The FDA approval of Dupixent was based on three randomized, double-blind, placebo-controlled trials which enrolled subjects 18 years of age and older with moderate-to-severe atopic dermatitis (AD) not adequately controlled by topical medication(s). Disease severity was defined by an Investigator’s Global Assessment (IGA) score ≥3 in the overall assessment of AD lesions on a severity scale of 0 to 4, an Eczema Area and Severity Index (EASI) score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%. All three trials assessed the primary endpoint, the change from baseline to Week 16 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and at least a 2-point improvement.

LIBERTY AD SOLO 1 and SOLO 2 enrolled 1,379 adults with moderate-to-severe AD in the identically-designed trials. Subjects were randomized into one of three treatment groups: dupilumab 300 mg subcutaneously once per week, dupilumab 300 mg subcutaneously every two weeks, or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously, or placebo. Both trials met the primary endpoints. For SOLO 1 and SOLO 2, respectively, 37 and 36% of patients who received dupilumab 300 mg weekly, and 38 and 36% of patients who received dupilumab 300 mg every two weeks, achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 10 and 8.5% with placebo (p less than 0.0001).

LIBERTY AD CHRONOS enrolled 700 adults with moderate-to-severe AD. The trial was designed to demonstrate the efficacy of dupilumab when administered concomitantly with topical corticosteroids through 16 weeks. Secondary objectives of the study included the long-term safety and efficacy of dupilumab up to 52 weeks. The primary endpoints at week 16 were reached: 39% of patients who received either dupilumab 300 mg weekly with TCS or dupilumab 300 mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12% of patients receiving placebo with TCS (p less than 0.0001). 64% of patients who received dupilumab 300 mg weekly with TCS, and 69% of patients who received dupilumab 300 mg every two weeks with TCS achieved EASI-75, a 75 percent reduction on an index measuring eczema severity, compared to 23% of patients receiving placebo with TCS (p less than 0.0001). The secondary endpoint 52-week results were also reached and showed the following: 40% of patients who received dupilumab 300 mg weekly with TCS, and 36% of patients who received dupilumab 300 mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12.5% of patients receiving placebo with TCS (p less than 0.0001). 64% of patients who received 300 mg weekly with TCS, and 65% of patients who received 300 mg every two weeks with TCS achieved EASI-75, compared to 22% with placebo with TCS (p less than 0.0001).

The Dupixent asthma development program included three randomized, double-blind, placebocontrolled, parallel-group, multi-center trials (AS Trials 1, 2, and 3) of 24 to 52 weeks in treatment duration which enrolled a total of 2888 subjects (12 years of age and older). Subjects enrolled in AS Trials 1 and 2 were required to have a history of 1 or more asthma exacerbations that required treatment with systemic corticosteroids or emergency department visit or hospitalization for the treatment of asthma in the year prior to trial entry. Subjects enrolled in AS Trial 3 required dependence on daily oral corticosteroids in addition to regular use of high-dose inhaled corticosteroids plus an additional controller(s). In all 3 trials, subjects were enrolled without requiring a minimum baseline blood eosinophil count. In AS Trials 2 and 3 subjects with screening blood eosinophil level of >1500 cells/mcL ((<1.3%) were excluded. Dupixent was administered as add-on to background asthma treatment. Subjects continued background asthma therapy throughout the duration of the studies, except in AS Trial 3 in which OCS dose was tapered.

In Trial 2 1902 patients 12 years of age or older with uncontrolled asthma were randomized in a 2:2:1:1 ratio to receive add-on subcutaneous dupilumab at a dose of 200 or 300 mg every 2 weeks or matched-volume placebos for 52 weeks. The primary end points were the annualized rate of severe asthma exacerbations and the absolute change from baseline to week 12 in the forced expiratory volume in 1 second (FEV1) before bronchodilator use in the overall trial population. Secondary end points included the exacerbation rate and FEV1 in patients with a blood eosinophil count of 300 or more per cubic millimeter. Asthma control and dupilumab safety were also assessed. The annualized rate of severe asthma exacerbations was 0.46 (95% confidence interval [CI], 0.39 to 0.53) among patients assigned to 200 mg of dupilumab every 2 weeks and 0.87 (95% CI, 0.72 to 1.05) among those assigned to a matched placebo, for a 47.7% lower rate with dupilumab than with placebo (P<0.001); similar results were seen with the dupilumab dose of 300 mg every 2 weeks. At week 12, the FEV1 had increased by 0.32 liters in patients assigned to the lower dose of dupilumab (difference vs. matched placebo, 0.14 liters; P<0.001); similar results were seen with the higher dose. Among patients with a blood eosinophil count of 300 or more per cubic millimeter, the annualized rate of severe asthma exacerbations was 0.37 (95% CI, 0.29 to 0.48) among those receiving lower-dose dupilumab and 1.08 (95% CI, 0.85 to 1.38) among those receiving a matched placebo (65.8% lower rate with dupilumab than with placebo; 95% CI, 52.0 to 75.6); similar results were observed with the higher dose. Blood eosinophilia occurred after the start of the intervention in 52 patients (4.1%) who received dupilumab as compared with 4 patients (0.6%) who received placebo.

In Trial 3 210 patients with oral glucocorticoid–treated asthma were randomly assigned to receive add-on dupilumab (at a dose of 300 mg) or placebo every 2 weeks for 24 weeks. After a glucocorticoid dose-adjustment period before randomization, glucocorticoid doses were adjusted in a downward trend from week 4 to week 20 and then maintained at a stable dose for 4 weeks. The primary end point was the percentage reduction in the glucocorticoid dose at week 24. Key secondary end points were the proportion of patients at week 24 with a reduction of at least 50% in the glucocorticoid dose and the proportion of patients with a reduction to a glucocorticoid dose of less than 5 mg per day. Severe exacerbation rates and the forced expiratory volume in 1 second (FEV1) before bronchodilator use were also assessed. The percentage change in the glucocorticoid dose was −70.1% in the dupilumab group, as compared with −41.9% in the placebo group (P<0.001); 80% versus 50% of the patients had a dose reduction of at least 50%, 69% versus 33% had a dose reduction to less than 5 mg per day, and 48% versus 25% completely discontinued oral glucocorticoid use.

The most common side effects reported were injection site reactions, conjunctivitis, blepharitis and oral herpes.

In March 2019, the FDA approved Dupixent for the treatment of moderate to severe atopic dermatitis (AD) in adolescents ages between 12 and 17 years old. The efficacy and safety of Dupixent monotherapy in this population was evaluated in a multicenter, randomized, double-blind, placebo-controlled trial of 251 adolescents with moderate to severe AD. All eligible patients had received prior treatment with topical medication. Mean age was 14.5 years, 46% of patients had moderate AD (IGA score of 3), 56% of patients had severe AD (IGA score of 4). The primary endpoint was the proportion of patients with an IGA 0 or 1 and at least a 2-point improvement from baseline to Week 16. At Week 16, compared to placebo, patients treated with Dupixent showed a statistically significant improvement in IGA (24% vs 2%), EASI (42% vs 8%) and peak pruritus NRS score (37% vs 5%) at the dose of 200mg every 2 weeks for patients less than 60kg and 300mg every 2 weeks for patients of at least 60 kg. No additional safety signal was found in this study.

In June 2019, the FDA approved Dupixent as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The efficacy and safety of Dupixent add-on therapy for this indication was evaluated in 2 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks (CSNP Trials 1 and 2). The studies included 724 subjects aged 18 years and older on background intranasal polyps who had CRSwNP despite prior sino-nasal surgery or treatment with, or who were ineligible to receive, systemic corticosteroids in the past 2 years. In CSNP Trial 1, a total of 276 subjects were randomized to receive either 300 mg DUPIXENT (N=143) or placebo (N=133) every other week for 24 weeks. In CSNP Trial 2, 448 subjects were randomized to receive either 300 mg DUPIXENT (N=150) every other week for 52 weeks, 300 mg DUPIXENT (N=145) every other week until week 24 followed by 300 mg DUPIXENT every 4 weeks until week 52, or placebo (N=153).

The co-primary endpoints were change from baseline to Week 24 in bilateral endoscopic nasal polys score (NPS; 0-8 scale) as graded by central blinded readers, and change from baseline to week 24 in nasal congestion/obstruction scored averaged over 28 days (NC; 0-3 scale), as determined by subjects using a daily dairy. 57% and 51% improvement in their nasal congestion/obstruction severity compared to a 19% and 15% improvement with placebo in SINUS-24 and SINUS-52, respectively (least squares [LS] mean change from baseline of -1.34 and -1.25 for Dupixent compared to -0.45 and -0.38 for placebo; difference between Dupixent and placebo: -0.89 and -0.87). 33% and 27% reduction in their nasal polyps score compared to a 7% and 4% increase with placebo in SINUS-24 and SINUS-52, respectively (LS mean change from baseline of -1.89 and -1.71 for Dupixent compared to 0.17 and 0.10 for placebo; difference between Dupixent and placebo: -2.06 and -1.80).

In both studies, key secondary end-points at Week 24 included change from baseline in LMK sinus CT scan score, daily loss of smell and 22-item sino-nasal outcome test (SNOT-22). 42% and 27% improvement in sinus opacification compared to 4% and 0% with placebo in SINUS-24 and SINUS-52, respectively (LS mean change from baseline of -8.18 and -5.21 for Dupixent compared to -0.74 and -0.09 for placebo). 52% and 45% improvement in loss of smell compared to a 12% and 10% improvement for placebo in SINUS-24 and SINUS-52, respectively (LS mean difference in Dupixent compared to placebo of -1.12 and -0.98 in SINUS-24 and SINUS-52, respectively). Dupixent reduced the proportion of patients who required corticosteroids by 74% compared with placebo. The proportion of patients who required surgery was reduced by 83% with Dupixent compared to placebo.

In May 2020, the FDA approved Dupixent for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The efficacy and safety of Dupixent use concomitantly with TCS in pediatric subjects was evaluated in a multicenter, randomized, double-blind, placebo-controlled trial (Trial 8; NCT03345914) in 367 subjects 6 to 11 years of age, with AD defined by an IGA score of 4 (scale of 0 to 4), an EASI score ≥ 21 (scale of 0 to 72), and a minimum BSA involvement of ≥ 15%. Eligible subjects enrolled into this trial had previous inadequate response to topical medication. Enrollment was stratified by baseline weight (<30 kg; ≥ 30 kg). Subjects in the Dupixent Q4W + TCS group received an initial dose of 600 mg on Day 1, followed by 300 mg Q4W from Week 4 to Week 12, regardless of weight. Subjects in the Dupixent Q2W + TCS group with baseline weight of <30 kg received an initial dose of 200 mg on Day 1, followed by 100 mg Q2W from Week 2 to Week 14, and subjects with baseline weight of ≥ 30 kg received an initial dose of 400 mg on Day 1, followed by 200 mg Q2W from Week 2 to Week 14. Subjects were permitted to receive rescue treatment at the discretion of the investigator. Subjects who received rescue treatment were considered non-responders. In Trial 8, the mean age was 8.5 years, the median weight was 29.8 kg, 50% of subjects were female, 69% were White, 17% were Black, and 8% were Asian. At baseline, the mean BSA involvement was 58%, and 17% had received prior systemic non-steroidal immunosuppressants. Also, at baseline the mean EASI score was 37.9, and the weekly average of daily worst itch score was 7.8 on a scale of 0-10. Overall, 92% of subjects had at least one co-morbid allergic condition; 64% had food allergies, 63% had other allergies, 60% had allergic rhinitis, and 47% had asthma. The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16. Other evaluated outcomes included the proportion of subjects with EASI-75 or EASI-90 (improvement of at least 75% or 90% in EASI from baseline, respectively), and reduction in itch as measured by the Peak Pruritus NRS (≥4-point improvement). A greater proportion of subjects randomized to DUPIXENT + TCS achieved an improvement in the Peak Pruritus NRS compared to placebo + TCS (defined as ³4-point improvement at Week 16).

Policy:
(Note: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)

I Dupilumab (Dupixent) is medically necessary when used for one of the following indications below and are subject to their corresponding guidelines based on FDA approved indication:
A. For the treatment of moderate to severe atopic dermatitis in members whose disease is not adequately controlled with topical prescription therapy or when those therapies are not advisable when member meets all of the following:

1. The member is at least 6 years or older; AND
2. The member does not have an FDA labeled contraindication to therapy; AND
3. The member has at least 10% body surface area involvement or the member has involvement of the palms and/or soles of the feet; AND
4. Documentation that member has continued pruritus and other symptoms such as erythema, edema, lichenification, crusting and oozing; AND
5. Member meets ONE of the following:
a. There is documentation the patient has tried and had an inadequate response to an oral systemic immunosuppressant (e.g., methotrexate, azathioprine, mycophenolate mofetil, cyclosporine) for a minimum of 3 months OR
b. There is documentation the patient has tried and had an inadequate response to BOTH at least a mid- potency topical steroid for a minimum of 4 weeks AND a topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) for a minimum of 6 weeks (documentation of medical records required) OR
c. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL oral systemic immunosuppressants, mid- potency topical steroids AND topical calcineurin inhibitors; AND
6. The member will continue the use of topical emollients to help prevent flares AND
7. The member will not be receiving live vaccines concurrently with Dupixent AND
8. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, dermatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
9. The requested drug will be administered in an office/outpatient setting by a healthcare professional or home infusion by a home-health nurse and is there is documentation that member will not be self-administering. Documentation must be provided stating the member is unable to self-administer due to one of the following reasons:
· Member has a history of anaphylaxis to prior therapy with a related pharmacologic or biologic agent despite standard premedication; or
· Member is unable to successfully self-administer with proper technique due to a motor/dexterity condition; or
· Member has acute mental status/cognitive changes or physical impairment due to another condition; or
· Member has in the past demonstrated compliance issues and therefore needs medical supervision to adequately receive the drug; or
· Member has clinically diagnosed needle phobia (supported by documentation including a psychiatric evaluation) and therefore cannot self-administer; or
· Member’s age prohibits them to successfully administer the medication and their medications cannot adequately be managed by a caregiver
B. For the treatment of moderate to severe asthma and when member meets all of the following:
1. Member is 12 years of age and over; AND
2. Member meets ONE of the following:
a. Has eosinophilic type asthma AND documentation of baseline blood eosinophilic count of 150 cells/microliter or higher while on high-dose inhaled corticosteroids or daily oral corticosteroids
OR
b. Has documentation of oral corticosteroid dependent type asthma;
AND
3. Member has baseline Forced Expiratory Volume (FEV1) that is less than 80% of predicted; AND
4. Evidence of reversibility; (This requirement is necessary to document that the condition being treated is asthma and not a restrictive or other chronic lung disease. Ideally, there should be demonstration of at least a >12% improvement in FEV1 or >20% improvement in PEF after using a short acting inhaled beta-2 agonist);
AND
5. Member has ONE of the following:
a. Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months OR
b. Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months OR
c. Controlled asthma that worsens when the doses of inhaled or systemic corticosteroids are tapered;
AND
6. Member has ONE of the following:
a. NOT currently being treated with the requested agent AND is currently treated with a maximally tolerated inhaled corticosteroid within the past 90 days; OR
b. Is currently being treated with the requested agent AND is currently treated with an inhaled corticosteroid that is dosed as needed to control symptoms; OR
c. Has a documented intolerance, FDA labeled contraindication, or hypersensitivity to inhaled corticosteroids;

7. Member has ONE of the following:
a. is currently treated with ONE of the following within the past 90 days:
1. A long-acting beta-2 agonist (LABA)
OR
2. A leukotriene receptor antagonist (LRTA)
OR
3. Long-acting muscarinic antagonist (LAMA)
OR
4. Theophylline
OR
b. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a long-acting beta-2 agonist (LABA), leukotriene receptor antagonist (LRTA), long-acting muscarinic antagonist (LAMA), AND theophylline; AND
8. The member will NOT receive the requested agent in combination with another biologic agent for the requested indication [e.g., Xolair, IL-5 inhibitor (Cinqair, Fasenra, Nucala)] AND
9. Member will continue asthma control therapy (e.g., ICS, LABA, LRTA, LAMA, theophylline) in combination with the requested agent AND
10. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
11. The requested drug will be administered in an office/outpatient setting by a healthcare professional or home infusion by a home-health nurse and is there is documentation that member will not be self-administering. Documentation must be provided stating the member is unable to self-administer due to one of the following reasons:
· Member has a history of anaphylaxis to prior therapy with a related pharmacologic or biologic agent despite standard premedication; or
· Member is unable to successfully self-administer with proper technique due to a motor/dexterity condition; or
· Member has acute mental status/cognitive changes or physical impairment due to another condition; or
· Member has in the past demonstrated compliance issues and therefore needs medical supervision to adequately receive the drug; or
· Member has clinically diagnosed needle phobia (supported by documentation including a psychiatric evaluation) and therefore cannot self-administer; or
· Member’s age prohibits them to successfully administer the medication and their medications cannot adequately be managed by a caregiver
C. Add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP)
1. Member is 18 years of age and over; AND
2. There is information indicating the patient’s diagnosis was confirmed by ONE of the following:
a. Anterior rhinoscopy or endoscopy OR
b. Computed tomography (CT) of the sinuses; AND
3. Member has ongoing symptoms of nasal congestion/blockage/obstruction with moderate to severe symptom severity and has another symptom such as loss of smell, rhinorrhea (anterior/posterior), etc. AND
4. Member meets ONE of the following:
a. The patient had an inadequate response to sinonasal surgery OR
b. The patient is NOT a candidate for sinonasal surgery OR
c. The patient has tried and had an inadequate response to oral systemic corticosteroids in the past 90 days OR
d. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL oral systemic corticosteroids; AND
5. Member meets ONE of the following:
a. The patient has tried and had an inadequate response to intranasal corticosteroids (e.g., fluticasone, Sinuva) for at least a 3-month trial OR
b. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL intranasal corticosteroids; AND
6. The patient will continue standard maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with the requested agent AND
7. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., otolaryngologist, immunologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
8. The requested drug will be administered in an office/outpatient setting by a healthcare professional or home infusion by a home-health nurse and is there is documentation that member will not be self-administering. Documentation must be provided stating the member is unable to self-administer due to one of the following reasons:
· Member has a history of anaphylaxis to prior therapy with a related pharmacologic or biologic agent despite standard premedication; or
· Member is unable to successfully self-administer with proper technique due to a motor/dexterity condition; or
· Member has acute mental status/cognitive changes or physical impairment due to another condition; or
· Member has in the past demonstrated compliance issues and therefore needs medical supervision to adequately receive the drug; or
· Member has clinically diagnosed needle phobia (supported by documentation including a psychiatric evaluation) and therefore cannot self-administer; or
· Member’s age prohibits them to successfully administer the medication and their medications cannot adequately be managed by a caregiver

· Step 1:
o Preferred controller: as-needed low-dose ICS-formoterol
o Alternative options: as needed ICS taken at the same time as a short acting b-agonist (SABA)
· Step 2:
o Preferred controller: daily low dose ICS plus as needed SABA or as needed low dose ICS-formoterol
o Alternative options: Leukotriene receptor antagonist (LTRA) or as needed ICS taken at the same time as a SABA
o LTRA are less effective than ICS, particularly for preventing exacerbations
· Step 3:
o Preferred controller: daily low dose ICS/LABA plus as needed SABA, or low dose ICS-formoterol as maintenance and reliever therapy
o Alternative options: Medium dose ICS maintenance or low dose ICS plus either LTRA or sustained release theophylline
· Step 4:
o Preferred controller: low dose ICS-formoterol as maintenance and reliever therapy or daily medium dose ICS/LABA plus as needed SABA
o Alternative options: High dose ICS, add-on tiotropium, LTRA or sustained release theophylline
· Step 5:
o Refer patients for phenotypic assessment and consideration of add on therapy (e.g., tiotropium, anti-IgE, anti-IL5/5R, anti-IL4R)
o Preferred controller: high dose ICS/LABA
o Alternative options that may be considered after optimization of existing therapy: add-on tiotropium; Add low dose oral corticosteroids (OCS), but consider side effects; Add on anti-IgE, anti-IL5/5R, or anti-IL4R
· Reliever therapy:
o Preferred: ICS-formoterol
o Alternative: SABA

Therapeutic Class	Examples (not all inclusive)
Inhaled Corticosteroids	Pulmicort, Flovent, Alvesco, Qvar, Advair, Dulera, Symbicort
LABA	Foradil, Serevent, Advair, Dulera, Symbicort
LAMA	Spiriva
LTRA	Singulair, Accolate

1. Atopic Dermatitis
a. Adults: 600 mg (two 300 mg dosing injections) subcutaneously followed by 300 mg subcutaneous injection given every other week.
b. Patients ages between 6 and 17 years old:
i. Between 15 to less than 30 kg: 600 mg (two 300 mg subcutaneous injections) initially followed by 300 mg subcutaneous injection every 4 weeks
i. Between 30 to less than 60 kg: 400 mg (two 200 mg subcutaneous injections) initially followed by 200 mg subcutaneous injection every other week
iii. Greater than or equal to 60 kg: 600 mg (two 300 mg subcutaneous injections) initially followed by 300 mg subcutaneous injection every other week
2. Asthma: 400 mg (two 200 mg injections) subcutaneously followed by 200 mg subcutaneous injection given every other week or 600 mg (two 300 mg injections) subcutaneously followed by 300 mg subcutaneous injection given every other week.
3. Chronic rhinosinusitis with nasal polyposis (CRSwNP): 300 mg subcutaneously every other week.
[INFORMATIONAL NOTE: As per the FDA approved package insert, DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT after training in subcutaneous injection technique using the pre-filled syringe. Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the “Instructions for Use".

Based on the FDA approved package insert, for patients with oral corticosteroids-dependent asthma, or with co-morbid moderate-to-severe atopic dermatitis for which Dupixent is indicated, start with an initial dose of 600 mg followed by 300mg given every other week.]

• The requested drug will be administered in an office/outpatient setting by a healthcare professional or home infusion by a home-health nurse and is there is documentation that member will not be self-administering. Documentation must be provided stating the member is unable to self-administer due to one of the following reasons:
  · Member has a history of anaphylaxis to prior therapy with a related pharmacologic or biologic agent despite standard premedication; or
  · Member is unable to successfully self-administer with proper technique due to a motor/dexterity condition; or
  · Member has acute mental status/cognitive changes or physical impairment due to another condition; or
  · Member has in the past demonstrated compliance issues and therefore needs medical supervision to adequately receive the drug; or
  · Member has clinically diagnosed needle phobia (supported by documentation including a psychiatric evaluation) and therefore cannot self-administer; or
  · Member’s age prohibits them to successfully administer the medication and their medications cannot adequately be managed by a caregiver
  Atopic Dermatitis
  1. Shown improvement from baseline such as reduction in flares or reduction/stabilization of affected body surface area:
  a. The member has reduction in symptoms such as pruritus, oozing, xerosis, crusting, lichenification; AND
  2. There is absence of unacceptable toxicity (e.g. conjunctivitis and keratitis, vasculitic rash, worsening pulmonary symptoms, parasitic infections, or hypersensitivity); AND
  3. The member will continue the use of emollients as part of maintenance therapy to prevent flares.
  Asthma:
  1. The member has had clinical response or disease stabilization with the requested agent as defined by ONE of the following:
  a. Increase in percent predicted Forced Expiratory Volume (FEV₁) from baseline OR
  b. Decrease in the dose of inhaled corticosteroids required to control the patient’s asthma OR
  c. Decrease in need for treatment with systemic corticosteroids due to exacerbations of asthma OR
  d. Decrease in number of hospitalizations, need for mechanical ventilation, or visits to urgent care or emergency room due to exacerbations of asthma
  AND
  2. There is absence of unacceptable toxicity (e.g. conjunctivitis and keratitis, vasculitic rash, worsening pulmonary symptoms, parasitic infections, or hypersensitivity); AND
  3. The member has ONE of the following:
  a. Currently treated and is compliant with standard therapy (e.g. inhaled corticosteroids, long-acting beta-2 agonist (LABA), leukotriene receptor antagonist (LRTA), long-acting muscarinic antagonist (LAMA), theophylline) within the past 90 days OR
  
  b. Has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL standard therapies
  
  Chronic rhinosinusitis with nasal polyposis (CRSwNP)
  1. The member has had clinical response or disease stabilization with the requested agent as defined by ONE of the following:
  a. Improvement in nasal obstruction/ congestion OR
  b. Improvement in loss of smell OR
  c. Decrease in amount of corticosteroid use OR
  d. Patient has not required surgery; AND
  2. There is absence of unacceptable toxicity (e.g. conjunctivitis and keratitis, vasculitic rash, worsening pulmonary symptoms, parasitic infections, or hypersensitivity) AND
  3. The patient will continue standard maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with the requested agent

Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.

**Note: Bullet 1 of the policy section referring to Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) does not apply for Medicare Advantage Products.

Per Local Coverage Article A53127 Self-Administered Drug Exclusion List, Dupilumab (Dupixent) is a self-administered drug. If a drug is SELF-ADMINISTERED by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage under Medicare Part B. Medicare covers drugs that are furnished “incident to” a physician’s service provided that the drugs are medically reasonable and necessary, approved by the Food and Drug Administration (FDA) and are not usually administered by the patients who take them. Medicare Advantage Products will cover Dupilumab (Dupixent) when administered by a licensed medical provider as part of a physician service when the Horizon BCBSNJ Medical policy criteria is met.

Local Coverage Article:Self-Administered Drug Exclusion List: (A53127). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370.

Medicaid Coverage

For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf

________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Dupilumab (Dupixent)
Dupixent (Dupilumab)
Atopic Dermatitis, Dupilumab (Dupixent) for

References:
1. Dupixent prescribing information. Regeneron Pharmaceutical Inc. Tarrytown, NY 10591. May 2020.

2. Eichenfield L, Tom W, Chamlin S, et al. Guidelines of care for the management of atopic dermatitis: Part 1: Diagnosis and Assessment of Atopic Dermatitis. J Am Acad Dermatol. 2014;70(2): 338–351.

3. Eichenfield L, Tom W, Berger T, 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;71(1):116-32. http://www.jaad.org/article/S0190-9622(14)01257-2/pdf

4. Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 1). NCT02277743. ClinicalTrials.gov.

5. Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 2). NCT02277769. ClinicalTrials.gov.

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Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

J3490
J3590