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Drug Category: Gastrointestinal

Medication Class/Individual Agents: Antidiarrheals, Antispasmodics, Bile Acid Agents, Bowel Preparations, Constipation Agents

I. Prior-Authorization Requirements

 Gastrointestinal Drugs – Antidiarrhea Medications

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

alosetron Lotronex PA  
bismuth subsalicylate * test  
crofelemer Mytesi PA  
difenoxin / atropine Motofen PA  
diphenoxylate / atropine Lomotil # test  
eluxadoline Viberzi PA  
loperamide * test  
opium tincture PA  

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.

 

Alosetron

  • Alosetron is a selective 5-HT3 receptor antagonist used to treat irritable bowel syndrome (IBS).
  • Due to the risk of serious gastrointestinal complications, providers prescribing alosetron must be enrolled in Lotronex Prescribing Program and document a signed physician-patient agreement.

Opium tincture

  • Opium tincture is not recommended for use in children and caution is recommended for use in the elderly.

Bowel Preparation Agents

  • All preparations are considered equally efficacious; however, certain products may have the advantage of reduced side effects or lower fluid requirements.
 

 Gastrointestinal Drugs – Antispasmodics

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

dicyclomine Bentyl # test  
hyoscyamine oral test  

 Gastrointestinal Drugs – Bile Acid Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

chenodiol PA  
cholic acid Cholbam PA  
obeticholic acid Ocaliva PA  
ursodiol Actigall # test  
ursodiol Urso # test  
ursodiol Urso Forte # test  

 Gastrointestinal Drugs – Bowel Preparation Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

polyethylene glycol-electrolyte solution-Colyte Colyte # test  
polyethylene glycol-electrolyte solution-Golytely Golytely # test  
polyethylene glycol-electrolyte solution-Moviprep Moviprep test  
polyethylene glycol-electrolyte solution-Nulytely Nulytely # test  
polyethylene glycol-electrolyte solution-Plenvu Plenvu PA  
sodium phosphate Osmoprep test  
sodium picosulfate / magnesium oxide / anhydrous citric acid-Clenpiq Clenpiq PA  
sodium picosulfate / magnesium oxide / anhydrous citric acid-Prepopik Prepopik test  
sodium sulfate / potassium sulfate / magnesium sulfate Suprep PA  

 Gastrointestinal Drugs – Constipation Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

aluminum hydroxide * test  
bisacodyl * test  
dextrin * test  
docusate enema Enemeez test  
docusate sodium * test  
lactulose packet PA  
lactulose solution test  
linaclotide Linzess PA  
lubiprostone Amitiza PA  
magnesium salts * test  
methylcellulose * test  
methylnaltrexone Relistor PA  
mineral oil * test  
naldemedine Symproic PA  
naloxegol Movantik PA  
plecanatide Trulance PA  
polyethylene glycol 3350 * test  
prucalopride Motegrity PA  
psyllium * test  
sennosides * test  

 Gastrointestinal Drugs – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

bezlotoxumab Zinplava PA  
bifidobacterium infantis Align PA   - ≥ 19 years
lactobacillus rhamnosus GG Culturelle PA   - ≥ 19 years
saccharomyces boulardii Florastor PA   - ≥ 19 years
teduglutide injection Gattex 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.
 
* 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: 

  • Bile acid synthesis disorders due to single enzyme defects with or without familial hypertriglyceridemia (Cholbam)
  • Bowel preparation prior to colonoscopy procedure or surgery (Clenpiq, Plenvu, Suprep)
  • Chronic idiopathic constipation (Amitiza, lactulose packet, Linzess, Motegrity, Trulance)
  • Gallstones (chenodiol)
  • IBS with constipation (Amitiza, lactulose packet, Linzess, Trulance)
  • Opioid-induced constipation in adults with chronic, non-cancer pain (Amitiza, Movantik, Relistor, Symproic)
  • Opioid-induced constipation in palliative care patients (lactulose packet, Relistor)
  • Peroxisomal disorders with or without familial hypertriglyceridemia (Cholbam)
  • Primary Biliary Cholangitis (Ocaliva)
  • Severe and chronic diarrhea-predominant IBS (alosetron, Viberzi)
  • Short bowel syndrome (Gattex)
  • Symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy (Mytesi)
  • Treatment of chronic diarrhea (Motofen, opium tincture)
  • Recurrent Clostridium difficile infection (Zinplava)

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).

 

Align, Culturelle, Florastor ≥ 19 years

  • Documentation of the following is required for the diagnosis of antibiotic associated diarrhea (prophylaxis):
    • appropriate diagnosis; and
    • inadequate response or adverse reaction within the last 90 days to two of the following 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
    • treatment for at least seven days within the last 90 days with one of the following: amoxicillin-clavulanic acid, chloramphenicol, ciprofloxacin, metronidazole, tetracycline, trimethoprim-sulfamethoxazole, rifaximin.
  • Documentation of the following is required for the diagnosis of chronic constipation:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to three of the following or contraindication to all of the following: docusate, fiber supplementation/bulk-forming laxatives, lubiprostone or linaclotide, 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 or adverse reaction within the last 90 days to one of the following 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 or adverse reaction to two of the following or contraindication to all of the following: docusate, fiber supplementation/bulk-forming laxatives, lubiprostone or linaclotide, 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 or adverse reaction to two of the following 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 or adverse reaction within the last 90 days to two of the following 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 must be a female ≥ 18 years of age; and
    • prescriber is a gastroenterologist or has documented a consultation with a gastroenterologist; and
    • dose is appropriate (0.5 mg twice daily initial, up to 1 mg twice daily maintenance); and
    • one of the following:
      • inadequate response or adverse reaction to three of the following: loperamide, diphenoxylate/atropine, bile acid sequestrant, bismuth subsalicylate, bulk-forming agent, TCA; or
      • contraindication to all less costly alternatives.

Amitiza

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • for a diagnosis of IBS with constipation, member is a female; and
    • quantity does not exceed 60 capsules/month; 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).

chenodiol

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 3 weeks of age; and
    • member's current weight.

Cholbam

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

Clenpiq, Plenvu, Suprep

  • Documentation of the following is required:
    • inadequate response or adverse reaction to one polyethylene glycol product available without PA; or
    • medical necessity for product.

SmartPA: Claims for Clenpiq, Plenvu, and Suprep will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for one polyethylene glycol product available without PA.

Gattex

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • dependence on parenteral nutrition or intravenous fluids for at least one year; and
    • dose is appropriate (0.05 mg/kg subcutaneously once daily).

lactulose packet

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

Linzess

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • quantity does not exceed 30 capsules/month; 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).

Motegrity, Movantik, Symproic, Trulance

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • quantity does not exceed 30 tablets/month; 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 Amitiza.

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, adverse reaction, or contraindication to loperamide or bismuth subsalicylate.

Mytesi

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response, adverse reaction, or contraindication to two of the following: loperamide, bismuth subsalicylate, or diphenoxylate/atropine; and
    • quantity does not exceed 60 tablets/30 days.

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
      • presence of antimitochondrial antibody
      • 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
    • quantity does not exceed 30 units/30 days; and
    • one of the following:
      • request is for initiation of treatment and requested dose is 5 mg once daily (Child-Pugh Class A) or once weekly (Child-Pugh Class B or C); 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 less than 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
            • Child Pugh Class B or C; 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, adverse reaction, or contraindication to two of the following agents: loperamide, bismuth subsalicylate, or diphenoxylate/atropine.

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
    • 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
    • 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 Movantik; and
    • one of the following:
      • inadequate response or adverse reaction to Linzess or Amitiza; or
      • contraindication to both Linzess and Amitiza.

Viberzi

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a gastroenterologist or has documented a consultation with a gastroenterologist; and
    • quantity does not exceed 60 tablets/30 days; and
    • one of the following:
      • inadequate response or adverse reaction to three of the following: loperamide, diphenoxylate/atropine, bile acid sequestrant, bismuth subsalicylate, bulk-forming agent, TCA; or
      • contraindication to all less costly alternatives.

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
    • dose is appropriate (10 mg/kg); and
    • quantity does not exceed 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:
      • metronidazole; or
      • vancomycin; or
      • fidaxomicin; or
      • rifaximin.

  

 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.


Original Effective Date: 05/2012

Last Revised Date: 08/2019


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Last updated 10/09/19