Pharmacy Prior Authorization Criteria

Exdensur (depemokimab) - PA, NF

Indications for Prior Authorization

Exdensur (depemokimab)

• For diagnosis of Severe eosinophilic asthma
  Indicated for the add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus.

Criteria

Exdensur

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [A]

• Diagnosis of 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/microliter [B]
AND
• One of the following:
• Patient has had two or more asthma exacerbations requiring systemic corticosteroids (e.g., prednisone) within the past 12 months [C]
OR
• Prior asthma-related hospitalization within the past 12 months
AND
• 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: [D]
• 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
AND
• One of the following:
• Trial and failure, contraindication or intolerance to two of the following:
• Dupixent (dupilumab)
• Fasenra (benralizumab)
• Nucala (mepolizumab)
• Tezspire (tezepelumab-ekko)
OR
• For continuation of prior therapy, defined as no more than a 45-day gap in therapy

Exdensur

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., reduction in clinically significant exacerbations requiring systemic corticosteroids)
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

Exdensur

Non Formulary

Length of Approval: 6 Months [A]

• Submission of medical records (e.g., chart notes) confirming diagnosis of severe asthma
AND
• Submission of medical records (e.g., chart notes) confirming asthma is an eosinophilic phenotype as defined by a baseline (pre-treatment) peripheral blood eosinophil level greater than or equal to 150 cells/microliter [B]
AND
• Submission of medical records (e.g., chart note) confirming one of the following:
• Patient has had two or more asthma exacerbations requiring systemic corticosteroids (e.g., prednisone) within the past 12 months [C]
OR
• Prior asthma-related hospitalization within the past 12 months
AND
• Patient is 12 years of age or older
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications: [D]
• 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
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming one of the following:
• Trial and failure, contraindication or intolerance to two of the following:
• Dupixent (dupilumab)
• Fasenra (benralizumab)
• Nucala (mepolizumab)
• Tezspire (tezepelumab-ekko)
OR
• Continuation of prior therapy, defined as no more than a 45-day gap in therapy

P & T Revisions

2026-02-04

References

1. Exdensur Prescribing Information. GlaxoSmithKline, LLC. Philadelphia, PA. December 2025.
2. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention 2025. www.ginasthma.org. Accessed January 2026.

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End Notes

1. The 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.
2. Inclusion criteria in the SWIFT-1 pivotal trial required an elevated peripheral blood eosinophil count of >=300 cells/microliter (mcL) demonstrated in the past 12 months prior to Visit 1 OR an elevated peripheral blood eosinophil count of >=150 cells/mcL at screening.
3. In two replicate 52-week studies, eligible patients were required to have 2 or more asthma exacerbations requiring treatment with systemic corticosteroids (SCS) in the prior year while on background asthma therapy consisting of a medium to high dose ICS plus at least one additional asthma controller with or without maintenance oral corticosteroids (OCS).
4. While the clinical trial inclusion criteria only required patients to be on medium-high dose inhaled ICS, the 2025 GINA guidelines define severe asthma as asthma that remains uncontrolled despite optimized treatment with high-dose ICS-LABA, or that requires high dose ICS-LABA to prevent it from becoming uncontrolled.

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Revision History

• 2026-02-04: New Program.

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