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Prior Authorization Protocol
SOLODYNR (minocycline extended release tablets), DORYXR (doxycycline hyclate delayed release tablets), ORACEAR (doxycycline capsules), ACTICLATETM (doxycycline hyclate)



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:
    Oracea
    • For the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
    Solodyn
    • To treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older
    Doryx, Acticlate
    • Rickettsial infections
    • Sexually transmitted infections
    • Respiratory tract infections
    • Specific bacterial infections
    • Ophthalmic infections
    • Anthrax, including inhalational anthrax (post-exposure)
    • Alternative treatment for selected infections when penicillin is contraindicated
    • Adjunctive therapy in acute intestinal amebiasis and severe acne
    • Prophylaxis of malaria
  2. Health Net Approved Indications and Usage Guidelines:
    SOLODYN, DORYX 200 mg and ACTICLATE
    • Failure of or clinically significant adverse effects to both generic immediate-release minocycline and doxycycline
    DORYX
    • Failure of or clinically significant adverse effects to generic immediate-release minocycline or doxycycline
    ORACEA
    • Treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients
    AND
    • One month failure of or clinically significant adverse effects to immediate-release doxycycline 50 mg
  3. Coverage is Not Authorized For:
    • Treatment of non-inflammatory lesions in acne vulgaris or rosacea
    • 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:
    • Tetracycline agents, including doxycycline and minocycline exhibit anti-inflammatory activities < 50 mg. Anti-inflammatory dose doxycycline does not exert antibiotic selection pressure and thus does not induce antibiotic resistance; its mechanism of action in rosacea appears to relate to the anti-inflammatory and biological activities of doxycycline.
    • Oracea did not demonstrate any meaningful effect for generalized erythema (redness) of rosacea.
    • Solodyn did not demonstrate any effect on non-inflammatory lesions.
    • To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doryx, Acticlate, and other antibacterial drugs, Doryx and Acticlate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    minocycline
    (MinocinR)

    Acne vulgaris
    50 mg PO QD - QID
    Various indications
    100-200 mg PO initially followed by 100 mg BID

    200 mg/day

    tetracycline

    Acne vulgaris
    250 mg PO QOD to 500 mg QD
    Various indications
    250-500 mg PO QID

    2 gram/day

    erythromycin

    Oral:
    250-500 mg QID
    Topical formulations:
    Once to twice daily

    4 gram/day

    doxycycline

    Acne Vulgaris and other indications
    100 mg PO BID on day 1 then 100 mg/day in 1-2 divided doses
    Rosacea
    40 mg or 50 mg PO QD

    200 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
    minocycline extended release (SolodynR)

    Solodyn is a once-daily PO tablet to be prescribed based on the patient`s weight to achieve approximately a 1 mg/kg dosage without any loading dose. The following table shows tablet strength and body weight to achieve approximately 1 mg/kg:

    Wt (lbs)Wt (kg)Tablet strength (mg)Actual mg/kg dose
    99-10945-49451-0.92
    110-13150-59551.10-0.93
    132-15760-71651.08-0.92
    158-18672-84801.11-0.95
    187-21285-96901.06-0.94
    213-24397-1101051.08-0.95
    244-276111-1251151.04-0.92
    277-300126-1361351.07-0.99

    Length of Benefit
    ActiclateTM (doxycycline hyclate)

    doxycycline hyclate delayed release (DoryxR)
    Adults:
    200 mg PO on the first day of treatment (administered 100 mg BID)
    followed by a maintenance dose of 100 mg QD
    Severe infections:
    100 mg PO BID
    For children above eight years of age:
    Weight 100 pounds or less - 2 mg/lb of body weight divided
    into two doses PO on the first day of treatment,
    followed by 1 mg/lb of body weight given as a single daily
    dose or divided into two doses on subsequent days.
    For more severe infections up to 2 mg/lb of body weight may be used.
    For children over 100 lbs, the usual adult dose should be used.
    Varies depending on the type of infection
    OraceaR (doxycycline capsules)

    40 mg PO QD

    Length of Benefit

  7. Product Availability:
    Solodyn extended release tablets: 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, 135 mg
    Doryx delayed release tablets: 80 mg, 100 mg, 150 mg, 200 mg
    Oracea capsules: 40 mg
    Acticlate tablets: 75 mg, 150 mg
  8. References:
    1. Doryx [Prescribing Information] Rockaway, NJ: Mayne Pharma International Ltd; February, 2015
    2. Ofori AO. Treatment of acne vulgaris. In: UpToDate, Basow DS (Ed), UpToDate, Waltham, MA, 2014. Available at www.uptodate.com. Accessed May 29, 2015.
    3. Solodyn [Prescribing Information] Scottsdale, AZ: Medicis Pharmaceutical Corporation; October, 2013
    4. Oracea [Prescribing Information] Fort Worth, TX: Galderma Laboratories, L.P.; July 2013.
    5. American Acne and Rosacea Society. Rosacea Medical Management Guidelines. Available at http://www.acneandrosacea.org/uploads/AARS_Rosacea_Guidelines.pdf, Accessed May 29, 2015.
    6. Acticlate [Prescribing Information] West Chester, PA: Aqua Pharmaceuticals; July 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.