TAPINAROF CREAM,TOP
Clinical Criteria Summary
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Diagnosis & Patient Selection
- Exclusion: Psoriasis other than the plaque variant
- Inclusion: Diagnosis of plaque psoriasis (any severity)
Provider Oversight
- Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated psoriasis expert.
Prior Therapy Requirements
- Tried and had intolerance or inadequate response (after ≥ 1 month) to topical roflumilast unless medically inadvisable.
- ONE of the following must be met:
- Tried and had intolerance or inadequate response to ≥ 2 other classes of topical antipsoriatics unless medically inadvisable (≥ 1 month / class; e.g., corticosteroids, vitamin D analogs, calcineurin inhibitors, etc.)
- Tried and had intolerance or inadequate response to 1 other class of topical antipsoriatic, and 1 systemic therapy (phototherapy, conventional immunomodulator, or targeted immunomodulator) unless medically inadvisable, not available, or not feasible.
Pregnancy & Reproductive Counseling
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception.
Additional Clinical Considerations & Definitions
- Roflumilast is preferred before tapinarof due to likely safety and potential cost advantages.
- Topical roflumilast is labeled for intertriginous (skin fold) areas affected by plaque psoriasis and may be preferred over tapinarof for intertriginous lesions or inverse plaque psoriasis.
- A prior trial of topical corticosteroids is not necessary and may be medically inadvisable for lesions in sensitive areas (e.g., face, intertriginous areas).
- Topical nonsteroidal treatments like tapinarof may be used alone or co-used with corticosteroids to reduce or prevent corticosteroid complications; therefore, prior trial of or inadequate response to corticosteroids is not always required.
- Examples of topical therapies (not all inclusive): Vitamin D analogs (Calcipotriene, calcipotriol), Calcineurin inhibitors (Tacrolimus, pimecrolimus), Retinoids (Tazarotene), Coal tar, Phosphodiesterase-4 Inhibitor (Roflumilast). Topical emollients and keratolytics do not count as topical antipsoriatics.
- Phototherapy is considered medically inadvisable if there is NO treatment benefit after 12 treatments or inadequate partial response after 24 treatments.
- Reasons phototherapy may be medically inadvisable include confirmed history of skin cancer, melanoma, or strong likelihood of developing them (e.g., Fitzpatrick skin type I or II = pale skin, easily sunburns).
- Conventional immunomodulator example: methotrexate.
- Systemic targeted immunomodulators examples: tumor necrosis factor inhibitors, interleukin-17A inhibitors (e.g., ixekizumab), interleukin-23 inhibitors (e.g., risankizumab-rzaa), interleukin-12/23 inhibitor (e.g., ustekinumab), and phosphodiesterase-4 inhibitors (e.g., apremilast).
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Indication & Patient Population
- • Topical treatment of plaque psoriasis in adults
- • Patients requiring topical nonsteroidal therapy (e.g., for treatment of lesions in sensitive areas or to limit corticosteroid use or complications)
Prior Therapy Requirements
- • Inadequate response or intolerance to topical roflumilast (unless medically inadvisable)
- • AND either:
- • ≥ 2 other classes of topical antipsoriatics (e.g., topical corticosteroids, vitamin D analogs, calcineurin inhibitors, retinoids/tazarotene, or coal tar)
- • OR 1 other class of topical antipsoriatics and 1 class of systemic antipsoriatics (e.g., phototherapy, conventional immunomodulator such as methotrexate, or biologic)
Dosing & Administration
- • Apply a thin layer of cream to affected areas once daily
- • Concentration: 1% cream
Safety & Clinical Considerations
- • Unknown safety and efficacy when used in combination with other antipsoriatic topical, systemic (including biologic), or ultraviolet light therapies
- • Limited long-term safety data and real-world experience with topical tapinarof
- • May be more preferable than tazarotene due to low risks of skin irritation and burning/stinging, and lack of desquamating effects
- • Less preferable than alternative antipsoriatic topical therapies in patients with a significant history of folliculitis
- • Not specifically labelled for application to facial or intertriginous areas (though studied)
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Diagnosis
- Diagnosis of atopic dermatitis
Prescribing and Monitoring Requirements
- Prescribed and monitored by a VA/VA Community Care dermatologist or locally designated expert
Prior Therapy Requirements (All must be met)
- A topical corticosteroid and a topical calcineurin inhibitor (e.g., tacrolimus ointment 0.1% or 0.03% or pimecrolimus cream 1%) are medically inadvisable, not tolerated, or not adequate after trials of ≥ 1 month per drug class
Additional Prior Therapy Requirements (One must be met)
- For mild to moderate atopic dermatitis: Topical crisaborole 2% ointment or roflumilast 0.15% cream is medically inadvisable, not tolerated, or not adequate after a trial of ≥ 1 month
- For moderate to severe atopic dermatitis: No prior topical agents required other than a corticosteroid and calcineurin inhibitor
Additional Patient-Specific Criteria
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy
Exclusion Criteria
- None