CurrentUnitedHealthcarePolicy N/A

Tezspire (tezepelumab) prior authorization for prefilled pen

Prior authorization and reauthorization rules for Tezspire prefilled pen (self-administration) under UnitedHealthcare pharmacy clinical programs for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Applies to covered members and providers submitting PA requests.

Policy Summary

PayerUnitedHealthcare

PolicyTezspire (tezepelumab) prior authorization for prefilled pen

Policy CodePolicy N/A

Change TypeAdded indicationupdated concomitant-use and site-of-care clarifications

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for the Tezspire prefilled pen and provide documentation of positive clinical response and that the drug is used as add-on maintenance therapy.

SourceLink

POLICY UPDATE CHANGES

Added criteria for the new indication of chronic rhinosinusitis with nasal polyps.

Updated statement on concomitant use restrictions throughout the policy.

Specified that the program applies to the prefilled pen for self-administration.

12 monthsAuthorization duration

≥12Indication age group

Prefilled penForm covered

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Coverage Criteria for Tezspire (tezepelumab)

Initial Therapy - Severe Asthma

Tezspire will be approved for severe asthma when ONE of the following two alternative sets is met:

Pathway 1: Established on Medical Benefit: (a) Patient has been established on therapy with Tezspire under an active UnitedHealthcare medical benefit prior authorization for the treatment of severe asthma; (b) Documentation of positive clinical response to Tezspire therapy; (c) Tezspire is being used as add-on maintenance therapy; (d) Patient is not receiving Tezspire in combination with any of the following for treatment of the same indication: anti-IL-5 agents (e.g., reslizumab, benralizumab, mepolizumab), anti-IgE therapy (e.g., omalizumab), or anti-IL-4 therapy (e.g., dupilumab).

Pathway 2: New initiation for severe asthma: (a) Diagnosis of severe asthma; (b) Tezspire is being used as add-on maintenance therapy; (c) Patient is not receiving Tezspire in combination with any of the following for treatment of the same indication: anti-IL-5 agents (e.g., reslizumab, benralizumab, mepolizumab), anti-IgE therapy (e.g., omalizumab), or anti-IL-4 therapy (e.g., dupilumab).

Initial Therapy - CRSwNP

Tezspire will be approved for CRSwNP when ONE of the following two alternative sets is met:

Pathway 1: Established on Medical Benefit for CRSwNP: (a) Patient has been established on therapy with Tezspire under an active UnitedHealthcare medical benefit prior authorization for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP); (b) Documentation of positive clinical response to Tezspire therapy; (c) Patient continues to receive Tezspire as add-on maintenance therapy in combination with another maintenance treatment for the same indication; (d) Patient is not receiving Tezspire in combination with any of the following for treatment of the same indication: anti-IL-5 agents (e.g., reslizumab, benralizumab, mepolizumab), anti-IgE therapy (e.g., omalizumab), or anti-IL-4 therapy (e.g., dupilumab).

Pathway 2: New initiation for CRSwNP: (a) Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP); (b) Patient has been unable to obtain symptom relief after previous therapies; (c) Patient will receive Tezspire as add-on therapy in combination with another maintenance treatment for the same indication; (d) Patient is not receiving Tezspire in combination with any of the following for treatment of the same indication: anti-IL-5 agents (e.g., reslizumab, benralizumab, mepolizumab), anti-IgE therapy (e.g., omalizumab), or anti-IL-4 therapy (e.g., dupilumab).

Initial Therapy — Consolidated initial authorization pathways

Initial authorization pathways for severe asthma and CRSwNP are described below; approval requires meeting ONE of the alternative pathways for the applicable indication.

Initial pathways: See the indication-specific initial authorization pathways for Severe Asthma and CRSwNP (each indication has two alternative pathways: established-on-medical-benefit with documented response OR new initiation with required add-on use and, for CRSwNP, prior therapy failure).

Use of Tezspire for relief of acute bronchospasm or status asthmaticus is excluded because this is not an indicated use.

Initial Authorization Requirements

Initial Therapy — Initial authorization pathways

Initial authorization pathways for severe asthma and CRSwNP as detailed in coverage criteria.

Initial pathways: Refer to the Severe Asthma and CRSwNP initial authorization criteria: each indication permits approval when ONE of two alternative sets of criteria is met (established on prior medical benefit with response OR new diagnosis with add-on use and CRSwNP prior therapy failure as applicable).

Reauthorization / Continuation Criteria

Reauthorization - Severe Asthma

Reauthorization for severe asthma requires all of the following:

Reauthorization criteria: (1) Documentation of positive clinical response to Tezspire therapy; (2) Tezspire is being used as add-on maintenance therapy; (3) Patient is not receiving Tezspire in combination with any of the following for treatment of the same indication: anti-IL-5 agents (e.g., reslizumab, benralizumab, mepolizumab), anti-IgE therapy (e.g., omalizumab), or anti-IL-4 therapy (e.g., dupilumab).

Reauthorization - CRSwNP

Reauthorization for CRSwNP requires all of the following:

Reauthorization criteria: (1) Documentation of positive clinical response to Tezspire therapy; (2) Patient will continue to receive Tezspire as add-on maintenance therapy in combination with another maintenance treatment for the same indication; (3) Patient is not receiving Tezspire in combination with any of the following for treatment of the same indication: anti-IL-5 agents (e.g., reslizumab, benralizumab, mepolizumab), anti-IgE therapy (e.g., omalizumab), or anti-IL-4 therapy (e.g., dupilumab).

Provider Documentation and Actions Required

Prior Authorization

Prior Authorization Required

Prior authorization required for Tezspire prefilled pen. Initial and reauthorization requests will be reviewed against the program criteria; authorization will be issued for 12 months when approved.

Program applies to the prefilled pen for self-administration
Authorization period: 12 months

Documentation Required

CRSwNP Prior Therapies and Initial Use

For CRSwNP initial therapy, patient must have a diagnosis of chronic rhinosinusitis with nasal polyps and documented inability to obtain symptom relief after previous therapies, and Tezspire must be prescribed as add-on therapy in combination with another maintenance treatment for the same indication. For patients already established on Tezspire under an active UnitedHealthcare medical benefit, documentation of that active authorization qualifies under initial criteria.

CRSwNP initial: diagnosis of chronic rhinosinusitis with nasal polyps

Prior Therapy and Step Requirements

Prior therapy	Required failure / inadequate response
Prior medical or surgical therapies for CRSwNP (e.g., topical intranasal corticosteroids, systemic corticosteroids, and prior sinonasal surgery)	Member has been unable to obtain symptom relief after previous therapies
Other maintenance biologics for the same indication (anti-IL-5 agents, anti-IgE, anti-IL-4)	Not eligible if receiving concomitant biologic therapy for the same indication; Tezspire must not be used in combination with listed biologics

Limitations of Use and Definitions

Limitations of use

Not an indicated useTezspire is not indicated for relief of acute bronchospasm or status asthmaticus.

Formulation coverage distinctionSingle‑dose vial and prefilled syringe for administration by a healthcare professional are typically covered under the medical benefit.

Prefilled pen coveragePrefilled pen is the formulation intended for self‑administration and is managed under the pharmacy clinical program.

Related medical benefit policyRefer to UnitedHealthcare Medical Benefit Drug Policy: Tezspire (tezepelumab‑ekko) for details on non‑pharmacy formulations and administration requirements.

Supply and Quantity Limits

Tezspire (tezepelumab‑ekko) prefilled pen — supply and program limits

Quantity/supply limitsSupply limitations may be in place for Tezspire (tezepelumab‑ekko) prefilled pen.

Potential medical necessity rulesMedical necessity reviews may be applied in addition to supply limits.

Automated approvalsUnitedHealthcare may approve initial and re‑authorization based on prior claim/medication history and diagnosis codes depending on program logic.

Site of Care and Benefit Design

Billing Rule

Site‑of‑care: pharmacy coverage for prefilled pen

The prefilled pen for self‑administration is covered under the pharmacy benefit; the single‑dose vial and prefilled syringe intended for administration by a healthcare professional are typically covered under the medical benefit.

Prefilled pen — pharmacy benefit (self‑administration)
Single‑dose vial and prefilled syringe — typically medical benefit (administration by HCP)

Background

Tezspire (tezepelumab) is an add-on maintenance biologic indicated for patients aged 12 years and older with severe asthma and for patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).