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Prior Authorization Protocol
FALESSATM Kit (levonorgestrel/ethinyl estradiol tablets with folic acid 1 mg tablets)

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:
    • Prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
  2. Health Net Approved Indications and Usage Guidelines:
  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:
    • Lessina is the generic equivalent to Alesse
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    levonorgestrel and ethinyl estradiol (Orsythia, Aviane, Falmina)

    One tablet PO QD

    One tablet PO QD

    levonorgestrel and ethinyl estradiol (LessinaTM)

    		One tablet PO QDOne tablet PO QD
    folic acid 1 mgOne tablet PO QDvaries
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Falessa Kit

    Oral Contraceptive
    Day 1-21: Levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg [21 orange tablets]: 1 tablet PO QD
    Day 2228: 7 white inactive tablets: 1 tablet PO QD
    Folate
    Day 1-28: Folic acid 1 mg: 1 tablet PO QD

    Length of Benefit

  7. Product Availability:
    Oral contraceptive tablets: Each blister card contains 28 tablets in the following order: 21 orange containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol; 7 white inert tablets
    Folate tablets: Each blister card contains 28 tablets containing 1 mg folic acid.
  8. References:
    1. Falessa Kit [Prescribing Information]. Atlanta, GA: Avion Pharmaceuticals, LLC; October 2013.
    2. Lessina [Prescribing Information]. Pomona, NY: Barr Laboratories; November 2002.
    3. MicromedexR Healthcare Series [Internet database]. Greenwood Village, CO: Thompson Healthcare. Updated periodically. Accessed June 4, 2015.
    4. Falessa Kit Web site. Availabile at: http://www.falessa.com/healthcare-professionals. Accessed June 4, 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: 13-MAY-14 MM
Approved By Health Net National P&T: 19-NOV-14, 18-NOV-15
Revised: 13-MAY-14 MM, 04-JUN-15 PT