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Prior Authorization Protocol
ENSTILAR FOAM, TACLONEX OINT (calcipotriene 0.005% and betamethasone dipropionate 0.064%), SERNIVO (betamethasone dipropionate 0.05% spray)
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:
    • Taclonex Ointment: Topical treatment of plaque psoriasis in patients 12 years of age and older.
    • Enstilar: Topical treatment of plaque psoriasis in patients 18 years of age and older.
    • Sernivo: Treatment of mild to moderate plaque psoriasis in patients 18 years of age and older.

  2. Health Net Approved Indications and Usage Guidelines:

    AND

    • Failure or clinically significant adverse effects to a medium to ultra high potency topical corticosteroid
    AND
    • For patients 18 years of age and older: Failure or clinically significant adverse effects to calcipotriene (DovonexR), calcitriol (VecticalR) or TazoracR (tazarotene)
  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:
    • Limitations of Use: Do not use on face, axillae, or groin. Do not use if skin atrophy is present at the treatment site.
    • As stated in the prescribing information, patients 18 years and older should not use more than 100 grams per week and patients 12 to 17 years should not use more than 60 grams per week. Treatment of more than 30% body surface area is not recommended.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    calcipotriene (DovonexR) cream, oint, soln

    apply topically to the
    affected area(s) BID

    Limit dosage to 100 gm/week

    calcitriol (VecticalR) oint

    apply topically to the affected area(s) BID

    Limit dosage to 200 gm/week

    TazoracR (tazarotene) gel, cream

    apply topically to the
    affected area(s) HS

    Once daily application

    Ultra High Potency

    augmented betamethasone dipropionate 0.05% (DiproleneR, AlphatrexR) ointment, gel
    clobetasol propionate 0.05% (TemovateR, Temovate ER ) cream, ointment, gel, solution
    diflorasone diacetate 0.05% (ApexiconR) ointment
    halobetasol propionate 0.05% (UltravateR) cream, ointment



    Apply topically to
    the affected area(s) BID



    Should not be used for
    longer than 2
    consecutive weeks

    High Potency

    augmented betamethasone dipropionate 0.05% (DiproloneR, DiproleneR AF) cream, lotion
    betamethasone dipropionate (brand not available) 0.05% ointment
    desoximetasone (TopicortR) 0.25%, 0.05% cream, ointment, gel
    diflorasone 0.05% (Apexicon ER) cream
    fluocinonide acetonide 0.05% (brand not available) cream, ointment, gel, solution
    triamcinolone acetonide 0.5% (AristocortR, KenalogR) cream, ointment

    Apply topically to
    the affected area(s) BID

    Should not be used for
    longer than 2
    consecutive weeks

    Medium/Medium to High Potency

    betamethasone dipropionate 0.05% (brand not available) cream
    desoximetasone 0.05% (TopicortR) cream, ointment, gel
    fluocinolone acetonide 0.025% (SynalarR) cream, ointment
    fluticasone propionate 0.05% (CutivateR) cream
    mometasone 0.1% (EloconR) cream, ointment, lotion
    triamcinolone acetonide 0.1%, 0.25%, 0.5% (AristocortR, KenalogR) cream, ointment

    Apply topically to
    the affected area(s) BID

    Should not be used for
    longer than 2
    consecutive weeks
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Taclonex Ointment

    Apply topically to the affected area(s) QD for up to 4 weeks

    One month.

    Enstilar Foam

    Apply topically to affected area(s) QD for up to 4 weeks

    One month.

    Sernivo Spray

    Apply topically to affected skin areas twice daily for up to 4 weeks

    One month.

  7. Product Availability:
    Taclonex Ointment 0.005%/0.064%: 60 gm, 100 gm
    Enstilar Foam0.005%/0.064%: 60 gm
    Sernivo Spray 0.05%: 60 mL, 120 mL
  8. References:

    1. Taclonex Ointment [Prescribing Information]. Parsippany, NJ: LEO Laboratories Ltd; December 2014.
    2. Enstilar [Prescribing Information]. Parsippany, NJ: LEO Laboratories Ltd; March 2016.
    3. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol 2009 Apr;60(4):643-59.
    4. DRUGDEXR System [Internet database]. Greenwood Village, Colorado, Truven Health Analytics. Available at: http://www.micromedexsolutions.com/ Accessed July 13, 2015.
    5. Sernivo [Prescribing Information]. San Antonio, TX: DPT Laboratories; February 2016.

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.