Policy Applies to

·         Commercial Plans

·         Healthcare Reform Plans

Agents addressed in this policy 

·         Dupixent (dupilumab)

 

FDA-Approved Indications

 

·         Per FDA label

 

Background

 

·         Dupilumab is a human monoclonal antibody targeting interleukin-4 receptor alpha, inhibiting signaling of inflammatory cytokines that contribute to the signs and symptoms of atopic dermatitis.

·         According the American Academy of Dermatology, topical corticosteroids are recommended for initial treatment of atopic dermatitis, followed by non-steroid therapies.

Approval Criteria

A.    Initial Authorization

When a benefit, Dupixent may be approved if the member meets all of the following criteria (1, 2, 3 and 4):

1.     Dupixent is being used for an FDA-approved indication.

2.     The member meets one of the following criteria (a, b or c):

a.     Adult members have failed at least two topical corticosteroids

b.    Pediatric members between the ages of 2 and 15 years have failed at least one non-fluorinated topical corticosteroid.

c.     Members requesting dupilumab for atopic dermatitis of the face have failed at least one non-fluorinated topical corticosteroid.

3.     The member has experienced therapeutic failure, intolerance or contraindication to all of the following products (a, b and c):

a.     tacrolimus ointment

b.    pimecrolimus cream

c.     crisaborole ointment

4.     The requested quantity does not exceed the recommended dosing regimen per FDA label.

 

B.    Reauthorization

When a benefit, reauthorization may be granted if the member meets the following criterion (1):

1.     The provider submits documentation that the member is responding to therapy.

For Commercial and Healthcare Reform members, coverage dupilumab for disease states outside of those listed above should be denied based on the lack of clinical data to support their effectiveness and safety in such conditions.

For members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.

For Commercial and Healthcare Reform members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made base on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform.

Automatic Approval Criteria:

None

Quantity Level Limitation

Not to exceed the maximum dosing per FDA label

Duration of Authorization: If approved, a 6 month authorization will be granted.

References:

1. DRUGDEX System. New York: Thomson Reuters; 2017.
2. Simpson EL, et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016;375:2335-48.
3. Atopic Dermatitis. American Academy of Dermatology. 2016 [accessed 2016 Dec 16]. Available from: https://www.aad.org/practice-tools/quality-care/clinical-guidelines/atopic-dermatitis/topical-therapy/topical-calcineurin-inhibitors-recommendations.

 

 

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