UCERIS, Budesonide (Intrarectal) Form

Budesonide (Uceris®) is a glucocorticosteroid.
FDA Approved Indication(s) Uceris is indicated:
• For the induction of remission in adult patients with active, mild to moderate ulcerative colitis (UC) (extended-release tablet). • For the induction of remission in patients with active mild to moderate distal UC extending up to 40 cm from the anal verge (rectal foam). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Uceris is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Ulcerative Colitis (must meet all):

1. Diagnosis of UC;
   2. Prescribed by or in consultation with a gastroenterologist;
   3. Age ≥ 18 years;
   4. Failure of a 4-week trial of aminosalicylates (e.g., sulfasalazine, mesalamine; see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated;
2. Member must use generic budesonide tablet or rectal foam, unless contraindicated or clinically significant adverse effects are experienced;

3. Dose does not exceed one of the following (a or b):
   a. Oral: 9 mg (1 tablet) per day; b. Rectal:
   Initial: 2 canisters (1 kit) for 2 weeks; i. ii. Maintenance: 2 canisters (1 kit) every 4 weeks. Approval duration:
   HIM – 12 months
   Commercial – 12 months or duration of request, whichever is less Page 1 of 7

   CLINICAL POLICY Budesonide B. Microscopic Colitis (off-label) (must meet all):

4. Diagnosis of microscopic colitis, including collagenous colitis or lymphocytic colitis;
   
   2. Prescribed by or in consultation with a gastroenterologist;
   3. Age ≥ 18 years;
   4. Request is for tablets;
   5. Medical justification supports inability to use budesonide capsules;
   6. Member must use generic budesonide tablet, unless contraindicated or clinically significant adverse effects are experienced;
   7. Dose does not exceed 9 mg (1 tablet) per day. Approval duration:
      HIM – 12 months Commercial – 12 months or duration of request, whichever is less C. Other diagnoses/indications (meet 1 or 2):
5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. All Indications in Section I (must meet all):
7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. For microscopic colitis, request is for tablets;
   4. Member must use generic budesonide tablet or rectal foam, unless contraindicated or clinically significant adverse effects are experienced;

8. Dose does not exceed one of the following (a or b):
   a. Oral: 9 mg (1 tablet) per day; b. Rectal: 2 canisters (1 kit) every 4 weeks. Page 2 of 7

   CLINICAL POLICY Budesonide Approval duration:
   HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

9. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or

10. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace, or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration UC: ulcerative colitis Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Dosing Regimen Drug Name 1 g PO QID for up to 8 weeks or 500 mg PR BID to TID Dose Limit/ Maximum Dose 4 g/day Pentasa® (mesalamine extended-release capsule) mesalamine delayed-release capsule (Delzicol®) 800 mg PO TID for 6 weeks 2.4 g/day Page 3 of 7

    CLINICAL POLICY Budesonide Drug Name Dosing Regimen Dose Limit/ Maximum Dose 4.8 g/day mesalamine delayed-release tablet (Lialda®, Asacol® HD) balsalazide (Colazal®, Giazo®) sulfasalazine (Azulfidine®, Azulfidine-EN tabs®) Lialda: 2.4 g to 4.8 g PO QD for up to 8 weeks Asacol HD: 1600 mg PO TID for 6 weeks 2.25 g (capsule) PO TID for 8 to 12 weeks or 3.3 g (tablet) PO BID for up to 8 weeks 6.75 g/day Adults: Initial: 3 to 4 g/day (enteric coated) PO in evenly divided doses with dosage interval not exceeding 8 hours, or 1 g (uncoated) PO Q6-8 hrs Maintenance: 2 g/day (enteric coated) or 500 mg PO Q6H (uncoated) Adults:
    4 g/day Children: 2 g/day Children 6 years and older: 40 to 60 mg/kg of body weight/day PO divided into 3 to 6 doses Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to budesonide or any of the ingredients in Uceris tablets or foam • Boxed warning(s): none reported Appendix D: General Information • Per the 2016 American Gastroenterological Association guidelines, budesonide 9 mg daily for 6 weeks is the preferred treatment option for microscopic colitis which includes lymphocytic colitis and collagenous colitis.
    V. Dosage and Administration
    Indication Dosing Regimen UC Tablet, extended-release: 9 mg PO daily in the morning for up to 8 weeks. Maximum Dose 9 mg/day Rectal foam: 2 mg (1 metered dose) PR BID for 2 weeks, followed by 2 mg (1 metered dose) PR QD for 4 weeks. 4 canisters over 6 weeks VI. Product Availability
    • Tablets, extended-release: 9 mg
    • Rectal foam: 1 kit of 2 canisters (14 doses per canister, 2 mg per metered dose) Page 4 of 7

    CLINICAL POLICY Budesonide VII.