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Pharmacy Medical Policy Injectable Asthma Medications Table of Contents • Related Polices

• Prior Authorization Information

• Summary • Policy

• Provider Documentation

• Individual Consideration • CPT /HCPCS / ICD Codes

• Policy History

• Forms

• References Policy Number: 017 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply to the following medications and can be found in Medical Policy #621A. • Medical Utilization Management (MED UM) & Pharmacy Prior Authorization Policy #033

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 3/15/2026 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☒ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason.

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We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.

Summary This is a comprehensive policy covering prior authorization and quantity limit requirements for injectable biologic agents used for the treatment of asthma and other related conditions.
Biologics are targeted therapies that yield better outcomes in specific patient types. They target key cells and mediators that drive inflammatory responses in the asthmatic lung. While most biologics use interleukin inhibition (IL-4, IL-5, and IL-13) to reduce eosinophils, Xolair and Tezspire target IgE and TSLP, respectively.
The variability observed in response to therapy with these biologics emphasize the necessity of accurate asthma typing, to facilitate a personalized treatment tailored for patients with high levels of inflammatory targets in the different subtypes of severe asthma. Biologics should only be considered for patients with the following characteristics Patients in whom: Who still have: Despite management with • Alternative diagnoses have been excluded • Comorbidities have been treated • Trigger factors have been removed (if possible) • Compliance with treatment has been monitored • poor asthma control • two or more exacerbations per year

• High-intensity asthma treatment • Systemic corticosteroids while maintaining adequate control

Tezspire is the only biologic approved for severe asthma with no phenotype (e.g., eosinophilic, or allergic) or biomarker limitation within its approved label. Policy Length of Approval 12 months Formulary Status All requests must meet the Prior Authorizations requirement. For all non-covered medications, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient.
Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug. Formulary status/requirements of the medications affected by this policy: Drug Formulary Status (BCBSMA Commercial Plan) Special Consideration Cinqair (reslizumab) Covered, PA

Fasenra (benralizumab) Covered, PA, QCD SPBO Nucala (mepolizumab) Covered, PA SPBO Tezspire (tezepelumab) Covered, PA,
SPBO Xolair (omalizumab) Covered, PA

PA – Prior Authorization; QCD – Quality Care Dosing (refer to policy #621b); SPBO: This medication is covered ONLY under the pharmacy benefit. (Refer to Policy 071)

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Prior Authorization Criteria
Cinqair Cinqair may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria are met:

1. A diagnosis of severe asthma; AND
2. Used as an add-on maintenance treatment; AND
3. Age  18 years; AND
4. Diagnosis of an eosinophilic phenotype, AND
5. The drug is prescribed by a board-certified or board-eligible Allergist or Dermatologist NOTE: Cinqair is NOT indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus. Coverage requests for these indications are considered NOT MEDICALLY NECESSARY and therefore not covered. Fasenra
   Fasenra may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria are met: I. Severe Asthma
6. A diagnosis of severe asthma, AND
7. Used as an add-on maintenance treatment, AND
8. Age  6 years, AND
9. The drug is prescribed by a board-certified or board-eligible Allergist or Pulmonologist, AND

10. Diagnosis of an eosinophilic phenotype.

    II. Eosinophilic Granulomatosis with Polyangiitis (EPGA) a. A diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA); AND b. Age  18 years

    NOTE: Fasenra is NOT indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus. Coverage requests for these indications are considered NOT MEDICALLY NECESSARY and therefore not covered Nucala
    Nucala may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria for each corresponding indication are met:

    I. COPD

11. A diagnosis of chronic obstructive pulmonary disease (COPD); AND
12. Used as an add-on maintenance treatment; AND
13. Age  18 years; AND
14. Diagnosis of an eosinophilic phenotype, AND
15. The drug is prescribed by a board-certified or board-eligible Allergist or Pulmonologist, AND
16. Inadequately controlled with current treatment

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II. Severe Asthma

1. A diagnosis of severe asthma; AND
2. Used as an add-on maintenance treatment; AND
3. Age  6 years; AND
4. Diagnosis of an eosinophilic phenotype, AND

5. The drug is prescribed by a board-certified or board-eligible Allergist or Pulmonologist

   III. Eosinophilic Granulomatosis with Polyangiitis (EPGA)

6. A diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA); AND

7. Age  18 years

   IV. Hypereosinophilic Syndrome (HES)

8. A diagnosis of hypereosinophilic syndrome (HES); AND
9. Age  12 years; AND

10. No identifiable non-hematologic secondary cause for at least 6 months

    V. Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

11. A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP), AND
12. Used as an add-on maintenance treatment, AND
13. Age  18 years, AND

14. Previous inadequate response to nasal corticosteroids Tezspire
    Tezspire may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria for each corresponding indication are met:

    I. Severe Asthma

15. A diagnosis of severe asthma, AND
16. Used as an add-on maintenance treatment, AND
17. Age  12 years, AND
18. The drug is prescribed by a board-certified or board-eligible Allergist or Pulmonologist II. Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
19. A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP), AND
20. Used as an add-on maintenance treatment, AND
21. Age  12 years, AND

22. Previous inadequate response to nasal corticosteroids

    NOTE: Tezspire is NOT indicated for the relief of acute bronchospasm or status asthmaticus. Coverage requests for this indication is considered NOT MEDICALLY NECESSARY and therefore not covered. Xolair
    Xolair may be considered MEDICALLY NECESSARY and covered when ALL of the following criteria for each corresponding indication are met:

    I. Moderate to Severe Asthma

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1. A diagnosis of allergic mediated moderate-to-severe asthma caused by perennial aeroallergen, AND
2. Age  6 years, AND
3. Asthma symptoms are not adequately controlled by > 3 months of continuous therapy of high dose inhaled steroids or oral steroids, AND
4. Positive skin test or in vitro testing for one or more perennial aeroallergen (ex: dust mites, mold, pet dander), AND
5. Patient is not receiving Xolair in combination with any of the following: Anti-interleukin 4 therapy [e.g., Dupixent (dupilumab)] Anti-interleukin 5 therapy [e.g., Nucala (mepolizumab), Cinqair (reslizumab), Fasenra (benralizumab)] Thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)]; AND
6. The drug is prescribed by a board-certified or board-eligible allergist or immunologist, pulmonologist or otorhinolaryngologist; AND

7. Recent IgE testing (defined as any time prior to treatment but within 6 months) within the below ranges: a. Age 6 -11 years old: IgE levels 30 to 1300 IU/mL b. Age 12 years and older: IgE levels 30 to 700 IU/mL Note: Initial authorization will be for no more than 12 months

   II. Chronic Idiopathic Urticaria (CIU)

8. A diagnosis of chronic idiopathic urticaria (CIU), AND
9. Age  12 years, AND
10. At least a 6-week history of urticaria (presence of hives), AND
11. Documented failure, contraindication, or intolerance to a four-week trial of one second- generation non-sedating histamine receptor type 1 (H1) antihistamine (ex: loratadine, cetirizine), AND
12. Patient is not receiving Xolair in combination with any of the following: Anti-interleukin 4 therapy [e.g., Dupixent (dupilumab)] Anti-interleukin 5 therapy [e.g., Nucala (mepolizumab), Cinqair (reslizumab), Fasenra (benralizumab)] Thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)]; AND
13. The drug is prescribed by a board-certified or board-eligible allergist or immunologist, pulmonologist or otorhinolaryngologist or Dermatologist, AND

14. Documented failure, contraindication, or intolerance to at least a two-week trial of ONE (1) of the following medications: a. Leukotriene receptor antagonist (ex: montelukast, zafirlukast), OR b. Histamine H2-receptor antagonist (ex: famotidine, ranitidine), OR
    c. First-generation (sedating) H1 antihistamine (ex: diphenhydramine, hydroxyzine), OR
    d. Substitution to a different second-generation non-sedating H1 antihistamine
    Note: Initial authorization will be for no more than 12 months

    III. Reduction of type I allergic reactions to food

15. A diagnosis of IgE-mediated food allergy, AND
16. Age  1 year, AND
17. Patient is not receiving Xolair in combination with any of the following: Anti-interleukin 4 therapy [e.g., Dupixent (dupilumab)]

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Anti-interleukin 5 therapy [e.g., Nucala (mepolizumab), Cinqair (reslizumab), Fasenra (benralizumab)] Thymic stromal lymphopoietin (TSLP) inhibitor [e.g., Tezspire (tezepelumab)]; AND

4. The drug is prescribed by a board-certified or board-eligible allergist or immunologist, pulmonologist or otorhinolaryngologist; AND
5. Xolair will be used in conjunction with food allergen avoidance, AND

6. Patient has been prescribed epinephrine for emergency treatment, AND

7. A. Patient has a documented IgE-mediated food allergy to at least one (1) of the following: a. Cashew b. Egg c. Hazelnut d. Wheat AND

   B. IgE-mediated food allergy to the specific food has been confirmed by both of the following: a) History of type I allergic reactions (e.g., nausea, vomiting, cramping, diarrhea, flushing, pruritus, urticaria, swelling of the lips, face or throat, wheezing, lightheadedness, syncope, anaphylaxis) within a short period of time following a known ingestion of the specific food; AND b) One (1) of following: i) Food specific skin prick testing (SPT), OR ii) IgE antibody in vitro testing, OR iii) Oral food challenge (OFC) OR

8. A. Patient has a documented IgE-mediated food allergy to at least one (1) of the following:
9. Milk
10. Peanut

11. Tree nuts AND B. IgE-mediated food allergy to the specific food has been confirmed by one (1) of the following: i. Food specific skin prick testing (SPT), OR ii. IgE antibody in vitro testing, OR iii. Oral food challenge (OFC)

    Note: Initial authorization will be for no more than 12 months

    IV. Nasal Polyps

12. A diagnosis of nasal polyps, AND
13. Age  18 years, AND
14. Concurrent use of nasal corticosteroids, AND

15. The drug is prescribed by a board-certified or board-eligible allergist or immunologist, pulmonologist or otorhinolaryngologist
    NOTE: Xolair is NOT covered except for the conditions listed above. Coverage requests for indications other than above is considered NOT MEDICALLY NECESSARY and therefore not covered. Initial authorization will be for no more than 12 months

    Prior Use Criteria The plan uses prescription claim records to support criteria for prior use within previous 130 days or the trial and failure of formulary alternatives when available. Additional documentation will be required from the provider when historic prescription claim data is either not available or the medication fill history fails to

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establish criteria for prior use or trial and failure of formulary alternatives. Documentation will also be required to support any clinical reasons preventing the trial and failure of formulary alternatives. Please see the section on documentation requirements for more information.
Provider Documentation Requirements
Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason.
Individual Consideration (For Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines.

Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to:

Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Phone: 1-800-366-7778 Fax: 1-800-583-6289

We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met.

CPT Codes / HCPCS Codes / ICD Codes

Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non- coverage as it applies to an individual member.

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Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity: HCPCS Codes HCPCS codes: Code Description J0517 Injection, benralizumab, 1 mg J2182 Injection, mepolizumab, 1 mg (Nucala ®) J2357 Injection, omalizumab, 5 mg (Xolair ™) J2786 Injection, reslizumab, 1 mg (Cinqair ®) ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description J44.9 Chronic obstructive pulmonary disease, unspecified J45.40 Moderate persistent asthma, uncomplicated J45.41 Moderate persistent asthma with (acute) exacerbation J45.42 Moderate persistent asthma with status asthmaticus J45.50 Severe persistent asthma, uncomplicated J45.51 Severe persistent asthma with (acute) exacerbation J45.52 Severe persistent asthma with status asthmaticus J45.901 Unspecified asthma with (acute) exacerbation J45.902 Unspecified asthma with status asthmaticus J45.909 Unspecified asthma, uncomplicated J45.991 Cough variant asthma J45.998 Other asthma

Policy History

Date Action 3/15/2026 Added expanded FDA indication for Tezspire. Removed drugs from Cotivity program. 9/15/2025 Added COPD as add-on treatment indication for Nucala. Updated Prior Authorization, Policy, and References. 1/2025 Clarified criteria for Xolair ‘s indication for reduction of type I allergic reactions to food, Urticaria, and Asthma and added Fasenra’s new indication. 10/2024 Updated Fasenra age limit. 8/2024 Updated prescriber requirements to the medications in the policy and dose and Frequency requirements. 10/2023 Reformatted Policy and updated IC to align with 118E MGL § 51A. 7/2023 Update to remove specialist requirement for Xolair. 4/2022 Updated to add Tezspire ™ to the policy. 8/2021 Updated to add New indication for Nucala ®. 1/2021 Updated to add new indication for Xolair ®. 10/2020 Updated to add new indication for Nucala ®. Removed deleted codes 4/2020 Updated criteria for Xolair on CIU diagnosis 11/2019 Updated age requirements for Nucala ®. 7/2019 Updated to add CinQair®, Nucala ®, and Fasenra™ to the Med UM program. 1/2019 Clarified coding information.

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4/2018 Clarified coding information. 2/2018 Updated to include Fasenra™ and a new indication for Nucala ®. 10/2017 Updated to clarify pediatric IgE levels. 6/2017 Update address for Pharmacy Operations. 1/2017 Updated to include New HCPCS/CPT codes. 10/2016 Updated to include CinQair® and allow all three medications to be billed on both Medical & Pharmacy. 6/2016 Updated to include Nucala® to Medical Only and changed the Policy Name. 7/2014 Updated to include ICD-10 and updated with new Indication CIU. 1/2014 Updated ExpressPAth language. 3/2012 Reviewed – Medical Policy Group - Allergy, Asthma, Immunology and ENT/Otolaryngology. No changes to policy statements.
11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
3/2011 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 3/2010 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 10/2009 Updated to reflect UM guidelines.
3/2009 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 3/2008 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 3/2007 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 9/2003 New policy, effective 9/2003, describing covered and non-covered indications.

Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434

References

1) Bernstein JA, Lang DM, Khan DA, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014 May;133(5):1270-7. 2) Buhl R, Hanf G, Solèr M, et al. The anti-IgE antibody omalizumab improves asthma-related quality of life in patients with allergic asthma. Eur Respir J. 2002;20:1088-1094. 3) Buhl R, Solèr M, Matz J, et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J. 2002;20:73-78. 4) Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184-190. 5) Cinqair ® [package insert]. Frazer, PA: Teva Pharmaceutical Industries Ltd; 03/2016. 6) Faserna ™ [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 09/2024. 7) Finn A, Gross G, van Bavel J, et al. Omalizumab improves asthma-related quality of life in patients with severe allergic asthma. J Allergy Clin Immunol. 2003;111(2):278-284. 8) Holgate S, Bousquet J, Wenzel S, Fox H, Liu J, Castellsague J. Efficacy of omalizumab, an anti- immunoglobulin E antibody, in patients with allergic asthma at high risk of serious asthma-related morbidity and mortality. Curr Med Res Opin. 2001;17(4):233-240. 9) Nucala ® [package insert]. Philadelphia, PA: GlaxoSmithKline LLC; 6/2025. 10) Solèr M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001;18:254-261.

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11) Xolair™ subcutaneous injection [package insert]. South San Francisco, CA and East Hanover, NJ:
Genentech, Inc. and Novartis Pharmaceuticals Corporation; 02/2024. 12) Tezspire [package insert]. Thousand Oaks, CA and Sodertalje Sweden: Amgen and AstraZeneca; 10/2025.