Gastro-Intestinal

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:  

• A previous 14-day trial of ranitidine syrup or a patient-specific, clinically significant reason why ranitidine syrup is not appropriate for the member; AND
• Famotidine suspension (Pepcid®) will have an age restriction of 6 years of age and younger.  Members older than 6 years of age will require a 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 trial of ranitidine syrup or a patient-specific, clinically significant reason why ranitidine syrup is not appropriate for the member; 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 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 ranitidine and famotidine or a patient-specific, clinically significant reason why ranitidine and famotidine are 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), 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. 

Prior Authorization form   

Tier 1

Tier 2

Tier 3

Special PA*

• dexlansoprazole (Dexilant®)
• esomeprazole (Nexium® Capsules)
• lansoprazole (Prevacid® Caps)
• omeprazole (Prilosec®)
• pantoprazole (Protonix® Tabs)

• esomeprazole (Nexium® Packets)
• lansoprazole (Prevacid® ODT)***
• pantoprazole (Protonix® I.V.)
• rabeprazole sodium (Aciphex® Tabs) 

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

• cimetidine tabs (Tagamet®)
• esomeprazole kit (ESCOMEP-EZS™) 
• famotidine (Pepcid® Suspension)*
• omeprazole/sodium bicarbonate (Zegerid®)
• nizatidine (Axid®) caps, sol
• ranitidine caps
• sucralfate susp UD cups

crofelemer (Fulyzaq™)

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

lubiprostone (Amitiza®)

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.

 Prior Authorization form

linaclotide (Linzess^TM)

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. 

 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

naloxegol (Movantik™)

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 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 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

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, 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 older 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   
• 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

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 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 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

PA 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 older 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
• 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  

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

Anti - emetic

doxylamine/pyridoxine (Bonjesta®) 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).
• Authorization of Bonjesta® requires a patient-specific, clinically significant reason why member cannot use Diclegis®.

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

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), 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 (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), 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.

lactulose packets for oral solution (Kristalose®)

Approval Criteria:

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

Prior Authorization form

eluxadoline (Viberzi™)

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   

rifaximin (Xifaxan®)

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

Ulcerative Colitis

 balsalazide

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.

balsalazide (Giazo®) Approval Criteria:

• An FDA approved diagnosis of mildly-to-moderately active ulcerative colitis (UC); AND
• Member must be 18 years of age or older; AND
• Member must be male (effectiveness of Giazo® was not demonstrated in female patients in clinical trials); AND
• A patient-specific, clinically significant reason why the member cannot use generic balsalazide 750mg capsules or other products available without prior authorization*; AND
• Approvals will be for the duration of eight weeks. After eight weeks of treatment the prescriber must document a patient-specific, clinically significant reason the member needs a longer duration of treatment.

Prior Authorization form

budesonide

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 

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

Pancreaze®, 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®.

bezlotoxumab (Zinplava™)

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  
• 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. 

Prior Authorization form

Clenpiq™, OsmoPrep®, Plenvu®, Prepopik®, 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