Topical

Aczone^® (Dapsone Gel) Approval Criteria: 

• An FDA approved indication of acne vulgaris; AND
• For Aczone^® 7.5% gel, the member must be 9 years of age or older; AND
• Member must be 20 years of age or younger; AND
• A previous trial of benzoyl peroxide or a patient-specific, clinically significant reason why benzoyl peroxide is not appropriate for the member; AND
• A previous trial of a topical antibiotic, such as clindamycin or erythromycin, or a patient-specific, clinically significant reason why a topical antibiotic is not appropriate for the member. 

Prior Authorization form

Amzeeq™ (Minocycline 4% Topical Foam) Approval Criteria:   

• An FDA approved indication of inflammatory lesions of non-nodular, moderate-to-severe acne vulgaris; AND
• Member must be 9 years of age or older; AND
• Amzeeq™ is not covered for members older than 20 years of age; AND
• A patient-specific, clinically significant reason why the member cannot use erythromycin 2% topical solution, or clindamycin 1% topical solution,  benzoyl peroxide, preferred tazarotene formulations, oral isotretinoin medications, and other generically available preferred oral or topical antibiotic products must be provided; and
• A quantity limit of 30 grams per 30 days will apply.   

Prior Authorization form

Tier 1 products are covered with no authorization necessary

• OTC products require a prescription.
• OTC products are covered for members age 0-20 years. For members age 21 and older, please use other Tier 1 products.

Criteria for Tier 2 Product:

• Documented, recent trials of at least two Tier-1 topical antifungal products for at least 90 days each; AND
• When the same medication is available in Tier-1, a patient-specific, clinically significant reason must be provided for using a special dosage form of that medication in Tier-2 (foams, shampoos, sprays, kits, etc.). 
• Authorization of combination products nystatin/triamcinolone cream, nystatin/triamcinolone ointment, or clotrimazole/betamethasone lotion requires a patient-specific, clinically significant reason why the member cannot use the individual components separately, or in the case of clotrimazole/betamethasone lotion why Tier-1 cream cannot be used.
• For treatment of onychomycosis, a trial of oral antifungals (6 weeks for fingernails and 12 weeks for toenails) will be required for consideration of approval of Penlac® (ciclopirox solution).

efinaconazole (Jublia®) and tavaborole (Kerydin™) Approval Criteria:

• An FDA approved diagnosis of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes; AND
• A trial of oral antifungals (12 weeks for toenails); AND
• A patient-specific, clinically significant reason why member cannot use Penlac® (ciclopirox solution); AND
• A clinically significant reason the member requires treatment for onychomycosis (cosmetic reasons will not be approved).

*Over-the-counter(OTC) antifungal products are covered for pediatric members 0-20 years of age without prior authorization.

**no products available for coverage by SoonerCare currently

Brimonidine 0.33% Topical Gel (Generic Mirvaso^®) Approval Criteria:

• An FDA approved diagnosis of persistent (non-transient) facial erythema of rosacea; AND
• Member must be 18 to 20 years of age; AND
• A patient-specific, clinically significant reason why the member cannot utilize clindamycin topical solution (generic), metronidazole 0.75% topical gel and cream, erythromycin 2% topical solution, oral isotretinoin medications, or other generically available preferred oral or topical antibiotic products must be provided; AND
• Must be prescribed by, or in consultation with, a dermatologist (or an advanced care practitioner with a supervising physician who is a dermatologist); AND
• Brand name Mirvaso^® is not a covered product; AND
• A quantity limit of 30 grams per 30 days will apply.

PA Criteria:

• An FDA approved diagnosis of multiple actinic or solar keratoses of the face and anterior scalp in adults; AND
• Carac® must be prescribed by a dermatologist or an advanced care practitioner with a supervising physician who is a dermatologist; AND
• A patient-specific, clinically significant reason why the member cannot use fluorouracil 5% cream, fluorouracil 5% solution, or fluorouracil 2% solution.

Prior Authorization form

Clindagel® (Clindamycin 1% Topical Gel) and Evoclin® (Clindamycin 1% Topical Foam) Approval Criteria:

• Member must have failed a trial of a different formulation of topical clindamycin such as lotion, solution, swabs, or the preferred generic clindamycin gel (generic for Cleocin T®; this generic medication is not interchangeable with Clindagel®); and
• Member must be 20 years of age or younger.

crotamiton 10% Lotion/Cream (Eurax®** and Crotan™) Approval Criteria:

• Diagnosis of scabies or pruritic skin; AND
• Member must be at least 18 years of age; AND
• For diagnosis of scabies, member must have used Permethrin 5% in the past 7-14 days with inadequate results; AND
• For a diagnosis of pruritic skin, a patient-specific, clinically significant reason why the member cannot use other available topical treatments used for pruritic skin must be provided; AND
• For authorization of Crotan™, a patient-specific, clinically significant reason why the member cannot use Eurax®** must be provided; AND
• A quantity limit of 1 tube or bottle per 30 days will apply. 

**no products available for coverage by SoonerCare currently 

Prior Authorization form

PA criteria:

• Clinical Diagnosis: short term and intermittent treatment for mild to moderate atopic dermatitis (eczema).
• The first 90 days of a 12 month period will be covered without a prior authorization.
• After the initial period, authorization will be granted with documentation of one trial of a tier 1 topical corticosteroid of six weeks duration within the past 90 days.
• Therapy will be approved only once each 90 day period to ensure appropriate short-term and intermittent utilization as advised by the FDA.
• Quantities will be limited to 30 grams for use on the face, neck, and groin, and 100 grams for all other areas.
• Authorizations will be restricted to those patients who are not immunocompromised.
• Exception for age restrictions granted only if prescription is written by a dermatologist.
• Age restrictions:
  • Elidel 1% ≥2 years of age
  • Protopic 0.03% for ≥2 years of age
  • Protopic 0.1% for ≥15 years of age (Approved for adult-use only)
   
• Prior Authorization form

Erythromycin 2% Swabs and 2% Topical Gel Approval Criteria:

• A patient specific, clinically significant reason why the member cannot use erythromycin 2% topical solution must be provided; and
• Member must be 20 years of age or younger.

Eucrisa® (Crisaborole Ointment) Approval Criteria:  

• An FDA approved indication for treatment of mild-to-moderate atopic dermatitis (eczema); AND
• Member must be at least 3 months of age or older; AND
• Member must have a documented trial within the last six months for a minimum of two weeks that resulted in failure with a topical corticosteroid or topical calcineurin inhibitor (or have a contraindication or documented intolerance); AND
• A quantity limit of one tube per 30 days will apply.
• Initial approvals will be for the duration of one month. Reauthorization may be granted if the prescriber documents the member is responding well to treatment.

Clinical Exceptions for Children Not Meeting Age Restriction:  

• Documented adverse effect, drug interaction, or contraindication to topical corticosteroids; OR  
• Atopic dermatitis of face or groin where prescriber does not want to use topical corticosteroids; OR  
• Prescribed by a dermatologist.  

Prior Authorization form   

Hyftor™ (Sirolimus Topical Gel) Approval Criteria [Facial Angiofibromas Associated with Tuberous Sclerosis Complex (TSC) Diagnosis]:

• Documented diagnosis of TSC; AND
• Member has facial angiofibromas that are at least 2mm in diameter with redness in each; AND
• Member must be 6 to 20 years of age; OR
  • For members older than 20 years of age, a clinical exception may apply for medical issues caused by facial angiofibromas (specific documentation of clinically significant medical issues must be provided; Hyftor™ is not covered for cosmetic use); AND
• Initial approvals will be for a duration of 12 weeks, as the need for continuing Hyftor™ should be reevaluated if symptoms do not improve within 12 weeks of treatment. Reauthorization may be granted if the prescriber documents the member is responding well to treatment and documents the anticipated duration of treatment.

Hyftor™ PA Form

Noritate^® (Metronidazole 1% Cream) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use metronidazole 0.75% cream, which is available without prior authorization, must be provided; AND
• Noritate^® is not covered for members older than 20 years of age.

Noritate^® (Metronidazole 1% Cream) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use metronidazole 0.75% cream, which is available without prior authorization, must be provided; AND
• Noritate^® is not covered for members older than 20 years of age.

Opzelura™ (Ruxolitinib 1.5% Cream) Approval Criteria:

• An FDA approved indication for short-term and non-continuous treatment of mild-to-moderate atopic dermatitis; and
• Member must be 12 years of age or older; and
• Member must not be immunocompromised; and
• Member must have a body surface area (BSA) involvement ≤20%; and
• Member must have documented trials within the last 6 months for a minimum of 2 weeks that resulted in failure with all of the following therapies (or have a contraindication or documented intolerance):
  • One medium potency to very-high potency Tier-1 topical corticosteroid (TCS); and
  • One topical calcineurin inhibitor (TCI) [e.g., Elidel^® (pimecrolimus), Protopic^® (tacrolimus)]; and
  • Eucrisa^® (crisaborole); and
• Concurrent use with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants (e.g., azathioprine, cyclosporine) will not generally be approved; and
• Prescriber must verify female members are not breastfeeding; and
• If the member is pregnant or becomes pregnant, prescriber must verify member has been counseled on potential risks of this medication and will report the exposure to the Opzelura™ pregnancy registry; and
• Approvals will be for a maximum duration of 8 weeks of treatment; and
• Reauthorization may be considered if member has a recent TCS, TCI, or Eucrisa^® trial (or a contraindication or documented intolerance); and
  • Additionally, the prescriber must document the member had a positive response to and tolerated previous treatment with Opzelura™; and
• Subsequent approvals will only be considered once each 90-day period to ensure appropriate short-term and non-continuous utilization.

Opzelura™ (Ruxolitinib 1.5% Cream) Approval Criteria [Nonsegmental Vitiligo Diagnosis]:

• An FDA approved indication of nonsegmental vitiligo; AND
• The member’s body surface area (BSA) involvement must be provided and must be ≤10%; AND
• Member must be 12 to 20 years of age; AND
• Member must have documented trials within the last 6 months for a minimum of 12 weeks that resulted in failure with all of the following therapies (or have a contraindication or documented intolerance):
  • 1 medium potency to very-high potency Tier-1 topical corticosteroid (used continuously or intermittently); AND
  • 1 topical calcineurin inhibitor [e.g., Elidel^® (pimecrolimus), Protopic^® (tacrolimus)]; AND
• Concurrent use with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants (e.g., azathioprine, cyclosporine) will not generally be approved; AND
• Prescriber must verify female members are not breastfeeding; AND
• If the member is pregnant or becomes pregnant, prescriber must verify member has been counseled on potential risks of this medication and will report the exposure to the Opzelura™ pregnancy registry; AND
• Initial approvals will be for a duration of 24 weeks of treatment; AND
• Reauthorization for an additional 28 weeks of treatment (to complete 1 year of treatment) may be considered if the prescriber documents both of the following:
  • The member had a positive response to and tolerated previous treatment with Opzelura™; AND
  • The member has been evaluated by the prescriber and continues to require treatment with Opzelura™; AND
• Further approval beyond 1 year of treatment will require patient-specific, clinically significant information to support the member’s need for additional treatment. 

Tier 1 products are available without prior authorization.

Tier 2 Authorization Criteria:

• An FDA approved diagnosis; AND
• A trial with one Tier-1 medication with inadequate response or adverse effect; AND
• Requested medication must be age-appropriate.
• A clinical exception to Tier-1 medications applies if there is known resistance to OTC permethrin and pyrethrin.

Tier 3 Authorization Criteria:

• An FDA approved diagnosis; AND
• A trial with one Tier-1 medication with inadequate response or adverse effect; AND
• Trials with all available Tier-2 medication(s) with inadequate response or adverse effect; AND
• Requested medication must be age-appropriate.
• A clinical exception to Tier-1 medications applies if there is known resistance to OTC permethrin and pyrethrin

Prior Authorization form

*Over-the-counter (OTC) treatments for lice are a covered benefit for children. A prescription is required for coverage, and fills are limited to 1 individual package size for a 7 day supply. OTC lice treatments are not covered for adults.

Picato®** (Ingenol Mebutate Gel) Approval Criteria:

• An FDA approved diagnosis of actinic keratosis (AK); and
• Member must be 18 years of age or older; and
• Patient-specific information must be documented on the prior authorization form, including all of the following:
  • Number of AK lesions being treated; and
  • Size of each lesion being treated; and
  • Location of lesions being treated; and
• Approval quantity and length will be based on patient-specific information provided, in accordance with Picato® prescribing information and FDA approved dosing regimen.

**no products available for coverage by SoonerCare currently 

PA criteria:

• An FDA approved diagnosis for the short-term (up to eight days) management of moderate pruritus in patients with atopic dermatitis or lichen simplex chronicus; AND
• Requests for longer use than eight days will not generally be approved. Chronic use beyond eight days may result in higher systemic levels and should be avoided. 

Prior Authorization form  

PA Criteria:

• An FDA approved diagnosis of primary axillary hyperhidrosis in pediatric patients 9 years of age to 20 years of age; AND
• Documentation of assessment by a licensed behavior specialist or the prescribing physician indicating the member’s hyperhidrosis is causing social anxiety, depression, or similar mental health-related issues that impact the member’s ability to function in day-to-day living must be provided; AND
• Member must have failed a trial of Drysol™ (20% aluminum chloride) at least three weeks in duration; AND
• Prescriber must verify that the member has received counseling on the safe and proper use of Qbrexza™; AND
• A quantity limit of one box (30 cloths) per 30 days will apply.  

Prior Authorization form

Qutenza^® (Capsaicin 8% Patch) Approval Criteria: 

Available through Medical claims only.

• An FDA approved diagnosis of postherpetic neuralgia or diabetic peripheral neuropathy of the feet; and
• Documented treatment attempts at recommended dosing or contraindication(s) to at least 1 agent from each of the following drug classes: 
  • For postherpetic neuralgia:
    • Tricyclic antidepressants; and
    • Anticonvulsants; and
    • Topical lidocaine; or
  • For diabetic peripheral neuropathy of the feet:
    • Duloxetine or tricyclic antidepressants; and
    • Anticonvulsants; and
    • Topical lidocaine; and
• Qutenza^® must be administered by a health care provider; and
• For a diagnosis of diabetic peripheral neuropathy of the feet, the prescriber must verify that they will examine the feet to detect skin lesions related to underlying neuropathy or vascular insufficiency prior to application of Qutenza^®; and
• Initial approvals will be for 1 treatment (for the duration of 90 days). For continuation, the prescriber must include information regarding improved response/effectiveness of this medication; and
• A quantity limit of no more than 4 patches per treatment every 90 days will apply.

Outpatient/Physician Prior Authorization Form  

PA Criteria:

• An FDA approved diagnosis of actinic keratosis (AK); AND
• Patient-specific information must be documented on the prior authorization form, including all of the following:
  • Number of AK lesions being treated; AND
  • Sizes of each lesion being treated; AND
  • Anticipated duration of treatment; AND
• Approval quantity and length will be based on patient-specific information provided, in accordance with Solaraze® prescribing information and FDA approved dosing regimen. 

Prior Authorization form

Tazorac^® (Tazarotene Cream and Gel) Approval Criteria:

• An FDA approved indication of acne vulgaris or plaque psoriasis; AND
• Female members must not be pregnant and must be willing to use an effective method of contraception during treatment; AND
• For a diagnosis of acne vulgaris, the following must be met:
  • Member must be 20 years of age or younger; AND
  • Tazarotene 0.1% cream will not require prior authorization for members 20 years of age or younger; AND
• Tazarotene 0.05% gel and tazarotene 0.1% gel will require a patient specific, clinically significant reason why the member cannot use tazarotene 0.1% cream, which is available without prior authorization for members 20 years of age and younger; AND
• A quantity limit of 100 grams per 30 days will apply.

Prior Authorization form

Tier 1 products are available without prior authorization.

Tier 2 authorization requires:

• Documented five-day trial of a Tier 1 product within the last 30 days.
• Clinical exception for adverse effects with all Tier 1 products, or unique indication not covered by Tier-1 products.
• Prior authorization will be for 10 days.

 **no products available for coverage by SoonerCare currently

Nuvessa™ Approval Criteria:

• An FDA approved diagnosis of bacterial vaginosis in non-pregnant women; AND
• A patient-specific, clinically significant reason why the member cannot use MetroGel-Vaginal® 0.75% (metronidazole vaginal gel 0.75%) or the generic metronidazole oral tablet.

Xaciato™ (Clindamycin Vaginal Gel) Approval Criteria:

• An FDA approved diagnosis of bacterial vaginosis; and
• A patient specific, clinically significant reason why the member cannot use clindamycin 2% vaginal cream, Clindesse^® (clindamycin phosphate 2% vaginal cream), and Cleocin^® vaginal ovules (clindamycin phosphate 2.5g vaginal suppositories), which are available without a prior authorization, must be provided. 

Tier-1 products are covered with no prior authorization necessary.

Tier-2 Topical Corticosteroid Approval Criteria:

• Documented trials of all Tier-1 topical corticosteroids of similar potency in the past 30 days that did not yield adequate relief; AND
• If Tier-1 trials are completed and do not yield adequate relief, the member must also provide a patient-specific, clinically significant reason for requesting a Tier-2 in the same potency instead of trying a higher potency; AND
• When the same medication is available in Tier-1, a patient-specific, clinically significant reason must be provided for using a special dosage formulation of that medication in Tier-2 (foams, shampoos, sprays, kits, etc.); AND
• Topical corticosteroid kits require tier trials and a patient-specific, clinically significant reason for use of the kit over other standard formulations.

Tier-3 Topical Corticosteroid Approval Criteria:

• Documented trials of all Tier-1 and Tier-2 topical corticosteroids of similar potency in the past 90 days that did not yield adequate relief; AND
• If Tier-1 and Tier-2 trials are completed and do not yield adequate relief, the member must also provide a patient-specific, clinically significant reason for requesting a Tier-3 in the same potency instead of trying a higher potency; AND
• When the same medication is available in Tier-1 or Tier-2, a patient-specific, clinically significant reason must be provided for using a special dosage form of that medication in Tier-3 (foams, shampoos, sprays, kits, etc.); AND
• Topical corticosteroid kits require tier trials and a patient-specific, clinically significant reason for use of the kit over other standard formulations.

hydrocortisone acetate 2.5% cream (MiCort™ HC) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use Proctosol-HC® (hydrocortisone 2.5% cream).  

halobetasol propionate/tazarotene 0.01%/0.045% lotion (Duobrii™) Approval Criteria:  

• An FDA approved indication of plaque psoriasis in adults; AND  
• Female members must not be pregnant and must be willing to use an effective method of contraception during treatment; AND
• A patient-specific, clinically significant reason why the member cannot use individual components of tazarotene and a topical corticosteroid separately must be provided; AND
• A quantity limit of 100 grams per 30 days will apply. 

Prior Authorization form

C = cream; F = foam; G = gel; L = lotion; O = ointment; Sh = shampoo; So = solution; Spr = spray;

Sus = suspension 

Vtama^® (Tapinarof 1% Cream) Approval Criteria:

• An FDA approved diagnosis of plaque psoriasis; AND
• Member must be 18 years of age or older; AND
• Member must have a body surface area (BSA) involvement of ≤20%; AND
• Must be prescribed by, or in consultation with, a dermatologist (or an advanced care practitioner with a supervising physician who is a dermatologist); AND
• Member must have documented trials within the last 6 months for a minimum of 2 weeks that resulted in failure with at least 2 of the following therapies (or have a contraindication or documented intolerance):
  • An ultra-high to high potency topical corticosteroid (TCS); OR
  • A generic topical calcipotriene product; OR
  • A topical tazarotene product; AND
• Initial approvals will be for the duration of 1 month. Reauthorization may be granted if the prescriber documents the member is responding well to treatment; AND
• A quantity limit of 60 grams per 30 days will apply.

Winlevi^® (Clascoterone 1% Cream) Approval Criteria:

• An FDA approved indication of acne vulgaris; and
• Member must be 12 to 20 years of age; and
• A patient-specific, clinically significant reason why the member cannot use erythromycin 2% topical solution, clindamycin 1% topical solution, benzoyl peroxide, preferred tazarotene formulations, oral isotretinoin medications, and other generically available preferred oral or topical antibiotic products must be provided; and
• A quantity limit of 60 grams per 30 days will apply. 

Zilxi^® (Minocycline 1.5% Topical Foam) Approval Criteria:

• 1.     An FDA approved diagnosis of inflammatory lesions of rosacea in adults; and
• 2.     Member must be 18 to 20 years of age; and
• 3.     A patient-specific, clinically significant reason why the member cannot utilize clindamycin topical solution (generic), metronidazole topical gel and cream 0.75%, erythromycin topical 2% solution, oral isotretinoin medications, and other generically available preferred oral or topical antibiotic products must be provided; and
• 4.     A quantity limit of 30 grams per 30 days will apply.

Zoryve™ (Roflumilast 0.3% Cream) Approval Criteria:

• An FDA approved diagnosis of plaque psoriasis; AND
• Member must be 12 years of age or older; AND
• Member must have a body surface area (BSA) involvement of ≤20%; AND
• Member must not have moderate-to-severe hepatic impairment (Child-Pugh B or C); AND
• Must be prescribed by, or in consultation with, a dermatologist (or an advanced care practitioner with a supervising physician who is a dermatologist); AND
• Member must have documented trials within the last 6 months for a minimum of 2 weeks that resulted in failure with at least 2 of the following therapies (or have a contraindication or documented intolerance):
  • An ultra-high to high potency topical corticosteroid (TCS); OR
  • A generic topical calcipotriene product; OR
  • A topical tazarotene product; AND
• Initial approvals will be for the duration of 1 month. Reauthorization may be granted if the prescriber documents the member is responding well to treatment; AND
• A quantity limit of 60 grams per 30 days will apply.

ZTlido™ (Lidocaine 1.8% Topical System) Approval Criteria:  

• An FDA approved diagnosis of pain due to postherpetic neuralgia (PHN); AND
• Documented treatment attempts, at recommended dosing, of at least one agent from two of the following drug classes that failed to provide adequate relief or contraindication(s) to all of the following classes:
  
  • Tricyclic antidepressants; OR
  • Anticonvulsants; OR
  • Topical or oral analgesics; AND 
• A patient-specific, clinically significant reason why the member cannot use lidocaine 5% topical patch(es), which are available without prior authorization, must be provided; AND
• A quantity limit of 3 patches per day with a maximum of 90 patches per month will apply.  

Prior Authorization form  

PA Criteria:

• An FDA approved diagnosis of actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults or topical treatment of external genital and perianal warts/condyloma acuminata (EGW) in patients 12 years and older; AND
• Member must be 12 years or older; AND
• Requests for a diagnosis of molluscum contagiosum in children 2 to 12 years of age will generally not be approved; AND
• A patient-specific, clinically significant reason why the member cannot use generic imiquimod 5% cream in place of Zyclara® (imiquimod) 2.5% and 3.75%. 

Prior Authorization form