HALOG, Halcinonide Form

Halcinonide (Halog®) is a high potency topical corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive actions. FDA Approved Indication(s) Halog is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses. 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 Halog is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Dermatologic Inflammation and Pruritus (must meet all):

1. Diagnosis of dermatologic inflammation or pruritus;

2. Failure of two formulary high potency topical corticosteroids in the previous 6 months, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B for examples);

   3. If request is for brand Halog cream or ointment, member must use generic halcinonide cream, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for generic halcinonide cream
   4. Dose does not exceed (a and b): a. 60 gm per month; b. One tube 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 Page 1 of 5

   CLINICAL POLICY Halcinonide 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. Dermatologic Inflammation and Pruritus (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);
3. Member is responding positively to therapy;
4. If request is for brand Halog cream or ointment, member must use generic halcinonide cream, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for generic halcinonide cream

5. If request is for a dose increase, new dose does not exceed (a and b): a. 60 gm per month; b. One tube per month. Approval duration: 12 months
   B. Other diagnoses/indications (must meet 1 or 2):

   1. 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
   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.
      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 Halcinonide 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 Dose Limit/ Maximum Dose Should not be used for longer than 2 consecutive weeks Apply topically to the affected area(s) BID Apply topically to the affected area(s) BID Apply topically to the affected area(s) BID Should not be used for longer than 2 consecutive weeks Should not be used for longer than 2 consecutive weeks augmented betamethasone 0.05% gel, cream, ointment, lotion (Diprolene) clobetasol propionate 0.05% cream, ointment, gel, solution (Temovate)
   diflorasone diacetate 0.05% ointment, cream (Apexicon®, Psorcon) halobetasol propionate 0.05% cream, ointment (Ultravate) fluocinonide acetonide 0.05% cream, ointment, gel, solution (Lidex) desoximetasone 0.25% cream, ointment (Topicort®)
   desoximetasone 0.05% cream, gel (Topicort)
   Mometasone furoate 0.1% ointment, cream 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. Should not be used for longer than 2 consecutive weeks Should not be used for longer than 2 consecutive weeks Should not be used for longer than 2 consecutive weeks Apply topically to the affected area(s) BID Apply topically to the affected area(s) BID Apply topically to the affected area(s) QD Should not be used for longer than 2 consecutive weeks Should not be used for longer than 2 consecutive weeks Apply topically to the affected area(s) BID Apply topically to the affected area(s) BID Appendix C: Contraindications/Boxed Warnings • Contraindication(s): history of hypersensitivity to any of the components of the preparation • Boxed warning(s): none reported V. Dosage and Administration
   Indication Dermatologic inflammation and pruritus Dosing Regimen Apply to the affected area BID to TID Maximum Dose 3 applications/day Page 3 of 5

   CLINICAL POLICY Halcinonide VI. Product Availability
   • Cream (0.1%): 30 g, 60 g • Ointment (0.1%): 60 g VII.