Gastrointestinal

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

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.

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

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

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• 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:

• 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.

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.

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; AND
• Trials with at least two non-pharmacologic therapies that have failed to relieve nausea and vomiting; AND
• Trials with at least two prescription medications 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:

• Approved Diagnosis
• A recent (within the past 6 months) trial of ondansetron used for at least 3 days or one cycle that resulted in inadequate response.

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 recent trial of ondansetron (within the past six months) used for at least three days or one cycle that resulted in inadequate response.
• 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.

methylnaltrexone bromide (Relistor®) PA criteria:

• FDA approved indication for the treatment of Opioid-Induced Constipation(OIC) in patients with severe terminal disease who are receiving only palliative care (life expectancy less than 6 months), AND
• Current use of opioid medications, AND
• Documented treatment attempts with a minimum of three alternate products, excluding bulk forming laxatives; AND
  • One of the three trials must be polyethylene glycol 3350 (PEG-3350)
  • Members with an oncology-related diagnosis are exempt from the trial requirements
• Mechanical gastrointestinal obstruction has been ruled out.
• The 12 mg single-use vials, syringes, or kits will be the preferred products. Criteria for consideration of 8 mg single-use syringes:
  • Weight range of 38-62 kg, and/or
  • Caregiver unable to draw up dose from vial.
• Quantity limit of 30 units per month will apply.