Currentculinary health fundPolicy N/A

Immunologicals - Tezspire Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing, and exclusions for Tezspire for asthma and chronic rhinosinusitis with nasal polyps for members of Culinary Health Fund.

Policy Summary

Payerculinary health fund

PolicyImmunologicals - Tezspire Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeEarly annual revision — added CRSwNPrevised CRSwNP criteria

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document required supporting information (diagnosis confirmation, prior therapy, and symptom history) before initiating Tezspire.

SourceLink

POLICY UPDATE CHANGES

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) indication and criteria were added to the policy.

Requirement added that diagnosis of CRSwNP must have been present for at least 6 months.

Defined list of other monoclonal antibody therapies with which concurrent use is not recommended.

210 mg q4wapproved dosing

6 monthsinitial approval duration

1 yearrenewal approval

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Coverage and Medical Necessity Criteria

Asthma

Covered when ONE of the following (A or B) is met

Asthma - initial or current therapy

Initial Therapy (A): i. Patient is ≥ 12 years of age; AND ii. Patient has received at least 3 consecutive months of combination therapy with BOTH of the following: (a) an inhaled corticosteroid; AND (b) at least one additional asthma controller or asthma maintenance medication; AND iii. Patient has asthma that is uncontrolled or was uncontrolled at baseline as defined by ONE of: (a) two or more exacerbations requiring systemic corticosteroids in the previous year; OR (b) one or more exacerbation(s) requiring hospitalization, emergency department, or urgent care visit in the previous year; OR (c) FEV1 < 80% predicted; OR (d) FEV1/FVC < 0.80; OR (e) asthma worsens upon tapering of oral (systemic) corticosteroid therapy; AND iv. Medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist
Examples of additional asthma controller or maintenance medications provided; combination inhaler containing both an inhaled corticosteroid and additional controller counts for both
Currently Receiving (B): i. Patient has already received at least 6 months of therapy with Tezspire; AND ii. Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler; AND iii. Patient has responded to therapy as determined by the prescriber
Examples of response: decreased exacerbations/symptoms/hospitalizations, improved lung function, decreased oral corticosteroid requirement

Chronic Rhinosinusitis with Nasal Polyps

Covered when ONE of the following (A or B) is met

CRSwNP - initial or current therapy

Initial Therapy (A): i. Patient is ≥ 12 years of age; AND ii. Chronic rhinosinusitis with nasal polyps evidenced by direct examination, endoscopy, or sinus CT; AND iii. Diagnosis present for at least 6 months; AND iv. Patient has experienced two or more of the following symptoms for at least 8 weeks: nasal congestion, nasal obstruction, nasal discharge, and/or reduction/loss of smell; AND v. BOTH: (a) at least 4 weeks of intranasal corticosteroid therapy; AND (b) patient will continue intranasal corticosteroid concomitantly with Tezspire; AND vi. Patient meets ONE of: (a) received at least one course of systemic corticosteroid within the previous year (one course defined as ≥ 3 consecutive days of treatment or one long-acting injectable dose); OR (b) contraindication to systemic corticosteroid therapy; OR (c) prior surgery for nasal polyps; AND vii. Medication is prescribed by or in consultation with an allergist, immunologist, or otolaryngologist (ENT)
Selected revision added requirement that diagnosis be present for at least 6 months
Currently Receiving (B): i. Patient has already received at least 6 months of therapy with Tezspire; AND ii. Patient continues to receive intranasal corticosteroid therapy; AND iii. Patient has responded to therapy as determined by the prescriber
Examples of response: reduced polyp size, improved congestion, decreased sinonasal symptoms, improved sense of smell

Tezspire is not recommended for use in certain conditions and situations. Specifically, coverage is not recommended for atopic dermatitis (Tezspire is not indicated for this use), chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria, based on available trial evidence that did not demonstrate consistent benefit in these conditions. (See supporting trial summaries in the source document.)

Concurrent administration of Tezspire with other monoclonal antibody therapies is not recommended because the safety and efficacy of combined use have not been established. The policy lists the following agents as examples of monoclonal antibody therapies with which concurrent use is not recommended: Adbry (tralokinumab-ldrm), Cinqair (reslizumab), Dupixent (dupilumab), Ebglyss (lebrikizumab-lbkz), Fasenra (benralizumab), Nemluvio (nemolizumab-alto), Nucala (mepolizumab), and Xolair (omalizumab).

Coverage is also not recommended for circumstances not explicitly listed in the Recommended Authorization Criteria; requests for indications outside the policy’s specified asthma and CRSwNP criteria are subject to denial.

Use of Tezspire for indications not listed in the policy’s Recommended Authorization Criteria is considered not recommended for approval. Examples of non‑covered indications include atopic dermatitis, COPD, and chronic spontaneous urticaria.

Requests for Tezspire outside the listed criteria — including any other off‑label or unlisted conditions — lack supporting evidence of benefit per the cited trials and are subject to denial under this policy.

Product Codes and Authorization Durations

Product identifierNDC | mixed

tezepelumab-ekko

Tezspire subcutaneous injection (product name/biologic identifier) - AstraZeneca/Amgen

inv-06: Initial approval duration

Initial approval durationApprove for 6 months for initial therapy

Applies toNew starts for Asthma and CRSwNP meeting initial therapy criteria

Related noteA patient who has received < 6 months of therapy should be considered under Initial Therapy criteria

inv-07: Continuation approval duration

Continuation approval durationApprove for 1 year for patients currently receiving Tezspire who meet continuation criteria

Applies toCurrent users with ≥6 months of prior Tezspire therapy

Prior Authorization, Required Therapy, and Documentation

Prior Authorization

Prior Authorization and Approval Durations

Prior authorization is recommended. Initial approvals for FDA‑approved indications are generally for 6 months; continuation approvals (patients currently receiving therapy who meet continuation criteria) are typically for 1 year. Requests for doses or regimens outside the dosing documented in the policy will be reviewed case-by-case by a clinician. Initial approval requires prescription by or consultation with a specialist in the treated condition (e.g., allergist, immunologist, or otolaryngologist for CRSwNP).

Initial approval duration: 6 months
Continuation/renewal approval duration: 1 year
Specialist prescriber or consultation required for initial approval

Step Therapy

Required Prior / Concomitant Therapy

Required prior or concomitant therapies must be documented before approval. For asthma: the patient must have received at least 3 consecutive months of combination therapy with an inhaled corticosteroid AND at least one additional asthma controller or maintenance medication (examples: LABA, LAMA, or a biologic). Combination inhalers containing both an inhaled corticosteroid and an additional controller count for both requirements. For chronic rhinosinusitis with nasal polyps (CRSwNP): the patient must have received at least 4 weeks of intranasal corticosteroid therapy and must continue intranasal corticosteroid therapy concomitantly with Tezspire. For CRSwNP, evidence of at least one course of systemic corticosteroid within the previous year OR contraindication to systemic corticosteroids OR prior nasal polyp surgery must be documented.

Key Definitions

inv-13: Definition — Uncontrolled severe asthma

DefinitionUncontrolled severe asthma is asthma that is uncontrolled despite adherence to optimized high-dose ICS/LABA therapy or that worsens when high-dose treatment is decreased

Identification criteriaPoor symptom control (ACQ ≥1.5 or ACT <20), frequent severe exacerbations (≥2 systemic corticosteroid bursts in prior year), serious exacerbation(s) (≥1 hospitalization/ICU/mechanical ventilation in prior year), or airflow limitation (FEV1 <80% predicted)

Clinical contextAlso defined as asthma requiring high-dose ICS plus a second controller (and/or systemic corticosteroids) to prevent loss of control or remaining uncontrolled despite that therapy

inv-14: Definition — One course of systemic corticosteroid

Definition of one courseOne course of systemic corticosteroid is defined as ≥3 consecutive days of treatment or one long-acting injectable dose

Drug Background and Indications

Tezspire (tezepelumab‑ekko) is a monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), and is indicated as add‑on maintenance therapy for severe asthma in patients aged ≥12 years and for chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged ≥12 years. Clinical trials evaluated efficacy over 52 weeks with some benefits observed as early as 2–4 weeks.

Pivotal studies required that patients be receiving standard baseline therapies prior to initiation of Tezspire; the policy therefore defines specific prior/concomitant therapy and documentation requirements for both the asthma and CRSwNP indications to align coverage with the trial populations.