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Prior Authorization Protocol
SOOLANTRAR (ivermectin 1%)
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:
    • For use in the treatment of inflammatory lesions of rosacea
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of rosacea.
    AND
    • Failure or clinically significant adverse effects to oral doxycycline, oral minocycline, topical metronidazole, or Finacea.
  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:
    • Safety and effectiveness of Soolantra cream in pediatric patients have not been established
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    metronidazole
    (MetrocreamR 0.75%, MetrogelR 1%, MetrolotionR 0.75%)
    Apply thin film topically to affected area QD
    (or BID for cream and lotion)

    No maximum dosage information is available

    FinaceaR (15% gel) (azelaic acid)
    Apply in a thin film topically to the affected area BID
    Reassess if no improvement in 12 weeks

    No maximum dosage information is available

    minocycline (DynacinR, MinocinR, SolodynR)

    IR:
    200 mg PO followed by 100 mg PO Q12H
    ER:
    1 mg/kg PO QD
    350 mg on day 1, then 200 mg/day
    doxycycline ( OraceaR)

    Lesions (papules and pustules): 
    40 mg PO once daily in the morning (1 hour before or 2 hours after a meal)

    300 mg/day PO;
    40 mg PO/day for Oracea

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
    SoolantraR (ivermectin) 1%

    Apply pea size amount to the affected areas of the face QD

    Length of benefit

  7. Product Availability:
    Topical cream: Soolantra 1% cream (supplied in tubes of 30 g)
  8. References:
    1. SOOLANTRATM [Prescribing Information] Fort Worth, TX: . Galderma Laboratories LP; Dec 2014.
    2. Gold et al. Efficacy and safety of Ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014:13(3):316-323.
    3. METROGEL. 3M Pharmaceuticals, Northridge, CA, 2003.
    4. FinaceaR topical gel, azelaic acid 15% topical gel. Intendis Manufacturing S.p.A, Segrate, Milan, Italy, 2010.
    5. AzelexR, azelaic acid cream 20%. Allergan, Irvine, CA, 2003.
    6. minocycline HCl oral tablets, minocycline HCl oral tablets. Par Pharmaceutical Companies, Inc. (per Manufacturer), Spring Valley, NY, 2011.
    7. Gold Standard, Inc. Doxycycline. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com. Accessed: Jan 13 2015.
    8. MicromedexR Healthcare Series. Retrieved June 15, 2015, from: www.micromedexsolutions.com Greenwood Village, CO: Thomson Micromedex.
    9. Rosacea: An update on Medical Therapies. Skintherapyletter. Available from: http://www.skintherapyletter.skin.ca/2014/19.3/1.html. Accessed: Jan 13 2015.
    10. RosaceaNet. Available from: http://www.skincarephysicians.com/rosaceanet/treatment_bumps.html. Accessed: June 15 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.