Gastro Intestinal

PA criteria:

• An FDA approved diagnosis of travelers’ diarrhea; AND
• Member must be 18 years of age or older; AND
• Travelers’ diarrhea must be due to non-invasive strains of Escherichia coli; AND
• A patient-specific, clinically significant reason why the member cannot use Xifaxan® (rifaximin) oral tablets must be provided; AND
• A quantity limit of 12 tablets per 3 days will apply. 

 Prior Authorization form

Amitiza® (Lubiprostone) Approval Criteria [Chronic Idiopathic Constipation (CIC) or Irritable Bowel Syndrome with Constipation (IBS-C) Diagnosis]:

• An FDA approved diagnosis of Chronic Idiopathic Constipation (CIC) in members 18 years of age or older, or Irritable Bowel Syndrome characterized by constipation (IBS-C) in female members 18 years of age or older; AND
• Documentation that constipation-causing therapies for other disease states have been discontinued (excluding opioid pain medications for cancer patients); AND
• Documented and updated colon screening for members 45 years of age or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Member must not have known or suspected gastrointestinal obstruction; and 
• Documentation of hydration attempts and trials of at least three different types of products that failed to relieve constipation.  Trials must be within the past 90 days. Products may be OTC or prescription (does not include fiber or stool softeners).
  • One of the three trials must be polyethylene glycol 3350 (PEG-3350)
  • Members with a oncology-related diagnosis are exempt from the trial requirements
• A patient-specific, clinically significant reason why the member cannot use Linzess^® (linaclotide) or Trulance^® (plecanatide) must be provided; and
• Approval will initially be for 12 weeks of therapy.  Further approval may be granted if prescriber documents member is responding well to treatment.
• A quantity limit of 60 units for a 30 day supply will apply.

Amitiza^® (Lubiprostone) Approval Criteria [Opioid-Induced Constipation (OIC) Diagnosis]:

• An FDA approved diagnosis of Opioid-Induced Constipation (OIC) in members 18 years of age or older with chronic, non-cancer pain who are currently on chronic opioid therapy, except methadone; AND
• Documentation of the underlying cause of chronic pain, or reason why member is on chronic opioid therapy; AND
• Documented and updated colon screening for members 45 years of age or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Member must not have known or suspected gastrointestinal obstruction; and 
• Documentation of hydration attempts and trials of at least three different types of products that failed to relieve constipation.  Trials must be within the past 90 days. Products may be OTC or prescription (does not include fiber or stool softeners).
  • One of the three trials must be polyethylene glycol 3350 (PEG-3350)
  • Members with a oncology-related diagnosis are exempt from the trial requirements
• Approval will initially be for 12 weeks of therapy.  Further approval may be granted if prescriber documents member is responding well to treatment.
• A quantity limit of 60 units for a 30 day supply will apply.

 Prior Authorization form

Amisulpride (Barhemsys®) Approval Criteria:

• An FDA approved indication of 1 of the following:
  • Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an anti-emetic of a different class; or
  • Treatment of PONV in members who have received anti-emetic prophylaxis with an agent of a different class or who have not received prophylaxis; and
• Member must be 18 years of age or older; and
• Member must not have received a preoperative dopamine-2 (D₂) antagonist (e.g., metoclopramide); and
• A patient-specific, clinically significant reason why the member cannot use other cost-effective therapeutic alternatives for the prevention or treatment of PONV (e.g. ondansetron, dexamethasone) must be provided.

Aponvie™ (Aprepitant 32mg/4.4mL Vial) Approval Criteria:

• An FDA approved indication for the prevention of postoperative nausea and vomiting (PONV); and
• A patient-specific, clinically significant reason why the member cannot use other cost-effective therapeutic alternatives for the prevention of PONV (e.g., ondansetron) must be provided. 

granisetron (Kytril®, Sancuso®), dolasetron (Anzement®), aprepitant (Emend®, Cinvanti™) and Emend® IV (Fosaprepitant) Approval Criteria:

• An FDA approved diagnosis; AND
• A recent trial of ondansetron (within the past six months) used for at least three days or one cycle that resulted in inadequate response is required for authorization in members receiving moderately emetogenic chemotherapy; AND
• No ondansetron trial is required for authorization of Emend® (aprepitant) in members receiving highly emetogenic chemotherapy; AND
• Approval length will be based on duration of need. 
• For Emend® (aprepitant) oral suspension, an age restriction of twelve years and younger will apply.  Members older than twelve years of age will require a patient-specific, clinically significant reason why the oral capsule formulation cannot be used.
• For Cinvanti™ [aprepitant intravenous (IV) emulsion], a previously failed trial of IV fosaprepitant (Emend® IV) that resulted in an inadequate response, or a patient-specific, clinically significant reason why IV fosaprepitant cannot be used must be provided; AND
• Approval length will be based on duration of need.

granisetron subcutaneous injection (Sustol®) Approval Criteria:

• An FDA approved indication for use in the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens; AND
• Chemotherapy regimen must be listed on the prior authorization request; AND
• A recent trial of ondansetron (within the past six months) used for at least three days or one cycle that resulted in inadequate response is required for authorization in members receiving MEC; AND 
• No ondansetron trial is required for authorization of granisetron in members receiving AC combination chemotherapy regimens; AND
• A patient-specific, clinically significant reason why the member cannot use Kytril® (granisetron hydrochloride injection); AND
• A quantity limit of one injection every seven days will apply.

nabilone (Cesamet®), dronabinol (Marinol® and Sydrose®) Approval Criteria:

• An FDA approved diagnosis; AND
• Approval length will be based on duration of need; AND
• For Marinol® (dronabinol) and Cesamet® (nabilone), a quantity limit of 60 capsules per 30 days will apply; AND
• Cesamet® (nabilone) will require a patient-specific, clinically significant reason why dronabinol oral capsules cannot be used; AND
• For Syndros® (dronabinol) oral solution, the quantity approved will be patient-specific depending on patient diagnosis, maximum recommended dosage, and manufacturer packaging; AND
• For Syndros® (dronabinol) oral solution, an age restriction of 6 years and younger will apply.  Members older than 6 years of age will require a patient-specific, clinically significant reason why dronabinol oral capsules cannot be used.

netupitant/Palonosetron (Akynzeo®) and Akynzeo® IV (Fosnetupitant/Palonosetron) Approval Criteria:

• An FDA approved diagnosis for the prevention of acute and delayed nausea AND vomiting associated with initial and repeat courses of cancer chemotherapy; AND
• For Akynzeo® oral capsules, a previously failed trial of oral aprepitant (Emend®) that resulted in inadequate response, or a patient-specific, clinically significant reason why oral aprepitant cannont be used must be provided; AND
• For Akynzeo® IV, a previously failed trial of intravenous (IV) fosaprepitant (Emend® IV) that resulted in an inadequate response, or a patient-specific, clinically significant reason why IV fosaprepitant cannot be used must be provided; AND
• Akynzeo® IV will require a patient-specific, clinically significant reason why the oral capsule formulation cannot be used; AND
• Approval length based on duration of need.
• A quantity limit of one capsule  or vial per chemotherapy cycle will apply.
• Akynzeo® oral capsules will not require a prior authorization for members with cancer and claims will pay at the point of sale if the member has a reported oncology diagnosis within the past six months of claims history.
  • Based on the current low net cost, Akynzeo® oral capsules will not require a prior authorization for members with cancer; however, Akynzeo® oral capsules will follow the original criteria and require a previously failed trial of aprepitant if the net cost increases compared to other available products. 

ondansetron (Zuplenz™) Approval Criteria:

• FDA-approved indication.
• Must provide a clinically significant reason why the member cannot take all other available formulations of generic ondansetron.  

rolapitant (Varubi™ and Varubi® IV) Approval Criteria:

• An FDA approved indication for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy; AND
• For oral Varubi®(rolapitant oral tablets), a previously failed trial of aprepitant (Emend®) that resulted in an inadequate response, or a patient-specific, clinically significant reason why aprepitant cannot be used must be provided; AND
• For Varubi® IV [rolapitant intravenous (IV) emulsion], a previously failed trial of IV fosaprepitant (Emend® IV) that resulted in an inadequate response, or a patient-specific, clinically significant reason why IV fosaprepitant cannot be used must be provided; AND
• Approval length based on duration of need.  
• A quantity limit of two tablets or two vials per chemotherapy cycle will apply.

 Prior Authorization form

Tier 1 products are available with no authorization necessary.

Criteria for Approval of a Tier 2 medication:

• A recent 14 day trial of all available Tier 1 medications titrated up to the recommended dose that has resulted in inadequate relief of symptoms or intolerable adverse effects; OR
• Contraindication to all available Tier 1 medications; OR
• An indication not covered by lower tiered medications.

Criteria for Approval of a Tier 3 medication:

• A recent 14 day trial all available Tier 1 and Tier 2 medications that has resulted in inadequate relief of symptoms or intolerable adverse effects; OR
• Contraindication to all available tier 2 medications.
• An indication not covered by lower tiered medications.
• Special formulations including ODTs, Sprinkle Capsules,Granules, Suspension, and Solution for I.V. require special reason for use.

Pediatric members under the age of 19 approval criteria:

• A recent 14 day trial of an H2 receptor antagonist that has resulted in inadequate relief of symptoms or intolerable adverse effects.
• Recurrent or severe disease such as GI Bleed, Zollinger-Ellison or similar disease.  
• Tier structure rules apply.

Special Prior Authorizations of Miscellaneous Products:

***Special Formulations including ODTs, Granules, Suspension and Solution for I.V. require special reason for use.

famotidine suspension (Pepcid®) Approval Criteria:  

• Famotidine suspension will have an age restriction of 6 years of age and younger. Members older than 6 years of age will require a patient- specific, clinically significant reason why the member needs the liquid formulation and cannot use the oral tablet formulation. 

glycopyrrolate tablet (Glycate®) Approval Criteria:  

• An FDA approved indication of adjunctive therapy in the treatment of peptic ulcer disease (PUD) in patients 12 years of age and older; AND
• A patient-specific, clinically significant reason why the member cannot use glycopyrrolate 1mg and 2mg tablets, which are available without a prior authorization, must be provided. 

nizatidine solution (Axid®):

• A previous 14-day trial of famotidine suspension or a patient-specific, clinically significant reason why famotidine suspension is not appropriate for the member must be provided; and
• Nizatidine solution (Axid^®) will have an age restriction of 6 years of age and younger. Members older than 6 years of age will require a patient- specific, clinically significant reason why the member needs the liquid formulation and cannot use the oral capsule formulation.

nizatidine capsules (Axid®) and cimetidine tablets (Tagamet®):

• A previous 14-day trial of famotidine or a patient-specific, clinically significant reason why famotidine is not appropriate for the member.

omeprazole/amoxicillin/rifabutin capsule (Talicia®) Approval Criteria:

• An FDA approved diagnosis; AND
• A patient-specific, clinically significant reason why the member cannot use the individual components of other triple-therapy treatments approved for the same diagnosis (e.g., omeprazole, amoxicillin, and clarithromycin), or brand name Pylera^® (bismuth subcitrate potassium/ metronidazole/tetracycline capsules), which are available without prior authorization, must be provided; AND
• A quantity limit of 168 capsules per 14 days will apply. 

ESOMEP-EZS™ (esomeprazole kit) Approval Criteria:

• A previous 14-day trial of esomeprazole magnesium and a patient-specific, clinically significant reason why other lower tiered proton pump inhibitors including omeprazole and esomeprazole along with over-the-counter (OTC) pill swallowing spray are not appropriate for the member must be provided; and
• Current Tier structure rules will also apply. 

Dartisla ODT™ [Glycopyrrolate Orally Disintegrating Tablet (ODT)] Approval Criteria:

• An FDA approved indication of adjunctive therapy in the treatment of peptic ulcer disease (PUD) in members 18 years of age and older; AND
• A patient-specific, clinically significant reason why the member cannot use glycopyrrolate 1mg and 2mg tablets, which are available without prior authorization, must be provided; AND
• A quantity limit of 120 ODTs per 30 days will apply.    

Konvomep™ (Omeprazole/Sodium Bicarbonate for Oral Suspension) and Zegerid^® (Omeprazole/Sodium Bicarbonate Capsules) Approval Criteria:

• Member must be 18 years of age or older; AND
• A patient specific, clinically significant reason why the member cannot use omeprazole and over-the-counter (OTC) sodium bicarbonate must be provided; AND
• For Konvomep™, requests for the 90mL or 150mL package size will require a patient-specific, clinically significant reason why the member cannot use the 300mL package size. 

Prior Authorization form

caps = capsules; I.V. = intravenous; ODT = orally disintegrating tablet; PA = prior authorization;

soln = solution; susp = suspension; tabs = tablets

*Special formulations including ODTs, granules, suspension, sprinkle capsules, and solution for IV require special reasoning for use.

**no products available for coverage by SoonerCare currently

⁺Individual criteria specific to each product applies.

Clenpiq™, OsmoPrep®, Plenvu®, Prepopik®, and SUPREP®, and Sutab^® Approval Criteria:

• An FDA approved indication for use in cleansing of the colon as a preparation for colonoscopy; AND
• A patient-specific, clinically significant reason other than convenience the member cannot use other bowel preparation medications available without prior authorization.
• If the member requires a low volume polyethylene glycol electrolyte lavage solution, Moviprep® is available without prior authorization. Other medications currently available without a prior authorization include: Colyte®, Gavilyte®, Golytely®, and Trilyte®.

Prior Authorization form

Consideration will be based on ALL of the following criteria:

PA criteria:

• An FDA approved diagnosis of non-infectious diarrhea in adult patients with HIV/AIDS currently on anti-retroviral therapy; AND
• Duration of diarrhea has been ≥4 weeks; AND
• Dietary modifications have failed; AND
• Prescribers must verify that infectious diarrhea has been ruled out via confirmation of ALL of the following:
  • CD4 count has been measured and possible opportunistic infections have been ruled out; AND
  • Members does not have fever; AND
  • Stool studies for pathogens are negative including 
    • Bacterial cultures
    • Ova, Parasite, Cryptosporidium and/or Giardia
    • Clostridium difficile (Clostridium difficile testing should include a glutamate dehydrogenase screen and if positive followed by a confirmatory test OR nucleic acid amplification test in patients with documented diarrhea. A toxin enzyme immunoassay should not be used as a stand-alone test.); AND 
• If stool study results are negative and the patient has severe symptoms, particularly in the case of advanced immunodeficiency, an endoscopy with biopsy is recommended, at the doctor's discretion, to rule out inflammatory bowel disease, cancer, cytomegalovirus (CMV) infection, microsporidium, or mycobacterium avium complex (MAC); AND
• A quantity limit of 60 tablets per 30 days will apply

*Please note that initial approval will be for 4 weeks of therapy. An additional 6 month approval may be granted if physician documents member is responding well to treatment.

Prior Authorization form

Gattex® (Teduglutide) Approval Criteria:

• An FDA approved diagnosis of severe Short Bowel Syndrome, AND
• Member must require parenteral support (PS) as indicated by the following: 
  • For adult members: Must require PS at least 3 times per week, every week, for the past 12 months; OR
  • For pediatric members: PS accounts for at least 30% of caloric and/or fluid/electrolyte needs; AND
• Documentation of all of the following:
  • Prior use of supportive therapies (e.g., anti-motility agents, proton pump inhibitors, bile acid sequestrants, and octreotide); AND
  • For adult members, colonoscopy within the previous six months, with removal of polyps if present; AND
  • For pediatric members, a fecal occult blood test within the previous 6 months; AND
    • If there is unexpected blood in the stool, a colonoscopy/ sigmoidoscopy was performed; AND 
  • Gastro-intestinal malignancy has been ruled out.
• Approval will be for the duration of 6 months, after which time, prescriber must verify benefit of medication by documented reduction of at least 20% in parenteral support. Subsequent approvals will be for the duration of a year.

Ibsrela^® (Tenapanor) Approval Criteria:

• An FDA approved diagnosis of irritable bowel syndrome with constipation (IBS-C) in members 18 years of age or older; AND
• Documentation that constipation-causing therapies for other disease states have been discontinued (excluding opioid pain medications for cancer patients); AND  
• Documented and updated colon screening for members older than 45 years of age or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Member must not have known or suspected gastrointestinal obstruction; and 
• Documentation of hydration attempts and trials of at least 3 different types of products that failed to relieve constipation. Trials must be within the past 90 days. Products may be over-the-counter (OTC) or prescription (does not include fiber or stool softeners); AND
  
  • One of the 3 trials must be polyethylene glycol 3350 (PEG-3350); ANDAND
  • Members with an oncology-related diagnosis are exempt from the trial requirements; AND   
• A patient-specific, clinically significant reason why member cannot use Amitiza® (lubiprostone), Linzess® (linaclotide), or Trulance® (plecanatide) must be provided; andAND  
• Approval will initially be for 12 weeks of therapy. Further approval may be granted if prescriber documents member is responding well to treatment; AND
• A quantity limit of 60 tablets per 30 days will apply.  

 Prior Authorization form

Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use the liquid lactulose formulation.

Prior Authorization form

Linzess^® (Linaclotide) Approval Criteria:

• An FDA approved diagnosis of 1 of the following:
  • Chronic idiopathic constipation (CIC) in members 18 years of age or older; or
  • Irritable bowel syndrome with constipation (IBS-C) in members 18 years of age or older; or
  • Functional constipation in members 6 to 17 years of age; and
• Documentation that constipation-causing therapies for other disease states have been discontinued (excluding opioid pain medications for cancer patients); and
• Documented and updated colon screening for members 45 years of age or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Member must not have known or suspected gastrointestinal obstruction; and
• Documentation of hydration attempts and trials of at least 3 different types of products that failed to relieve constipation. Trials must be within the past 90 days. Products may be over-the-counter (OTC) or prescription (does not include fiber or stool softeners); and
• 1 of the 3 trials must be polyethylene glycol 3350 (PEG-3350); and
• Members with an oncology-related diagnosis are exempt from the trial requirements; and
• Approvals will initially be for 12 weeks of therapy. Further approval may be granted if the prescriber documents the member is responding well to treatment; and
• A quantity limit of 30 capsules per 30 days will apply. 

 Prior Authorization form

Motegrity^® (Prucalopride) Approval Criteria:

• An FDA approved diagnosis of chronic idiopathic constipation (CIC) in members 18 years of age or older; AND
• Documentation that constipation-causing therapies for other disease states have been discontinued (excluding opioid pain medications for cancer patients); AND
• Documented and updated colon screening for members 45 years of age or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Member must not have known or suspected gastrointestinal obstruction; and  
• Documentation of hydration attempts and trials of at least 3 different types of products that failed to relieve constipation. Trials must be within the past 90 days. Products may be over-the-counter (OTC) or prescription (does not include fiber or stool softeners); AND
  
  • One of the 3 trials must be polyethylene glycol 3350 (PEG-3350); AND
  • Members with an oncology-related diagnosis are exempt from the trial requirements; AND 
• A patient-specific, clinically significant reason why member cannot use Linzess® (linaclotide), Amitiza® (lubiprostone), or Trulance® (plecanatide) must be provided; AND
• Approval will initially be for 12 weeks of therapy. Further approval may be granted if prescriber documents member is responding well to treatment; AND
• A quantity limit of 30 tablets per 30 days will apply.  

 Prior Authorization form

PA criteria:

• An FDA approved diagnosis of acute nonspecific diarrhea or acute exacerbations of chronic functional diarrhea; AND
• Member must not be 2 years of age or younger; AND
• Member must not have diarrhea associated with organisms that penetrate the intestinal mucosa (e.g., toxigenic Escherichia coli, Salmonella species, Shigella) or pseudomembranous colitis associated with broad spectrum antibiotics; AND
• A patient-specific, clinically significant reason why the member cannot use Lomotil® (diphenoxylate/atropine) and loperamide must be provided; AND
• A quantity limit of 16 tablets per 2 days will apply. 

 Prior Authorization form

Movantik^® (Naloxegol) Approval Criteria:

• An FDA approved diagnosis of opioid-induced constipation (OIC) in members 18 years of age or older with chronic, non-cancer pain who are currently on chronic opioid therapy including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opiod dosage escalation; AND
• Member must not have known or suspected gastrointestinal obstruction;AND
• Documentation of the underlying cause of chronic pain, or reason why member is on chronic opioid therapy; AND
• Documented and updated colon screening for members 45 years of age or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Documentation of hydration attempts and trials with a combination of at least 3 different types of products that failed to relieve constipation.  Trials must be within the past 90 days. Products may be OTC or prescription (does not include fiber or stool softeners); AND
  • One of the 3 trials must be polyethylene glycol 3350 (PEG-3350); AND
  • Members with an oncology-related diagnosis are exempt from the trial requirements; AND 
• Approval will initially be for 12 weeks of therapy.  Further approval may be granted if prescriber documents member is responding well to treatment. 
• Movantik™ must be discontinued if treatment with the opioid pain medication is also discontinued. 
• A quantity limit of 30 tablets for a 30 day supply will apply

Prior Authorization form  

Ortikos™ [Budesonide Extended-Release (ER) Capsule] Approval Criteria:

•  An FDA approved indication of 1 of the following:
  •  For the treatment of mild-to-moderate active Crohn’s disease (CD) involving the ileum and/or the ascending colon, in members 8 years of age or older; or
  • For the maintenance of clinical remission of mild-to-moderate CD involving the ileum and/or the ascending colon for up to 3 months duration in adult members; and
• Member must have previous failure of Entocort^® EC (budesonide controlled ileal-release enteric coated capsules) within the last 3 months at recommended dosing and a reason for trial failure with Entocort^® EC must be provided; or
• A patient-specific, clinically significant reason (beyond convenience) why the member cannot use other oral corticosteroids, including Entocort^® EC, that are available without prior authorization must be provided; and
• Dosing regimen and duration of therapy must be in accordance with the Ortikos™ Prescribing Information; and
• Approval length will be based on the manufacturer maximum recommended duration of therapy; and
• A quantity limit of 30 capsules per 30 days will apply

Pertzye® and Viokace® Approval Criteria:

• An FDA approved diagnosis of pancreatic insufficiency; AND
• Documented trials of inadequate response to Creon® and Zenpep® or a patient-specific, clinically significant reason why the member cannot use Creon® or Zenpep®.

Pizensy™ (Lactitol) Approval Criteria: 

• An FDA approved indication for the treatment of chronic idiopathic constipation (CIC) in members 18 years of age or older; and
• Member must not have a known contraindication to Pizensy™ (i.e., suspected gastrointestinal obstruction, galactosemia); and
• Documentation that constipation-causing therapies for other disease states have been discontinued (excluding opioid pain medications for cancer patients); and
• Documented and updated colon screening for members 45 years of age or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Member must not have known or suspected gastrointestinal obstruction; and 
• Documentation of hydration attempts and trials of at least 3 different types of products that failed to relieve constipation. Trials must be within the past 90 days. Products may be over-the-counter (OTC) or prescription (does not include fiber or stool softeners); and
  • 1 of the 3 trials must be polyethylene glycol 3350 (PEG-3350); and
  • Members with an oncology-related diagnosis are exempt from the trial requirements; and
• A patient-specific, clinically significant reason why the member cannot use Linzess^® (linaclotide), Amitiza^® (lubiprostone), or Trulance^® (plecanatide) must be provided; and
• Use of the unit-dose packets will require a patient-specific, clinically significant reason why the member cannot use the multi-dose bottle; and
• Approval will initially be for 12 weeks of therapy. Further approval may be granted if prescriber documents member is responding well to treatment; and
• A quantity limit of 560 grams per 28 days will apply.

Relistor^® (Methylnaltrexone) Tablets Approval Criteria:

• An FDA approved diagnosis of opioid-induced constipation (OIC) in members 18 years of age or older with chronic, non-cancer pain who are currently on chronic opioid therapy; AND
• Member must not have known or suspected gastrointestinal obstruction; AND
• Documentation of the underlying cause of chronic pain, or reason why member is on chronic opioid therapy; AND
• Documented and updated colon screening for members 45 years of age or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Documentation of hydration attempts and trials of at least three different types of products that failed to relieve constipation.  Trials must be within the past 90 days.  Products may be over-the-counter (OTC) or prescription (does not include fiber or stool softeners); AND
  • One of the three trials must be polyethylene glycol 3350 (PEG-3350); AND
  • Members with an oncology-related diagnosis are exempt from the trial requirements; AND  
• A patient-specific, clinically significant reason why member cannot use Amitiza® (lubiprostone), Movantik® (naloxegol), or Symproic® (naldemedine)  must be provided; AND
• Approval will initially be for 12 weeks of therapy.  Further approval may be granted if prescriber documents member is responding well to treatment.
• Relistor® must be discontinued if treatment with the opioid pain medication is also discontinued.
• A quantity limit of 90 tablets for a 30 day supply will apply.

Relistor^® (Methylnaltrexone) Injection Approval Criteria [Opioid-Induced Constipation (OIC) in Chronic Non-Cancer Pain Diagnosis]:

• Member must be 18 years of age or older; AND
• An FDA approved diagnosis of opioid-induced constipation (OIC) in patients with chronic pain unrelated to cancer; AND
• Documentation of the underlying cause of chronic pain, or reason why member is on chronic opioid therapy; AND
• Member must have current use of opioid medications; AND
• Documented and updated colon screening for members 45 years of age or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Documentation of hydration attempts and trials of at least three different types of products that failed to relieve constipation.  Trials must be within the past 90 days.  Products may be OTC or prescription (does not include fiber or stool softeners); AND
  • One of the three trials must be polyethylene glycol 3350 (PEG-3350); and
  • Members with an oncology-related diagnosis are exempt from the trial requirements; AND  
• Mechanical gastrointestinal obstruction has been ruled out; AND
• A patient-specific, clinically significant reason why member cannot use Amitiza® (lubiprostone), Movantik™ (naloxegol); or Symproic® (naldemedine)  must be provided; AND
• A patient-specific, clinically significant reason why member cannot use the tablet formulation of Relistor®; AND
• The 12mg single-use vials, syringes, or kits will be the preferred products. Criteria for consideration of 8mg single-use syringes: 
  • Weight range of 38kg to 62kg; and/or 
  • Caregiver unable to draw up dose from vial. 
• Approval will initially be for 12 weeks of therapy.  Further approval may be granted if prescriber documents member is responding well to treatment.
• A quantity limit of 30 units per month will apply.

Prior Authorization form

Symproic^® (Naldemedine) Approval Criteria:

• An FDA approved diagnosis of opioid-induced constipation (OIC) in members 18 years of age or older with chronic, non-cancer pain who are currently on chronic opioid therapy, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation; AND
• Member must not have known or suspected gastrointestinal obstruction; AND
• Documentation of the underlying cause of chronic pain, or reason why the member is on chronic opioid therapy; AND
• Documented and updated colon screening for members 45 years of age or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Documentation of hydration attempts and trials of at least three different types of products that failed to relieve constipation.  Trials must be within the past 90 days. Products may be over-the-counter (OTC) or prescription (does not include fiber or stool softeners); AND
  • One of the three trials must be polyethylene glycol 3350 (PEG-3350); AND
  • Members with an oncology-related diagnosis are exempt from the trial requirements; AND
• Approval will initially be for 12 weeks of therapy.  Further approval may be granted if the prescriber documents the member is responding well to treatment. 
• Symproic® must be discontinued if treatment with the opioid pain medication is also discontinued. 
• A quantity limit of 30 tablets for a 30-day supply will apply.

 Prior Authorization form

Trulance^® (Plecanatide) Approval Criteria:

• An FDA approved diagnosis of chronic idiopathic constipation (CIC)  or irritable bowel syndrome with constipation (IBC-C) in members 18 years of age or older; AND
• Documentation that constipation-causing therapies for other disease states have been discontinued (excluding opioid pain medications for cancer patients); AND
• Documented and updated colon screening for members 45 years of age 1.      or older using 1 of the following methods (results must be submitted):
  • Recent colonoscopy (within the last 10 years or sooner depending on risk factors and/or previous screening results); or
  • Recent negative Cologuard^® test (within the last 3 years or sooner depending on risk factors and/or previous screening results); and
• Member must not have known or suspected gastrointestinal obstruction; and 
• Documentation of hydration attempts and trials of at least three different types of products that failed to relieve constipation.  Trials must be within the past 90 days.  Products may be over-the-counter (OTC) or prescription (does not include fiber or stool softeners); AND
  • One of the three trials must be polyethylene glycol 3350 (PEG-3350); AND  
  • Members with an oncology-related diagnosis are exempt from the trial requirements; AND
• Approval will initially be for 12 weeks of therapy.  Further approval may be granted if the prescriber documents the member is responding well to treatment.
• A quantity limit of 30 tablets for a 30-day supply will apply. 

 Prior Authorization form

The following medications do not require prior authorization: Colazal^® (balsalazide) capsules, Cortenema^® (hydrocortisone) enemas, Apriso^® (mesalamine) extended-release (ER) capsules, Canasa^® (mesalamine) suppositories, Delzicol^® (mesalamine) delayed-release (DR) capsules, Lialda^® (mesalamine) DR capsules, brand name Pentasa^® (mesalamine) ER capsules, Rowasa^® (mesalamine) rectal suspension enemas, Dipentum^® (olsalazine) capsules, sulfasalazine 500mg tablets, and sulfasalazine DR 500mg tablets.

PA criteria:

• An FDA approved diagnosis of irritable bowel syndrome with diarrhea (IBS-D); AND
• Member must be 18 years of age or older; AND
• Member must not have any of the contraindications for use of Viberzi® (e.g., removed gallbladder; biliary duct obstruction or sphincter of Oddi disease or dysfunction; alcoholism, alcohol abuse, or alcohol addiction; history of pancreatitis or structural diseases of the pancreas; severe hepatic impairment; history of chronic or severe constipation; mechanical gastrointestinal obstruction); AND
• Documentation of trials of two of the following three medications that failed to relieve diarrhea: loperamide, dicyclomine, or diphenoxylate/atropine (each trial should be for at least 10-14 consecutive days at the recommended dosing). 
• Trials must be within the past 90 days. Documentation should be provided including dates, dosing, and reason for trial failure.
• Approval will initially be for 12 weeks of therapy.  Further approval may be granted if prescriber documents member is responding well to treatment.
• A quantity limit of 60 tablets for a 30 day supply will apply.

Prior Authorization form

PA criteria:

• An FDA approved diagnosis of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy; AND
• Member must be 18 years of age or older; AND
• Member must have been taking a stable dose of SSA therapy for the last three months and be inadequately controlled (four or more bowel movements per day); AND
• Prescriber must verify member will continue taking SSA therapy in combination with Xermelo™; AND
• Approval will initially be for 12 weeks of therapy.  Further approval may be granted if prescriber documents member is responding well to treatment.
• A quantity limit of 90 tablets for a 30-day supply will apply.

 Prior Authorization form

Xifaxan® (Rifaximin) 200mg Approval Criteria:

• An FDA approved diagnosis of traveler’s diarrhea (TD); AND
• Member must be 12 years of age or older; AND
• TD must be due to noninvasive strains of Escherichia coli; AND
• A quantity limit of 9 tablets for a 3 day supply will apply.

Xifaxan® (Rifaximin) 550mg Approval Criteria:  

• An FDA approved indication for the reduction in risk of overt hepatic encephalopathy (HE) recurrence; OR
• An FDA approved diagnosis of irritable bowel syndrome with diarrhea (IBS-D); AND
  • For the diagnosis of IBS-D: Documentation of trials of two of the following three medications that failed to relieve diarrhea: loperamide, dicyclomine, OR diphenoxylate/atropine (each trial should be for at least 10-14 consecutive days at the recommended dosing). Trials must be within the past 90 days. Documentation should be provided including dates, dosing, and reason for trial failure; AND
  • For the diagnosis of IBS-D: Member must be 18 years of age or older. 
• A quantity limit of 60 tablets for a 30 day supply will apply.  Patients with the diagnosis of IBS-D needing 42 tablets for a 14-day treatment regimen (550mg three times daily for 14 days) will be approved for a quantity limit override upon meeting Xifaxan® approval criteria.  Patients with IBS-D who experience a recurrence of symptoms can be retreated up to two times with the same dosage regimen (550mg three times daily for 14 days).

Prior Authorization form

bezlotoxumab (Zinplava™) Approval Criteria:

• An FDA approved diagnosis of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence; AND
  • Prescriber must document the member has one or more of the following risk factors for high risk of CDI recurrence:
    • Age of 65 years or older; OR
    • One or more episodes of CDI within the six months prior to the episode under treatment; OR
    • Need for ongoing therapy with concomitant antibiotics during treatment for CDI; OR
    • Severe underlying medical disorders; OR
    • Immunocompromised; OR
    • Clinically severe CDI (Zar score ≥ 2); AND
• Current or planned antibacterial drug for CDI must be provided on the prior authorization request to ensure medication is within standard of care; AND
• Prescriber must document that Zinplava™ (bezlotoxumab) will be administered while the member is receiving antibacterial drug treatment of CDI; AND  
• Zinplava™ must be prescribed by, or in consultation with, a gastroenterologist, infectious disease specialist, or a specialist with expertise in the treatment of CDI; AND
• The member must not be using Zinplava™ in combination with Rebyota™ (fecal microbiota, live-jslm) or Vowst™ (fecal microbiota spores, live-brpk); AND
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; AND
• Approvals will be for 1 treatment course.

Prior Authorization form