sign in sign up
<<
Home , Ciclopirox, Nystatin

Cigna National Formulary Coverage Policy

Drug Quantity Management – Per Days Topical Products Duration Limit

Table of Contents Product Identifier(s)

National Formulary Medical Necessity ...... 1 59481 Conditions Not Covered...... 4 Background ...... 4 References ...... 5 Revision History ...... 6

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

National Formulary Medical Necessity

Drugs Affected • hcl 1% cream (Mentax) • olamine 0.77% cream (Loprox, Loprox Cream Kit, generic available for 90 gm tube only, not kit) • ciclopirox 0.77% gel (generics) • ciclopirox 1% shampoo (Loprox, generics) • ciclopirox olamine 0.77% suspension (Loprox, Loprox Suspension Kit, generic available for 60 ml bottle only, not kit) • 1% cream (generics) • clotrimazole 1% solution (generics) • clotrimazole/ cream (Lotrisone, generics) • clotrimazole/betamethasone lotion (generics) • nitrate 1% cream (generics) • econazole nitrate 1% foam (Ecoza) • 2% cream (generics) Page 1 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Topical Antifungal Products • ketoconazole 2% foam (Extina, generics) • ketoconazole 2% gel (Xolegel) • ketoconazole 2% shampoo (Nizoral, generics) • luliconazole1% cream (Luzu, generics) • nitrate, zinc oxide, white petrolatum 0.25%/15%/81.35% ointment (Vusion) • hcl 1% and 2% cream (Naftin, generics) • naftifine hcl 1% and 2% gel (Naftin, generics for 1% gel only) • 100,000 units per gram cream (generics) • nystatin 100,000 units per gram ointment (generics) • nystatin/ acetonide 100,000 units per gram/0.1% cream (generics) • nystatin/ 100,000 units per gram/0.1% ointment (generics) • nitrate 1% cream (Oxistat, generics) • oxiconazole nitrate 1% lotion (Oxistat) • nitrate 2% cream (Ertaczo) • nitrate 1% cream (Exelderm) • sulconazole nitrate 1% solution (Exelderm)

Table 1. Quantity Level Limits Medication Name and Strength Quantity Level Limit per 28 Days Mentax (butenafine) 1% cream 30 grams Loprox (ciclopirox) 0.77% cream 90 grams Loprox 0.77% cream kit 1 kit/544 gms (contains 90 gm ciclopirox cream + 454 gm Rehyla Hair and Body Cleanser) ciclopirox 0.77% gel 45 grams Loprox (ciclopirox) 1% shampoo 120 ml Loprox (ciclopirox) 0.77% suspension 60 ml Loprox 0.77% suspension kit 1 kit/60 ml (contains 60 ml ciclopirox suspension + 454 gm Rehyla Hair and Body Cleanser) clotrimazole 1% cream 45 grams clotrimazole 1% solution 30 ml Lotrisone (clotrimazole-betamethasone) cream 45 grams clotrimazole-betamethasone lotion 60 ml econazole 1% cream 85 grams Ecoza (econazole) 1% foam 70 grams ketoconazole 2% cream 60 grams Extina (ketoconazole) 2% foam 100 grams Xolegel 2% gel 45 grams Nizoral (ketoconazole) 2% shampoo 120 ml Luzu () 1% cream 60 grams Vusion ointment 50 grams Naftin (naftifine) 1%, 2% cream 60 grams Naftin 1%, 2% gel 60 grams nystatin cream/ointment 30 grams nystatin-triamcinolone cream/ointment 60 grams Oxistat (oxiconazole) 1% cream 60 grams Oxistat 1% lotion 60 ml Ertaczo 2% cream 60 grams Exelderm 1% cream 60 grams Exelderm 1% solution 60 ml

Page 2 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Topical Antifungal Products The initial quantity limit for topical antifungal products supplies a sufficient quantity for each of the topical antifungal products to treat 9% of an individual’s body surface area (BSA) when applied up to twice a day for 14 days. For individuals treating a larger surface area or for a longer duration than 14 days, additional quantities listed below are available through coverage review. The objective of this program is to prevent stockpiling, misuse and/or overuse.

Criteria

Cigna covers quantities as medically necessary when the following criteria are met:

1. For individuals treating greater than 9% of their BSA or treating the condition for longer than 14 days, additional quantities can be approved according to Table 3 below:

Table 3. Override Quantities Medication Name and Strength One-time override quantities Mentax (butenafine) 1% cream 30 grams Loprox (ciclopirox) 0.77% cream 90 grams Loprox 0.77% cream kit 1 kit/544 gms (contains 90 gm ciclopirox cream + 454 gm Rehyla Hair and Body Cleanser) ciclopirox 0.77% gel 45 grams Loprox (ciclopirox) 1% shampoo No overrides allowed Loprox (ciclopirox) 0.77% suspension 60 ml Loprox 0.77% suspension kit 1 kit/60 ml (contains 60 ml ciclopirox suspension + 454 gm Rehyla Hair and Body Cleanser) clotrimazole 1% cream 45 grams clotrimazole 1% solution 30 ml Lotrisone (clotrimazole-betamethasone) cream 45 grams clotrimazole-betamethasone lotion 60 ml econazole 1% cream 85 grams Ecoza (econazole) 1% foam 70 grams ketoconazole 2% cream 60 grams Extina (ketoconazole) 2% foam 100 grams Xolegel 2% gel 45 grams Nizoral (ketoconazole) 2% shampoo No overrides allowed Luzu (luliconazole) 1% cream 60 grams Vusion ointment No overrides allowed Naftin (naftifine) 1%, 2% cream 60 grams Naftin 1%, 2% gel 60 grams nystatin cream/ointment 30 grams nystatin-triamcinolone cream/ointment 60 grams Oxistat (oxiconazole) 1% cream 60 grams Oxistat 1% lotion 60 ml Ertaczo 2% cream 60 grams Exelderm 1% cream 60 grams Exelderm 1% solution 60 ml

Page 3 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Topical Antifungal Products Conditions Not Covered

Any other exception is considered not medically necessary, including the following:

1. No overrides are recommended for use in compounded formulations. 2. No overrides are recommended for any other indications not listed in the prescribing information.

Background

Overview Topical antifungal products are used to treat a variety of superficial fungal (e.g., tinea, ) diaper dermatitis, and seborrheic dermatitis. Frequency of administration is typically one to two times daily. Duration of treatment varies depending on the being treated, but is most often used for an initial two week period or less. Treatment can last for up to four weeks in some cases if no clinical improvement is seen after two weeks of treatment. Table 2 below provides drug specific approved indications.

Table 2. Drug Specific Indications Drug Indication Loprox (ciclopirox) cream and suspension tinea cruris tinea pedis ciclopirox gel seborrheic dermatitis Extina (ketoconazole)Foam Loprox shampoo Xolegel gel clotrimazole cream and solution candidiasis tinea corporis tinea cruris tinea pedis econazole cream tinea corporis Exelderm cream tinea cruris Oxistat (oxiconazole) cream tinea pedis Oxistat lotion tinea versicolor Ecoza Foam tinea pedis Ertaczo cream Exelderm Solution tinea corporis tinea cruris tinea versicolor

ketoconazole cream candidiasis tinea corporis tinea cruris tinea pedis tinea versicolor seborrheic dermatitis clotrimazole-betamethasone lotion tinea corporis Lotrisone cream tinea cruris Luzu cream tinea pedis Naftin (naftifine) cream Naftin gel Mentax cream and gel tinea versicolor

Page 4 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Topical Antifungal Products Nizoral (ketoconazole)shampoo nystatin cream and ointment candidiasis nystatin-triamcinolone cream and ointment

Vusion ointment diaper dermatitis complicated by candidiasis

References

1. Mentax® 1% Cream [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals, Inc.; June 2018. 2. Loprox® 0.77% Cream [prescribing information]. West Fairfield, NJ: Medimetriks Pharmaceuticals, Inc.; January 2016. 3. Ciclopirox 0.77% gel [prescribing information]. Mahwah, NJ: Glenmark Pharmaceuticals Ltd.; January 2017. 4. Loprox® 1% Shampoo [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC .; May 2019. 5. Loprox® 0.77% Suspension [prescribing information]. West Fairfield, NJ: Medimetriks Pharmaceuticals, Inc.; March 2016. 6. Clotrimazole 1% cream [prescribing information]. Mahwah, NJ: Glenmark Pharmaceuticals Ltd.; September 2014. 7. Clotrimazole 1% solution [prescribing information]. Hawthorne, NY: Taro Pharmaceuticals U.S.A, Inc.; December 2012. 8. Lotrisone® cream [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; June 2019. 9. Clotrimazole/betamethasone lotion [prescribing information]. Melville, NY: Fougera Pharmaceuticals, Inc.; December 2015. 10. Econazole 1% cream [prescribing information]. Hawthorne, NY: Taro Pharmaceuticals Inc.; February 2020. 11. Ecoza® 1% foam [prescribing information]. Mahwah, NJ: Glenmark Therapeutics Inc., USA; November 2019. 12. Ketoconazole 2% cream [prescribing information]. Melville, NY: Fougera Pharmaceuticals, Inc.; May 2012. 13. Extina® 2% foam [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals Inc.; August 2018. 14. Xolegel® 2% gel [prescribing information]. West Chester, PA: Aqua Pharmaceuticals,; December 2019. 15. Nizoral® 2% shampoo [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; December 2017. 16. Luzu® 1% cream [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC; April 2020. 17. Vusion® Ointment [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals Inc.; August 2018. 18. Naftin® 1% and 2% cream [prescribing information]. Roswell, GA: Sebela Pharmaceuticals Inc.; February 2018. 19. Naftin® 1% and 2% gel [prescribing information]. Roswell, GA: Sebela Pharmaceuticals Inc.; May 2018. 20. Nystatin cream [prescribing information]. Allegan, MI: Perrigo; July 2015.. 21. Nystatin ointment [prescribing information]. Allegan, MI: Perrigo; August 2015.. 22. Nystatin-triamcinolone cream [prescribing information]. Parsippany, NJ: ActavisPharma, Inc.; May 2015. 23. Nystatin-triamcinolone ointment [prescribing information]. Parsippany, NJ: ActavisPharma, Inc.; May 2015. 24. Oxistat® 1% cream and lotion [prescribing information]. Melville, NY: Fougera Pharmaceuticals, Inc.; January 2012. 25. Ertaczo® 2% cream [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC.; November 2017. 26. Exelderm® 1% cream [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; May 2018. 27. Exelderm® 1% solution [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; May 2018.

Page 5 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Topical Antifungal Products

Revision History

Type of Summary of Changes Date Revision Annual Reviewed by Clinical Specialists. No changes to criteria. 06/11/2020 Revision

“Cigna Companies” refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. © 2021 Cigna.

Page 6 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Topical Antifungal Products