FDA-approved, for example: 

• Alagille syndrome (Bylvay, Livmarli)
• Bile acid synthesis disorders due to single enzyme defects with or without familial hypertriglyceridemia (Cholbam)
• Bowel preparation prior to colonoscopy procedure or surgery (Clenpiq, Sutab)
• Chronic idiopathic constipation (lactulose packet, Linzess, lubiprostone, Motegrity, Trulance)
• Gallstones (chenodiol, ursodiol)
• IBS with constipation (Ibsrela, lactulose packet, lubiprostone, Trulance)
• Opioid-induced constipation in adults with chronic, non-cancer pain (lubiprostone, Movantik, Relistor, Symproic)
• Opioid-induced constipation in palliative care members (lactulose packet, Relistor)
• Peroxisomal disorders with or without familial hypertriglyceridemia (Cholbam)
• Prevention of gallstone formation (ursodiol)
• Prevention of recurrent Clostridium difficile infection (Rebyota, Vowst)
• Primary biliary cholangitis (Ocaliva)
• Progressive familial intrahepatic cholestasis (Bylvay)
• Severe and chronic diarrhea-predominant IBS (alosetron, Viberzi)
• Short bowel syndrome (Gattex)
• Symptomatic relief of non-infectious diarrhea in adult members with HIV/AIDS on anti-retroviral therapy (Mytesi)
• Treatment of chronic diarrhea (Motofen, opium tincture)
• Recurrent Clostridium difficile infection (Zinplava)

Non-FDA-approved, for example:

• Cerebrotendinous xanthomatosis (chenodiol)
• Hepatic encephalopathy (lactulose packet)
• Pediatric requests for chronic idiopathic constipation or irritable bowel syndrome with constipation (lubiprostone)

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.

Align, Culturelle, Florastor ≥ 22 years of age

• Documentation of the following is required for the diagnosis of antibiotic associated diarrhea (prophylaxis):
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ seven days of therapy) or adverse reaction within the last 90 days to two or contraindication to all of the following: alosetron, bismuth subsalicylate, diphenoxylate/atropine, loperamide; and
  • current antibiotic therapy.
• Documentation of the following is required for the diagnosis of bacterial overgrowth:
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ seven days of therapy) or adverse reaction within the last 90 days to one of the following: amoxicillin-clavulanic acid, ciprofloxacin, doxycycline, metronidazole, neomycin, tetracycline, trimethoprim-sulfamethoxazole, rifaximin.
• Documentation of the following is required for the diagnosis of chronic constipation:
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ seven days of therapy) or adverse reaction within the last 90 days to three or contraindication to all of the following: docusate, fiber supplementation/bulk-forming laxatives, lubiprostone or Linzess or Motegrity or Trulance, osmotic laxatives, saline laxatives, stimulant laxatives.
• Documentation of the following is required for the diagnosis of C. difficile associated diarrhea:
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ seven days of therapy) or adverse reaction within the last 90 days to one or contraindication to all of the following: fidaxomicin, metronidazole, rifaximin, oral vancomycin.
• Documentation of the following is required for the diagnosis of irritable bowel syndrome associated with constipation (IBS-C):
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ seven days of therapy) or adverse reaction within the last 90 days to two or contraindication to all of the following: docusate, fiber supplementation/bulk-forming laxatives, lubiprostone or Linzess or Trulance, osmotic laxatives, saline laxatives, stimulant laxatives.
• Documentation of the following is required for the diagnosis of irritable bowel syndrome associated with diarrhea (IBS-D):
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ seven days of therapy) or adverse reaction within the last 90 days to two or contraindication to all of the following: antibiotic (rifaximin), anti-diarrheal, antispasmodic, bile acid sequestrant, tricyclic antidepressant (TCA).
• Documentation of the following is required for the diagnosis of recurrent vaginitis:
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ seven days of therapy) or adverse reaction within the last 90 days to two or contraindication to all of the following: butoconazole, clindamycin, clotrimazole, fluconazole, metronidazole, miconazole, terconazole.

alosetron

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a gastroenterologist or consultation notes from a gastroenterologist are provided; and
  • appropriate dosing (0.5 mg twice daily initial, up to 1 mg twice daily maintenance); 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, TCAs.

Bylvay 

• Documentation of the following is required for diagnosis of progressive familial intrahepatic cholestatis (PFIC):
  • appropriate diagnosis; and
  • genetic testing does not indicate PFIC type 2 with ABCB11 variants encoding for nonfunction or absence of BSEP-3; and
  • member is ≥ three months of age; and
  • presence of moderate to severe pruritus; and
  • no evidence of portal hypertension or decompensated cirrhosis; and 
  • no history of liver transplant; and
  • no history of biliary diversion surgery within the past six months; and
  • inadequate response, adverse reaction, or contraindication to ursodiol 30 mg/kg/day; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: cholestyramine 4 g/day, rifampin 10 mg/kg/day; and
  • member's current weight; and
  • appropriate dosing.

• Documentation of the following is required for diagnosis of Alagille syndrome:
  • appropriate diagnosis; and
  • member is ≥ one year of age; and
  • genetic testing documenting JAG1 or NOTCH2 deletion or genetic testing confirming mutation in GAA gene; and 
  • member has moderate to severe pruritus caused by cholestasis; and 
  • prescriber is a specialist (hepatologist, gastroenterologist, or Alagille syndrome specialist) or consult notes from a specialist are provided; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: bile acid sequestrant, naltrexone, rifampin, sertraline, ursodiol; and
  • inadequate response, adverse reaction, or contraindication to Livmarli; and
  • member's current weight; and 
  • appropriate dosing.

chenodiol

• Documentation of the following is required for a diagnosis of cerebrotendinous xanthomatosis (CTX):
  • appropriate diagnosis; and
  • results of molecular genetic testing confirming the diagnosis of cerebrotendinous xanthomatosis; and
  • appropriate dosing or documentation that the member is stable on a lower or higher dose; and
  • member’s current weight.

• Documentation of the following is required for a diagnosis of gallstones:  
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to an ursodiol product; and
  • member's current weight.

Cholbam

• Documentation of the following is required:  
  • appropriate diagnosis; and
  • member is ≥ three weeks of age; and
  • member's current weight.

Clenpiq and Sutab

• Documentation of the following is required:
  • one of the following:
    • inadequate response or adverse reaction to one bowel prep product available without PA; or
    • medical necessity for the requested product; and
  • for Sutab, inadequate response or adverse reaction to one or contraindication to all of the following: Osmoprep, Plenvu, polyethylene glycol-electrolyte solution (Moviprep), sodium sulfate/potassium sulfate/magnesium sulfate (Suprep).

Gattex

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ one year of age; and
  • dependence on parenteral nutrition or intravenous fluids for at least one year; and
  • appropriate dosing.

Ibsrela

• Documentation of the following is required for diagnosis of chronic idiopathic constipation
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • requested quantity is ≤ two units/day; and
  • inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk forming laxatives, osmotic laxatives, saline laxatives, stimulant laxatives); and
  • inadequate response, adverse reaction, or contraindication to lubiprostone; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: Linzess and Trulance.

lactulose packet

• Documentation of the following is required:
  • appropriate diagnosis; and
  • medical records documenting an adverse reaction or contraindication to lactulose solution.

Linzess 72 mcg capsule

• Documentation of the following is required for members ≥ 18 years of age for chronic idiopathic constipation:
  • inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk-forming laxatives, osmotic laxatives, saline laxatives, stimulant laxatives); and
  • one of the following:
    • requested quantity is ≤ one unit/day; or
    • both of the following:
      • requested quantity is ≤ two units/day; and
      • adverse reaction to Linzess 145 mcg capsule.

• Documentation of the following is required for members ≥ two years of age and <18 years of age for chronic idiopathic constipation:
  • prescriber is a gastroenterologist and consult notes from a specialist are provided; and
  • inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk-forming laxatives, osmotic laxatives, saline laxatives, stimulant laxatives); and
  • one of the following:
    • requested quantity is ≤ one unit/day; or
    • both of the following:
      • requested quantity is ≤ two units/day; and
      • adverse reaction to Linzess 145 mcg capsule.

Livmarli

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ three months of age; and
  • genetic testing documenting JAG1 or NOTCH2 deletion or genetic testing confirming mutation in GAA gene; and 
  • member has moderate to severe pruritus caused by cholestasis; and 
  • prescriber is a specialist (hepatologist, gastroenterologist, or Alagille syndrome specialist) or consult notes from a specialist are provided; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: bile acid sequestrant, naltrexone, rifampin, sertraline, ursodiol; and
  • member's current weight; and
  • appropriate dosing.

lubiprostone

• Documentation of the following is required for members ≥ 18 years of age:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk-forming laxatives, osmotic laxatives, saline laxatives, stimulant laxatives); and
  • for a diagnosis of IBS with constipation or chronic idiopathic constipation, inadequate response or adverse reaction to one or contraindication to both of the following: Linzess and Trulance; and
  • appropriate dosing. 

• Documentation of the following is required for members ≥ three years of age and <18 years of age:
  • diagnosis of chronic idiopathic constipation or irritable bowel syndrome with constipation; and
  • prescriber is a specialist in gastroenterology; and
  • inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk-forming laxatives, osmotic laxatives, saline laxatives, stimulant laxatives); and
  • appropriate dosing.

Motegrity, Movantik, Symproic

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • requested quantity is ≤ one unit/day; and
  • inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk-forming laxatives, osmotic laxatives, saline laxatives, stimulant laxatives); and
  • inadequate response, adverse reaction, or contraindication to lubiprostone; and
  • for Motegrity, inadequate response or adverse reaction to one or contraindication to both of the following: Linzess and Trulance; and
  • for a compounded formulation of Motegrity, appropriate dosing.

Motofen

• Documentation of the following is required:  
  • appropriate diagnosis; and
  • member is ≥ 12 years of age; and
  • inadequate response, adverse reaction, or contraindication to diphenoxylate/atropine; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: bismuth subsalicylate and loperamide.

Mytesi

• 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 to all of the following: bismuth subsalicylate, diphenoxylate/atropine, loperamide; and
  • requested quantity is ≤ two units/day.

Non-preferred Probiotics

• Documentation of the following is required:
  • Diagnosis of one of the following:
    • antibiotic associated diarrhea (prophylaxis); or
    • bacterial overgrowth; or
    • chronic constipation; or
    • C. difficile associated diarrhea; or
    • irritable bowel syndrome with constipation; or 
    • irritable bowel syndrome with diarrhea; or
    • recurrent vaginitis; and
  • member must meet all criteria as written above for the listed diagnosis; and
  • inadequate response, adverse reaction, or contraindication to all of the following: Align, Culturelle, Florastor.

Ocaliva

• Documentation of the following is required:
  • appropriate diagnosis of primary biliary cholangitis supported by laboratory testing results and medical records documenting two of the following:
    • alkaline phosphatase elevation; or
    • presence of antimitochondrial antibody; or
    • histopathologic evidence of cholangitis and destruction of small or medium-sized bile ducts on biopsy, if performed; and
  • member is ≥ 18 years of age; and
  • one of the following:
    • alkaline phosphatase > upper limit of normal; or
    • total bilirubin > upper limit of normal; and
  • one of the following:
    • inadequate response to ursodiol at a dose of 13 to 15 mg/kg/day for at least one year and request is for use with ursodiol 13 to 15 mg/kg/day; or
    • adverse reaction or contraindication to ursodiol; and
  • one of the following:
    • member does not have cirrhosis; or
    • member has compensated cirrhosis without evidence of portal hypertension; and
  • requested quantity is ≤ one unit/day; and
  • one of the following:
    • request is for initiation of treatment and requested dose is 5 mg once daily; or
    • request is for continuation of treatment beyond three months and both of the following:
      • if request is for continuation of treatment beyond 12 months, one of the following:
        • if alkaline phosphatase was > upper limit of normal at baseline, alkaline phosphatase < 1.67-times upper limit of normal; or
        • ≥ 15% decrease in alkaline phosphatase; or
        • if total bilirubin was > upper limit of normal at baseline, total bilirubin ≤ upper limit of normal; or
        • clinical rationale for continued treatment; and
      • one of the following:
        • requested dose is 10 mg once daily; or
        • requested dose and/or frequency is ≤ 10 mg once daily and one of the following:
          • positive response to therapy at current dose (defined as alkaline phosphatase < 1.67-times upper limit of normal, total bilirubin ≤ upper limit of normal, and ≥ 15% decrease in alkaline phosphatase); or
          • clinical rationale for not titrating the dose to 10 mg once daily.

opium tincture

• Documentation of the following is required:
  • diagnosis of chronic diarrhea; and
  • member is ≥ 18 years of age; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: bismuth subsalicylate, diphenoxylate/atropine, loperamide.

Rebyota

• Documentation of the following is required:
  • diagnosis for prevention of recurrent Clostridium difficile infection with ≥ two episodes of Clostridium difficile infection following initial infection (≥ three total episodes of CD including initial infection); and
  • prescriber is an infectious disease specialist or gastroenterologist or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • inadequate response, adverse reaction or contraindication to Zinplava; and
  • medical necessity for requested agent instead of fecal microbiota transplant via other methods (e.g., IND protocol, stool banks); and
  • requested quantity is ≤ single dose.

Relistor

• Documentation of the following is required for diagnosis of opioid induced constipation with advanced illness receiving palliative care:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and
  • inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes(bulk-forming laxatives, osmotic laxatives, saline laxatives, stimulant laxatives).

• Documentation of the following is required for diagnosis of opioid induced constipation with chronic non-cancer pain:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and
  • inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes(bulk-forming laxatives, osmotic laxatives, saline laxatives, stimulant laxatives); and
  • inadequate response or adverse reaction to one or contraindication to both of the following: Movantik and Symproic; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: Linzess and lubiprostone.

Trulance

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • requested quantity is ≤ one unit/day; and
  • inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk forming laxatives, osmotic laxatives, saline laxatives, stimulant laxatives); and
  • inadequate response, adverse reaction, or contraindication to Linzess.

ursodiol 200 mg, 400 mg

• Documentation of the following is required for the diagnosis of gallstones:
  • appropriate diagnosis; and
  • member is not a candidate for cholecystectomy; and
  • medical necessity for the requested agent instead of an ursodiol product available without PA; and
  • member's current weight.

• Documentation of the following is required for the prevention of gallstone formation:
  • appropriate diagnosis; and
  • medical necessity for the requested agent instead of an ursodiol product available without PA.

Viberzi

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a gastroenterologist or provides consult notes from a gastroenterologist; and
  • requested quantity is ≤ two units/day; 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, TCAs.

Vowst

• Documentation of the following is required:
  • diagnosis for prevention of recurrent Clostridium difficile infection with ≥ two episodes of Clostridium difficile infection following initial infection (≥ three total episodes of CD including initial infection); and
  • member is ≥ 18 years of age; and
  • prescriber is a gastroenterologist or provides consult notes from a gastroenterologist; and
  • inadequate response, adverse reaction, or contraindication to Zinplava; and
  • medical necessity for requested agent instead of fecal microbiota transplant via other methods (IND protocol, stool banks); and
  • requested quantity is ≤ 12 capsules for one course of therapy.

Zinplava

• Documentation of the following is required:
  • diagnosis of recurrent Clostridium difficile infection with ≥ 1 episode of Clostridium difficile infection following initial infection; and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and
  • requested quantity is ≤ a single dose; and
  • medication will be used in combination with an antibiotic being used for the treatment of Clostridium difficile infection including at least one of the following: fidaxomicin, metronidazole, rifaximin, or vancomycin.   

^† 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 plans.