Effective Date

Date of Origin   

07-01-2025           

VTAMA®

(tapinarof)

Cream

Topical treatment of plaque psoriasis in adults

Topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older

1

Psoriasis (PS)

Psoriasis (PS) is a chronic inflammatory skin and systemic disorder. It is a complex disease that affects the skin and joints and is associated with numerous comorbidities, including obesity and inflammatory bowel disease. Psoriasis vulgaris, or plaque psoriasis, is a cutaneous form that often presents with pink plaques with silvery scale on the scalp, elbows, knees, or presacral region, but any area of the skin may be involved.(3,4) Plaque psoriasis is the most common form (affecting 90% of adults with psoriasis), but others include guttate, erythrodermic, pustular, inverse, nail, and psoriatic arthritis. PS is clinically diagnosed based on the presence of cutaneous and systemic symptoms, and treatment is similar for most forms but is guided by the body surface area (BSA) involved.(6)

The American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) categorize psoriasis severity as mild (less than 3% of body surface area [BSA]), moderate (3% to 10% of BSA), or severe (greater than 10% of BSA). The AAD/NPF guidelines also note that psoriasis can be considered severe irrespective of BSA when it occurs in select locations (e.g., hands, feet, scalp, face, or genital area) or when it causes intractable pruritus.(2)

Topical therapies are most commonly used to treat mild to moderate PS, but they may be used in combination with phototherapy, systemic, or biologic therapies for the treatment of moderate to severe PS.(2) Topical therapies alone can be sufficient for managing limited disease and also have fewer significant adverse effects compared to systemic treatment options.(3)

Topical corticosteroids (TCS) have high efficacy and good safety for the treatment of PS, especially localized disease.(2) TCS have shown to be the most effective topical treatment for psoriasis plaques.(7) Moderate to high potency TCS are generally recommended as initial therapy, but very high (super) potency TCS may be required for thick, chronic plaques. Lower potency TCS should be used to treat PS on the face or intertriginous areas, or areas that are susceptible to skin atrophy and adverse effects.(2) It is important to consider the anatomical site, BSA of application, patient age, and severity of the disease when choosing a steroid potency and vehicle.(2,5) Studies have shown that different potency TCS were effective and safe at 2 to 4 weeks in the treatment of mild to severe plaque psoriasis. To decrease the risk of corticosteroid adverse effects, TCS may be used short term (e.g., 2 to 4 weeks) to treat flares, while vitamin D analogues, topical retinoids, and calcineurin inhibitors can be used as maintenance treatment.(2)

Topical calcineurin inhibitors (TCIs), such as tacrolimus and pimecrolimus, are often used in the treatment of psoriasis.(2) The use of TCIs can lead to the avoidance of adverse effects secondary to long term TCS use, and can be beneficial for prolonged treatment of areas of thinner skin, the face, and intertriginous areas.(2,7)

Vitamin D analogues (e.g., calcipotriene and calcitriol) have been shown to be safe and effective for the treatment of mild to moderate PS.(2) Vitamin D analogues may be used as monotherapy, but combination therapy with a TCS has shown superior efficacy.(2,7) Calcipotriene ointment combined with topical tacrolimus is also more efficacious than tacrolimus alone.(2)

Tazarotene is a topical retinoid that is recommended for the treatment of mild to moderate PS. Tazarotene has been shown to be efficacious as monotherapy, but adding a TCS as combination therapy increases efficacy. The combination use with a medium to high potency TCS has been shown to increase the duration of treatment effect and the time of remission. Tazarotene can also be beneficial for the treatment of palmar-plantar psoriasis and nail psoriasis. Studies have shown topical tazarotene has similar efficacy to fluocinonide cream, crude coal tar 5% ointment, and calcipotriene 0.005% ointment.(2)

Other topical medications that can be used for the treatment of PS include salicylic acid and coal tar, and both are recommended for the treatment of mild to moderate psoriasis.(2) Salicylic acid is an effective treatment as monotherapy, or it can be combined with a TCS or TCI to increase efficacy and the penetration of the combined agent.(2,7) Coal tar may be combined with phototherapy to reduce the time of clearance and improve therapeutic outcomes compared to phototherapy alone. Topical anthralin is also an effective treatment for mild to moderate psoriasis.(2)

For the treatment of PS in the pediatric patient population, topical corticosteroids are the mainstay option based on extensive clinical experience that supports efficacy. Topical calcineurin inhibitors are also a treatment option and may be preferred for psoriasis of the face, genitalia, and body folds. Vitamin D analogues are recommended as a treatment option for childhood plaque psoriasis and are considered safe, effective, and generally well tolerated. Vitamin D analogues are frequently used in combination with TCS. Other topical therapies that may be used for the treatment of pediatric psoriasis include tazarotene, anthralin, and coal tar.(5)

Atopic Dermatitis (AD)

Atopic dermatitis (AD), also known as atopic eczema, is a chronic, pruritic inflammatory dermatosis affecting up to 25% of children and 1-5% of adults. AD follows a relapsing course and is associated with elevated serum immunoglobulin (IgE) levels and a personal or family history of type I allergies, allergic rhinitis, and/or asthma. Onset is most common between 3 and 6 months of age, with approximately 60% of patients developing the eruption in the first year of life and 90% by age 5. While the majority of affected individuals have resolution of disease by adulthood, 10 to 30% do not, and a smaller percentage first develop symptoms as adults. AD has a complex pathogenesis involving genetic, immunologic, and environmental factors, which lead to a dysfunctional skin barrier and dysregulation of the immune system. Clinical findings include erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and lichenification. These clinical findings vary by patient age and chronicity of lesions. Pruritus is a hallmark of the condition that is responsible for much of the disease burden borne by patients and their families. Typical patterns include facial, neck and extensor involvement in infants and children; flexure involvement in any age group, with sparing of groin and axillary regions.(8)

Goals of treatment are to reduce symptoms (pruritus and dermatitis), prevent exacerbations, and minimize therapeutics risks.(9) Despite its relapsing and remitting nature, the majority of patients with AD can achieve clinical improvement and disease control with topical emollient/moisturizer use and conventional topical therapies (including corticosteroids and calcineurin inhibitors).(9,10) Moisturizers reduce signs, symptoms, and inflammation in AD, and can improve severity while also increasing time between flares. Moisturizers are considered generally safe and are strongly recommended to be used as part of a treatment regimen for AD, either as monotherapy or as concurrent use with pharmacologic treatments.(11)

Topical therapies remain the mainstay of treatment due to their proven track record and generally favorable safety profile. They can be utilized individually or in combination with other topical, physical, and/or systemic treatments; as different classes of treatment have different mechanisms of action, combining therapies allows for the targeting of AD via multiple disease pathways. The American Academy of Dermatology (AAD) strongly recommends the following topical agents:(11)

• Topical corticosteroids (TCS)
• Calcineurin inhibitors (TCIs) (e.g., tacrolimus, pimecrolimus)
• Topical PDE-4 inhibitors (e.g., crisaborole) [mild to moderate AD]
• Topical JAK inhibitors (e.g., ruxolitinib) [mild to moderate AD]

TCS are the most commonly utilized FDA-approved therapies in AD and are commonly used as first-line treatment for mild-to severe dermatitis in all skin regions. TCS target a variety of immune cells and suppress the release of proinflammatory cytokines. High to very high (super) potency TCS can be used to control flares and treat severe disease, while medium potency TCS are utilized for longer courses and as maintenance therapy. Lower potency TCS may be used, and it is important to consider the anatomical site (i.e., using lower potency agents on the face, neck, genitals, and body folds) and severity of the disease when choosing a steroid potency. Most studies of TCS in AD management involve twice daily application, but some studies (particularly for potent TCS) suggest once daily use may be sufficient. Traditionally, TCS were stopped once AD signs and symptoms of an AD flare were controlled. Maintenance in between AD flares with once to twice weekly use of TCS is another approach.(11)

TCIs are a safe anti-inflammatory option for mild-to-severe AD, particularly when there is concern for adverse events secondary to corticosteroid use. Both tacrolimus and pimecrolimus have been shown to be effective in treating AD, but pimecrolimus may be more appropriate for patients who have milder disease or are sensitive to local reactions.(11) Prescribing information for pimecrolimus cream and tacrolimus ointment indicate evaluation after 6 weeks if symptoms of AD do not improve for adults and pediatrics.(12,13).

Efficacy

Atopic Dermatitis
Two multicenter, randomized, double-blind, vehicle-controlled trials were conducted to evaluate the safety and efficacy of VTAMA cream for the treatment of adult and pediatric subjects 2 years of age and older with atopic dermatitis (ADORING 1 [NCT05014568] and ADORING 2 [NCT05032859]). These trials were conducted in a total of 813 subjects (80% of subjects were 2 to 17 years of age) randomized 2:1 to VTAMA cream or vehicle cream applied once daily for 8 weeks to any lesion regardless of anatomic location.(1)

Baseline disease severity was graded using the 5-point validated Investigator’s Global Assessment (vIGA-AD™). The majority of subjects had “Moderate” disease (87%), while 13% had “Severe” disease at baseline. The extent of disease involvement assessed by mean affected BSA, excluding the scalp, was 16.8% (range 5 to 44%). The mean baseline Eczema Area and Severity Index (EASI) score was 12.9 (range 4.4 to 36.0). The mean baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score for subjects 12 years of age and older was 6.4 on a scale of 0-10. Subjects ranged in age from 2 to 81 years, with a median age of 11 years. Overall, 54% of the subjects were female, 51% were White, 31% were Black, and 12% were Asian. For ethnicity, 78% of subjects identified as non-Hispanic or Latino.(1)

The primary efficacy endpoint in both trials was the proportion of subjects who achieved treatment success, defined as a vIGA-AD score of “Clear” (0) or “Almost Clear” (1) and at least a 2-grade improvement from baseline. Efficacy results of the primary endpoint at Week 8 from the two trials are summarized in the table below.(1)

Of the 431 subjects randomized to VTAMA who completed 8 weeks of treatment in ADORING 1 and ADORING 2 and elected to continue follow-up, 51 subjects achieved complete disease clearance (vIGA-AD = 0) and had VTAMA withdrawn. These subjects were followed for up to 48 additional weeks with a median time to first worsening (vIGA-AD greater than or equal to 2 [“Mild”]) of 57 days (95% CI: 30, 79).(1)

Plaque Psoriasis
Two multicenter, randomized, double-blind, vehicle-controlled trials were conducted to evaluate the safety and efficacy of VTAMA cream for the treatment of adults with plaque psoriasis (PSOARING 1 [NCT03956355] and PSOARING 2 [NCT03983980]). These trials were conducted in a total of 1025 subjects randomized 2:1 to VTAMA cream or vehicle cream applied once daily for 12 weeks to any lesion regardless of anatomic location. Baseline disease severity was graded using the 5-point Physician’s Global Assessment (PGA). The majority of subjects had “Moderate” disease (82%), while 10% had “Mild” disease, and 8% had “Severe” disease at baseline. The extent of disease involvement assessed by mean body surface area (BSA), excluding the scalp, palms, and soles, was 8% (range 3 to 20%).(1)

The primary efficacy endpoint in both studies was the proportion of subjects who achieved treatment success, defined as a PGA score of “Clear” (0) or “Almost Clear” (1) and at least a 2-grade improvement from baseline. At week 12, patients treated with VTAMA achieved treatment success at a 29% greater rate than placebo in PSOARING 1 and at a 34% greater rate than placebo in PSOARING 2. Following 12 weeks of treatment, 73 subjects randomized to VTAMA achieved complete disease clearance (PGA 0) and had VTAMA withdrawn. These subjects were followed for up to 40 additional weeks with a median time to first worsening (PGA greater than or equal to 2 [“Mild”]) of 114 days (95% CI: 85, 142).(1)

Safety

VTAMA has no FDA labeled contraindications for use.(1)

1

VTAMA prescribing information. Dermavent Sciences Inc. December 2024.

2

Elmets CA, Korman NJ, Prater EF, et al. Joint AAD–NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. Journal of the American Academy of Dermatology. 2021;84(2):432-470. doi:10.1016/j.jaad.2020.07.087

3

Menter A, Gelfand JM, Connor C, et al. Joint American Academy of Dermatology–National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. Journal of the American Academy of Dermatology. 2020;82(6):1445-1486. doi:10.1016/j.jaad.2020.02.044

4

Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal of the American Academy of Dermatology. 2019;80(4):1029-1072. doi:10.1016/j.jaad.2018.11.057

5

Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology–National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. Journal of the American Academy of Dermatology. 2020;82(1):161-201. doi:10.1016/j.jaad.2019.08.049

6

Garner KK, Hoy KDS, Carpenter AM. Psoriasis: Recognition and Management Strategies. Am Fam Physician. 2023;108(6):562-573.

7

Shreiber AM, Friery E. Psoriasis: Update on topical therapy from the American Academy of Dermatology. Am Fam Physician. 2022;105(5):558-560.

8

Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of Care for the Management of Atopic Dermatitis: Section 1. Diagnosis and Assessment of Atopic Dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51.

9

Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33.

10

Davis DM, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. Journal of the American Academy of Dermatology. 2024;90(2):e43-e56. doi:10.1016/j.jaad.2023.08.102

11

Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20.

12

Pimecrolimus cream prescribing information. Oceanside Pharmaceuticals. September 2020.

13

Tacrolimus ointment prescribing information. Glenmark Pharmaceuticals Inc., USA. August 2023.

Vtama

tapinarof cream

1 %

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Vtama

tapinarof cream

1 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

PA

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following
   1. The patient has a diagnosis of plaque psoriasis AND ALL of the following:
      1. The patient's affected body surface area (BSA) is less than or equal to 20% AND
      2. ONE of the following:
         1. The patient has tried and had an inadequate response to a topical corticosteroid used in the treatment of plaque psoriasis after at least a 2-week duration of therapy OR
         2. The patient has an intolerance or hypersensitivity to therapy with a topical corticosteroid used in the treatment of plaque psoriasis OR
         3. The patient has an FDA labeled contraindication to ALL topical corticosteroids used in the treatment of plaque psoriasis AND
      3. ONE of the following:
         1. The patient has tried and had an inadequate response to another topical psoriasis agent with a different mechanism of action (e.g., vitamin D analogs, calcineurin inhibitors, tazarotene) OR
         2. The patient has an intolerance or hypersensitivity to another topical psoriasis agent with a different mechanism of action OR
         3. The patient has an FDA labeled contraindication to ALL other topical psoriasis agents with a different mechanism of action OR
   2. The patient has a diagnosis of atopic dermatitis (AD) AND ALL of the following:
      1. ONE of the following:
         1. The patient has tried and had an inadequate response to at least a low-potency topical corticosteroid used in the treatment of AD after at least a 4-week duration of therapy OR
         2. The patient has an intolerance or hypersensitivity to at least a low-potency topical corticosteroid used in the treatment of AD OR
         3. The patient has an FDA labeled contraindication to ALL topical corticosteroids used in the treatment of AD AND
      2. ONE of the following:
         1. The patient has tried and had an inadequate response to a topical calcineurin inhibitor used in the treatment of AD after at least a 6-week duration of therapy OR
         2. The patient has an intolerance or hypersensitivity to a topical calcineurin inhibitor used in the treatment of AD OR
         3. The patient has an FDA labeled contraindication to ALL topical calcineurin inhibitors used in the treatment of AD AND
      3. BOTH of the following:
         1. The patient is currently treated with topical emollients and practicing good skin care AND
         2. The patient will continue the use of topical emollients and good skin care practices in combination with the requested agent OR
   3. The patient has another FDA labeled indication for the requested agent and route of administration AND
2. If the patient has an FDA labeled indication, then ONE of the following:
   1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
   2. There is support for using the requested agent for the patient’s age for the requested indication AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
4. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 3 months for atopic dermatitis; 12 months for plaque psoriasis and all other indications

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
2. The patient has had clinical benefit with the requested agent AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
4. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months