Dermatologic

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

Adbry™ (Tralokinumab-ldrm Injection) Approval Criteria:

• An FDA approved diagnosis of moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies are not advisable; AND
• Member must be 12 years of age or older for use of the prefilled syringe; or
• 18 years of age or older for use of the autoinjector; and
• Member must have a documented trial within the last 6 months for a minimum of 2 weeks that resulted in failure with both of the following topical therapies (or have a contraindication or documented intolerance):
  • 1 medium potency to very-high potency Tier-1 topical corticosteroid; AND
  • 1 topical calcineurin inhibitor [e.g., Elidel® (pimecrolimus), Protopic® (tacrolimus)]; AND
• Member’s body surface area (BSA) of atopic dermatitis involvement must be provided and the member must have a documented BSA involvement of ≥10% (can apply to member’s current BSA or a historical value prior to treatment); and
• Adbry™ must be prescribed by a dermatologist, allergist, or immunologist or the member must have been evaluated by a dermatologist, allergist, or immunologist within the last 12 months (or an advanced care practitioner with a supervising physician who is a dermatologist, allergist, or immunologist); AND
• Requests for concurrent use of Adbry™ with other biologic medications will be reviewed on a case-by-case basis and will require patient-specific information to support the concurrent use (Adbry™ has not been studied in combination with other biologic therapies); AND
• Initial approvals will be for the duration of 16 weeks. Reauthorization may be granted for the duration of 1 year if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval.

Adbry PA 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.

Topical Antifungal Products Tier-2 Approval Criteria:

• 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 (e.g., foams, shampoos, sprays, kits); and 
• Authorization of combination products nystatin/triamcinolone, 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; and 
• 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).

Jublia® (Efinaconazole) and Kerydin® (Tavaborole) Approval Criteria:

• An FDA approved diagnosis of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes; and
• Member must have a documented 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% gel or 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

Ebglyss™ (Lebrikizumab-lbkz) Approval Criteria:

• An FDA approved diagnosis of moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies are not advisable; and
• Member must be 12 years of age or older and weigh ≥40kg; and
• Member must have documented trials within the last 6 months for a minimum of 2 weeks that resulted in failure with both of the following topical therapies (or have a contraindication or documented intolerance):
  • 1 medium potency to very-high potency Tier-1 topical corticosteroid; and
  • 1 topical calcineurin inhibitor [e.g., Elidel^® (pimecrolimus), Protopic^® (tacrolimus)]; and
• Member’s body surface area (BSA) of atopic dermatitis involvement must be provided and the member must have a documented BSA involvement of ≥10% (can apply to member’s current BSA or a historical value prior to treatment); and
• Must be prescribed by a dermatologist, allergist, or immunologist or the member must have been evaluated by a dermatologist, allergist, or immunologist within the last 12 months (or an advanced care practitioner with a supervising physician who is a dermatologist, allergist, or immunologist); and
• Requests for concurrent use of Ebglyss™ with other biologic medications will be reviewed on a case-by-case basis and will require patient-specific information to support the concurrent use (Ebglyss™ has not been studied in combination with other biologic therapies); and
• Initial approvals will be for a quantity limit override for the initial dosing for the duration of 16 weeks; and
• Reauthorization may be granted for the maintenance dosing of 250mg every 4 weeks for a duration of 1 year if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval. 

Ebglyss™ PA Form

Elidel^® (Pimecrolimus Cream) and Protopic^® (Tacrolimus Ointment) Approval Criteria:

• The first 90 days of a 12-month period will be covered without prior authorization; and
• After the initial period, authorization may be granted with documentation of 1 trial with a Tier-1 topical corticosteroid at least 6 weeks in duration within the past 90 days; and
• Therapy will be approved only once each 90-day period to ensure appropriate short-term and intermittent utilization as advised by the FDA; and
• Quantities will be limited to 30 grams for use on the face, neck, and groin, and 100 grams for all other areas; and
• Authorizations will be restricted to those members who are not immunocompromised; and
• Clinical exceptions for the trial requirement may be considered for the following:
  • Documented adverse effect, drug interaction, or contraindication to Tier-1 topical corticosteroids; or
  • Atopic dermatitis of the face or groin where prescriber does not want to use topical corticosteroids. 

Prior Authorization form

Erythromycin 2% Swabs Approval Criteria:

• A patient specific, clinically significant reason why the member cannot use erythromycin 2% topical gel or 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 6 months for a minimum of 2 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 1 tube per 30 days will apply; 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.
• Clinical exceptions for the trial requirement may be considered for the following:
  • 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
• Clinical exceptions for the age restriction (for members younger than the FDA approved age) may be considered for the following:
  • Prescribed by a dermatologist. 
    

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

Metronidazole 1% Gel Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use metronidazole 0.75% gel, which is available without prior authorization, must be provided; AND
• Metronidazole 1% gel 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.

Ycanth™ (Cantharidin 0.7% Solution) Approval Criteria:

• An FDA approved indication for the treatment of molluscum contagiosum lesions; and
• Member must be 2 years of age or older; and
• Member must meet 1 of the following:
  • Is immunocompromised; or
  • Is experiencing itching or pain; or
  • Has concomitant bacterial infection; or
  • Has concomitant atopic dermatitis; or
  • There is concern for contagion (e.g., siblings, daycare) and the spread of lesions cannot be reasonably prevented using good hygiene or covered using a bandage; and
• Prescriber must attest that it has been at least 6 months since the onset of the current infection unless the member is experiencing severe symptoms; and
• Unless contraindicated, member must have a trial of:
  • At least 1 of the following physical removal procedures:
    • Cryotherapy; or
    • Curettage; or
    • Laser therapy; and
  • At least 1 of the following medications:
    • Potassium hydroxide; or
    • Salicylic acid; and
    • Other pharmacological treatment for removal of molluscum contagiosum lesions (supporting evidence must be provided with the request); and
• Member must not have lesions exclusively on genitals or around eyes; and
• Ycanth™ must be dispensed to and administered by a health care professional (HCP) trained in the administration of Ycanth™. Approvals will not be granted for self-administration. Requests must indicate who will administer Ycanth™ and in what setting; and
• Prescriber must attest that the member or caregiver has been counseled to wash off lesions treated with Ycanth™ with soap and water 24 hours after application and to avoid skin contact with water, including bathing, prior to the 24-hour mark; and
• Prescriber must attest that the member or caregiver has been counseled on all precautions prior to and during treatment with Ycanth™ that are listed in the package labeling, including avoiding contact with the eyes and mouth and avoiding close contact with open flames, even after the medication has dried; and
• Approvals will be for a maximum of 12 weeks of therapy; and
• A quantity limit of 2 applicators every 3 weeks for a maximum of 4 applications will apply; and
• Reauthorization is not permitted. A new prior authorization request must be submitted, and the member must meet all initial approval criteria for each molluscum contagiosum infection.

Zelsuvmi™ (Berdazimer 10.3% Gel) Approval Criteria:

• An FDA approved indication for the treatment of molluscum contagiosum lesions; and
• Member must be 1 year of age or older; and
• Member must meet 1 of the following:
  • Is immunocompromised; or
  • Is experiencing itching or pain; or
  • Has concomitant bacterial infection; or
  • Has concomitant atopic dermatitis; or
  • There is concern for contagion (e.g., siblings, daycare) and the spread of lesions cannot be reasonably prevented using good hygiene or covered using a bandage;
• Prescriber must attest that it has been at least 6 months since the onset of the current infection unless the member is experiencing severe symptoms; and
• Unless contraindicated, member must have a trial of: 
  • At least 1 of the following physical removal procedures:
    • Cryotherapy; or
    • Curettage; or
    • Laser therapy; and
  • At least 1 of the following medications:
    • Potassium hydroxide; or
    • Salicylic acid; or
    • Other pharmacological treatment for removal of molluscum contagiosum lesions (supporting evidence must be provided with the request); and
• Member must not have lesions exclusively on genitals or around eyes; and
• Prescriber must attest that the member or caregiver has been counseled on and demonstrates understanding of the proper storage and preparation of Zelsuvmi™; and
• Prescriber must attest that the member or caregiver has been counseled on and has demonstrated understanding of the proper administration of Zelsuvmi™, including the medication’s drying time and avoiding contact with the eyes, mouth, and genital areas; and
• A patient-specific, clinically significant reason (beyond convenience) why the member cannot use Ycanth™ (cantharidin) must be provided; and
• Approvals will be for a maximum of 12 weeks of therapy; and
• A quantity limit of 1 carton (14-gram tube of Zelsuvmi™ and 17 gram tube of hydrogel) every 30 days for a maximum of 3 cartons will apply; and
• Reauthorization is not permitted. A new prior authorization request must be submitted, and the member must meet all initial approval criteria for each molluscum contagiosum infection

Nemluvio^® (Nemolizumab-ilto) Approval Criteria [Atopic Dermatitis Diagnosis]:

• An FDA approved diagnosis of moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies; and
• Member must be 12 years of age or older; and
• Member must have documented trials within the last 6 months for a minimum of 2 weeks that resulted in failure with both of the following topical therapies (or have a contraindication or documented intolerance):
  • 1 medium potency to very-high potency Tier-1 topical corticosteroid; and
  • 1 topical calcineurin inhibitor [e.g., Elidel^® (pimecrolimus), Protopic^® (tacrolimus)]; and
• Member must agree to continue using a topical corticosteroid and/or a topical calcineurin inhibitor in combination with Nemluvio^® until the disease has sufficiently improved; and
• Member’s body surface area (BSA) of atopic dermatitis involvement must be provided and the member must have a documented BSA involvement of ≥10% (can apply to member’s current BSA or a historical value prior to treatment); and
• A patient-specific, clinically significant reason the member cannot use Adbry^® (tralokinumab-ldrm), Dupixent^® (dupilumab), and Ebglyss^® (lebrikizumab-lbkz) must be provided; and
• Must be prescribed by a dermatologist, allergist, or immunologist or the member must have been evaluated by a dermatologist, allergist, or immunologist within the last 12 months (or an advanced care practitioner with a supervising physician who is a dermatologist, allergist, or immunologist); and
• Requests for concurrent use of Nemluvio^® with other biologic medications will be reviewed on a case-by-case basis and will require patient-specific information to support the concurrent use (Nemluvio^® has not been studied in combination with other biologic therapies); and
• Initial approvals will be for the initial dosing for the duration of 16 weeks; and
• Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval; and
  • A dosage of 30mg every 8 weeks will be approved for reauthorization; or
  • If a dosage of 30mg every 4 weeks is requested for reauthorization, additional patient-specific information will be required to support the need for continuing the every 4 week dosing regimen.

Nemluvio® (Nemolizumab-ilto) Approval Criteria [Prurigo Nodularis (PN) Diagnosis]:

• An FDA approved diagnosis of PN for at least 3 months; and
• Member must have severe pruritus as defined by a Peak Pruritus Numeric Rating Scale (PP-NRS) score of ≥7; and
• Member must have ≥20 PN lesions; and
• Member must be 18 years of age or older; and
• Must be prescribed by a dermatologist, allergist, or immunologist or the member must have been evaluated by a dermatologist, allergist, or immunologist for PN within the last 12 months (or an advanced care practitioner with a supervising physician who is a dermatologist, allergist, or immunologist); and
• Prescriber must verify that all other causes of pruritus have been ruled out; and
• Member must have documented trials within the last 6 months for a minimum of 2 weeks that resulted in failure with both of the following therapies (or have a contraindication or documented intolerance):
  • 1 medium potency to very-high potency Tier-1 topical corticosteroid; and
  • 1 topical calcineurin inhibitor [e.g., Elidel^® (pimecrolimus), Protopic^® (tacrolimus)]; and
• A patient-specific, clinically significant reason why the member cannot use Dupixent^® (dupilumab) must be provided; and
• Requests for concurrent use of Nemluvio^® with other biologic medications will be reviewed on a case-by-case basis and will require patient-specific information to support the concurrent use (Nemluvio^® has not been studied in combination with other biologic therapies); and
• The member’s recent weight must be provided, and approval quantities will be based on the FDA approved dosing regimen; and
• Initial approvals will be for the duration of 16 weeks. Reauthorization (for a duration of 1 year) may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval.

Nemluvio® 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.

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 2 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 2 of the following therapies (or have a contraindication or documented intolerance):
  • One medium potency to very-high potency Tier-1 topical corticosteroid (TCS); or
  • One topical calcineurin inhibitor (TCI) [e.g., Elidel^® (pimecrolimus), Protopic^® (tacrolimus)]; or
  • 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

Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition

Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).

OTC = over-the-counter

*Due to supplemental rebate agreements, brand Natroba™ and generic spinosad (NDC 52246057004 only) are preferred. All other generic NDCs are non-preferred and will require a prior authorization. 

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  

Sofdra™ (Sofpironium 12.45% Topical Gel) Approval Criteria:

• An FDA approved diagnosis of primary axillary hyperhidrosis; and
• Member must be 9 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, at least 3 weeks in duration, with the following:
  • Xerac^® AC (aluminum chloride hexahydrate 6.25% topical solution) or at least 1 over-the-counter Certain Dri^® antiperspirant; and
  • Drysol^® (aluminum chloride 20% topical solution); and
• Prescriber must verify that the member has received counseling on the safe and proper use of Sofdra™; and
• A quantity limit of 40.2mL per 30 days will apply; and
• Initial approvals will be for the duration of 3 months. Subsequent approvals will be for 1 year if the prescriber documents the member is responding well to treatment.

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

Sorilux® (Calcipotriene 0.005% Foam) Approval Criteria:

• An FDA approved diagnosis of plaque psoriasis of the scalp and body in members 12 years of age and older; and
  
• A patient-specific, clinically significant reason why the member cannot use the generic formulations of topical calcipotriene, which are available without a prior authorization, must be provided; and
  
• A quantity limit of 120 grams per 30 days will apply.
  

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% cream, 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:

• A documented 5 day trial of a Tier 1 product within the last 30 days; or
• Clinical exceptions apply for adverse effects with all Tier 1 products, or for a unique indication not covered by Tier-1 products; and
• Approvals will be for the duration of 10 days.

+Unique criteria applies

Neo-Synalar^® (Neomycin 0.5%/Fluocinolone 0.025% Cream) Approval Criteria:

• An FDA approved diagnosis of corticosteroid-responsive dermatoses with secondary infection; and
• A patient specific, clinically significant reason why the member cannot use a Tier-1 topical antibiotic in combination with a Tier-1 medium to very-high potency topical corticosteroid must be provided; and
• Approvals will be for 1 tube for the duration of 7 days. 

Nuvessa® (Metronidazole 1.3% Vaginal Gel) 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 must be provided.

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.

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. 

Proctofoam^® HC (Hydrocortisone/Pramoxine 1%/1% Rectal Foam) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use Epifoam® (hydrocortisone/pramoxine 1%/1% rectal foam) or other rectal formulations of hydrocortisone available without a prior authorization must be provided.

Prior Authorization form

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

Sus = suspension 

Vtama® (Tapinarof) Approval Criteria [Atopic Dermatitis Diagnosis]:

• An FDA approved diagnosis of atopic dermatitis; and
• Member must be 2 years of age or older; and
• Must be prescribed by, or in consultation with, an allergist, dermatologist, or immunologist (or an advanced care practitioner with a supervising physician who is an allergist, dermatologist, or immunologist); 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):
  • 1 medium potency to very-high potency Tier-1 topical corticosteroid (TCS); and
  • 1 topical calcineurin inhibitor (TCI) [e.g., Elidel® (pimecrolimus), Protopic® (tacrolimus)]; and
  • Eucrisa® (crisaborole); and
• Initial approvals will be for the duration of 2 months. 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. 

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 gel or 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 or 0.3% Foam) Approval Criteria [Plaque Psoriasis Diagnosis]:

• An FDA approved diagnosis of plaque psoriasis; AND
• Requested product must be FDA approved for the member’s age; and
  • 0.3% Cream: Member must be 6 years of age or older; or
  • 0.3% Foam: Member must be 12 years of age or older; and
• Member must have a body surface area (BSA) involvement of ≤20% (or ≤25% if both the scalp and body are being treated); AND
• Member must not have moderate-to-severe hepatic impairment (Child-Pugh B or C); 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.

Zoryve^® (Roflumilast 0.15% or 0.05% Cream) Approval Criteria [Atopic Dermatitis Diagnosis]:

• An FDA approved diagnosis of mild-to-moderate atopic dermatitis; and
• Requested product must be FDA approved for the member’s age; and
  • 0.15% Cream: Member must be 6 years of age or older; or
  • 0.05% Cream: Member must be 2 to 5 years of age; 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):
  • 1 medium potency to very-high potency Tier-1 topical corticosteroid (TCS); and
  • 1 topical calcineurin inhibitor (TCI) [e.g., Elidel^® (pimecrolimus), Protopic^® (tacrolimus)]; and
  • Eucrisa^® (crisaborole); 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. 

Zoryve^® (Roflumilast 0.3% Foam) Approval Criteria [Seborrheic Dermatitis Diagnosis]:

• An FDA approved diagnosis of seborrheic dermatitis; and
• Prescriber must confirm member’s condition is moderate or severe; and
• Member must be 9 years of age or older; and
• Member must have a body surface area (BSA) involvement of ≤20%; and
• Member must not have moderate or severe hepatic impairment (Child-Pugh B or C); and
• If the affected area is limited to the scalp, member must have documented trials within the last 6 months for a minimum of 2 weeks that resulted in failure with at least 1 product from all of the following categories (or have a contraindication or documented intolerance):
  • Over-the-counter (OTC) antifungal shampoo (e.g., selenium sulfide, zinc pyrithione); and
  • OTC coal tar shampoo; and
  • Tier-1 prescription antifungal shampoo (e.g., ketoconazole 2% shampoo); and
  • Tier-1 topical corticosteroid; and
• If the affected area includes the face or body, member must have documented trials within the last 6 months for a minimum of at least 2 weeks that resulted in failure with at least 1 product from all of the following categories (or have a contraindication or documented intolerance):
  • Tier-1 topical antifungal (e.g., ketoconazole, ciclopirox); and
  • Tier-1 topical corticosteroid; and
  • Topical calcineurin inhibitor (e.g., pimecrolimus 1% cream, tacrolimus 0.1% ointment); and
• Initial approvals will be for a duration of 8 weeks. After 8 weeks, the prescriber will need to provide clinical documentation that the member is improving on the medication and provide justification for continuation of therapy; and
• A quantity limit of 60 grams per 30 days will apply. 

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