Pharmacy Prior Authorization Criteria

Dupixent (dupilumab)

Indications for Prior Authorization

Dupixent (dupilumab)

• For diagnosis of Atopic Dermatitis (AD)
  Indicated for the treatment of adult and pediatric patients aged 6 months 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. Dupixent can be used with or without topical corticosteroids.

• For diagnosis of Asthma
  Indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.

  Limitations of use: Dupixent is not indicated for the relief of acute bronchospasm or status asthmaticus.

• For diagnosis of Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)
  Indicated as an add-on maintenance treatment in patients 12 years of age and older with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

• For diagnosis of Eosinophilic Esophagitis (EoE)
  Indicated for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).

• For diagnosis of Prurigo Nodularis (PN)
  Indicated for the treatment of adult patients with prurigo nodularis (PN).

• For diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  Indicated in COPD with evidence of type 2 inflammation.

Criteria

Dupixent

*Product may require step therapy

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Atopic Dermatitis

• Diagnosis of moderate to severe atopic dermatitis
AND
• One of the following:
• Involvement of at least 10% body surface area (BSA)
• SCORing Atopic Dermatitis (SCORAD) index value of at least 25 [A]
AND
• Trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to at least ONE of the following [2]:
• Medium or higher potency topical corticosteroid
• Pimecrolimus cream
• Tacrolimus ointment
• Eucrisa (crisaborole) ointment
AND
• Patient is 6 months of age or older
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Allergist/Immunologist

Dupixent

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Atopic Dermatitis

• Patient demonstrates a positive clinical response to therapy as evidenced by at least ONE of the following:
• Reduction in BSA involvement from baseline
• Reduction in SCORAD index value from baseline [A]

Dupixent

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [B]
For diagnosis of Eosinophilic Asthma

• Diagnosis of moderate to severe asthma
AND
• Asthma is an eosinophilic phenotype as defined by a baseline (pre-treatment) peripheral blood eosinophil level greater than or equal to 150 cells per microliter [C, D]
AND
• One of the following:
• Patient has had at least two or more asthma exacerbations requiring systemic corticosteroids (e.g., prednisone) within the past 12 months [4, 5, 7]
OR
• Prior asthma-related hospitalization within the past 12 months [4, 5, E]
AND
• One of the following:
• Both of the following:
• Patient is 6 years of age or older but less than 12 years of age
AND
• Patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications:
• Both of the following:
• Medium-dose inhaled corticosteroid (e.g., greater than 100 – 200 mcg fluticasone propionate equivalent/day)
• Additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium])
OR
• One medium dosed combination ICS/LABA product (e.g., Advair Diskus [fluticasone propionate 100mcg/ salmeterol 50mcg], Symbicort [budesonide 80mcg/ formoterol 4.5mcg] Breo Ellipta [fluticasone furoate 50 mcg/ vilanterol 25 mcg])
OR
• Both of the following:
• Patient is 12 years of age or older
AND
• Patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications:
• Both of the following:
• High-dose inhaled corticosteroid (ICS) (e.g., greater than 500 mcg fluticasone propionate equivalent/day)
• Additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium])
OR
• One maximally-dosed combination ICS/LABA product (e.g., Advair [fluticasone propionate 500mcg/ salmeterol 50mcg], Symbicort [budesonide 160mcg/ formoterol 4.5mcg], Breo Ellipta [fluticasone 200mcg/ vilanterol 25mcg])
AND
• Prescribed by or in consultation with one of the following:
• Pulmonologist
• Allergist/Immunologist

Dupixent

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Eosinophilic Asthma

• Patient demonstrates a positive clinical response to therapy (e.g., reduction in exacerbations, improvement in forced expiratory volume in 1 second [FEV1], decreased use of rescue medications)
AND
• Patient continues to be treated with an inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide) with or without additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium]) unless there is a contraindication or intolerance to these medications
AND
• Prescribed by or in consultation with one of the following:
• Pulmonologist
• Allergist/Immunologist

Dupixent

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [B]
For diagnosis of Oral Corticosteroid Dependent Asthma

• Diagnosis of moderate to severe asthma
AND
• Patient is currently dependent on oral corticosteroids for the treatment of asthma
AND
• One of the following:
• Both of the following:
• Patient is 6 years of age or older but less than 12 years of age
AND
• Patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications:
• Both of the following:
• Medium-dose inhaled corticosteroid (e.g., greater than 100 – 200 mcg fluticasone propionate equivalent/day)
• Additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium])
OR
• One medium dosed combination ICS/LABA product (e.g., Advair Diskus [fluticasone propionate 100mcg/ salmeterol 50mcg], Symbicort [budesonide 80mcg/ formoterol 4.5mcg] Breo Ellipta [fluticasone furoate 50 mcg/ vilanterol 25 mcg])
OR
• Both of the following:
• Patient is 12 years of age or older
AND
• Patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications:
• Both of the following:
• High-dose inhaled corticosteroid (ICS) (e.g., greater than 500 mcg fluticasone propionate equivalent/day)
• Additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium])
OR
• One maximally-dosed combination ICS/LABA product (e.g., Advair [fluticasone propionate 500mcg/ salmeterol 50mcg], Symbicort [budesonide 160mcg/ formoterol 4.5mcg], Breo Ellipta [fluticasone 200mcg/ vilanterol 25mcg])
AND
• Prescribed by or in consultation with one of the following:
• Pulmonologist
• Allergist/Immunologist

Dupixent

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Oral Corticosteroid Dependent Asthma

• Patient demonstrates a positive clinical response to therapy (e.g., reduction in exacerbations, improvement in forced expiratory volume in 1 second [FEV1], reduction in oral corticosteroid dose)
AND
• Patient continues to be treated with an inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide) with or without additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium]) unless there is a contraindication or intolerance to these medications
AND
• Prescribed by or in consultation with one of the following:
• Pulmonologist
• Allergist/Immunologist

Dupixent

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic rhinosinusitis with nasal polyposis (CRSwNP)

• Diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP)
AND
• Patient is 12 years of age or older
AND
• Unless contraindicated, the patient has had an inadequate response to 2 months of treatment with an intranasal corticosteroid (e.g., fluticasone, mometasone) [8, 9]
AND
• Used in combination with another agent for CRSwNP [F]
AND
• Prescribed by or in consultation with one of the following:
• Allergist/Immunologist
• Otolaryngologist
• Pulmonologist

Dupixent

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic rhinosinusitis with nasal polyposis (CRSwNP)

• Patient demonstrates a positive clinical response to therapy (e.g., reduction in nasal polyps score [NPS; 0-8 scale], improvement in nasal congestion/obstruction score [NC; 0-3 scale])
AND
• Used in combination with another agent for CRSwNP [F]
AND
• Prescribed by or in consultation with one of the following:
• Allergist/Immunologist
• Otolaryngologist
• Pulmonologist

Dupixent

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Eosinophilic Esophagitis (EoE)

• Diagnosis of eosinophilic esophagitis (EoE)
AND
• Patient has symptoms of esophageal dysfunction (e.g., dysphagia, food impaction, heartburn, abdominal pain) [13-15]
AND
• Patient has at least 15 intraepithelial eosinophils per high power field (HPF) [1, 13-15]
AND
• Other causes of esophageal eosinophilia have been excluded [13-15]
AND
• Both of the following:
• Patient is at least 1 year of age
• Patient weighs at least 15 kg
AND
• Trial and failure (of a minimum 8-week duration), contraindication, or intolerance to one of the following:
• Proton pump inhibitors (e.g., pantoprazole, omeprazole)
• Topical (esophageal) corticosteroids (e.g., budesonide, fluticasone)
AND
• Prescribed by or in consultation with one of the following:
• Gastroenterologist
• Allergist/Immunologist

Dupixent

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Eosinophilic Esophagitis (EoE)

• Patient demonstrates a positive clinical response to therapy as evidenced by improvement of at least one of the following from baseline [1, 13-15]:
• Symptoms (e.g., dysphagia, food impaction, heartburn, chest pain)
• Histologic measures (e.g., esophageal intraepithelial eosinophil count)
• Endoscopic measures (e.g., edema, furrows, exudates, rings, strictures)

Dupixent

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Prurigo Nodularis (PN)

• Diagnosis of prurigo nodularis (PN)
AND
• Patient has at least 20 nodular lesions
AND
• Trial and failure, contraindication, or intolerance to one medium or higher potency topical corticosteroid [16, 17]
AND
• Prescribed by or in consultation with one of the following:
• Allergist/Immunologist
• Dermatologist

Dupixent

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Prurigo Nodularis (PN)

• Patient demonstrates a positive clinical response to therapy as evidenced by at least ONE of the following:
• Reduction in the number of nodular lesions from baseline
• Improvement in symptoms (e.g., pruritus, inflammation) from baseline

Dupixent

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Chronic obstructive pulmonary disease (COPD)

• Diagnosis of chronic obstructive pulmonary disease (COPD )
AND
• Presence of Type 2 inflammation evidenced by blood eosinophils greater than or equal to 300 cells per microliter at baseline
AND
• Patient is receiving one of the following therapies at maximally tolerated doses
• Triple therapy (i.e., an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA)
• If ICS are contraindicated, a LAMA and a LABA
AND
• Patient must have post-bronchodilator forced expiratory volume [FEV1] / forced vital capacity [FVC] ratio less than 0.70
AND
• Patient has had one of the following within the past 12 months:
• At least two exacerbations where systemic corticosteroids [intramuscular, intravenous, or oral (e.g., prednisone)] were required at least once
OR
• COPD-related hospitalization
AND
• Patient experiences dyspnea during everyday activities (e.g., needs to stop for breath when walking on level ground) [G]

Dupixent

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic obstructive pulmonary disease (COPD)

• Patient demonstrates a positive clinical response to therapy (e.g., improved lung function, a reduction in COPD exacerbations)
AND
• Patient continues to receive one of the following therapies:
• Triple therapy (i.e., an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA)
• If ICS are contraindicated, a LAMA and a LABA

P & T Revisions

2024-11-25, 2024-10-18, 2024-09-27, 2024-08-02, 2024-05-21, 2024-03-06, 2023-08-22, 2023-08-22, 2023-04-26, 2022-11-20, 2022-07-14, 2022-05-13, 2022-04-07, 2022-03-03, 2021-12-01, 2021-11-01, 2021-08-03, 2021-05-25, 2021-03-01, 2020-06-29, 2020-02-06, 2019-12-31, 2019-12-02

References

1. Dupixent Prescribing Information. Sanofi-aventis U.S. LLC. Bridgewater, NJ. January 2024.
2. 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; 71(1):116-32.
3. Institute for Clinical and Economic Review (ICER). Biologic therapies for treatment of asthma associated with type 2 inflammation: effectiveness, value, and value-based price benchmarks. https://icer.org/wp-content/uploads/2020/10/ICER_Asthma-Final-Report_Unredacted_08122020.pdf. Published December 20, 2018. Accessed March 2, 2021.
4. Wenzel S, Castro M, Corren J, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high dose inhaled corticosteroids plus a long-acting B2 agonist: a randomized double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016;388:31-44.
5. Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018; 378(26):2486-96.
6. Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018; 378(26):2475-85.
7. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2023 update). 2023 www.ginasthma.org. Accessed April 2024.
8. Peters AT, Spector S, Hsu J, et al. Diagnosis and management of rhinosinusitis: a practice parameter update. Ann Allergy Asthma Immunol. 2014;113(4):347-85.
9. Orlandi RR, Kingdom TT, Hwang PH, et al. International consensus statement on allergy and rhinology: rhinosinusitis. Int Forum Allergy Rhinol. 2016 Feb; Suppl 1:S22-209.
10. European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis: the SCORAD index. Consensus report of the European Task Force on atopic dermatitis. Dermatology. 1993; 186:23-31.
11. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet 2017; 389(10086)(suppl):2287-2303.
12. Oranje AP. Practical issues on interpretation of scoring atopic dermatitis: SCORAD index, objective SCORAD, patient-oriented SCORAD and three-item severity score. Curr Probl Dermatol. 2011; 41:149-55.
13. Gonsalves NP, Aceves SS. Diagnosis and treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2020;145(1):1-7.
14. Hirano I, Chan ES, Rank MA, et al. AGA Institute and the Joint Task Force on allergy-immunology practice parameters clinical guidelines for the management of eosinophilic esophagitis. Gastroenterology. 2020;158:1776-86.
15. Dellon ES, Khoury P, Muir AB, et al. A clinical severity index for eosinophilic esophagitis: development, consensus, and future directions. Gastroenterology. 2022;1-18 [Epub ahead of print].
16. Williams KA, Huang AH, Belzberg M, et al. Prurigo nodularis: pathogenesis and management. J Am Acad Dermatol. 2020;83(6):1567-75.
17. Leis M, Fleming P, Lynde CW. Prurigo nodularis: review and emerging treatments. Skin Therapy Lett. 2021;26(3):5-8.
18. BOREAS trial | Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation | https://clinicaltrials.gov/study/NCT03930732
19. Modified Medical Research Council (mMRC) dyspnea scale | https://www.uptodate.com/contents/image?imageKey=PULM/86426
20. NOTUS trial | Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation | https://clinicaltrials.gov/study/NCT04456673?term=notus&rank=1

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End Notes

1. The Scoring Atopic Dermatitis (SCORAD) index is a clinical tool for assessing the severity of atopic dermatitis lesions based on affected body area and intensity of plaque characteristics. [10, 11] The extent and severity of AD over the body area (A) and the severity of 6 specific symptoms (erythema, edema/papulation, excoriations, lichenification, oozing/crusts, and dryness) (B) are assessed and scored by the Investigator. Subjective assessment of itch and sleeplessness is scored by the patient (C). The SCORAD score is a combined score (A/5 + 7B/2 + C) with a maximum of 103. Higher scores indicate greater severity/worsened state. A score of 25 to 50 indicates moderate disease severity and greater than 50 indicates severe disease. [12]
2. The Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention update recommends that patients with asthma should be reviewed regularly to monitor their symptom control, risk factors and occurrence of exacerbations, as well as to document the response to any treatment changes. Ideally, response to Type 2-targeted therapy should be re-evaluated every 3-6 months, including re-evaluation of the need for ongoing biologic therapy for patients with good response to Type 2 targeted therapy.
3. In AS Trial 2, reductions in exacerbations were significant in the subgroup of subjects with baseline blood eosinophils greater than or equal to 150 cells/mcL. In subjects with baseline blood eosinophil count less than 150 cells/mcL, similar severe exacerbation rates were observed between Dupixent and placebo. [1]
4. The Institute for Clinical and Economic Review (ICER) defines eosinophilic inflammation as a blood eosinophil level greater than or equal to 150 cells per microliter at initiation of therapy. This is the lowest measured threshold for eosinophilic asthma in pivotal trials. [3]
5. Recommendation inferred from the national P&T committee meeting, December 2015, regarding similar agent first-in-class IL-5 antagonist Nucala (mepolizumab) in the use of severe eosinophilic asthma.
6. Other agents used for CRSwNP include intranasal corticosteroids and nasal saline.
7. In the BOREAS trial, the inclusion criteria included a grade of greater than or equal to 2 on the Medical Research Council (MRC) Dyspnea Scale. [18,19]

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Revision History

• 2024-11-25: Nov P&T COPD: Addition of criterion 'Patient must have post-bronchodilator FEV1/FVC ratio less than 0.70' and removal of prescriber requirement.
• 2024-10-18: Removed criterion 4 of COPD criteria, asking for FEV1/ FVC ratio of less than 0.7 following P&T feedback. Updated trial options for PN. Addition of age criterion for CRSwNP due to age expansion.
• 2024-09-27: Addition of criteria for new indication of COPD.
• 2024-08-02: Addition of GPIs for Dupixent 200mg to EoE criteria.
• 2024-05-21: 2024 annual review. Background changes. Updated criteria language and formatting for asthma indication to align with other drugs within the class, including spliting the age criterion into two: a) 6-11 yrs old b)12 yrs plus, to allow for differences in optimal treatment. Updated EoE language to match Eohilia with no change to clinical intent.
• 2024-03-06: Updated criteria for Eosinophilic Esophagitis (EoE) as per FDA labelling update. Background updates.
• 2023-08-22: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-08-22: GPI clean up
• 2023-04-26: 2023 UM Annual Review. No criteria changes. Background updates
• 2022-11-20: Addition of criteria for prurigo nodularis
• 2022-07-14: Addition of criteria for eosinophilic esophagitis; updated atopic dermatitis age criterion to include patients 6 months or older, and added additional examples to define contraindication to the embedded step; updated the number of asthma exacerbations for eosinophilic asthma from one to two or more per the latest GINA guidelines definition of uncontrolled asthma
• 2022-05-13: Annual review - minor verbiage updates; background updates
• 2022-04-07: AD embedded step updated to include Eucrisa as an option and added minimum trial durations. Additional AD clinical criteria added to both initial and reauth sections, and initial approval reduced to 6 months to align with other systemic AD agents.
• 2022-03-03: March P&T Therapeutic Class Review - For asthma indications, included examples of systemic corticosteroid, LTRA, and LABA. Reauth criteria updated to better align with GINA 2021 guidelines on how to de-escalate patients who have positive response to biologic therapy.
• 2021-12-01: Updated age in asthma indications to include patients 6 years of age or older. Added new 100 mg strength.
• 2021-11-01: Updated CRSwNP criteria to align with Nucala
• 2021-08-03: Added new GPI for 200mg (175mg/ml) auto-injector (pre-filled pen) as target.
• 2021-05-25: Addition of EHB formulary. No changes to criteria
• 2021-03-01: Annual Review; updated criteria
• 2020-06-29: Updated indications and added new GPI for Dupxient 300 mg/2 mL pre-filled pen
• 2020-02-06: Annual Review; updated criteria
• 2019-12-31: GPI replication update (added 9027302000E515, removed 4460352000E530)
• 2019-12-02: Added option of otolaryngologist to CRSwNP indication to align with Med D guidelines (brought up as CMS review concern).

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