ROFLUMILAST CREAM,TOP
Clinical Criteria Summary
Document 462
Exclusion Criteria
- Psoriasis other than the plaque variant
- Moderate to severe liver impairment (Child-Pugh B or C)
Required Inclusion Criteria (All must be met)
- Diagnosis of plaque psoriasis (any severity)
- Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated psoriasis expert
Additional Inclusion Criteria (One of the following must be met)
- Tried and had intolerance or inadequate response to ≥ 2 classes of topical antipsoriatics unless medically inadvisable (≥ 1 month per class; e.g., corticosteroids, vitamin D analogs, calcineurin inhibitors, etc.; roflumilast required before tapinarof)
- Tried and had intolerance or inadequate response to 1 class of topical antipsoriatics and 1 systemic therapy (phototherapy, conventional immunomodulator, or targeted immunomodulator) unless medically inadvisable, not available, or not feasible
Pregnancy & Lactation Considerations
- Pregnant patients or those planning pregnancy: Counseling provided on potential risks vs benefits; patient informed that it is not known whether use will harm the unborn baby. Avoid use during labor and delivery.
- Breastfeeding patients or those planning to breastfeed: Counseling provided on minimizing drug exposure via breast milk per prescribing information. Advise against applying directly to nipple/areola; if applied to chest, avoid direct contact with infant's skin.
Clinical Definitions & Clarifications
- Prior trial of topical corticosteroids is not necessary and may be medically inadvisable for lesions in sensitive areas (face, intertriginous/skin-to-skin areas).
- Topical emollients and keratolytics do not count as topical antipsoriatics.
- Examples of topical antipsoriatic classes: Vitamin D analogs (calcipotriene, calcipotriol), Calcineurin inhibitors (tacrolimus, pimecrolimus), Retinoids (tazarotene), Coal tar, Aryl hydrocarbon receptor agonist (tapinarof).
- Phototherapy medically inadvisable reasons include confirmed history of skin cancer/melanoma or strong likelihood of developing them (e.g., Fitzpatrick skin type I or II).
- Phototherapy response criteria: NO treatment benefit after 12 treatments or inadequate partial response after 24 treatments.
- Systemic targeted immunomodulators include 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).
- Conventional immunomodulator example: methotrexate.
Document 463
Indication & Patient Population
- • Topical treatment of plaque psoriasis, including intertriginous areas
- • Patients 12 years of age and older
Dosage & Administration
- • Applied once daily to affected areas
- • Cream 0.3% (3 mg/g) in 60-g tubes
Prior Therapy Requirements (Place in Therapy)
- • May be used for patients with plaque psoriasis who have an inadequate response or intolerance to:
- – ≥ 2 classes of topical antipsoriatics (e.g., topical corticosteroids, vitamin D analogs, calcineurin inhibitors, retinoids [tazarotene], or coal tar), unless the therapy is medically inadvisable; OR
- – 1 class of topical antipsoriatic and 1 class of systemic antipsoriatic (e.g., phototherapy, methotrexate, or biologic), unless medically inadvisable, not available, or not feasible
Safety Considerations & Contraindications
- • Contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C)
- • Requires assessment of risk-benefits for potential drug interactions with CYP3A4 and CYP1A2 inhibitors, gestodene, and ethinyl estradiol
Clinical Limitations & Considerations
- • Safety and efficacy of application to the scalp, palms, and soles are unknown (though treatment could be applied to affected palms and soles, these areas were not evaluated for efficacy)
- • Unknown safety and efficacy of concomitant use with other topical, systemic, or ultraviolet light therapies
- • Unknown topical corticosteroid sparing effects
- • Limited long-term safety data and real-world experience
Document 637
Exclusion Criteria
- Moderate to severe liver impairment (Child-Pugh B or C)
Inclusion Criteria
- Moderate to severe seborrheic dermatitis
- Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated expert
- Tried and had intolerance or inadequate response to a combination of topical antifungal (including shampoo) plus topical corticosteroid for ≥ 4 consecutive weeks unless medically inadvisable
- Tried and had intolerance or inadequate response to a combination of topical antifungal (including shampoo) plus topical calcineurin inhibitor (e.g., tacrolimus ointment or pimecrolimus cream) for ≥ 4 consecutive weeks unless medically inadvisable
Additional Inclusion Criteria (Special Populations)
- Pregnancy/Planning pregnancy: Counseling provided on potential risks vs benefits of treatment; patient informed that it is not known whether use will harm the unborn baby. Avoid use during labor and delivery.
- Breastfeeding/Planning breastfeeding: Counseling provided on how to minimize potential drug exposure to the breastfed infant via breast milk per prescribing information. Advise patients not to apply directly to the nipple or areola, and if applied to the chest, to avoid direct contact with the infant’s skin.
Document 652
Indication & Patient Population
- Treatment of seborrheic dermatitis (SD) in adults
- Moderate to severe SD (predominantly moderate disease severity)
- Patients with an inadequate response, intolerance, or medical inadvisability to combination topical antifungal plus TCS and combination topical antifungal plus topical calcineurin inhibitor
Place in Therapy & Step Requirements
- 2nd-line alternative for SD of the face in patients requiring frequent use of TCSs
- May be added to topical antifungal therapy
- Alternative to a TCI for maintenance therapy
- First nonsteroidal, non-antifungal product approved for the treatment of SD
Dosage & Administration Parameters
- Applied once daily to affected areas on skin and/or scalp when not wet
- Topical foam 0.3% in 60-gram pressurized cans
- Maximum body surface area (BSA) of 20%
Safety & Contraindications
- Contraindicated in moderate to severe liver impairment (Child-Pugh B or C)
- Flammable formulation requiring appropriate handling precautions
- PDE4-related adverse events (psychiatric and gastrointestinal) occurred at significantly lower rates than vehicle
- Local adverse events occurred at similar rates to vehicle
Document 702
Exclusion Criteria
- Moderate to severe liver impairment (Child-Pugh B or C) – relative contraindication
Core Inclusion Criteria
- Diagnosis of mild to moderate atopic dermatitis
- Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated expert
- Tried a topical corticosteroid and a topical calcineurin inhibitor (e.g., tacrolimus ointment 0.1% or 0.03% or pimecrolimus cream 1%) for ≥ 1 month per drug class, unless medically inadvisable, and had intolerance or an inadequate response
Additional Inclusion Criteria (Pregnancy & Lactation)
- Pregnancy or planning to become pregnant: Counseling provided on potential risks vs benefits of treatment; patient informed that it is not known whether use will harm the unborn baby
- Lactating, providing breastmilk to an infant, or planning to do so: Counseling provided on how to minimize potential drug exposure to the breastfed infant via breast milk, as recommended in prescribing information
Administration & Counseling Requirements
- Avoid use during labor and delivery
- Advise breastfeeding women not to apply roflumilast directly to the nipple or areola; if applied to the patient’s chest, avoid exposure via direct contact with the infant’s skin