Pharmacy Policy Bulletin
Dupixent (dupilumab) – Commercial and Healthcare Reform
Number: J-539 Category: Prior Authorization
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial (1.):

  1. Miscellaneous Specialty Injectable = Yes w/ Prior Authorization

Healthcare Reform: Not Applicable
Region(s):

All
Delaware
Pennsylvania
West Virginia

Additional Restriction(s):

None


Drugs Products
  • 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

I.      Initial Authorization

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

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

B.    The member has a diagnosis of moderate-to-severe atopic dermatitis. The member meets one of the following criteria (1. or 2.) Therapeutic failure is defined as failure to achieve at least a two-grade improvement in ISGA score.

1.     Members have failed at least two topical corticosteroids.

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

C.    The member has experienced therapeutic failure, intolerance or contraindication to all of the following products (1., 2., and 3.) Therapeutic failure is defined as failure to achieve at least a two-grade improvement in ISGA score.

1.     tacrolimus ointment

2.     pimecrolimus cream

3.     crisaborole ointment

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

 

II.    Reauthorization

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

A.    The provider submits documentation that the member is responding to therapy, defined as at least a two-grade improvement in ISGA score.

 

III.   Quantity Limitations

Induction Therapy: Four (4) 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).

 

IV.   For Commercial or 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.


Limitations of Coverage

I.      Coverage of dupilumab for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

II.    For Commercial and Healthcare Reform 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.


Authorization Duration
  • Commercial and Healthcare Reform Plans: If approved, a 6 month authorization will be granted.


Automatic Approval Criteria

None


Version: J-539-004
Effective Date Begin: 02/17/2018
Effective End Begin: 11/18/2018
Original Date: 03/14/2017
Review Date: 01/31/2018


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.




Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.