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Prior Authorization Protocol
UCERISR (budesonide)


NATL

Interim Guidelines; Final Review and Approval by the P&T Committee Pending

Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Uceris capsules: For the induction of remission in patients with active, mild to moderate ulcerative colitis.
    • Uceris rectal foam: For the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.
  2. Health Net Approved Indications and Usage Guidelines:
    • Patient has active, mild to moderate ulcerative colitis.
    AND
    • Failure or clinically significant adverse effects to a one-month course of aminosalicylates (e.g., sulfasalazine, mesalamine)
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    This field intentionally left blank.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    PentasaR (mesalamine)

    1000 mg PO QID

    Children:
    25 to 50 mg/kg/day PO divided BID or TID

    1000 mg PO QID

    Lialda (mesalamine)

    2.4 gm to 4.8 gm (2 to 4 tablets) PO QD

    4.8 gm

    Asacol HD (mesalamine)

    Two 800 mg tablets PO TID for 6 weeks

    4.8 gm

    AzulfidineR
    (sulfasalazine)

    Azulfidine-EN tabsR
    (sulfasalazine extended release) oral tablets

    Adults:
    3 to 4 gm (6 to 8 x 500 mg tablets) PO daily
    in evenly divided doses with dosage interval not exceeding 8 hours.

    Children 6 years and older:
    40 to 60 mg/kg of body weight PO in each 24-hour period,
    divided into 3 to 6 doses.

    4 gm

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Uceris Capsules

    9 mg PO in the morning

    Length of Benefit

    Uceris Foam

    One metered dose administered twice daily for 2 weeks followed by one metered dose administered once daily for 4 weeks.

    Length of Benefit

  7. Product Availability:
    Capsules: 9 mg
    Rectal foam: 2 mg per metered dose.
  8. References:
    1. Uceris Capsules. Prescribing Information. Santarus. January 2013.
    2. Uceris Rectal Foam. Prescribing Information. Salix. October 2014 .
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.