Tezepelumab-ekko (Tezspire) — Notification (coverage criteria)
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Defines medical necessity, initial and continuation authorization, site-of-care criteria, dosing limits, and documentation requirements for tezepelumab-ekko (Tezspire) for patients ≥12 years with severe asthma or CRSwNP; applies to providers requesting administration by a healthcare professional. Affects Blue Cross NC members and treating clinicians.
For CRSwNP indication: diagnostic requirement of at least 2 inadequately controlled symptoms for ≥12 consecutive weeks and requirement for diagnostic confirmation by anterior rhinoscopy, nasal endoscopy, or sinus CT imaging.
For CRSwNP continuation criteria: added requirement for documented demonstration of positive clinical response.
Asthma exacerbation history language reformatted for clarity without changing intent.
HCPCS code J2356 and dosing reference (210 mg SC every 4 weeks) with a maximum units value listed.
Coverage and Medical Necessity Criteria
Initial and Continuation Therapy Criteria
Covered when ALL of the following are met for the indicated condition and setting:
Initial Approval for Severe Asthma
- Age: Patient is 12 years of age or older>=12
- Evidence of uncontrolled disease: History of inadequately controlled asthma despite adherence to asthma control therapy as demonstrated by ONE of: (1) Two or more severe asthma exacerbations requiring systemic corticosteroid bursts in the past 12 months; OR (2) One or more serious exacerbation requiring hospitalization, mechanical ventilation, emergency room or urgent care visit in the past 12 months; OR (3) Controlled asthma that worsens when inhaled and/or systemic corticosteroids are tapered; OR (4) Baseline (pre-therapy) FEV1 < 80% predicted
Medical record documentation required
- Current treatment: Currently treated with and adherent to maximally tolerated conventional therapies to include BOTH: (1) an inhaled corticosteroid regimen for the past 3 months (or documented contraindication/intolerance to all ICS); AND (2) a regimen containing either a LABA, LTRA, LAMA, theophylline, or zileuton for the past 3 months (or documented contraindication/intolerance to all those classes)
Medical record documentation required
- Concomitant therapy: Will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with tezepelumab
- Prescriber is a relevant specialist or has consulted with one (e.g., allergist, immunologist, pulmonologist)
- No combination biologic: Will not receive tezepelumab in combination with another biologic immunomodulator for the same indication
Examples listed in policy
- Administration reason: Patient has a physical or cognitive limitation that makes self-administration unsafe or not feasible, demonstrated by BOTH: (a) inability to self-administer AND (b) lack of caregiver/support
Medical record documentation required
- Quantity and site-of-care: Requested quantity does not exceed maximum units allowed and site-of-care criteria apply for inpatient/outpatient hospital administration
See Site of Care Medical Necessity Criteria
Initial Approval for CRSwNP
- Age: Patient is 12 years of age or older>=12
- Symptoms: At least TWO inadequately controlled symptoms consistent with chronic rhinosinusitis for at least 12 consecutive weeks prior to therapy: nasal obstruction/blockage/congestion; nasal discharge (rhinorrhea/post-nasal drainage); facial pain/pressure; or reduction/loss of smell>=2 symptoms for >=12 weeks
- Diagnostic confirmation: Diagnosis confirmed by ONE of: anterior rhinoscopy, nasal endoscopy, or CT of the sinuses
Medical record documentation required
- Prior procedures or candidacy: Either prior surgery for nasal polyps OR documentation that the patient is not a candidate for sinus surgery
Medical record documentation required
- Prior medical therapy: Either tried and had inadequate response to intranasal corticosteroid therapy for at least 4 consecutive weeks within 12 weeks prior to initiation OR intolerance/hypersensitivity to intranasal corticosteroid OR clinical contraindication to ALL intranasal corticosteroids>=4 weeks trial when applicable
Medical record documentation required
- Concomitant therapy: Will continue intranasal corticosteroid therapy where applicable or has contraindication/intolerance to all intranasal corticosteroids
- Prescriber is a relevant specialist or has consulted with one (e.g., otolaryngologist)
- No combination biologic: Will not receive tezepelumab in combination with another biologic immunomodulator for the same indication
Examples listed in policy
- Administration reason: Physical/cognitive limitation to self-administration must be documented if requesting administration by a healthcare professional
Medical record documentation required
Continuation Criteria for Severe Asthma
- Clinical response: Demonstrated improvement or stabilization from baseline indicated by ONE or more: increased percent predicted FEV1; decreased rescue medication use; decreased frequency of exacerbations; OR reduction in asthma-related symptoms (e.g., awakening symptoms, cough, shortness of breath, wheeze)
Medical record documentation required
- Ongoing therapy: Currently treated and compliant with asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline)
- Specialist and no combination biologic: Prescriber is a specialist or consulted specialist and patient will not be on another biologic for same indication
- Administration and quantity: Physical/cognitive limitation documented if applicable, requested quantity within maximum units, and site-of-care criteria apply
Site of Care Medical Necessity Criteria
Site-of-Care Specific Criteria (applies when request is for injection/infusion in a facility):
Details listed in policy
Tezepelumab-ekko (Tezspire) is not indicated for relief of acute bronchospasm or status asthmaticus and should not be used for emergency treatment of acute asthma exacerbations.
Requests for administration in an inpatient or outpatient hospital setting must meet the policy's Site of Care Medical Necessity Criteria. If the Site of Care Criteria are not met and the injection/infusion could be provided in a lower-acuity setting (for example, home-based infusion or physician office), the request for inpatient or outpatient hospital administration may not be authorized and may be redirected to a lower-acuity site of care.
For approved administrations in facility settings, documentation that the patient has a physical or cognitive limitation preventing safe self-administration and lack of caregiver support is required when requesting healthcare-professional administration. The requested quantity must also not exceed the policy maximum units for the approval period.
Billing Codes and Dosing Limits
| J2356 | tezepelumab-ekko (Tezspire) subcutaneous injection |
Provider Requirements, Authorization, and Documentation
Prior Authorization Required
Prior authorization is required. Approval duration is 365 days. FDA dosing: 210 mg subcutaneous every 4 weeks. Provider must not bill for combination use with another biologic immunomodulator for the same indication. HCPCS billing guidance: J2356. Maximum units for the approval period must not be exceeded.
- Prior authorization required for initial and continuation therapy; duration = 365 days.
- FDA dosing: 210 mg SC every 4 weeks.
- HCPCS: J2356.
- Maximum units limit applies (see dosing table); do not exceed 2,730 units for approval period.
- Do not co-administer with another biologic immunomodulator for the same indication (e.g., benralizumab, depemokimab, dupilumab, mepolizumab, omalizumab, reslizumab).
Step Therapy Requirements
Step therapy / prior or concurrent treatment requirements apply. For asthma, members must be currently treated with and adherent to maximally tolerated conventional therapies. For CRSwNP, members must have tried and had inadequate response to an intranasal corticosteroid for at least 4 consecutive weeks within 12 weeks prior to initiation unless intolerant or contraindicated.
- Asthma: Documented adherence to an inhaled corticosteroid regimen (e.g., ICS or ICS/LABA) for the past 3 months.
- Asthma: Use of additional controller(s) as appropriate — LABA, LTRA, LAMA, theophylline, or zileuton for the past 3 months unless intolerant/contraindicated.
- CRSwNP: Trial of intranasal corticosteroid for ≥4 consecutive weeks within 12 weeks prior to therapy initiation, unless intolerance/contraindication.
- If clinical intolerance/contraindication to ALL listed conventional therapies is present, medical record documentation must support this.
Documentation Requirements
Required medical record documentation must be submitted with the request. Documentation must confirm diagnosis, prior therapy trials/adherence, exacerbation history or objective measures, specialist involvement when required, and any limitations supporting non‑use of self‑administered formulations.
- For severe asthma: Evidence of inadequate control despite adherence to asthma control therapy demonstrated by ONE of: ≥2 steroid bursts in past 12 months; OR ≥1 serious exacerbation requiring hospitalization/ventilation/ED in past 12 months; OR worsening on corticosteroid taper; OR baseline FEV1 <80% predicted.
- Documentation of adherence to inhaled corticosteroid regimen for past 3 months and to additional controller therapy (LABA/LTRA/LAMA/theophylline/zileuton) for past 3 months, or documentation of clinical intolerance/contraindication to these therapies.
- For CRSwNP: Documentation of ≥2 inadequately controlled CRS symptoms for ≥12 consecutive weeks prior to initiation, and diagnostic confirmation by anterior rhinoscopy, nasal endoscopy, or sinus CT.
- For CRSwNP: Documentation of prior nasal polyp surgery OR documentation patient is not a surgical candidate.
- Documentation of trial and inadequate response to intranasal corticosteroid for ≥4 consecutive weeks within 12 weeks prior to initiation, or documented intolerance/contraindication to intranasal corticosteroids.
- Prescriber is a specialist (allergist, immunologist, pulmonologist, otolaryngologist) or specialist consultation is documented when required.
- Documentation that the patient will not receive the requested agent in combination with another biologic for the same indication.
- If requesting non–self-administered formulation, documentation of physical/cognitive limitation and lack of caregiver support (both required).
- For continuation requests: documentation of clinical benefit (reduced exacerbations, decreased rescue med use, improved symptoms or objective measures for CRSwNP) as applicable.
Background
Tezepelumab-ekko (Tezspire) is an FDA-approved monoclonal antibody indicated as add-on maintenance treatment for severe asthma and for inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 years and older. It is administered by subcutaneous injection at the FDA-recommended dose of 210 mg every 4 weeks (HCPCS J2356). Use is for maintenance therapy and it is not for acute bronchospasm or status asthmaticus. Administration by a healthcare professional may be required when self-administration is unsafe or infeasible.
Definitions and Diagnostic Criteria
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