Policy Applies to

• Commercial Plans
• Healthcare Reform Plans

Drugs Addressed in this policy 

·         Dupixent (dupilumab)

 

FDA-Approved Indications

 

• Treatment of moderate to severe atopic dermatitis (eczema) in adult patients inadequately controlled on topical prescription therapies or patients who are not candidates for treatment with topical prescription therapies

 

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.

·         Severity of atopic dermatitis is defined by the Investigator’s Static Global Assessment (ISGA)

0 -   Clear: minor residual hypopigmentation/ hyperpigmentation; no erythema or induration/ papulation; no oozing or crusting

1 -   Almost Clear: trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting

2 -   Mild: faint pink erythema with mild induration/ papulation and no oozing/crusting

3 -   Moderate: pink-red erythema with moderate induration/papulation with or without oozing/ crusting

4 -   Severe: deep or bright red erythema with severe induration/papulation and with oozing/crusting

 

Approval Criteria

A.    Initial Authorization

 

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

1.     The member is 18 years of age or older.

2.     The member has a diagnosis of moderate-to-severe atopic dermatitis.The member meets one of the following criteria (aor b) Therapeutic failure is defined as failure to achieve at least a two-grade improvement in ISGA score.

a.     Members have failed at least two topical corticosteroids.

b.    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) Therapeutic failure is defined as failure to achieve at least a two-grade improvement in ISGA score.

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, defined as at least a two-grade improvement in ISGA score.

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.

Quantity Level Limitation

Induction Therapy: Three (3) 300 mg syringes within the first 4 weeks of therapy

Maintenance Therapy: Two (2) 300 mg syringes every 4 weeks

 

Coding of quantity level limitations is at the maintenance therapy threshold. Claims for quantities of dupilumab prefilled syringes that exceed maintenance therapy limitations will reject at point of sale. Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).

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

References:

1. Dupixent [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; March 2017.
2. DRUGDEX System. New York: Thomson Reuters; 2017.
3. Simpson EL, et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016;375:2335-48.
4. 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.