation of all of the following is required:
    • diagnosis of irritable bowel syndrome with diarrhea; and
    • age ≥ 18 years old; and
    • dose is appropriate; and
    • inadequate response or adverse reaction to three of the following: loperamide, diphenoxylate/atropine, bile acid sequestrant, bismuth subsalicylate, bulk-forming agent, tricyclic antidepressant (TCA); or
    • contraindication to all less-costly alternatives (noted above).

   

Xifaxan 550 mg for hepatic encephalopathy

  • Documentation of all of the following is required:
    • diagnosis of hepatic encephalopathy; and
    • age ≥ 18 years old; and
    • inadequate response, adverse reaction, or contraindication to lactulose; and
    • request is for ≤ 60 tablets/month.

SmartPA: Claims for Xifaxan 550 mg (≤ 60 tablets/month) will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for a diagnosis of hepatic encephalopathy, member's age is ≥ 18 years old, and a history of paid MassHealth pharmacy claims for lactulose.

     

   

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 plan.


Original Effective Date: 07/2008

Last Revised Date: 08/2019


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Last updated 11/15/19