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.

Aemcolo

• Documentation of all 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 one of the following: ciprofloxacin, levofloxacin; or
    • inadequate response, adverse reaction, or contraindication to azithromycin; or
    • contraindication to fluoroquinolones and azithromycin; and
  • inadequate response, adverse reaction, or contraindication to Xifaxan (rifaximin) 200 mg
  • requested quantity is ≤ 12 tablets/three days.

amoxicillin/clavulanate extended-release, azithromycin powder packet, cefaclor extended-release, cefaclor suspension, cefadroxil tablet, cefpodoxime suspension, cephalexin 750 mg capsule, ciprofloxacin 100 mg tablet, 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
  • medical necessity for the requested formulation instead of formulations available without PA.

Alinia tablet

• Documentation of all of the following is required for a diagnosis of giardiasis: 
  • appropriate diagnosis; and
  • appropriate dosing; and
  • member is ≥ 12 years of age; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: metronidazole, tinidazole.
• Documentation of all of the following is required for a diagnosis of cryptosporidiosis: 
  • appropriate diagnosis; and
  • appropriate dosing; and
  • member is ≥ 12 years of age.
• Documentation of all of the following is required for a diagnosis of Helicobacter pylori:
  • appropriate diagnosis; and
  • member is ≥ 12 years of age; and
  • inadequate response, adverse reaction, or contraindication to both of the following:
    • clarithromycin-based triple therapy containing metronidazole: proton pump inhibitor, clarithromycin, and metronidazole; and
    • bismuth quadruple therapy: proton pump inhibitor, bismuth subsalicylate, metronidazole, and tertracycline.

Alinia suspension

• Documentation of all of the following is required for a diagnosis of giardiasis: 
  • appropriate diagnosis; and
  • appropriate dosing; and
  • member is ≥ one year of age; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: metronidazole, tinidazole.
• Documentation of all of the following is required for a diagnosis of cryptosporidiosis: 
  • appropriate diagnosis; and
  • appropriate dosing; and
  • member is ≥ one year of age.
• Documentation of all of the following is required for a diagnosis of Helicobacter pylori:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to both of the following:
    • clarithromycin-based triple therapy containing metronidazole: proton pump inhibitor, clarithromycin, and metronidazole; and
    • bismuth quadruple therapy: proton pump inhibitor, bismuth subsalicylate, metronidazole, and tertracycline.

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 specialist) or consult notes from a specialist are provided.

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
    • requested dose is too difficult to measure using the 250/62.5 mg/5 mL formulation.

Baxdela tablet and 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 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 inadequate response or adverse reaction to one or contraindication to all of the following: sulfamethoxazole-trimethoprim, clindamycin, vancomycin IV, linezolid, doxycycline, minocycline; or
    • member has a history of past MRSA infection and inadequate response or adverse reaction to two or contraindication to all of the following: sulfamethoxazole-trimethoprim, clindamycin, vancomycin IV, linezolid, doxycycline, minocycline; and
  • for suspected or confirmed mixed pathogen infections (including MRSA), inadequate response, adverse reaction, or contraindication to one other antibiotic with gram negative coverage available without 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 or adverse reaction to two or contraindication to all antibiotics with appropriate coverage for pathogens available without 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
  • for suspension or chewable tablet, one of the following:
    • member is < 13 years of age; or
    • medical necessity for use of chewable tablet or suspension formulation instead of the capsule formulation; and
  • for capsules, requested quantity is ≤ one unit/day; and
  • one of the following:
    • inadequate response or adverse reaction to one or contraindication (e.g., culture not susceptible) to both of the following: cefdinir, 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 ≤ one 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 of age, 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 of age, 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 ≤ one tablet/day.^†

Coartem > 24 units/365 days

• Documentation of all of the following is required: 
  • appropriate diagnosis; and
  • medical necessity for exceeding the quantity limit.

Dificid

• Documentation of all of the following is required:
  • diagnosis of clostridium difficile-associated diarrhea (CDAD) that is not considered to be fulminant disease; and
  • member is ≥ six months of age; and
  • appropriate dosing.

Doryx (doxycycline hyclate delayed-release 60 mg and 120 mg tablet),  doxycycline hyclate 50 mg, 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 available without PA; and
  • medical necessity for the requested formulation instead of doxycycline formulations available 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 consult notes from an infectious disease specialist regarding the use of the agent are provided; and
  • appropriate dosing.

Krintafel > 2 units/365 days

• Documentation of all of the following is required: 
  • appropriate diagnosis; and
  • member is receiving the requested agent in combination with chloroquine therapy; and
  • medical necessity for exceeding the quantity limit.

Lampit

• Documentation of all of the following is required for pediatric members:
  • appropriate diagnosis; and
  • member is < 18 years of age; and
  • appropriate dosing based on member weight; and
  • requested duration is ≤ 60 days; and
  • for members ≥ two to < 13 years of age, inadequate response, adverse reaction, or contraindication to benznidazole.
• Documentation of all of the following is required for adult members:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • appropriate dosing based on member weight; and
  • requested duration is ≤ 90 days; and
  • inadequate response, adverse reaction, or contraindication to benznidazole.
• For recertification, documentation of medical necessity for duration of therapy exceeding 60 days in pediatric members or 90 days in adult members.

linezolid suspension and Sivextro tablet

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • for linezolid suspension, medical necessity for use of the suspension formulation instead of the tablet formulation; and
  • one of the following:
    • vancomycin-resistant enterococcus (VRE) infection or suspected VRE infection and one of the following:
      • 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
      • for linezolid suspension; or
    • culture is positive for methicillin-resistant Staphylococcus aureus (MRSA) and inadequate response or adverse reaction to one or contraindication to all of the following: clindamycin, doxycycline, linezolid, minocycline, sulfamethoxazole/trimethoprim, vancomycin IV; or
    • member has a history of past MRSA infection and inadequate response or adverse reaction to two or contraindication to all of the following: clindamycin, doxycycline, linezolid, minocycline, sulfamethoxazole/trimethoprim, vancomycin IV.

Lymepak

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ eight years of age and weighs ≥ 45 kg; and
  • appropriate dosing; and
  • inadequate response, adverse reaction, or contraindication to all doxycycline formulations available without prior authorization; and
  • medical necessity for the requested formulation instead of doxycycline 100 mg formulations available without prior authorization.

mebendazole

• Documentation of all of the following is required for a diagnosis of pinworm: 
  • appropriate diagnosis; and
  • appropriate dosing; and
  • inadequate response, adverse reaction, 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, and Minolira

• 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 
    • medical necessity for the requested formulation instead of minocycline capsules; and
  • for minocycline extended-release tablet formulations, inadequate response, adverse reaction, or contraindication to both of the following: minocycline capsules, Solodyn. 

nitrofurantoin 25 mg/5 mL suspension and nitrofurantoin 50 mg/5 mL suspension

• Documentation of all of the following is required:  
  • appropriate diagnosis; and
  • appropriate dosing; and
  • medical necessity for use of the suspension formulation instead of the capsule formulation.

ofloxacin

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

pyrimethamine

• Documentation of all of the following is required for toxoplasmosis treatment: 
  • appropriate diagnosis; and
  • appropriate dosing and frequency; and
  • requested agent will be used as combination therapy.

• Documentation of all of the following is required for primary prophylaxis of toxoplasmosis:
  • indication is for primary prophylaxis of toxoplasmosis; and
  • appropriate dose and frequency; and
  • inadequate response, adverse reaction, or contraindication to trimethoprim-sulfamethoxazole; and
  • one of the following:
    • CD-4 count is < 200 cells/mm³; or
    • clinical rationale for prophylaxis; and
  • requested agent will be used as combination therapy.

• Documentation of all of the following is required for secondary prophylaxis of toxoplasmosis:
  • indication is for secondary prophylaxis of toxoplasmosis; and
  • appropriate dose and frequency; and
  • one of the following:
    • CD-4 count is < 200 cells/mm³; or
    • clinical rationale for prophylaxis; and
  • requested agent will be used as combination therapy.

Sirturo

• Documentation of all of the following is required:  
  • appropriate diagnosis; and
  • requested agent will be used in combination with at least two other antitubercular agents.

Solosec

• Documentation of all of the following is required for a diagnosis of bacterial vaginosis:
  • 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.

• Documentation of all of the following is required for a diagnosis of trichomoniasis:
  • appropriate diagnosis; and 
  • member is ≥ 18 years of age; and 
  • appropriate dosing; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: oral metronidazole, oral tinidazole.

Tobi Podhaler

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

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

• Documentation of all of the following is required for a diagnosis of hepatic encephalopathy:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response, adverse reaction, or contraindication to lactulose; and
  • requested quantity is ≤ two tablets/day.
• Docuentation of all of the following is required for a diagnosis of irritable bowel syndrome with diarrhea:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and
  • inadequate response or adverse reaction to three or contraindication to all of the following: bile acid sequestrant, bismuth subsalicylate, bulk-forming agent, diphenoxylate/atropine, loperamide, tricyclic antidepressant (TCA).
• Documentation of all of the following is required for a diagnosis of small intestinal bacterial overgrowth (SIBO):
  • appropriate diagnosis; and
  • member is ≥ 12 years of age; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: amoxicillin-clavulanate, metronidazole added to either a cephalosporin or sulfamethoxazole-trimethoprim; and
  • appropriate dosing (550 mg three times daily for 14 days).

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 of age, 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.