Subject:
Retinoids, Topical
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Retinoids are a class of keratolytic drugs derived from retinoic acid or vitamin A1 acid. Tretinoin, a form of retinoids, is a vitamin A metabolite used topically to treat acne vulgaris. It decreases cohesiveness of the follicular epithelial cells and increases epidermal cell mitosis and cell turnover. Another form of retinoids, adapalene, is also indicated to treat acne. In addition, Tazorac is indicated for plaque psoriasis and acne. Panretin is indicated for treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma, and Targretin is indicated for the topical treatment of lesions in patients with cutaneous T-cell lymphoma. Tretinoin is also available as a component of some multi-ingredient products, which are currently indicated only for cosmetic purposes.
Retinoids for topical application are available in gels, creams and liquids, and in various strengths. They are marketed as Retin-A (tretinoin, various forms and strengths), Renova (tretinoin 0.05% and 0.02% cream), Avita (tretinoin 0.025% cream/gel), Retin A Micro (microsphere tretinoin, 0.04% and 0.1% gel), Tretin-X (tretinoin, various forms and strengths), Atralin (tretinoin 0.05% gel), ReFissa (tretinoin 0.05% emollient cream), Differin (adapalene 0.1% gel/solution/cream/pledget/lotion and 0.3% gel), Epiduo (adapalene/ benzoyl peroxide 0.1%/ 2.5% gel), Tazorac (tazarotene 0.05% and 0.1% gel/cream), Avage (tazarotene 0.1% cream), Fabior (tazarotene 0.1% foam), Targretin (bexarotene 1% gel), Panretin (alitretinoin 0.1% gel), Aklief (trifarotene cream 0.005%), and Altreno (tretinoin lotion 0.05%). Tretinoin is also available topically in combination product as Tri-Luma (fluocinolone 0.01%, hydroquinone 4%, tretinoin 0.05% cream). Ziana Gel and Veltin Gel (clindamycin phosphate 1.2% and tretinoin 0.025%) are lincosamide antibiotic and tretinoin combination products that are FDA approved for the treatment of acne vulgaris in patients 12 years or older.
[INFORMATIONAL NOTE: The FDA-approved tretinoins (excluding Ziana and Veltin) are Pregnancy Category D. Tazorac and Fabior are Pregnancy Category X. They may cause fetal harm and should not be administered to a pregnant woman.]
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
1. Retinoids for topical application must be prescribed by the treating physician.
2. Retin-A, Retin-A Micro, Tretin X,Avita, Ziana, Veltin, Differin, Epiduo, Tazorac, Fabior, Adapalene Atralin, Aklief or Altreno is medically necessary for topical application in the treatment of acne. This is consistent with the FDA-approved indication.
- Member should meet the following:
- Confirmed diagnosis of acne vulgaris; AND
- The member's medication history includes use of TWO generic topical retinoids (documentation of medical records required)
- 9 years of age or older for Epiduo, Aklief or Altreno
- 10 years of age or older for Atralin
- 18 years of age or older for Tazorac cream
- 12 years of age or older for all other products
Epidemiological studies have shown that the prevalence of acne in individuals significantly decreases by the mid- 30’s.
Veltin and Ziana are contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. Systemic absorption of clindamycin has been demonstrated following topical use. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin..]
3. Tazorac is medically necessary for topical application in the treatment of plaque psoriasis. This is consistent with the FDA-approved indications for Tazorac.
- Member should meet the following for psoriasis:
- Confirmed diagnosis of plaque psoriasis up to 20% body surface area involvement
- 18 years of age or older (if requested agent is Tazorac cream)
- 12 years of age or older (if requested agent is Tazorac gel)
4. Panretin is medically necessary for topical application in the treatment of cutaneous lesions in members with AIDS-related Kaposi's sarcoma. This is consistent with the FDA-approved indication for Panretin.
- Member should meet the following:
- Definitive diagnosis of AIDS-related Kaposi’s sarcoma with ≤ 10 Kaposi's sarcoma lesions in the previous month
- No symptomatic lymphedema, pulmonary KS, or visceral involvement
5. Targretin is medically necessary for topical treatment of cutaneous lesions in patients with cutaneous T-cell lymphoma (CTCL) (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies. This is consistent with the FDA-approved indication for Targretin.
- Member should meet the following:
- Confirmed diagnosis of CTCL Stage IA or IB
- Refractory or intolerance to at least two prior therap
y (including,but not limited to, topical corticosteroids, mechlorethamine, carmustine, tazarotene, phototherapy or topical imiquimod).
6. The following are considered medically necessary “off-label” uses for Retin-A, Retin-A Micro gel, Avita, Tretin X, Atralin, or Altreno
· Treatment of actinic keratosis, hyperkeratotic skin disease (such as keratosis folicularis, Darier's disease, and Darier-White disease)
· For treatment of Rosacea, member should meet the following:
o The member has had previous treatment with a topical metronidazole product and generic tretinoin cream/gel
7. Targretin is medically necessary for the following “off-label” uses
· Primary cutaneous B-cell Lymphomas
o Topical therapy for primary cutaneous marginal zone or follicle center lymphoma
· Mycosis Fungoides/Sezary Syndrome
o primary treatment or treatment for relapsed or persistent for stage IA mycosis fungoides (MF), as a single agent or in combination with other skin-directed therapies (skin-limited/local)
o treatment in combination with systemic therapy for stage IA MF that is refractory to multiple previous therapies (skin-limited/local)
o primary treatment or treatment for relapsed MF that is stage IB-IIA with a lower skin disease burden (eg, predominantly patch disease), as a single agent or in combination with other skin-directed therapies (skin-limited/local)
o primary treatment or treatment for relapsed or persistent MF that is stage IIB with limited tumor lesions, as a single agent (skin-limited/local)
· Adult T cell Leukemia/Lymphoma
o For chronic/smoldering subtype as first-line skin-directed therapy
8. Medical necessity for continued therapy for the above products will be considered if there is improvement and member can tolerate therapy, and there is no sign of unacceptable toxicity such as excessive pruritis, burning, skin redness or peeling.
9. Renova is FDA-approved as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin. For this reason, use of Renova is considered cosmetic.
10. Avage is FDA-approved as an adjunctive agent in the mitigation (palliation) of facial fine wrinkling, facial mottled hyperpigmentation and hypopigmentation, and benign facial lentigines. For this reason, use of Avage is considered cosmetic.
11. Tri-luma is indicated for the short-term (up to 8 weeks) intermittent treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. For this reason, use of Tri-luma is considered cosmetic.
12. ReFissa is FDA-approved as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs. For this reason, use of ReFissa is considered cosmetic.
13. Solage is FDA-approved for the treatment of solar lentigines and the palliation of fine facial wrinkles. For this reason, use of Solage is cosmetic.
14. "Off-label" use of Retin-A, Retin-A Micro, Tretin X, Avita, Ziana, Differin, Tazorac, Atralin, Panretin, Aklief or Altreno for treatment of photodamaged skin (clinically manifested as wrinkling, irregular pigmentation, laxity, skin roughness/dryness, sallowness, telangiectasia, and/or brown spots) is considered cosmetic.
15. Other uses of Retin-A, Retin-A Micro, Tretin X,, Avita, Ziana, Veltin, Renova, Differin, Epiduo, Tazorac, Avage, Panretin, Targretin, Tri-luma, Atralin, Aklief or Altreno are considered investigational.
Medicare Coverage
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL specifically for these drugs. Per Local Coverage Article A53127 Self-Administered Drug Exclusion List, Medicare covers drugs that are furnished “incident to” a physician’s service provided that the drugs are medically reasonable and necessary, approved by the Food and Drug Administration (FDA) and are not usually administered by the patients who take them. Therefore, Medicare Advantage Products will cover Topical Retinoids when administered by a licensed medical provider as part of a physician service.
For members with a Medicare drug plan (Part D) Topical Retinoids may be covered under that plan. Local Coverage Article: Self-Administered Drug Exclusion List (A53127). Available to be accessed at: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370&_afrLoop=495035768360390#!%40%40%3F_afrLoop%3D495035768360390%26centerWidth%3D100%2525%26contentId%3D00024370%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D5zwo8yst8_21.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Retinoids, Topical
Tretinoin
Avita
Renova
Retin-A
Tazorac
Tazarotene
Differin
Epiduo
Adapalene
Avage
Panretin
Alitretinoin
Targretin
Bexarotene
Solage
Tri-luma
Tretin- X
Altinac
Retin-A Micro
Ziana
Veltin
Atralin
ReFissa
Fabio
Akilef
Altrenor
References:
1. Dinehart SM. Actinic Keratosis: Scientific Evaluation and Public Health Implications. Journal of the American Academy of Dermatology. January 2000;42:S258.
2. 2004 Physicians' Desk Reference. 58th Edition. Medical Economics Publishing Company.
3. 1998 Physicians' Desk Reference Generics. 4th Edition. Medical Economics Publishing Company.
4. Callen JP, Bickers DR, Moy RL. Actinic Keratosis. Journal of the American Academy of Dermatology. April 1997;36(4):651-653.
5. Humphreys TR, Werth V, Dzubow L, Kligman A. Treatment of photodamaged skin with trichloroacetic acid and topical tretinoin. J Am Acad Dermatol. 1996;34:638-44.
6. Noble S, Wagstaff AJ. Tretinoin: A Review of its Pharmacological Properties and Clinical Efficacy in the Topical Treatment of Photodamaged Skin. Drugs & Aging. 1995;6(6).
7. American Medical Association Drug Evaluations. Spring 1993.
8. American Hospital Formulary Service Drug Information, 2000.
9. United States Pharmacopeia Drug Information, 2000.
10. Alizerai M, Dupuy P, Amblard P, et al. Clinical evaluation of topical isotretinoin in the treatment of actinic keratosis. J Am Acad Dermatol. 1994 Mar;30(3):447-451.
11. Misiewicz J, Sendagorta E, Golebiowska A, et al. Topical treatment of multiple actinic keratoses of the face with arotinoid methyl sulfone (Ro 14-9706) cream versus tretinoin
cream: a double-blind, comparative study. J Am Acad Dermatol. 1991 Mar;24(3):448-451.
12. Medicare Coverage Policy. Decision Memorandum: Actinic Keratoses Treatment (#CAG-00049). July 9, 2001.
<www.hcfa.gov/coverage/8b3-t4.htm> (accessed 08/20/01)
13. Orfanos CE, Zouboulis CC, Almond-Roesler B, et al. Current use and future potential role of retinoids in dermatology. Drugs 1997;53(3):358-388.
14. Kang S, Fisher GJ, Voorhees JJ. Photoaging: pathogenesis, prevention, and treatment. Clin Geriatr Med 2001 Nov;17(4):643-659.
15. Griffiths CE. The role of retinoids in the prevention and repair of aged and photoaged skin. Clin Exp Dermatol 2002 Oct;26(7):613-618.
16. Bershad S. Developments in topical retinoid therapy for acne. Semin Cutan Med Surg 2001 Sep;20(3):154-161.
17. Lawrence N. New and emerging treatments for photoaging. Dermatol Clin 2000 Jan;18(1):99-112.
18. Haas AA, Arndt KA. Selected therapeutic applications of topical tretinoin. J Am Acad Dermatol 1986 Oct;15(4 Pt 2):870-877.
19. Differin (adapalene) package insert. Galderma Laboratories. L.P. Fort Worth. December 2013.
20. Tazorac (tazarotene) package insert. Allergan, Inc. Irvine, CA. July 2017.
21. Panretin (alitretinoin) package insert. Ligand Pharmaceuticals Inc. San Diego, CA. December 2017.
22. Avage (tazarotene) package insert. Allergan, Inc. Irvine, CA. July 2017.
23. Targretin (bexarotene) package insert. Valeant Pharmaceuticals. Bridgewater, NJ. October 2016.
24. Solage (mequinol 2%, tretinoin 0.01%, hydroquinone 4%, tretinoin 0.05%) package insert. Westwood-Squibb Pharmaceuticals Inc. Buffalo, NY. August 2002.
25. Tri-luma (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) package insert. Galderma Laboratories. Fort Worth, TX. March 2014.
26. ZIANA (clindamycin and tretinoin) package insert. Medicis Pharmaceutical Corporation. Scottsdale, AZ. March 2012.
27. Tretinoin [AHFS Drug information] March 2006, American Society of Health-System Pharmacists, Inc.
28. Tretin-X (tretinoin) package insert. Onset Dermatologies, LLC. March 2014.
29. Atralin (tretinoin) package insert. Valeant Pharmaceuticals. Bridgewater, NJ. August 2014.
30. Rowlewski SL. Clinical review: Topical retinoids. Dermatol Nurs. 2003; 15(5) 447-450, 459-465.
31. Berson DS. Topical retinoids in primary care practice. P&G Pharmaceuticals. 2004 July.
32. Stern RS. Treatment of photoaging. N Engl J Med. 2004 April; 350(15): 1526-1534.
33. Weinberg JM. Topical therapy for actinic keratoses: Current and evolving therapies. Reviews on recent clinical trials. 2006: 53-60.
34. Epi-Duo (adapalene / benzoyl peroxide) package insert. Fort Worth, TX. Galderma laboratories, LP. January 2013.
35. Differin® Lotion 0.01% (adapalene) Prescribing Information. Galderma Laboratories. Fort Worth, TX. July 2014.
36. Veltin (clindamycin phosphate and tretinoin) Gel. Prescribing Information. Stiefel Laboratories. San Antonio, TX. March 2014.
37. Facts & Comparisons eAnswers. Wolters Kluwer. [Available at: http://online.factsandcomparisons.com/index.aspx?]
38. Micromedex Health Series. Thomson Gateway. [Available at: http://www.thomsonhc.com/hcs/librarian/PFPUI/AH1fgpoxqU9YR]
39. Clinical Pharmacology. Elsevier/Gold Standard. [Available at: https://www.clinicalpharmacology.com/Forms/login.aspx?ReturnUrl=%2fdefault.aspx]
40. Fabior (tazarotene) package insert. Mayne Pharma. Greenville, NC. June 2018.
41. ReFissa (tretinoin cream) package insert. Suneva Medical, Inc. 2013.
42. Retin-A (tretinoin cream) package insert. . Valeant Pharmaceuticals. Bridgewater, NJ. June 2018.
43. Retin-A Micro (tretinoin gel) package insert. Valeant Pharmaceuticals. Bridgewater, NJ. January 2015.
44. Avita (tretinoin gel) package insert. Mylan Pharmaceuticals, Inc. June 20118.
45. Epiduo Forte (adapalene and benzoyl peroxide) package insert. Galderma Laboratories.July 2015.
46. Zelenetz A, Gordon L, Wierda W, et al. NCCN Clinical Practice Guidelines in Oncology: Non-Hodgkin's Lymphoma. National Comprehensive Cancer Network. Version 4.2014. Available at:
www.nccn.org/about/nhl.pdf
47. Horwitz S. Hverkos B., et al. NCCN Clinical Practice Guidelines in Oncology: T-Cell Lymphomas. National Comprehensive Cancer Network. Version 2.2018.
48. Horwitz S. Hverkos B., et al. NCCN Clinical Practice Guidelines in Oncology: Primary Cutaneous B-Cell Lymphomas. National Comprehensive Cancer Network. Version 1.2018.
49. Oge, Linda K., et al. “Rosacea: Diagnosis and Treatment.” AAFP Home, 1 Aug. 2015, www.aafp.org/afp/2015/0801/p187.html.
50. Altreno prescribing information. Valeant Pharmaceuticals North America LLC. August 2018.
51. Aklief prescribing information. Galderma Laboratories, L.P. October 2019.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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