Gastro Intestinal

Tier 1 products are available with no authorization necessary.

Criteria for Approval of a Tier 2 medication:

• A 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 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.

Proton Pump Inhibitors for 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
   
  Prior Authorization form

Special Prior Authorizations of Miscellaneous Products

• ranitidine (Zantac® Effervescent Tabs) - must have reason why member cannot take other dosage forms.
• famotidine (Pepcid® Suspension) - reserved for members less than 1 month old.

Tier 1

Tier 2

Tier 3

• omeprazole (Prilosec®)
• pantoprazole (Protonix® Tabs)

• dexlansoprazole (Dexilant®)
• lansoprazole (Prevacid® Caps and ODT)***
• rabeprazole sodium (Aciphex® Tabs)

• dexlansoprazole (Dexilant® SoluTab)
• esomeprazole (Nexium® Capsules, Packets, and I.V.)***
• esomeprazole strontium
• omeprazole (Prilosec ® Suspension and Powder)***
• pantoprazole (Protonix® Suspension & I.V.)***
• rabeprazole sodium (Aciphex Sprinkles®)

Mandatory Generic Plan Applies:

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

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

PA criteria:

Amitiza® (Lubiprostone) Approval Criteria – Chronic Idiopathic Constipation (CIC) or Irritable Bowel Syndrome:

• 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 >50 years of age; 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.

Amitiza® (Lubiprostone) Approval Criteria – Opioid-Induced Constipation (OIC):

• 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 >50 years of age; 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.

PA criteria:

• An FDA approved diagnosis of Chronic Idiopathic Constipation (CIC) or Irritable Bowel Syndrome characterized by 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 >50 years of age; 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 30 units for a 30 day supply will apply. 

PA 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 greater than 50 years of age; 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
• 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

doxylamine/pyridoxine (Diclegis®)

Approval Criteria:
Consideration for approval will be based on all of the following criteria:     

• An FDA approved diagnosis of nausea and vomiting associated with pregnancy that is not responsive to conservative management; AND
• Trials with at least two non-pharmacologic therapies that have failed to relieve nausea and vomiting; AND
• A patient-specific, clinically significant reason why member cannot use OTC doxylamine and OTC Vitamin B-6 (pyridoxine).

granisetron (Kytril®, Sancuso®), dolasetron (Anzement®), aprepitant (Emend®)

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.

nabilone (Cesamet®), dronabinol (Marinol®)

Approval Criteria:

• For the diagnosis of HIV related loss of appetite: approve for 6 months
• For chemotherapy induced nausea and vomiting: A recent (within the past 6 months) trial of ondansetron used for at least 3 days or one cycle that resulted in inadequate response.

netupitant/Palonosetron (Akynzeo®)  

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
• A previously failed trial of aprepitant (Emend®) that resulted in inadequate response, or a patient-specific, clinically significant reason why aprepitant cannont be used must be provided; AND
• Approval length based on duration of need.
• A quantity limit of one capsule per chemotherapy cycle will apply.

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™) 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
• 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
• Approval length based on duration of need.  
• A quantity limit of two tablets per chemotherapy cycle will apply.

 Prior Authorization form

PA 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 greater than 50 years of age; 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) or Movantik® (naloxegol) 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 (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 greater than 50 years of age; 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) or Movantik™ (naloxegol) 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.

Approval Criteria:

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

Prior Authorization form

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
• 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

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 patient-specific, clinically significant reason why the member cannot use a fluoroquinolone antibiotic (e.g., ciprofloxacin, levofloxacin) must be provided.
• 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

balsalazide (Colazal®) Capsules Quantity Limit Approval Criteria: 

• A quantity limit of 270 capsules per 30 days will apply.
• The first twelve weeks of treatment would not require prior authorization.
• After twelve weeks of treatment:
  
  • Provider must document a patient-specific, clinically significant reason member needs longer duration of treatment.
• An age restriction of five years and older will apply.

Prior Authorization form

budesonide (Uceris®) Extended-Release Tablets Approval Criteria: 

• An FDA approved diagnosis of induction of remission in patients with active, mild-to-moderate ulcerative colitis; AND
• Previous failure of at least two of the following:
  
  • Oral aminosalicylates; OR 
  • Topical mesalamine; OR
  • Topical steroids; OR
  • A contraindication to all preferred medications; AND
• A patient-specific, clinically significant reason why the member cannot use other oral corticosteroids available without prior authorization; AND
• Approvals will be for the duration of eight weeks in accordance with manufacturer maximum recommended duration of therapy.
• A quantity limit of 30 tablets per 30 days will apply.

budesonide (Uceris®) Rectal Foam Approval Criteria:

• An FDA approved diagnosis of induction of remission in patients with active, mild-to-moderate distal ulcerative colitis extending up to 40cm from the anal verge; AND
• A patient-specific, clinically significant reason why the member cannot use oral aminosalicylates, topical mesalamine, or other topical (rectally administered) corticosteroids available without prior authorization; AND
• Approvals will be for the duration of six weeks in accordance with manufacturer recommended duration of therapy. 
• A quantity limit of 133.6 grams per 42 days will apply.

Prior Authorization form

mesalamine (Asacol® HD) Delayed-Release Tablets Approval Criteria: 

• An FDA approved indication of the treatment of moderately active ulcerative colitis; AND
• A patient-specific, clinically significant reason the member cannot use other available mesalamine products that do not require prior authorization; AND
• Approvals will be for the duration of six weeks in accordance with manufacturer recommended duration of therapy; AND
• A quantity limit of 180 tablets per 30 days will apply.

mesalamine (Canasa®) Suppositories Quantity Limit Approval Criteria: 

• A quantity limit of 30 suppositories per 30 days will apply.
• The first six weeks of treatment would not require prior authorization.
• After six weeks of treatment:
  
  • Provider must document a patient-specific, clinically significant reason member needs longer duration of treatment.

mesalamine (Lialda®) Delayed-Release Capsules Quantity Limit Approval Criteria: 

• A quantity limit of 60 capsules per 30 days will apply.
• For quantity limit requests for greater than two capsules per day:
  
  • An FDA approved indication for the induction of remission in patients with active, mild-to-moderate ulcerative colitis; AND
  • A patient-specific, clinically significant reason the member cannot use other available mesalamine products that are indicated to induce remission that do not require prior authorization; AND
  • Approvals will be for the duration of eight weeks in accordance with manufacturer recommended duration of therapy; AND
  • A maximum approval of 120 capsules per 30 days will apply.

mesalamine (Pentasa®) 250mg Controlled-Release Capsules Quantity Limit Approval Criteria: 

• A quantity limit of 480 capsules per 30 days will apply.
• The first eight weeks of treatment would not require prior authorization.
• After eight weeks of treatment:
  
  • Provider must document a patient-specific, clinically significant reason member needs longer duration of treatment.

mesalamine (Pentasa®) 500mg Controlled-Release Capsules Approval Criteria: 

• An FDA approved indication for the induction of remission or for the treatment of patients with mildly to moderately active ulcerative colitis; AND
• A patient-specific, clinically significant reason the member cannot use Pentasa® 250mg controlled-release capsules or other available mesalamine products that do not require prior authorization; AND
• Approvals will be for the duration of eight weeks in accordance with manufacturer recommended duration of therapy; AND
• A quantity limit of 240 capsules per 30 days will apply.

mesalamine (Rowasa®) Rectal Suspension Enema Approval Criteria: 

• The first three weeks of treatment would not require prior authorization.
• An FDA approved indication for the treatment of active, mild-to-moderate distal ulcerative colitis, proctosigmoiditis, or proctitis; AND
• A patient-specific, clinically significant reason the member cannot use Canasa® (mesalamine suppositories) which do not require prior authorization; AND
• Provider documentation member is still having active symptoms after three weeks of treatment; AND
• Approvals will be for the duration of six weeks in accordance with manufacturer recommended duration of therapy; AND
• A quantity limit of 30 enemas (1,800mL) per 30 days will apply.

Prior Authorization form

OsmoPrep®, Prepopik®, Suclear®, and SUPREP® 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