FINACEA, Azelaic Acid Form

Azelaic acid 15% (Finacea®) topical gel/foam is a naturally-occurring saturated dicarboxylic acid. ____ FDA Approved Indication(s) Finacea is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitation(s) of Use:
Efficacy of finacea gel for the treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Finacea is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Rosacea (must meet all):

1. Diagnosis of rosacea;
2. Age ≥ 18 years;

3. Failure of ≥ 6 consecutive weeks of maximally tolerated doses of one of the following (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated: oral doxycycline, oral minocycline, topical ivermectin, or topical metronidazole;
   PA may be required for ivermectin cream.

   4. Member must use generic azelaic acid gel 15%, unless contraindicated or clinically significant adverse effects are experienced;
   5. Dose does not exceed 50 g (1 tube or can) per month.
      Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
   6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): Page 1 of 5

   CLINICAL POLICY
   Azelaic Acid a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
      II. Continued Therapy A. Rosacea (must meet all):
   3. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
4. Member is responding positively to therapy;

5. Member must use generic azelaic acid gel 15%, unless contraindicated or clinically significant adverse effects are experienced;

   4. If request is for a dose increase, new dose does not exceed 50 g (1 tube or can) per month.
      Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
   5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
   6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace or evidence of coverage documents. Page 2 of 5

   CLINICAL POLICY
   Azelaic Acid IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen metronidazole
   (Metrocream® 0.75%, Metrogel® 1%, Metrolotion® 0.75% ) minocycline (Solodyn®) doxycycline (Oracea)® Apply thin film topically to affected area QD for 1% and BID for 0.75% IR: 200 mg PO followed by 100 mg PO Q12H ER: 1 mg/kg PO QD 40 mg PO once daily in the morning (1 hour before or 2 hours after a meal) Dose Limit/ Maximum Dose No maximum dosage information is available.
   300 mg on day 1, then 200mg/day 300 mg/day PO; 40 mg PO/day for Oracea 4 oz/topical application ivermectin cream 1% (Soolantra®) Apply a pea-size amount to the affected areas of the face (forehead, chin, nose, each cheek) once daily. Spread as a thin layer, avoiding the eyes and lips. Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
   Indication Rosacea Dosing Regimen Apply a thin layer BID to the affected area(s) Maximum Dose N/A VI. Product Availability
   Gel (50 g): 15% Foam (50 g): 15% VII.