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.

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, Nuzyra tablet, and Xenleta 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: amoxicillin, amoxicillin/clavulanate, ampicillin/sulbactam, azithromycin, cefotaxime, cefpodoxime, ceftriaxone, cefuroxime, clarithromycin, doxycycline, levofloxacin, moxifloxacin.

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.

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.

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, 80 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. 

Egaten

• Documentation of all of the following is required:
  • diagnosis of Fascioliasis; and
  • member is ≥ six years of age; and
  • prescriber is an infectious disease specialist or prescriber provides consultation notes from an infectious disease specialist regarding the use of the agent; and
  • appropriate dosing.

Krintafel > 2 units/365 days

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

Lampit

• Documentation of all of the following is required:
  • appropriate diagnosis; and 
  • member is < 18 years of age; and
  • dosing is appropriate based on member weight; and
  • dose requested cannot be consolidated; and
  • requested duration is ≤ 60 days; and
  • for members ≥ two to < 13 years of age, inadequate response, adverse reaction, or contraindication to benznidazole.
• For recertification, documentation of medical necessity for duration of therapy exceeding 60 days is required.

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 tablet

• 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: 
  • 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, hookworm, or roundworm:
  • 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, Minolira, and Ximino

• Documentation of all of the following is required:  
  • appropriate diagnosis; and 
  • for minocycline immediate-release tablet, both of the following:
    • inadequate response to minocycline capsule; and 
    • clinical rationale as to why the requested formulation is preferred over minocycline capsules; and
  • for minocycline extended-release tablet and capsule formulations, inadequate response, adverse reaction, or contraindication to minocycline capsules and Solodyn. 

moxifloxacin tablet and ofloxacin

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

nitazoxanide tablet

• Documentation of all of the following is required for a diagnosis of giardiasis: 
  • appropriate diagnosis; and
  • member is ≥ 12 years of age; and
  • inadequate response, adverse reaction, or contraindication to metronidazole.
• Documentation of all of the following is required for a diagnosis of cryptosporidiosis: 
  • appropriate diagnosis; and
  • member is ≥ 12 years of age.

pretomanid

• Documentation of all of the following is required:  
  • appropriate diagnosis; and
  • the agent will be used in combination with Sirturo and linezolid; and
  • request is for ≤ one tablet/day.

pyrimethamine

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

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 in combination with at least three 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 (Kitabis Pak, Tobi); or
    • medical necessity for the use of the Podhaler formulation. 

tobramycin inhalation solution (Bethkis)

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to tobramycin inhalation solution (Kitabis Pak, Tobi). 

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 ≤ two tablets/day.

SmartPA: Claims for Xifaxan 550 mg (≤ two tablets/day) 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.