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.
• Contraindication to all available tier 1 medications.
• An indication not covered by lower tiered medications.

• A 14 day trial all available tier 2 medications that has resulted in inadequate relief of symptoms or intolerable adverse effects.
• Contraindication to all available tier 2 medications.
• An indication not covered by lower tiered medications.

• 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

• omeprazole (Prilosec® 10 mg, 20 mg & 40 mg caps)
• pantoprazole (Protonix® Tabs)

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

• omeprazole/antacid
  
• esomeprazole (Nexium® Caps and I.V.)***
• omeprazole (Prilosec ® Susp)***
• pantoprazole (Protonix® Susp & I.V.)***

Consideration will be based on ALL of the following 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.

PA criteria:

• Chronic Idiopathic Constipation, Opioid-Induced Constipation in Adults With Chronic, Non-cancer Pain in males and females 18 years of age and older, or IBS-Constipation predominant in females 18 years of age or older who meet the following criteria
  • Have documentation that constipating therapies for other disease states have been discontinued (excluding opioid pain medications for cancer patients).
  • Documented and updated Colon Screening. (>50 years of age) 
    
• Hydration and treatment attempts with a minimum of three alternate products must be documented.
• Initial approval for 12 weeks of therapy. An additional year approval may be granted if physician documents client is responding well to treatment.
• Quantity limit of 100 units for a 50 day supply.

PA criteria:

• Members 18 years of age or older with an FDA approved diagnosis, and
  • Documentation that constipation-causing therapies for other disease states have been discontinued (excluding opioid pain medications for cancer patients).
  • Documented and updated Colon Screening for members >50 years of age.
• Documented 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.
• Approval will initially be for 12 weeks of therapy. Further approval may be granted if prescriber documents member is responding well to treatment.
• Quantity limit apply based on maximum recommended daily dose.

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

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.

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 three prescription medications that have failed to relieve nausea and vomiting; (must include a trial of ondansetron); AND
• A patient-specific, clinically significant reason why member cannot use OTC doxylamine and OTC Vitamin B-6 (pyridoxine).

PA criteria:

• FDA approved indication for the treatment of opioid-induced constipation 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
• Mechanical gastrointestinal obstruction has been ruled out.
• 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.