Last Review Date: 09/04/2025

Date of Origin: 12/04/2015

Dates Reviewed: 12/2015, 07/2016, 03/2017, 06/2017, 09/2017, 12/2017, 01/2018, 03/2018, 06/2018, 10/2018, 10/2019, 01/2020, 10/2020, 03/2021, 08/2021, 02/2022, 10/2022, 10/2023, 10/2024, 01/2025, 09/2025

1. Length of Authorization

• Initial: Prior authorization validity will be provided initially for 12 months, unless otherwise specified.
  • Severe Eosinophilic Asthma and CRSwNP: Prior authorization validity will be provided initially for 6 months.
•  Renewal: Prior authorization validity may be renewed every 12 months thereafter.

2. Dosing Limits

      Max Units (per dose and over time) [HCPCS Unit]:

Severe Eosinophilic Asthma

• 100 billable units every 28 days

EGPA

• 300 billable units every 28 days

Hypereosinophilic Syndrome

• 300 billable units every 28 days

CRSwNP

• 100 billable units every 28 days

COPD

• 100 billable units every 28 days

3. Initial Approval Criteria

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following:
   1. The requested agent is eligible for continuation of therapy AND ONE of the following:
      1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; OR
      2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; OR
   2. BOTH of the following:
      1. ONE of the following:
         1. The patient has a diagnosis of severe eosinophilic asthma and ALL of the following:
            1. The patient’s diagnosis has been confirmed by ONE of the following:
               1. The patient has a baseline (prior to therapy with the requested agent) blood eosinophil count of 150 cells/microliter or higher while on high-dose inhaled corticosteroids or daily oral corticosteroids; OR
               2. The patient has a fraction of exhaled nitric oxide (FeNO) of 20 parts per billion or higher while on high-dose inhaled corticosteroids or daily oral corticosteroids; OR
               3. The patient has sputum eosinophils 2% or higher while on high-dose inhaled corticosteroids or daily oral corticosteroids; AND
            2. The patient has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:
               1. Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months; OR
               2. Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months; OR
               3. Controlled asthma that worsens when the doses of inhaled and/or systemic corticosteroids are tapered; OR
               4. The patient has baseline (prior to therapy with the requested agent) Forced Expiratory Volume (FEV1) that is less than 80% of predicted; OR
         2. The patient has a diagnosis of chronic obstructive pulmonary disease (COPD) AND ALL of the following:
            1. The requested agent is FDA labeled or compendia supported for COPD; AND
            2. The patient's diagnosis was confirmed by spirometry with a post-bronchodilator FEV1/FVC ratio less than 0.7; AND
            3. The patient has an eosinophilic phenotype defined by a baseline (prior to therapy with the requested agent) blood eosinophil count of 300 cells/microliter or higher; AND
            4. ONE of the following:
               1. The patient has a history of inadequately controlled COPD while on COPD inhaled maintenance therapy as demonstrated by ONE of the following:
                  1. Frequent COPD exacerbations (i.e., 2 or more moderate exacerbations) requiring one or more courses of systemic corticosteroids within the past 12 months; OR
                  2. A severe COPD exacerbation requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months; OR
               2. The patient’s medication history indicates use of a biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of COPD within the past 12 months (treatment on samples is not approvable); OR
         3. The patient has a diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) and ALL of the following:
            1. The requested agent is FDA labeled or compendia supported for EGPA; AND
            2. ONE of the following:
               1. The patient has a baseline (prior to therapy for the requested indication) blood eosinophil count greater than or equal to 1000 cells/microliter; OR 
               2. The patient has a baseline (prior to therapy for the requested indication) blood eosinophil level greater than or equal to 10% eosinophils on white blood cell differential count; AND
            3. The patient has a history or presence of asthma; AND
            4. The patient does NOT have severe disease with organ- or life-threatening manifestations (e.g., alveolar hemorrhage, glomerulonephritis, central nervous system vasculitis, mononeuritis multiplex, cardiac involvement, mesenteric ischemia, limb/digit ischemia); AND
            5. ONE of the following:
               1. BOTH of the following:
                  1. The patient is currently treated within the past 90 days with oral corticosteroid (OCS) therapy for at least 4 weeks; AND
                  2. The patient will be using oral corticosteroid (OCS) therapy in combination with the requested agent; OR
               2. The patient has an intolerance or hypersensitivity to therapy with an oral corticosteroid (OCS); OR
               3. The patient has an FDA labeled contraindication to ALL oral corticosteroids; AND
            6. The patient will be using the requested agent for ONE of the following:
               1. Treatment of relapsing or refractory disease; OR
               2. Treatment for maintenance of disease remission; OR
         4. The patient has a diagnosis of hypereosinophilic syndrome (HES) and ALL of the following:
            1. The requested agent is FDA labeled or compendia supported for HES; AND
            2. The patient has had a diagnosis of HES for at least 6 months; AND
            3. The patient’s diagnosis of HES was confirmed by BOTH of the following:
               1. ONE of the following:
                  1. The patient has a peripheral blood eosinophil count of 1000 cells/microliter or greater; OR
                  2. The patient has a percentage of eosinophils in bone marrow section exceeding 20% of all nucleated cells; OR
                  3. The patient has marked deposition of eosinophil granule proteins found; OR
                  4. The patient has tissue infiltration by eosinophils that is extensive in the opinion of a pathologist; AND
               2. There has been evaluation of hypereosinophilia-related organ involvement (e.g., fibrosis of lung, heart, digestive tract, skin; thrombosis with or without thromboembolism; cutaneous erythema, edema/angioedema, ulceration, pruritis, or eczema; peripheral or central neuropathy with chronic or recurrent neurologic deficit; other organ system involvement such as liver, pancreas, kidney); AND
            4. The patient does NOT have an identifiable non-hematologic secondary (reactive) cause of HES (e.g., infection [e.g., HIV infection or parasitic helminth infection], allergy/atopy, medications [e.g., drug hypersensitivity], collagen vascular disease, metabolic [e.g., adrenal insufficiency], solid tumor/lymphoma [e.g., non-hematologic malignancy]); AND
            5. The patient does NOT have FIP1L1-PDGFRA-positive disease; AND
            6. The patient has a history of at least 2 HES flares within the past 12 months (i.e., worsening of clinical symptoms and/or blood eosinophil counts requiring an escalation in therapy); AND
            7. ONE of the following:
               1. The patient has tried and had an inadequate response to ONE of the following:
                  1. Oral corticosteroid (OCS) therapy; OR
                  2. Hydroxyurea; OR
                  3. Interferon-a; OR
                  4. Another immunosuppressive agent (e.g., cyclosporine, methotrexate); OR
               2. The patient has an intolerance or hypersensitivity to therapy with an oral corticosteroid, hydroxyurea, interferon-a, or an immunosuppressive agent (e.g., cyclosporine, methotrexate) used in the treatment of HES; OR
               3. The patient has an FDA labeled contraindication to hydroxyurea, interferon-a, and ALL oral corticosteroids and immunosuppressive agents (e.g., cyclosporine, methotrexate) used in the treatment of HES; OR
         5. The patient has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) AND ALL of the following:
            1. The requested agent is FDA labeled or compendia supported for CRSwNP; AND
            2. The patient has at least TWO of the following symptoms consistent with chronic rhinosinusitis (CRS): 
               1. Nasal discharge (rhinorrhea or post-nasal drainage) 
               2. Nasal obstruction or congestion
               3. Loss or decreased sense of smell (hyposmia)
               4. Facial pressure or pain; AND
            3. The patient has had symptoms consistent with chronic rhinosinusitis (CRS) for at least 12 consecutive weeks; AND
            4. The patient’s diagnosis was confirmed by ONE of the following:
               1. Anterior rhinoscopy or endoscopy; OR
               2. Computed tomography (CT) of the sinuses; AND
            5. ONE of the following:
               1. The patient has tried and had an inadequate response to ONE intranasal corticosteroid therapy (e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva) after at least a 4-week duration of therapy; OR
               2. The patient has an intolerance or hypersensitivity to ONE intranasal corticosteroid therapy (e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva); OR
               3. The patient has an FDA labeled contraindication to ALL intranasal corticosteroids; OR
         6. The patient has another FDA labeled indication for the requested agent and route of administration; AND
      2. If the patient has an FDA labeled indication, then ONE of the following:
         1. The patient’s age is within FDA labeling for the requested indication for the requested agent; OR
         2. There is support for using the requested agent for the patient’s age for the requested indication; OR
   3. The patient has another indication that is supported in compendia for the requested agent and route of administration; AND
2. If the patient has a diagnosis of severe eosinophilic asthma, then ALL of the following:
   1. ONE of the following:
      1. The patient is NOT currently treated with the requested agent AND is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months AND has been adherent for 90 days within the past 120 days; OR
      2. The patient is currently treated with the requested agent AND ONE of the following:
         1. The patient is currently treated with an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms AND has been adherent for 90 days within the past 120 days; OR
         2. The patient is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months AND has been adherent for 90 days within the past 120 days; OR
      3. The patient has an intolerance or hypersensitivity to therapy with an inhaled corticosteroid; OR
      4. The patient has an FDA labeled contraindication to ALL inhaled corticosteroids; AND
   2. ONE of the following:
      1. The patient is currently treated for at least 3 months AND has been adherent for 90 days within the past 120 days with ONE of the following:
         1. A long-acting beta-2 agonist (LABA); OR
         2. A long-acting muscarinic antagonist (LAMA); OR
         3. A leukotriene receptor antagonist (LTRA); OR
         4. Theophylline; OR
      2. The patient has an intolerance or hypersensitivity to therapy with a long-acting beta-2 agonist (LABA), a long-acting muscarinic antagonist (LAMA), a leukotriene receptor antagonist (LTRA), or theophylline; OR
      3. The patient has an FDA labeled contraindication to ALL long-acting beta-2 agonists (LABA) AND long-acting muscarinic antagonists (LAMA); AND
   3. The patient will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with the requested agent; AND
3. If the patient has a diagnosis of chronic obstructive pulmonary disease (COPD), then ALL of the following:
   1. ONE of the following:
      1. The patient is currently treated with an inhaled corticosteroid (ICS) for at least 3 months AND has been adherent for 90 days within the past 120 days; OR
      2. The patient has an intolerance or hypersensitivity to ONE inhaled corticosteroid; OR
      3. The patient has an FDA labeled contraindication to ALL inhaled corticosteroids; AND
   2. The patient is currently treated with a long-acting muscarinic antagonist (LAMA) AND a long-acting beta-2 agonist (LABA) used in combination (LAMA/LABA dual therapy) for at least 3 months AND has been adherent for 90 days within the past 120 days; AND
   3. The patient will continue COPD inhaled maintenance therapy (i.e., ICS/LAMA/LABA triple therapy, LAMA/LABA dual therapy) in combination with the requested agent; AND
4. If the patient has a diagnosis of hypereosinophilic syndrome (HES), then the patient will continue existing HES therapy (e.g., OCS, hydroxyurea, interferon-a, immunosuppressant) in combination with the requested agent; AND
5. If the patient has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP), then BOTH of the following:
   1. The patient is currently treated with standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]); AND
   2. The patient will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) in combination with the requested agent; AND
6. If the requested agent is Nucala vial, then BOTH of the following:

• Self administration requirement does not apply if patient is 12 years of age or younger.

6. 1. ONE of the following (reference table above):
      1. The patient has tried a self-administered trial product for the requested agent; OR
      2. There is support for the use of a provider-administered product over self-administered products; AND
   2. ONE of the following (reference table above):
      1. The requested agent does NOT require a preferred provider-administered trial product; OR
      2. The patient has tried a preferred provider-administered trial product for the requested agent; OR
      3. There is support for the use of the requested agent over ALL preferred provider-administered trial products; AND
7. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist, rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
8. ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 
   1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); OR
   2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent; AND
      2. There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required); AND
9. The patient does NOT have any FDA labeled contraindications to the requested agent; AND
10. The requested quantity (dose) is within FDA labeled dosing (or supported in compendia) for the requested indication

Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

4. Renewal Criteria

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Medical Drug Review process [Note: patients not previously approved for the requested agent will require initial evaluation review]; AND
2. ONE of the following:
   1. The patient has a diagnosis of severe eosinophilic asthma AND BOTH of the following:
      1. The patient has had improvements or stabilization with the requested agent from baseline (prior to therapy with the requested agent) as indicated by ONE of the following:
         1. Increase in percent predicted Forced Expiratory Volume (FEV1); OR
         2. Decrease in the dose of inhaled corticosteroids required to control the patient’s asthma; OR
         3. Decrease in need for treatment with systemic corticosteroids due to exacerbations of asthma; OR
         4. Decrease in number of hospitalizations, need for mechanical ventilation, or visits to urgent care or emergency room due to exacerbations of asthma; AND
      2. The patient is currently treated within the past 90 days and is compliant with asthma control therapy (e.g., inhaled corticosteroids [ICS], ICS/long-acting beta-2 agonist [ICS/LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], theophylline); OR
   2. The patient has a diagnosis of chronic obstructive pulmonary disease (COPD) AND BOTH of the following:
      1. The patient has had clinical benefit with the requested agent; AND
      2. The patient is currently treated within the past 90 days and is compliant with COPD inhaled maintenance therapy (i.e., inhaled corticosteroid [ICS]/long-acting muscarinic antagonist [LAMA]/long-acting beta-2 agonist [LABA] triple therapy, LAMA/LABA dual therapy); OR
   3. The patient has a diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) AND the patient has had improvements or stabilization with the requested agent from baseline (prior to therapy with the requested agent) as indicated by ONE of the following:
      1. Remission achieved with the requested agent; OR
      2. Decrease in oral corticosteroid maintenance dose required for control of symptoms related to EGPA; OR
      3. Decrease in hospitalization due to symptoms of EGPA; OR
      4. Dose of maintenance corticosteroid therapy and/or immunosuppressant therapy was not increased; OR
   4. The patient has a diagnosis of hypereosinophilic syndrome (HES) AND BOTH of the following:
      1. The patient has had improvements or stabilization with the requested agent from baseline (prior to therapy with the requested agent) as indicated by ONE of the following:
         1. Decrease in incidence of HES flares; OR
         2. Escalation of therapy (due to HES-related worsening of clinical symptoms or increased blood eosinophil counts) has NOT been required; AND
      2. The patient will continue existing HES therapy (e.g., OCS, hydroxyurea, interferon-a, immunosuppressant) in combination with the requested agent; OR
   5. The patient has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) AND BOTH of the following:
      1. The patient has had clinical benefit with the requested agent; AND
      2. The patient will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) in combination with the requested agent; OR
   6. The patient has a diagnosis other than severe eosinophilic asthma, COPD, EGPA, HES, or CRSwNP AND has had clinical benefit with the requested agent; AND
3. If the requested agent is Nucala vial, then BOTH of the following:

• Self administration requirement does not apply if patient is 12 years of age or younger.

3. 1. ONE of the following (reference table above):
      1. The patient has tried a self-administered trial product for the requested agent; OR
      2. There is support for the use of a provider-administered product over self-administered products; AND
   2. ONE of the following (reference table above):
      1. The requested agent does NOT require a preferred provider-administered trial product; OR
      2. The patient has tried a preferred provider-administered trial product for the requested agent; OR
      3. There is support for the use of the requested agent over ALL preferred provider-administered trial products; AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist, rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
5. ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 
   1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); OR
   2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent; AND
      2. There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required); AND
6. The patient does NOT have any FDA labeled contraindications to the requested agent; AND
7. The requested quantity (dose) is within FDA labeled dosing (or supported in compendia) for the requested indication

Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS Code:

• J2182 - Injection, mepolizumab, 1 mg; 1 billable unit = 1 mg

NDC(s):

• Nucala 100 mg/mL lyophilized powder single-dose vial: 00173-0881-xx
• Nucala 100 mg/mL single-dose prefilled autoinjector or syringe (cartons of 1): 00173-0892-xx
• Nucala 40 mg/0.4 mL single-dose prefilled syringe (cartons of 1): 00173-0904-xx

7. References

1. Nucala prescribing information. GlaxoSmithKline LLC. May 2025.
2. Chung KF, Wenzel SE, Brozek J, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. The European Respiratory Journal. 2014;43(2):343-373. doi:10.1183/09031936.00202013.
3. Louis R, Satia I, Ojanguren I, et al. European Respiratory Society guidelines for the diagnosis of asthma in adults. European Respiratory Journal. 2022;60(3):2101585. doi:10.1183/13993003.01585-2021.
4. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, 2024. Updated May 2024. Available from: https://ginasthma.org/.
5. Watanabe R, Hashimoto M. Eosinophilic Granulomatosis with Polyangiitis: Latest Findings and Updated Treatment Recommendations. Journal of Clinical Medicine. 2023;12(18):5996. doi:10.3390/jcm12185996.
6. Chung SA, Langford CA, Maz M, et al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody–Associated Vasculitis. Arthritis & Rheumatology. 2021;73(8):1366-1383. doi:10.1002/art.41773.
7. Grayson PC, Ponte C, Suppiah R, et al. 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology Classification Criteria for Eosinophilic Granulomatosis with Polyangiitis. Annals of the Rheumatic Diseases. 2022;81(3):309-314. doi:10.1136/annrheumdis-2021-221794.
8. Roufosse F, Kahn JE, Rothenberg ME, et al. Efficacy and safety of mepolizumab in hypereosinophilic syndrome: A phase III, randomized, placebo-controlled trial. Journal of Allergy and Clinical Immunology. 2020;146(6):1397-1405. doi:10.1016/j.jaci.2020.08.037.
9. Valent P, Klion AD, Horny HP, et al. Contemporary Consensus Proposal on Criteria and Classification of Eosinophilic Disorders and Related Syndromes. J Allergy Clin Immunol. 2012;130(3):607-612.
10. Shomali W, Gotlib J. World Health Organization‐defined eosinophilic disorders: 2022 update on diagnosis, risk stratification, and management. American Journal of Hematology. 2021;97(1):129-148. doi:10.1002/ajh.26352.
11. Klion AD. Approach to the patient with suspected hypereosinophilic syndrome. Hematology. 2022;2022(1):47-54. doi:10.1182/hematology.2022000367.
12. Kuang FL, Klion AD. Biologic Agents for the Treatment of Hypereosinophilic Syndromes. J Allergy Clin Immunol Pract. 2017;5(6):1502-1509.
13. Stevens WW, Schleimer RP, Kern RC. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016;4(4):565-572. doi:10.1016/j.jaip.2016.04.012.
14. Rank MA, Chu DK, Bognanni A, et al. The Joint Task Force on Practice Parameters GRADE guidelines for the medical management of chronic rhinosinusitis with nasal polyposis. J Allergy Clin Immunol. 2023;151(2):386-398. doi:10.1016/j.jaci.2022.10.026.
15. Wechsler ME, Akuthota P, Jayne D, et al. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. New England Journal of Medicine. 2017;376(20):1921-1932. doi:10.1056/nejmoa1702079.
16. Wechsler M, Nair P, Terrier B, et al. Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis. New England Journal of Medicine. 2024;390(10):911-921. doi:10.1056/nejmoa2311155.
17. Kostikas K, Brindicci C, Patalano F. Blood Eosinophils as Biomarkers to Drive Treatment Choices in Asthma and COPD. Curr Drug Targets. 2018 Dec;19(16):1882-1896.
18. Orlandi RR, Kingdom TT, Smith TL, et al. International consensus statement on allergy and rhinology: rhinosinusitis 2021. International Forum of Allergy & Rhinology. 2021;11(3):213-739. doi:10.1002/alr.22741.
19. Bourdin A, Brusselle G, Couillard S, et al. Phenotyping of severe asthma in the era of broad-acting anti-asthma biologics. The Journal of Allergy and Clinical Immunology in Practice. 2024;12(4):809-823. doi:10.1016/j.jaip.2024.01.023.
20. Emmi G, Bettiol A, Gelain E, et al. Evidence-Based Guideline for the diagnosis and management of eosinophilic granulomatosis with polyangiitis. Nature Reviews Rheumatology. 2023;19(6):378-393. doi:10.1038/s41584-023-00958-w.
21. Fokkens W, Lund VJ, Mullol J, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020;0(0):1-464. doi:10.4193/rhin20.600.
22. Fokkens WJ, Viskens A, Backer V, et al. EPOS/EUFOREA update on indication and evaluation of Biologics in Chronic Rhinosinusitis with Nasal Polyps 2023. Rhinology. 2023;0(0):194-202. doi:10.4193/rhin22.489.
23. Hellmich B, Sanchez-Alamo B, Schirmer JH, et al. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update. Annals of the Rheumatic Diseases. 2023;83(1):30-47. doi:10.1136/ard-2022-223764.
24. Nguyen L, Saha A, Kuykendall A, Zhang L. Clinical and therapeutic intervention of hypereosinophilia in the era of molecular diagnosis. Cancers. 2024;16(7):1383. doi:10.3390/cancers16071383.  
25. Valent P. Mepolizumab in hypereosinophilic syndromes: Proposed therapeutic algorithm. The Journal of Allergy and Clinical Immunology in Practice. 2022;10(9):2375-2377. doi:10.1016/j.jaip.2022.06.027.
26. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2025 Report). 2025. https://goldcopd.org/2025-gold-report/.

Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist

Non-quantitative treatment limitations (NQTLs) refer to the methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan. These may include things like utilization review or prior authorization. The utilization management NQTL applies comparably, and not more stringently, to mental health/substance use disorder (MH/SUD) Medical Benefit Prescription Drugs and medical/surgical (M/S) Medical Benefit Prescription Drugs. The table below lists the factors that were considered in designing and applying prior authorization to this drug/drug group, and a summary of the conclusions that Prime’s assessment led to for each.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A