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Prior Authorization Protocol

ABSORICATM, AMNESTEEMR, CLARAVISTM, MYORISANTM, SOTRETR, ZENATANETM (isotretinoin)

NATL

HNCA: Level l w/PA if dose is > 100 mg/day or if duration > 150 days

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:
    • Absorica: Treatment of severe recalcitrant nodular acne in patients 12 years of age and older
    • Amnesteem, Claravis, Myorisan, Sotret, Zenatane: Treatment of severe recalcitrant nodular acne
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of severe recalcitrant nodular acne
    AND
    • For AbsoricaR requests, failure or clinically significant adverse effects to isotretinoin AmnesteemR, ClaravisTM, MyorisanTM, SotretR, or ZenataneTM)
    AND
    • For requests beyond 20 weeks, patient has had a 2 month break off therapy or a total cumulative dose of 150 mg/kg has not been reached.
  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:
    • Severe be definition, means many as opposed to few or several nodules. The nodules may become suppurative or hemorrhagic.
    • Micromedex classifies the use of isotretinoin for the Non-FDA Labeled indication of acne vulgaris as a Class II-a strength of recommendation.
    • The American Academy of Dermatology recognizes that isotretinoin is also useful for the management of lesser degrees of acne that are treatment-resistant or for the management of acne that is producing either physical or psychological scarring.
    • Micromedex classifies the use of isotretinoin for the Non-FDA Labeled indication of rosacea as a Class II-a strength of recommendation.
    • The American Acne and Rosacea Society Consensus Recommendations recognize that isotretinoin has been shown to be effective in treating some refractory cases of papulopustular rosacea, but therapeutic benefit may require continued use. Due to the limited data on the management of refractory rosacea, isotretinoin should only be considered in select cases.
    • Because of the risk of teratogenicity and to minimize fetal exposure, isotretinoin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called iPLEDGE. Isotretinoin must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Isotretinoin must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive isotretinoin only from wholesalers registered with iPLEDGE. For more information call 866-495-0654 or visit http://www.ipledgeprogram.com.
    • Isotretinoin may have a negative effect on bone mineral density in some patients. Caution should be used when prescribing isotretinoin to patients with a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism. This would include patients diagnosed with anorexia nervosa and those who are on chronic drug therapy that causes drug-induced osteoporosis/osteomalacia and/or affects vitamin D metabolism such as systemic corticosteroids and any anticonvulsant.
    • The safety of once daily dosing with isotretinoin has not been established. Once daily dosing is not recommended.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Topical Retinoids

    adapalene (DifferinR)

    Cream: 0.1%; Gel: 0.1%, 0.3% 
    Apply topically QD

    N/A

    tretinoin (Retin-AR)

    Cream: 0.025%, 0.05%, 0.1%; Gel: 0.01%, 0.025% 
    Apply topically QD

    N/A

    tretinoin microsphere (Retin-A MicroR)

    Microsphere Gel: 0.04%, 0.1% 
    Apply topically QD

    N/A

    TazoracR (tazarotene)

    Cream: 0.05%, 0.1%; Gel: 0.05%, 0.1% 
    A
    pply topically QD

    N/A

    Topical Antibiotics

    benzoyl peroxide-erythromycin (BenzamycinR)

    Gel:5% benzoyl peroxide/3% erythromycin 
    Apply topically BID



    N/A

    clindamycin (Cleocin TR, ClindagelR, ClindamaxR)
    Solution: 1%; Gel: 1%; Lotion: 1% 
    Apply topically BID

    N/A

    benzoyl peroxide-clindamycin phosphate (DuacR)

    Gel: 1.2% clindamycin/5% benzoyl peroxide
    Apply topically QD

    N/A

    erythromycin (EmgelR, ErygelR)

    Solution: 2%; Gel:2%
    Apply topically QD to BID

    N/A

    sulfacetamide 10%/sulfur 5%

    Cream: 10% sulfacetamide/5% sulfur
    Apply topically QD to TID

    N/A

    Oral Antibiotics

    tetracycline (SumycinR)

    Varies: 125-250 mg PO Q6H for 2 wks, then decrease to 125-500 mg PO QD or QOD

    1 gm/day

    erythromycin (EESR, Erythromycin Base FilmtabR,Ery-TabR, ErycR)

    250-500 mg PO BID

    1 gm/day

    minocycline (DynacinR, MyracR, MinocinR)

    IR: 100 mg PO BID
    ER: 1 mg/kg PO QD

    200 mg/day

    doxycycline (MonodoxR)

    50-100 PO mg PO QD

    200 mg/day

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

    Absorica, Amnesteem, Claravis, Myorisan, Sotret, Zenatane

    0.5 - 1 mg/kg/day PO divided into 2 doses

    Maximum dose
    2 mg/kg/day

    Body Weight
    Daily Dose
    Kg
    Lbs
    0.5 mg/kg/day
    1 mg/kg/day
    2 mg/kg/day
    40
    88
    20
    40
    80
    50
    110
    25
    50
    100
    60
    132
    30
    60
    120
    70
    154
    35
    70
    140
    80
    176
    40
    80
    160
    90
    198
    45
    90
    180
    100
    220
    50
    100
    200

    Up to 20 weeks
    Therapy may be approved beyond 20 weeks if a cumulative dose of 150 mg/kg has not been reached.
    A second course of therapy may be approved after at least 2 months off therapy and if warranted by persistent or recurring severe cystic acne.
    No processing allowed through mail-order.

  7. Product Availability:
    Amnesteem, Mysorian, capsules: 10 mg, 20 mg, 40 mg
    Zenatane, , Claravis, Sotret capsules: 10 mg, 20 mg, 30 mg, 40 mg
    Absorica capsules: 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg
  8. References:
    1.     Absorica [Prescribing Information] Jacksonville, FL: Ranbaxy Laboratories Inc.; August 2014.
    2.     Amnesteem [Prescribing information] Morgantown, WV: Mylan Pharmaceuticals Inc.; May 2012.
    3.     Claravis [Prescribing information] Sellersville, PA: Teva Pharmaceuticals USA; July 2014.
    4.     Myorisan [Prescribing Information] Marietta, GA: VersaPharm Incorporated; May 2012.
    5.     Sotret [Prescribing Information] Jacksonville, FL: Ranbaxy Laboratories Inc.; November 2006.
    6.     Zenatane [Prescribing Information] Bachupally, India: Dr. Reddy’s Laboratories Limited; November 2014.
    7.     Strauss JS, Krowchuk DP, Leyden JL, et al. Guidelines of care for acne vulgaris management. J Am Acad Dermatol 2007;56:651-663.
    8.     Goldsmith LA, Bolognia JL, Callen JP, et al. American Academy of Dermatology Consensus Conference on the safe and optimal use of isotretinoin: summary and recommendations. J Am Acad Dermatol 2004;50:900-906.
    9.     American Academy of Dermatology and AAD Association. Position statement on isotretinoin, 2010. http://www.aad.org/Forms/Policies/Uploads/PS/PS-Isotretinoin.pdf. Accessed July 3, 2015.
    10. Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, Part 3: A status report on systemic therapies. Cutis 2014;93:18-28.
    11. Khuri FR, Lee JJ, Lippman SM, et al. Randomized phase III trial of low-dose isotretinoin for prevention of second primary tumors in stage I and II head and neck cancer patients. J Natl Cancer Inst 2006;98(7):441-50.
    12. Perry CF, Stevens M, Rabie I, et al. Chemoprevention of head and neck cancer with retinoids: a negative result. Arch Otolaryngol Head Neck Surg 2005;131(3):198-203.
    13. Isotretinoin. American Hospital Formulary Service Drug Information. Available at http://www.medicinescomplete.com/mc/ahfs/current. Accessed July 3, 2015.
    14. MicromedexR Healthcare Series [Internet Database]. Greenwood Village, CO: Thompson Healthcare. Updated periodically. Accessed July 3, 2015.
    15. Clinical Pharmacology Web Site. Available at: http://cpip.gsm/com/. Accessed July 3, 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.