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Pharmacy & Medical Clinical Guidelines Acne and Rosacea Topical Medications Document Number: 9.155 Effective Date: 03/05/2013 MassHealth Product Applicability: Summary: BMC HealthNet Plan will authorize coverage of acne and rosacea medications when appropriate criteria are met. Description of Item or Service: Topical retinoid products are FDA approved for the treatment of acne vulgaris. They work by normalizing follicular hyperkeratosis and prevent formation of microcomedo. Topical retinoids are frequently used in the management of acne vulgaris and are used as monotherapy or in combination with topical antimicrobials for patients with inflammatory acne. They can also be used to treat wrinkles, but are not FDA approved as such (with the exception of Renova). Treatment of wrinkles with topical retinoids is a cosmetic use. BMC HealthNet Plan does not cover medications used for purely cosmetic purposes. Azelex (azelaic acid) is a dicarboxylic acid with antimicrobial, comedolytic, and antiinflammatory properties also FDA-approved for the treatment of acne vulgaris. The effectiveness of azelaic acid has been shown to be limited in clinical use compared to other available treatment options. Aczone (dapsone) is a newer topical product with anti-inflammatory and antimicrobial properties. Clinical trials have demonstrated improvement in acne lesions. However, sufficient evidence has not been established demonstrating greater efficacy of topical dapsone to currently available generic antimicrobial products such as clindamycin and erythromycin, both of which are commonly used in the treatment of acne vulgaris. Rosacea is an acneiform disorder that is characterized by vascular dilation of the central face. Initial treatment of rosacea consists of topical antibiotics or benzoyl peroxide to relieve the inflammatory lesions. Metronidazole is frequently used as initial therapy and
This guideline provides information on BMC HealthNet Plan claims adjudication processing guidelines. The use of this guideline is not a guarantee of payment and will not determine how a specific claim(s) will be paid. Reimbursement is based on member benefits and eligibility, medical necessity review, where applicable, coordination of benefits, adherence to Plan policies, clinical coding criteria, and the BMC HealthNet Plan agreement with the rendering or dispensing provider. Reimbursement policies may be amended at BMC HealthNet Plans discretion. BMC HealthNet Plan will always use the most recent CPT and HCPCS coding guidelines. BMC HealthNet Plan Acne and Rosacea (Topical)

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has been shown to be effective in reducing inflammatory lesion counts and erythema. Finacea (azelaic acid) is another topical treatment option FDA-approved for the treatment of rosacea. It has been shown to be effective in treating mild to moderate rosacea.

Clinical Guideline Statement: BMC HealthNet Plan may authorize coverage of topical medications for the treatment of acne vulgaris and rosacea for members meeting the following criteria: Acne Vulgaris (Duration of Approval maximum of 2 years) Automatic Approval tretinoin (generic) An automatic approval will be generated at the point of sale when the following criteria are met: 1. The member is less than 27 years of age Prior Authorization A prior authorization request will be required for the following acne medications when the above criteria for automatic approval are not met. These requests will be approved when the following criteria are met: Tretinoin (generic) Documentation of the following: 1. A diagnosis of acne vulgaris Atralin, Avita (gel/cream), Retin-A Micro, Tretin-X (cream) Documentation of the following: 1. A diagnosis of acne vulgaris; AND 2. An allergy to an excipient in the covered topical formulations of tretinoin. Adapalene, Differin(lotion), Tazorac, Azelex Documentation of the following: 1. A diagnosis of acne vulgaris; AND An inadequate response or intolerance to a trial of tretinoin; OR
This guideline provides information on BMC HealthNet Plan claims adjudication processing guidelines. The use of this guideline is not a guarantee of payment and will not determine how a specific claim(s) will be paid. Reimbursement is based on member benefits and eligibility, medical necessity review, where applicable, coordination of benefits, adherence to Plan policies, clinical coding criteria, and the BMC HealthNet Plan agreement with the rendering or dispensing provider. Reimbursement policies may be amended at BMC HealthNet Plans discretion. BMC HealthNet Plan will always use the most recent CPT and HCPCS coding guidelines. BMC HealthNet Plan Acne and Rosacea (Topical)

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2. A diagnosis of psoriasis (Tazorac only); AND An inadequate response or intolerance to a trial of a prescription-strength topical corticosteroid Aczone Documentation of the following: 1. A diagnosis of acne vulgaris; AND 2. An inadequate response or intolerance to a trial of two other topical antimicrobial agents, each in combination with benzoyl peroxide or a retinoid Acanya(clindamycin phosphate/benzoyl peroxide) , Epiduo(adapalene/benzoyl peroxide), Veltin (clindamycin phosphate/tretinoin), Ziana(clindamycin phosphate/tretinoin) Documentation of the following: 1. An inadequate response to concurrent use of the single agents contained in the requested medication; AND 2. An inadequate response, intolerance, or contraindication to a trial of at least one other combination topical acne medication regimen Branded Topical Acne medication kits - See Branded Polypills-Convenience Packaging Medications Policy Rosacea (Duration of Approval maximum of 2 years) Prior Authorization Finacea A prior authorization request will be required for all prescriptions for Finacea. These requests will be approved when the following criteria are met: Documentation of the following: 1. A diagnosis of rosacea; AND 2. An inadequate response or intolerance to a trial of topical metronidazole Limitations: BMC HealthNet Plan will not approve coverage of Adapalene, Acanya, Aczone, Atralin, Avita (gel), Azelex, Differin lotion, Epiduo, Finacea, Retin-A Micro, Tazorac tretinoin, Tretin-X(cream), Veltin, or Ziana in the following instances: 1. When the criteria above have not been met.
This guideline provides information on BMC HealthNet Plan claims adjudication processing guidelines. The use of this guideline is not a guarantee of payment and will not determine how a specific claim(s) will be paid. Reimbursement is based on member benefits and eligibility, medical necessity review, where applicable, coordination of benefits, adherence to Plan policies, clinical coding criteria, and the BMC HealthNet Plan agreement with the rendering or dispensing provider. Reimbursement policies may be amended at BMC HealthNet Plans discretion. BMC HealthNet Plan will always use the most recent CPT and HCPCS coding guidelines. BMC HealthNet Plan Acne and Rosacea (Topical)

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2. Renova will not be covered because it is solely indicated for palliation of wrinkles. 3. If the requested product is a convenience package kit Clinical Background Information and References: 1. Ofori AO. Treatment of acne vulgaris. UptoDate, accessed 2012 Oct; available from http://uptodate.com 2. Strauss JS, Krowchuk DP, Leyden JJ, Lucky AW, Shalita AR, Siegfried EC, et al; American Academy of Dermatology. Guidelines of care for acne vulgaris management. J Am Acad Dermatol. 2007 Apr [cited 2011 Oct];56(4):651-663. 3. Goldstein BG, Goldstein AG. Rosacea. UptoDate, accessed 2012 Oct; available from http://uptodate.com

Document History: Approved by: Pharmacy and Therapeutics Committee - November 8, 2007 Change Date (11/13/2008) P&T Annual Review, modified criteria to include steptherapy for brand-name products after trial of generic tretinoin, added Atralin to policy, changed criteria for Ziana, removed coverage of Tretin-X Change Date (11/12/2009) P&T Annual Review, renamed Topical Retinoids policy Acne and Rosacea added Tazorac, Azelex, Acanya, Epiduo, added rosacea criteria for Finacea Change Date (11/11/2010) P&T Annual Review, added Aczone, Differin lotion and Veltin to criteria, added criteria requiring a trial of a prescription-strength corticosteroid for Tazorac Change Date (11/10/2011) P&T Annual Review, added trial of benzoyl peroxide or retinoid for Aczone, and required 2 combination trials for branded combination products, added criteria for Tretin-X Change Date (11/08/2012) P&T Annual Review, specified policy applies to Tretin-X cream formulation

This guideline provides information on BMC HealthNet Plan claims adjudication processing guidelines. The use of this guideline is not a guarantee of payment and will not determine how a specific claim(s) will be paid. Reimbursement is based on member benefits and eligibility, medical necessity review, where applicable, coordination of benefits, adherence to Plan policies, clinical coding criteria, and the BMC HealthNet Plan agreement with the rendering or dispensing provider. Reimbursement policies may be amended at BMC HealthNet Plans discretion. BMC HealthNet Plan will always use the most recent CPT and HCPCS coding guidelines. BMC HealthNet Plan Acne and Rosacea (Topical)

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IMPORTANT NOTE: Not all services are covered for all products or employer groups. This medical policy expresses the Plan's determination of whether certain services or supplies are medically necessary, experimental or investigational or cosmetic. The Plan has reached these conclusions based upon the regulatory status of the technology and a review of clinical studies published in peer-reviewed medical literature. Even though this policy may indicate that a particular service or supply is considered covered or not covered, this conclusion is not based upon the terms of a members particular benefit plan. Each benefit plan contains its own specific provisions for coverage and exclusions. Not all services that are determined to be medically necessary will necessarily be covered services under the terms of a members benefit plan. Members and their providers need to consult the applicable benefit plan document (e.g., Evidence of Coverage) to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between this medical policy and the benefit plan document, the provisions of the benefit plan document will govern. In addition, this policy and the benefit plan document are subject to applicable state and federal laws that may mandate coverage for certain services and supplies.

This guideline provides information on BMC HealthNet Plan claims adjudication processing guidelines. The use of this guideline is not a guarantee of payment and will not determine how a specific claim(s) will be paid. Reimbursement is based on member benefits and eligibility, medical necessity review, where applicable, coordination of benefits, adherence to Plan policies, clinical coding criteria, and the BMC HealthNet Plan agreement with the rendering or dispensing provider. Reimbursement policies may be amended at BMC HealthNet Plans discretion. BMC HealthNet Plan will always use the most recent CPT and HCPCS coding guidelines. BMC HealthNet Plan Acne and Rosacea (Topical)

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