Effective Date

Date of Origin 

01-01-2025            

VTAMA®

(tapinarof)

Cream

Topical treatment of plaque psoriasis in adults

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)

Efficacy

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 does not have any FDA labeled contraindications for use.(1)

1

VTAMA prescribing information. Dermavent Sciences Inc. December 2023.

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.

Vtama

tapinarof cream

1 %

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Vtama

tapinarof cream

1 %

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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 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: 12 months

*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