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 patients aged 12 years and older with moderate-to-severe atopic dermatitis (eczema) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
  • Add-on maintenance treatment for moderate-to-severe asthma in patients aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma


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 and asthma.

 

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

 

Asthma

  • The standard of care for moderate to severe asthma is maintenance use of a moderate- or high-dose inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) ± oral corticosteroids taken as daily or alternate-day therapy.
  • Eosinophilic phenotype asthma is associated with tissue and sputum eosinophilia, thickening of basement membrane zone, and often by response to corticosteroids.
  • According to asthma guidelines, it is recommended to attempt to reduce systemic corticosteroid use when asthma is well controlled.
  • Appropriate diagnosis of asthma (versus etiology of pulmonary fibrosis, e.g. COPD or idiopathic pulmonary fibrosis) may be confirmed by measurement of FEV1 reversibility after administration of albuterol. As a standard guideline, 12% or 200 mL is generally accepted as FEV1

Estimated Comparative Daily Inhaled Corticosteroid Dosages for Patients ≥ 12 years old

Drug

Low Dose

Moderate Dose

High Dose

Beclomethasone

80-240 mcg

> 240-480 mcg

> 480 mcg

Budesonide DPI

180-600 mcg

> 600-1200 mcg

> 1200 mcg

Flunisolide

500-1000 mcg

> 1000-2000 mcg

> 2000 mcg

Flunisolide HFA

320 mcg

> 320-640 mcg

> 640 mcg

Fluticasone HFA/MDI

88-264 mcg

> 264-440 mcg

> 440 mcg

Fluticasone DPI

100-300 mcg

> 300-500 mcg

> 500 mcg

Mometasone DPI

200 mcg

400 mcg

> 400 mcg

Triamcinolone acetonide

300-750 mcg

> 750-1500 mcg

> 1500 mcg

Abbreviations: DPI, dry powder inhaler; HFA, hydrofluoroalkane; MDI, metered-dose inhaler

 

  • Prescribing Considerations:
    • Dupixent (dupilumab) is not indicated for treatment of other eosinophilic conditions nor for relief of acute bronchospasm or status asthmaticus.
    • Patients should not utilize dual therapy with another monoclonal antibody for the treatment of asthma.
    • Patients with pre-existing helminth infections should be treated prior to initiating therapy with these agents.


Approval Criteria

I.      Atopic Dermatitis

A.    Initial Authorization

When a benefit, coverage of Dupixent may be approved when all of the following criteria are met (1. through 4.):

1.     The member is 12 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 (a. or 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 of Dupixent may be granted if the following criterion is met (1.):

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

 

II.    Asthma

A.    Initial Authorization

When a benefit may be approved when all of the following criteria are met (1. through 6.):

1.     The member is 12 years of age or older

2.     The member has a diagnosis of moderate-to-severe asthma

3.     The member has documented FEV1 reversibility of at least 12% or 200 milliliters (mL) after albuterol (salbutamol) administration

4.     Meets one of the following criteria (a. or b.):

a.     Eosinophilic phenotype with documented blood eosinophils ≥ 150 cells/mcL

b.    The member is currently taking daily or alternate-day oral corticosteroids

5.     The member is using a medium- or high-dose inhaled corticosteroid and a long acting beta agonist

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

B.    Reauthorization

When a benefit, reauthorization of Dupixent may be granted when one of the following criteria is met (1., 2., or 3.):

1.     The provider submits attestation that the member has decreased rescue medication or oral corticosteroid use

2.     The provider submits attestation that the member has had a decrease in frequency of severe asthma exacerbations

3.     The provider submits attestation of increase in pulmonary function from baseline, e.g. FEV1

 

Quantity Limitations

I.      Atopic Dermatitis

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

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

II.    Asthma

Induction therapy: Four (4) 200 mg syringes within the first 4 weeks of therapy or four (4) 300 mg syringes within the first 4 weeks of therapy

Maintenance therapy: Two (2) 200 mg or 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).

 

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 Dupixent 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-539-006
Effective Date Begin: 05/02/2019
Effective End Begin: 09/16/2019
Original Date: 03/14/2017
Review Date: 05/01/2019


References:

  1. Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; March 2019.
  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].
  5. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Heart, Lung and Blood Institute, National Institutes of Health. August 2007 [accessed 2018 Nov 2].
  6. Walford HH, et al. Diagnosis and management of eosinophilic asthma: a US perspective. J Asthma Allergy. 2014;7:53–65.




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.