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Prior Authorization Protocol
RESTASISR (cyclosporine ophthalmic emulsion 0.05%)

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:
    • To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of moderate to severe keratoconjunctivitis sicca (chronic dry eye disease (CDED)) confirmed by an ophthalmologist or optometrist
    AND
    • Failure or clinically significant adverse effects to any non-prescription wetting agents in the form of drops, ointments, or gels.
  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:
    • Artificial tears are the standard therapy for all severity of dry eyes.
    • RestasisR is likely to be given in conjunction with artificial tears.
    • Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Various Products (OTC)

    1-2 drops in affected eye(s) TID or QID

    N/A

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

    RestasisR

    1 drop twice daily in each eye approximately 12 hours apart

    Length of benefit

    For AHCS requests: One Year

  7. Product Availability:

    Single Use vial: 0.05%, 0.4 mL 30 vials/tray and 60 vials/tray

  8. References:
    1. Restasis [Prescibing Information]. Irvine, CA: Allergan; January 2014.
    2. Sall K, Stevenson OD, Mundorf TK, et al for the CsA Phase 3 Study Group. Ophthalmic emulsion in moderate to severe dry eye disease. Ophthalmology 2000;107:631-639.
    3. Restasis, In: DRUGDEXR System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/. Accessed June 17, 2015
    4. Restasis. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 17, 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.