Rosacea, Topical Products - Cigna
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EFFECTIVE 1/1/2021
Drug and Biologic Coverage Policy
Effective Date ............................................ 1/1/2021
Next Review Date… ..................................... 1/1/2022
Coverage Policy Number ............................... IP0003
Rosacea, Topical Products
Table of Contents Related Coverage Resources
Overview ...................................................................1
Coverage Policy Statement ......................................1
FDA Indication Criteria..............................................2
Other Uses with Supportive Evidence Criteria .........2
Specific Additional Criteria ........................................2
Preferred Product Requirement Criteria ...................2
Conditions Not Covered............................................3
Background ...............................................................3
References ...............................................................4
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.
Overview
This policy supports medical necessity review for topical products indicated for the treatment of rosacea.
Note that Finacea cream 20% is only indicated for treatment for acne.
Coverage Policy Statement
Topical rosacea products (Finacea® 15% foam/gel, MetroCream® 0.75% cream, Metrogel® 0.75% gel,
MetroLotion® 0.75% lotion, Noritate® 1% cream, Soolantra® 1% cream) are medically necessary when the
following are met:
1. Criteria associated with FDA Indications
2. Criteria associated with Other Uses with Supportive Evidence
3. Specific Additional Criteria [when part of Cigna managed drug list or plan requirements]
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Coverage Policy Number: IP0003EFFECTIVE 1/1/2021
4. Preferred Product Requirement Criteria [when part of Cigna managed drug list or plan requirements]
When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of
care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted
based upon severity, alternative available treatments, and previous response to therapy.
Approval duration is 12 months unless otherwise stated.
Note: Receipt of sample product does not satisfy any criteria requirements for coverage.
Documentation: When documentation is required, the prescriber must provide written documentation
supporting the trials of these other agents. Documentation may include, but is not limited to, chart notes,
prescription claims records, and/or prescription receipts
Refer to each criteria section below.
FDA Indication Criteria
None.
Other Uses with Supportive Evidence Criteria
None.
Specific Additional Criteria
None.
Preferred Product Requirement Criteria
Coverage varies across plans. Refer to the customer’s benefit plan document for coverage details. Where
coverage requires the use of preferred products, the following criteria apply:
Approve for an individual when there is documentation of ONE of the following:
• The individual has had inadequate efficacy OR contraindication according to FDA label OR significant
intolerance to ALL of covered alternatives according to the table below OR
• The individual is not a candidate for ALL covered alternatives according to the table below due to being
subject to a warning per the prescribing information (labeling), having a disease characteristic, individual
clinical factor[s], or other attributes/conditions or is unable to administer and requires this dosage
formulation
Non-Covered Standard / Value / Cigna Total Legacy
Product Performance Advantage Savings
Finacea 15% Individuals with rosacea:
Foam (azelaic acid) TWO formulary topical products from the following: azelaic acid 15% gel, sodium
sulfacetamide 10%/sulfur 5%, metronidazole 0.75% or 1% (cream, gel, or lotion)
Individuals with acne vulgaris:
TWO formulary topical products from the following: topical antibiotic products (for
example, clindamycin, erythromycin, benzoyl peroxide), topical retinoids (for example,
tretinoin, adapalene, tazarotene), azelaic acid 15% gel, sulfacetamide-containing
products
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Coverage Policy Number: IP0003EFFECTIVE 1/1/2021
Non-Covered Standard / Value / Cigna Total Legacy
Product Performance Advantage Savings
Finacea 15% Gel Individuals with rosacea:
(azelaic acid) TWO formulary topical products from the following: azelaic acid 15% gel, sodium
sulfacetamide 10%/sulfur 5%, metronidazole 0.75% or 1% (cream, gel, or lotion)
Individuals with acne vulgaris:
TWO formulary topical products from the following: topical antibiotic products (for
example, clindamycin, erythromycin, benzoyl peroxide), topical retinoids (for example,
tretinoin, adapalene, tazarotene), azelaic acid 15% gel, sulfacetamide-containing
products
MetroCream TWO formulary topical metronidazole products from the following: metronidazole 0.75%
0.75% Cream cream, metronidazole 0.75% or 1% gel, metronidazole 0.75% lotion
(metronidazole)
MetroGel 0.75% TWO formulary topical metronidazole products from the following: metronidazole 0.75%
Gel (metronidazole) cream, metronidazole 0.75% or 1% gel, metronidazole 0.75% lotion
Metrolotion 0.75% TWO formulary topical metronidazole products from the following: metronidazole 0.75%
Lotion cream, metronidazole 0.75% or 1% gel, metronidazole 0.75% lotion
(metronidazole)
Noritate 1% Cream TWO formulary topical metronidazole products from the following: metronidazole 0.75%
(metronidazole) cream, metronidazole 0.75% or 1% gel, metronidazole 0.75% lotion
Soolantra 1% TWO formulary topical products from the following: azelaic acid 15% gel, sodium
Cream (ivermectin) sulfacetamide 10%/sulfur 5%, metronidazole 0.75% or 1% (cream, gel, or lotion)
Conditions Not Covered
Any other exception is considered not medically necessary.
Background
Rosacea, a chronic, inflammatory facial skin disorder, affects approximately 16 million people in the US.1-3 The
prevalence of rosacea has been estimated to range from < 1% to > 20%.2 Both cultural and social perceptions of
the disease (among other factors, including study methodology and study populations) may confound the
prevalence reporting; hence, the wide range in the estimate. Rosacea is more common in fair-skinned people of
Northern and Eastern European descent, but it has been reported in people of other ethnicities.3 The hallmark of
rosacea is central facial persistent erythema, typically affecting the cheeks, chin, forehead, and nose; the perioral
and periocular regions are generally unaffected.2 Patients with rosacea typically present with clinical
manifestations that include flushing, persistent facial edema, dryness, burning and stinging skin, inflammatory
papules and pustules, telangiectasia or dilation of blood vessels, and watery or irritated eyes.3 Up to 50% of
patients with rosacea can also have ocular involvement.4,5 Rosacea has a negative impact on quality of
life. Some studies have reported higher rates of depression in patients with rosacea.2 In a survey by the National
Rosacea Society involving more than 400 patients, 75% of respondents reported that rosacea lowered their self-
esteem and the majority of patients reported embarrassment and frustration.4
There are multiple risk factors for the development of rosacea, including age, gender, and ultraviolet (UV)
exposure. The onset of rosacea is generally between 30 and 50 years of age; it is less frequently reported in
children and adolescents.2-4 The gender distribution is generally equal or female-predominant.2 UV exposure is a
commonly-accepted risk factor, although the pathogenic relationship remains unknown. UV exposure may also
induce rosacea by triggering innate immune responses. The cause of rosacea is unclear, but the pathogenesis
of rosacea includes aberrations in innate immunity, dermal matrix degradation, and vasodilation.2,3 Interactions
between microbial organisms may also play a role.6 Antimicrobial peptides, processing enzymes, and toll-like
receptors may be involved in promoting inflammation in rosacea skin.3 The role of Demodex folliculorum, a
house mite, has been reviewed and studies have suggested a temporal relationship between Demodex
infestation and rosacea.2 Furthermore, Demodex harbors a gram-negative bacterium, Bacillus oleronius, which
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Coverage Policy Number: IP0003EFFECTIVE 1/1/2021
produces proinflammatory proteins. Taphylococcus epidermis bacteria have also been isolated from pustules in
some patients with papulopustular rosacea.
In 2002, rosacea was divided into four subtypes.2,4,5 However, many patients present with more than one
subtype. Subtype 1 or erythematotelangiectatic rosacea is most common and is characterized by flushing and
persistent facial erythema; other features include edema and roughness or scaling. The prevalence of subtype 1
is estimated to be approximately 4-fold greater than that for subtype 2. Subtype 2 or papulopustular rosacea is
characterized by persistent central facial erythema with transient papules/pustules in a central facial
distribution. Some patients have subtypes 1 and 2 rosacea; other patients develop subtype 2 rosacea following
subtype 1 rosacea. Subtype 3 or phymatous rosacea is rather uncommon and is characterized by thickened skin
with irregular nodules and localized enlargement. Of the subtypes, this subtype usually occurs in men. Subtype 4
or ocular rosacea is diagnosed based on one or more ocular-related manifestations, including: watery or
bloodshot appearance, foreign body sensation, burning or stinging, dryness, itching, light sensitivity, blurring of
vision, and corneal complications (including corneal infiltrate ulcers and keratitis).
The goal of therapy is to manage the clinical signs and the physical symptoms of rosacea.5,6 Non-pharmacologic
modalities include: avoidance of triggers (e.g., extreme hot or cold temperature, wind, sun exposure); dietary
changes (avoid spicy foods, alcohol); and use of daily sunscreen and gentle cleansers. Proper skin care is also
necessary to control rosacea. Good skin care is imperative for the overall management of rosacea symptoms; a
good skin regimen has been shown to improve therapeutic outcomes and to reduce skin irritation.5 At this time,
there are no comparative studies to definitively recommend particular skin products; a regimen should be
selected based on its ability to enhance skin hydration and reduce the likelihood of skin irritation associated with
topical medication application.
References
1. Sarnoff DS. Therapeutic update on rosacea. J Drugs Dermatol. 2014;13(1):10-11.
2. Tan J, Berg M. Rosacea: current state of epidemiology. J Am Acad Dermatol. 2013 Dec;69(6 Suppl 1):S27-35.
3. Feldman SR, Huan WW, Huynh TT. Current drug therapies for rosacea: a chronic vascular and inflammatory
skin disease. J Manag Care Pharm. 2014;20(6):623-629.
4. Wollina U. Recent advances in the understanding and management of rosacea. Prime Reports. 2014;6:50-57.
5. Del Rosso JQ, Thiboutot D, Gallo R. Consensus recommendations from the American Acne & Rosacea
Society on the management of rosacea, part 1: a status report on the disease state, general measures, and
adjunctive skin care. Cutis. 2013;92(5):234-240.
6. Data on file. Submission of Clinical and Economic Data Supporting Formulary Consideration
for: Soolantra®. Galderma Laboratories; January 7, 2015.
7. MetroCream® [prescribing information]. Fort. Worth, TX: Galderma; January 2017.
8. Rosadan® gel, gel kit [prescribing information]. Fairfield, NJ: Medimetriks; May 2017.
9. MetroLotion® [prescribing information]. Fort. Worth, TX: Galderma; February 2017.
10. MetroGel® 1% [prescribing information]. Fort. Worth, TX: Galderma; June 2012.
11. Noritate® [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC; June 2019.
12. Finacea® gel [prescribing information]. Whippany, NJ: Bayer Healthcare Pharmaceuticals; August 2016.
13. Finacea® foam [prescribing information]. Madison, NJ: LEO Pharma Inc.; August 2018.
14. Soolantra® cream [prescribing information]. Fort Worth, TX: Galderma; July 2018.
15. Mirvaso® [prescribing information]. Fort Worth, TX: Galderma Laboratories; November 2017.
16. Rosadan® cream kit [prescribing information]. Fairfield, NJ: Medimetriks; February 2011.
17. Rhofade™ cream [prescribing information]. Irvine, CA: Allergan; January 2017.
18. Siddiqui K, Stein Gold L, Gill J. The efficacy, safety, and tolerability of ivermectin compared with current
topical treatments for the inflammatory lesions of rosacea: a network meta-analysis. Springerplus. 2016 Jul
22;5(1):1151.
19. Elewski BE, Fleischer AB, Pariser DM. A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in
the topical treatment of papulopustular rosacea. Arch Dermatol. 2003;139:1444-1450.
20. Wolf JE, Kerrouch N, Arsonnaud S. Efficacy and safety of once-daily metronidazole 1% gel compared with
twice-daily azelaic acid 15% gel in the treatment of rosacea. Cutis. 2006:77(Suppl 4):3-11.
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Coverage Policy Number: IP0003EFFECTIVE 1/1/2021
21. DelRosso JQ, Bruce S, Jarratt M, et al. Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline
40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular
rosacea. J Drugs Dermatol. 2010;9(6):607-613.
22. Taieb A, Ortonne JP, Ruzicka T, et al. The ivermectin Phase III study group. Superiority of ivermectin 1%
cream over metronidazole 0.75% cream in treating inflammatory lesions of rosacea: a randomized,
investigator-blinded trial. Br J Dermatol. 2015;172(4):1103-1110.
23. Del Rosso JQ, Thiboutot D, Gallo R. Consensus recommendations from the American Acne & Rosacea
Society on the management of rosacea, part 5: a guide on the management of
rosacea. Cutis. 2014;93(3):134-138.
24. Stein Gold L, Kircik L, Fowler J, et al. Long-term safety of ivermectin 1% cream vs. azelaic acid 15% gel in
treating inflammatory lesions of rosacea: results of two 40-week controlled, investigator-blinded trials. J
Drugs Dermatol. 2014;13(11):1380-1386.
25. Colon LE, Johnson LA, Gottschalk RW. Cumulative irritation potential among metronidazole gel 1%,
metronidazole gel 0.75%, and azelaic acid gel 15%. Cutis. 2007;79:317-321.
26. Metronidazole 0.75% gel [prescribing information]. Mason, OH: Prasco Laboratories; September 2014.
27. van Zuuren EJ, Fedorowicz Z, Tan J, et al. Interventions for rosacea based on the phenotype approach: an
update systematic review including GRADE assessments. Br J Dermatol. 2019;181:65-79.
“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
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