Medication Policy Manual. Topic: Dupixent, dupilumab Date of Origin: March 10, Committee Approval: March 10, 2017 Next Review Date: May 2018

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1 Independent licensees of the Blue Cross and Blue Shield Association Medication Policy Manual Policy No: dru493 Topic: Dupixent, dupilumab Date of Origin: March 10, 2017 Committee Approval: March 10, 2017 Next Review Date: May 2018 Effective Date: March 10, 2017 IMPORTANT REMINDER This Medication Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status. Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. The purpose of Medication Policy is to provide a guide to coverage. Medication Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care. Description Dupilumab (Dupixent) is an interleukin-4 receptor antagonist used in the treatment of moderate to severe atopic dermatitis when conventional therapy is not effective. dru493.0 Page 1 of 5

2 Policy/Criteria I. Most contracts require prior authorization approval of dupilumab (Dupixent) prior to coverage. Dupilumab (Dupixent) may be considered medically necessary when medical criteria A through D below are met. A. Dupilumab (Dupixent) is prescribed by a specialist in dermatology, allergy, or pulmonology. B. The patient is age 18 or older. C. The patient has a diagnosis of moderate to severe atopic dermatitis. D. Clinical documentation of functional impairment due to atopic dermatitis, which may include (but is not limited to) documentation of limitation of activities of daily living (ADLs), such as skin infections or sleep disturbances. E. Both of the following have been documented in clinical notes to be ineffective, contraindicated, or not tolerated. 1. A moderate to very high-potency corticosteroid (See Appendix 1) 2. Topical tacrolimus Note: Ineffectiveness is defined as failure to achieve and maintain remission or a low disease activity state despite treatment with a daily regimen, applied for 28 days or for the maximum duration recommended by the product prescribing information (e.g., 14 days for high or very-high potency topical corticosteroids). II. III. Administration, Quantity Limitations, and Authorization Period A. Regence Pharmacy Services considers dupilumab (Dupixent) to be a self-administered medication. B. When prior authorization is approved, dupilumab (Dupixent) may be authorized according to the prescribing information. C. Authorization shall be reviewed at least every 6 months to confirm that current medical necessity criteria are met and that the medication is effective as defined by a reduction in body surface area involvement, pruritus severity, skin infections, or sleep disturbances. Dupilumab (Dupixent) is considered investigational when used for all other conditions, including, but not limited to: A. Asthma B. Atopic dermatitis in children (< 18 years of age) C. Eosinophilic esophagitis D. Nasal polyps dru493.0 Page 2 of 5

3 Position Statement Summary - AD is a chronic, pruritic inflammatory skin disease. It is often associated with elevated serum immunoglobulin (IgE) levels and a personal or family history of type I allergies, allergic rhinitis, and asthma. - Treatment guidelines recommend the use of topical corticosteroids in patients who have failed to respond to good skin care and regular use of emollients alone. Topical calcineurin inhibitors are recommended as second-line agents. Guidelines recommend using topical calcineurin inhibitors in the following situations: patients refractory to topical corticosteroids, use in sensitive areas (e.g. face, axilla, anogenital region, and skin folds), patients with steroid induced-atrophy, and in patients who require long-term treatment. - While there are two topical calcineurin inhibitors currently available, topical tacrolimus is a indicated for moderate to severe AD whereas pimecrolimus (Elidel) is indicated for mild to moderate disease. - Goals of treatment include clearance of skin lesions, control of itch, prevention of adverse events and triggers associated with various treatment modalities, and preventing future exacerbations. Guidelines [1] - Guidelines state that the majority of patients can achieve clinical improvement and disease control with nonpharmacologic interventions, conventional topical therapies (including corticosteroids and calcineurin inhibitors), and environmental modifications. - Topical corticosteroids are recommended for in patients who have failed to respond to good skin care and regular use of emollients alone. They are the mainstay of care and have a long history of use. Overall, they are well tolerated, but prolonged use may result in skin atrophy and continued use of higher potency topical corticosteroids may cause systemic side effects, although the risk is low. - Topical calcineurin inhibitors are recommended and effective for acute and chronic treatment. Both topical tacrolimus and pimecrolimus are FDA-approved as second-line agents. - Topical calcineurin inhibitors may be preferred to topical corticosteroids in the following situations: patients refractory to topical corticosteroids, use in sensitive areas (e.g. face, axilla, anogenital region, and skin folds), patients with steroid induced-atrophy, and in patients who require long-term treatment. - Topical calcineurin inhibitors are well tolerated but contain a boxed warning for malignancy. Rare cases of malignancy (e.g., skin cancer and lymphoma) have been reported. - Guidelines have not addressed the role of dupilumab (Dupixent) Investigational Uses - Dupilumab (Dupixent) is currently being studied for several other disease states, including asthma, eosinophilic esophagitis, and nasal polyps. - The available studies for dupilumab have only included patients aged 18 years or older. Additional studies in younger patients are needed in this population to determine efficacy and safety. dru493.0 Page 3 of 5

4 Dosing Appendices Appendix 1: Relative potencies of topical corticosteroids [1] Class Drug Dosage Form Strength (%) Very high Augmented betamethasone Ointment 0.05 potency dipropionate Clobetasol propionate Cream, foam, ointment 0.05 Diflorasone diacetate Ointment 0.05 Halobetasol propionate Cream, ointment 0.05 High potency Amcinonide Cream, lotion, ointment 0.1 Augmented betamethasone dipropionate Cream 0.05 Betamethasone dipropionate Cream, foam, ointment, solution 0.05 Desoximetasone Cream, ointment 0.25 Desoximetasone Gel 0.05 Diflorasone diacetate Cream 0.05 Fluocinonide Cream, gel, ointment, solution 0.05 Halcinonide Cream, ointment 0.1 Mometasone furoate Ointment 0.1 Triamcinolone acetonide Cream, ointment 0.5 Medium Potency Lower medium potency Betamethasone valerate Cream, foam, lotion, ointment 0.1 Clocortolone pivalate Cream 0.1 Desoximetasone Cream 0.05 Fluocinolone acetonide Cream, ointment Flurandrenolide Cream, ointment 0.05 Fluticasone propionate Cream 0.05 Fluticasone propionate Ointment Mometasone furoate Cream 0.1 Triamcinolone acetonide Cream, ointment 0.1 Hydrocortisone butyrate Cream, ointment, solution 0.1 Hydrocortisone probutate Cream 0.1 Hydrocortisone valerate Cream, ointment 0.2 Prednicarbate Cream 0.1 dru493.0 Page 4 of 5

5 Appendix 1: Relative potencies of topical corticosteroids [1] Low potency Alclometasone dipropionate Cream, ointment 0.05 Desonide Cream, gel, foam, ointment 0.05 Fluocinolone acetonide Cream, solution 0.01 Lowest potency Dexamethasone Cream 0.1 Hydrocortisone Cream, lotion, ointment, solution 0.25, 0.5, 1 Hydrocortisone acetate Cream, ointment Cross References Eucrisa, Crisaborole Medication Manual, Policy No. 492 References 1. Eichenfield, LF, Tom, WL, Berger, TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. Journal of the American Academy of Dermatology Jul;71(1): PMID: Revision History Revision Date Revision Summary 3/10/2017 New policy dru493.0 Page 5 of 5