HN Logo
Prior Authorization Protocol
UCERISR (budesonide)


NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Uceris extended release tablet: 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

    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

    (sulfasalazine)
    AzulfidineR

    (sulfasalazine delayed release) oral tablets
    Azulfidine-EN tabsR

    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 Extended Release Tablet

    9 mg PO in the morning

    Length of Benefit

    Uceris Foam

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

    Length of Benefit

  7. Product Availability:
    Extended ReleaseTablets : 9 mg
    Rectal foam: 2 mg per metered dose.
  8. References:
    1. Uceris Capsules [Prescribing Information] Santarus. January 2015.
    2. Uceris Rectal Foam [Prescribing Information] Salix. October 2014.
    3. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/default.aspx.  Accessed June 7, 2015
    4. MicromedexR Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed June 7, 2015.
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.
Draft Prepared: 02-MAY-13 RG
Approved By Health Net National P&T: 21-AUG-13, 19-NOV-14, 06-MAY-15, 18-NOV-15
Revised: 14-JUL-14 DT, 13-JAN-15 RG, 07-JUN-15 JS