Harvard Pilgrim Health Care – Pharmacy Prior Authorization Guideline

Guideline Name Dermatological Immunomodulators: Elidel (pimecrolimus) and Protopic (tacrolimus)

1. Criteria

Product Name: Brand Elidel, generic pimecrolimus cream, Brand Protopic, generic tacrolimus ointment Approval Length 12 Month(s)* Therapy Stage Initial Authorization Guideline Type Step Therapy, Non-Formulary

Approval Criteria

1 - Diagnosis of one of the following: • Atopic dermatitis (eczema) • Dermatitis on the face • Lichenoid mucositis • Lichen sclerosis • Lichen planus • Psoriasis • Vitiligo on the face, head, or neck AND/OR in those less than 18 years of age

AND

2 - One of the following:

2.1 - Trial and failure with TWO medium to high potency topical corticosteroids (e.g., betamethasone dipropionate 0.05% cream or ointment, fluocinonide 0.05% cream or ointment, mometasone 0.1% cream or ointment, triamcinolone 0.1% cream or ointment [also see table in background section])

OR

2.2 - There is clinical rationale to avoid use with topical corticosteroids (e.g., the affected area of the body is either the head, face, neck, or intertriginous area; patient has potential for significant skin discoloration with topical corticosteroid use; patient has experienced adrenal suppression or patient is at risk for adrenal suppression)

AND

3 - For Brand Protopic and Elidel requests only, trial and failure with OR clinical rationale to avoid use with the therapeutically equivalent generic Notes *Generic approvals should be entered for “MSC=Y” only.

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Product Name: Brand Elidel, generic pimecrolimus cream, Brand Protopic, generic tacrolimus ointment Approval Length 24 Month(s)* Therapy Stage Reauthorization Guideline Type Step Therapy, Non-Formulary

Approval Criteria

1 - Patient has experienced improvement with therapy Notes *Generic approvals should be entered for “MSC=Y” only.

2. Background

Benefit/Coverage/Program Information RATIONALE In order to ensure that Protopic (tacrolimus) and Elidel (pimecrolimus) are not being used as first line therapy before corticosteroid use, unless a corticosteroid is contraindicated, ineffective or intolerable.

FDA APPROVED INDICATIONS As second line therapy for short-term and intermittent long-term therapy in the treatment of patients age 2 years and older with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or are intolerant of alternative, conventional therapies.

STEP THERAPY*: Prescriptions that meet the initial step therapy requirements will adjudicate at the point of service. If the member does not meet the initial step therapy criteria, then the prescription will deny at point of service with a message indicating that prior authorization (PA) is required. Members who do not meet the step therapy criteria at point of service will need to submit a request for clinical review. First level drug therapy required include the following: • Two medium to high potency topical corticosteroids (see table below) • Lookback is 365 days, • Lookback will also look for itself.

Potency Drug Dosage form Strength Very High betamethasone gel, lotion, ointment 0.05% dipropionate augmented clobetasol propionate cream, foam, gel, lotion, 0.05% ointment, shampoo, spray diflorasone diacetate ointment 0.05% halobetasol propionate cream, ointment lotion 0.05% fluocinonide cream 0.1% High betamethasone cream 0.05%

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dipropionate augmented betamethasone cream 0.05% dipropionate betamethasone valerate ointment 0.1% fluocinonide cream 0.05% fluticasone ointment 0.005% mometasone ointment 0.1% triamcinolone cream, ointment 0.5% desoximetasone cream, gel, ointment 0.05% desoximetasone cream, liquid, ointment 0.25% amcinonide cream, lotion, ointment 0.1% Medium betamethasone lotion 0.05% dipropionate betamethasone valerate cream 0.1% fluocinolone cream, ointment 0.025% fluocinonide cream (emulsified) 0.05% fluticasone cream 0.05% hydrocortisone butyrate cream, lotion, ointment, 0.1% solution mometasone cream, solution (lotion) 0.1% prednicarbate ointment 0.1% triamcinolone cream, lotion, ointment 0.025%, 0.1%

*Brand Protopic and Brand Elidel are Non-Formulary. Therefore, Step Therapy point of service coding described above does not apply.

REFERENCES • Elidel (pimecrolimus) [prescribing information]. Bridgewater, NJ: Bausch Health, LLC; September 2020. • Protopic (tacrolimus) [prescribing information]. Madison, NJ. LEO Pharma Inc. February 2019. • Lebwohl, M. et al. Tacrolimus ointment is effective for facial and intertriginous psoriasis. Journal of the American Academy of Dermatology 51.5 (2004):723-30 • Goldstein B, Goldstein A, et al. Topical corticosteroids: Potency. UpToDate. Waltham, MA; UpToDate Inc. http://www.uptodate.com (Accessed on June 4, 2021).

Created: 06/11/02 Revised: • Annual Review (effective: 1/1/20) • 7/2/20 - Annual review: background changes; PA changed to ST for generics; brands require trial of generic; allowed for vitiligo on face/head/neck or in pediatrics as an acceptable diagnosis; reduced initial approvals from 24 to 12 months (effective: 9/1/20) • 6/9/21 - Annual review: updated background; added corticosteroids to the potency table; no changes to criteria P&T Approval: 12/13/21 Effective: 9/1/21

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