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

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial:

Prior Authorization (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
  • Add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP)


Background:
  • Dupixent 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.
  • Tacrolimus, pimecrolimus, and crisaborole are non-steroid therapies for topical treatment of atopic dermatitis.
    • Elidel (pimecrolimus) cream 2% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.
    • Protopic (tacrolimus) ointment 0.03% (adults and children 2 years of age and older) and 0.1% (adults) is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate-to-severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.
    • Eucrisa (crisaborole) is a topical phosphodiesterase 4 (PDE-4) inhibitor indicated for topical treatment of mild-to-moderate atopic dermatitis in patients 2 years of age and older.
  • Severity of atopic dermatitis is defined by the Investigator’s Static Global Assessment (ISGA)
  • Clear: minor residual hypopigmentation/ hyperpigmentation; no erythema or induration/ papulation; no oozing or crusting
  • Almost Clear: trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting
  • Mild: faint pink erythema with mild induration/ papulation and no oozing/crusting
  • Moderate: pink-red erythema with moderate induration/papulation with or without oozing/ crusting
  • Severe: deep or bright red erythema with severe induration/papulation and with oozing/crusting
  • Therapeutic failure is defined as failure to achieve at least a two-grade improvement in ISGA score.

 

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

 

Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)

  • Chronic rhinosinusitis is defined as inflammation of the nose and paranasal sinuses that lasts for more than 12 weeks and usually responses incompletely to therapy, which may need to be continued long-term.
  • According to the British Society for Allergy and Clinical Immunology (BSACI) guidelines, all patients should have a trial of medical treatment before surgery unless the nature of the polyps is in doubt.
  • Smaller polyps may respond to topical corticosteroids only, initially betamethasone nasal drops. Larger polyps may respond to a medical polypectomy include prednisolone and betamethasone nasal drops.
  • Other treatment options for CRSwNP include anti-leukotrienes, antibiotics, azelastine, aspirin desensitization and surgery.
  • The Nasal Congestion Score is a tool used to measure changes in nasal congestion and obstruction. It ranges from 0 – 3, and is the monthly average of the daily morning AM patient-assessed daily symptom severity (0 = no symptoms to 3 = severe symptoms).
  • The Nasal Polyp Score is used to characterize the patient’s polyps from 0 = no polyps to 4 = severe disease with large polyps causing complete obstruction of the inferior nasal cavity.
  • Prescribing Considerations:
    • Dupixent 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 5.):

1.     The member is 12 years of age or older.

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

3.     The member meets one of the following criteria (a. or b.):

a.     The member has experienced a therapeutic failure to at least two (2) topical corticosteroids.

b.    The member is requesting Dupixent for atopic dermatitis of the face and has experienced therapeutic failure to at least one (1) non-fluorinated topical corticosteroid.

4.     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

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

 

B.    Reauthorization

When a benefit, reauthorization of Dupixent may be approved if the following criterion is met (1.):

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

 

C.    Quantity Limitations

When prior authorization is approved, Dupixent may be authorized in quantities as follows:

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

2.     Maintenance Therapy: Two (2) 200 or 300 mg syringes every 4 weeks

 

II.    Asthma

 

A.    Initial Authorization

When a benefit, coverage of Dupixent 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.     The member 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 approved 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

 

C.    Quantity Limitations

When prior authorization is approved, Dupixent may be authorized in quantities as follows:

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

2.     Maintenance therapy: Two (2) 200 or 300 mg syringes every 4 weeks

 

III.   Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)

 

A.    Initial Authorization

When a benefit, coverage of Dupixent may be approved when all of the following criteria are met (1. through 5.):

1.     The member is 18 years of age or older

2.     The member has a diagnosis of chronic rhinosinusitis with nasal polyposis.

3.     The physician provides documentation of the patient’s baseline polyp score.

4.     The physician provides documentation of the patient’s baseline nasal congestion score.

5.     The member has experienced therapeutic failure, intolerance, or contraindication to both of the following (a. and b.):

a.     Intra-nasal corticosteroid

b.    14 day course of oral corticosteroids

 

B.    Reauthorization

When a benefit, reauthorization of Dupixent may be approved when both of the following criteria are met (1. and 2.):

1.     The provider submits attestation that the member has a decrease in their nasal polyp score.

2.     The provider submits attestation that the member has a reduction in their nasal congestion/obstruction severity score.

 

C.    Quantity Limitations

When prior authorization is approved, Dupixent may be authorized in quantities as follows:

1.     Induction therapy: None

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

 

III.   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 HCR members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made based 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 HCR 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 HCR Plans: If approved, up to a 6 month authorization will be granted.


Automatic Approval Criteria

None


Version: J-539-007
Effective Date Begin: 09/17/2019
Effective End Begin: 11/17/2019
Original Date: 03/14/2017
Review Date: 08/07/2019


References:

  1. Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; June 2019.
  2. DRUGDEX System. New York: Thomson Reuters; 2019.
  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. 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. J Am Acad Dermatol. 2014 Jul;71(1):116-32.
  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 May 28, 2019.  
  6. Walford HH, et al. Diagnosis and management of eosinophilic asthma: a US perspective. J Asthma Allergy. 2014;7:53–65.
  7. Peters AT, et al. Ann Allergy Asthma Immunol. 2014; 113(4): 347-85.
  8. Alobid I et al. Journal of Investigational Allergology and Clinical Immunology 2011; 21(Suppl 1): 1-58.
  9. Orlandi RR, et al. International Consensus Statement on Allergy and Rhinology: Rhinosinusitis 2016; 6 (Suppl 1): S22-S209.

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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.


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