Tezspire (tezepelumab-ekko) coverage
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Defines prior authorization, coverage criteria, and utilization management for Tezspire (tezepelumab-ekko) as an add-on maintenance treatment for severe asthma and for chronic rhinosinusitis with nasal polyps across applicable Univera Healthcare lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Severe asthma — Initial therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Initial approval 6 months; recertifications 2 years; dosing 210 mg SC every 4 weeks.
inv-02: Chronic rhinosinusitis with nasal polyps (CRSwNP) — Initial therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Initial approval 6 months; recertifications 2 years; dosing 210 mg SC every 4 weeks.
Requests for Tezspire will be denied when there is concurrent use with other biologic therapies specified in the policy. Specifically, concurrent use with omalizumab (Xolair) or interleukin inhibitors (Adbry, Dupixent, Fasenra, Cinqair, Nucala) is not authorized and such combinations will not be approved.
Tezspire is only approved for subcutaneous (SC) administration. Administration by any other route is not authorized and requests for non‑subcutaneous administration will be denied.
If Tezspire treatment is started using manufacturer samples and the member does not meet the policy coverage criteria prior to the start of those samples, coverage will not be granted once the sample period is completed. Initiating therapy with samples does not substitute for meeting authorization requirements.
The policy notes that dosing guidance includes recommended ranges for inhaled corticosteroid regimens and accompanying products, and it explicitly states that some doses are outside the approved product information recommendations. Clinicians should refer to product labeling and apply clinical judgment when doses fall outside those recommendations.
In pediatric inhaled glucocorticoid tables the policy cautions that some doses may be outside approved package labeling, especially in the high‑dose range. When high‑dose regimens are considered, verify local product labeling and approval for the specific age group and formulation.
Tezspire is not indicated for acute rescue therapy. Use for relief of acute bronchospasm or status asthmaticus is not authorized and such requests will be denied under this policy.
Initial Authorization Criteria by Indication
inv-30: Initial therapy — Initial authorization criteria by indication
Initial authorization criteria by indication
Initial approval typically 6 months; dosing 210 mg SC every 4 weeks.
inv-31: ICS dose classification (Table 1) — Suggested total daily doses for low, medium, and high dose inhaled glucocorticoid regimens
Suggested total daily doses for low, medium, and high dose inhaled glucocorticoid regimens
Suggested doses based on GINA, NAEPP, and product labeling; clinician judgment required.
Recertification and Continuation Criteria
inv-32: Recertification — Recertification requirements and duration
Recertification requirements and duration
Recertification duration: 2 years.
Step Therapy Requirements
| Step | Required trial | Dose & duration | Compliance verification | Coverage status |
|---|---|---|---|---|
| 1 | ||||
| Documented inadequate response to mometasone nasal spray | ||||
| 2 sprays in each nostril twice daily for ≥3 months | ||||
| Pharmacy claims history reflecting expected supply (each inhaler = 17 g = 120 sprays; claims should reflect ~34 g/30 days for required dosing) | ||||
| Must fail before Tezspire is authorized |
| Step | Recommendation | Action when control achieved | Notes | Coverage status |
|---|---|---|---|---|
| 1 | ||||
| Use a stepwise dosing approach for initiation and adjustment of therapy | ||||
| After clinical control is achieved, titrate the dose to the minimum effective dose required to maintain control | ||||
| Clinician must monitor multiple clinical parameters and adjust dose accordingly; clinician judgment is primary determinant of appropriate dosing | ||||
| Neutral — guidance only; coverage contingent on meeting all indication-specific criteria |
Provider Actions & Documentation Requirements
Prior authorization required — submit specialty, diagnosis, prior trials, and labs
Prior authorization is required for initial approval. Submit documentation that the patient is managed by an allergist/immunologist or pulmonologist, the diagnosis (severe asthma or CRSwNP), prior therapy trials (including ≥3 months high‑dose ICS + controller for asthma or ≥3 months mometasone nasal spray and Xhance for CRSwNP where applicable), recent labs/clinical history (including eosinophil count when required), and any documentation needed for medical‑benefit requests (inability to self‑inject; caregiver inability for pediatric patients).
- Provider specialty: allergist/immunologist or pulmonologist for asthma; Allergist/Immunologist or Otolaryngologist for CRSwNP
- Prior therapy: ≥3 months high‑dose ICS with controller for asthma (compliance verified by pharmacy refill history)
- Labs/clinical: eosinophils <150 cells/µL measured within last 6 weeks (as required for severe asthma)
- Medical benefit requests: documentation of inability to self‑inject; pediatric patients require caregiver inability documentation
Policy header and dosing excerpt — refer to dosing (no PA codes listed)
This section contains the drug policy header and dosing excerpt describing Tezspire dosing (210 mg subcutaneously every 4 weeks) and formulation presentation; it does not list specific prior‑authorization codes. Use the dosing and product information when preparing authorization requests.
- Approved dosing: 210 mg SC once every 4 weeks
- Product forms: vial, prefilled syringe, prefilled pen (administration details in policy guidelines)
Verify HCPCS and prior‑authorization coding before billing
The policy includes a HCPCS section for billing but does not list specific codes in this excerpt; verify applicable codes and prior‑authorization code applicability against the member's contract and payer systems before billing.
- HCPCS header present but no codes listed in these pages
- Eligibility and code coverage are contract dependent — verify per member subscriber contract
CRSwNP step therapy — document ≥3 months compliant mometasone and Xhance trials
For new CRSwNP starts, document failed, compliant use of mometasone nasal spray (2 sprays each nostril twice daily) for ≥3 months AND failed, compliant use of Xhance (2 sprays each nostril twice daily) for ≥3 months; compliance must be verified via pharmacy claims (notes on expected claims volumes provided).
- Mometasone nasal spray: 2 sprays/nostril twice daily for ≥3 months; claims should reflect ~34 g/30 days for required dosing
- Xhance nasal spray: 2 sprays/nostril twice daily for ≥3 months; claims should reflect ~32 mL/30 days for required dosing
- Compliance verification: pharmacy claims history
Stepwise dosing — reduce to minimum effective dose after control
Follow a stepwise dosing approach: once control is achieved, clinicians should titrate the therapy down to the minimum effective dose necessary to maintain asthma control to reduce adverse effects.
- Clinician judgment is primary determinant of dosing; monitor response and adjust
- Titrate to the minimum dose required to maintain control
No other step therapy specified in this excerpt
The extracted policy text does not include additional explicit step‑therapy requirements beyond those specified for CRSwNP; no other step‑therapy sequences are provided in these chunks.
- Only CRSwNP step therapy (mometasone + Xhance) is specified in the excerpt
Documentation required — provider specialty and objective evidence of diagnosis/prior therapy
Authorization requests must include prescriber specialty (allergist/immunologist, pulmonologist, or otolaryngologist as applicable) and objective evidence of the diagnosis and prior therapies (e.g., exam/endoscopy/imaging for CRSwNP, pharmacy refill history for compliance, prior nasal surgery or systemic steroid course when required).
- Confirm specialty of ordering provider (allergist/immunologist, pulmonologist, or otolaryngologist)
- Attach objective diagnostic evidence for CRSwNP (exam, endoscopy, or imaging)
- Include pharmacy refill history or progress notes to verify compliance with prior therapies
Monitor response and titrate to minimum effective dose
Clinicians must monitor patient response on clinical parameters and adjust dosing accordingly, titrating to the minimum effective dose needed to maintain control to limit adverse effects.
- Monitor response (symptoms, exacerbations, rescue med use, polyp size/imaging as applicable)
- Adjust dose and titrate down once control is achieved
Read policy and verify coding — updates may outpace policy
Providers should read the full policy and guideline statements carefully before submitting requests; coding sections may be incomplete in the policy and AMA/CMS code updates can occur more frequently than policy updates, so verify codes separately.
- Policy text: codes may not be all‑inclusive; verify against current AMA/CMS updates
- Eligibility and coverage are contract dependent—refer to subscriber contract
Denial risk — concurrent biologics, non‑SC administration, or non‑FDA dosing
Requests will be denied for concurrent use with omalizumab (Xolair) or interleukin inhibitors (Adbry, Dupixent, Fasenra, Cinqair, Nucala); non‑subcutaneous administration, use for acute bronchospasm/status asthmaticus, or any non‑FDA dosing regimen are also not authorized.
- Concurrent biologic therapy with omalizumab or listed interleukin inhibitors is prohibited
- Administration routes other than subcutaneous will not be authorized
- Non‑FDA dosing regimens and use for acute bronchospasm/status asthmaticus are excluded
No additional authorization/denial criteria in this excerpt
The provided excerpt focuses on clinical dosing and criteria; it does not present a standalone set of explicit authorization or denial rules beyond the coverage criteria and exclusions already stated.
- Authorization/denial decisions rely on coverage criteria and exclusions in the policy rather than additional procedural rules in this excerpt
Coverage depends on member's benefit contract — verify eligibility and codes
Coverage and reimbursement are contingent on the member's subscriber contract; codes and coverage may vary by contract and may not be covered in all circumstances—verify eligibility and code applicability per the member's benefits.
- Eligibility for reimbursement depends on subscriber contract terms
- Verify whether codes and services are covered under the member's plan
Coding
Site of Care
Site of care — vial/PFS medical benefit; pen may be pharmacy or medical benefit
Tezspire vial and prefilled syringe are intended for administration by a healthcare provider and are covered under the medical benefit; the prefilled pen may be administered by patients/caregivers or providers and can be covered under the pharmacy or medical benefit.
- Vial/PFS: intended for provider administration — medical benefit
- Prefilled pen: may be administered by patient/caregiver or provider — pharmacy or medical benefit
Background
Asthma affects millions and an estimated 3–10% of patients have severe asthma. Thymic stromal lymphopoietin (TSLP) is an upstream epithelial‑cell–derived cytokine that plays a central role in initiating airway inflammation by activating multiple downstream effector pathways. Tezspire (tezepelumab‑ekko) is a human monoclonal antibody that binds to and blocks TSLP, and it is indicated as an add‑on maintenance treatment for severe asthma in patients aged ≥12 years and for chronic rhinosinusitis with nasal polyps in patients >12 years. By targeting TSLP, Tezspire acts upstream of multiple type 2 inflammatory pathways, potentially reducing exacerbations and improving control when used as part of background controller therapy.
Definitions
Revision History
Policy revised (most recent documented revision).
P&T Committee review and approval recorded.
Policy revised.
Policy revised.
Policy revised.
Policy revised.
P&T Committee review and approval recorded.
Policy revised.
Policy revised.
Reviewed with P&T Committee approval.
Policy revised.
Policy revised.
Policy revised.
Policy revised.
Policy revised.
P&T Committee approval recorded.
Policy revised (month listed as 08/2022).
Policy revised (month listed as 06/2022).
Policy created, P&T Committee approval and became effective.
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