ModifiedAnthemPolicy CC-0212

Medical Drug Clinical Criteria

Clinical prior authorization criteria for Tezspire (tezepelumab-ekko) as add-on maintenance treatment for individuals aged 12 years and older with severe asthma or chronic rhinosinusitis with nasal polyps (CRSwNP), including initial and continuation criteria, approval durations, quantity limits, and applicable codes.

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria

Policy CodePolicy CC-0212

Change TypeAdded CRSwNP criteria; quantity limit; wording updates

Effective DateJul 1, 2022

Next Review Date

Key ActionSubmit documentation to demonstrate age >=12, diagnosis (severe asthma or CRSwNP), required objective testing, prior therapy trials and exacerbation history as specified for prior authorization.

POLICY UPDATE CHANGES

Add clinical criteria for new indication for chronic rhinosinusitis with nasal polyps.

Select Review updating clinical criteria and administrative documentation.

Add quantity limit for Tezspire dosage form.

Update continuation criteria and wording/formatting changes.

2Covered Indications

1/28dQuantity Limit

6m / 12mApproval Durations

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Clinical prior authorization criteria for Tezspire (tezepelumab-ekko) as add-on maintenance treatment for individuals aged 12 years and older with severe asthma or chronic rhinosinusitis with nasal polyps (CRSwNP). Initial approval duration is 6 months; continuation approval duration is 12 months. Quantity limit: 1 prefilled syringe/vial per 28 days.

Key thresholds and quick facts

FEV1 percent predicted (pretreatment)< 80% predicted

FEV1 reversibility after albuterol>= 12% and >= 200 milliliters

Asthma exacerbations in prior 12 months>= 2 exacerbations requiring systemic corticosteroid or temporary increase in maintenance oral corticosteroids

Quantity limit1 prefilled syringe/vial per 28 days

Approval durationsInitial 6 months; Continuation 12 months

Initial Therapy Criteria — Severe Asthma

Initial Therapy for Severe Asthma

Initial requests for Tezspire for severe asthma may be approved if ALL of the following are met:

ALL of the following

Individual is 12 years of age or older
Individual has a diagnosis of severe asthma
Evidence of asthma is demonstrated by the following
- A pretreatment forced expiratory volume in 1 second (FEV1) less than 80% predictedFEV1 < 80% predicted (pretreatment)
  NAEPP 2008
- FEV1 reversibility of at least 12% and 200 milliliters after albuterol administrationFEV1 reversibility >= 12% and >= 200 mL after albuterol
  NAEPP 2008
Documentation is provided that individual has had a 3 month trial and inadequate response or intolerance to combination controller therapy (high dose inhaled corticosteroids plus long acting beta2-agonists, leukotriene modifiers, long-acting muscarinic antagonists or oral corticosteroids)3 month trial requirement
GINA 2024
Individual has experienced two or more asthma exacerbations in the prior 12 months requiring use of a systemic corticosteroid or temporary increase in the individual's usual maintenance dosage of oral corticosteroids>= 2 exacerbations in prior 12 months
ERS/ATS 2013

Continuation Therapy Criteria — Severe Asthma

Continuation Therapy for Severe Asthma

Continuation requests for Tezspire for severe asthma may be approved if ALL of the following are met:

ALL of the following

ALL of the following
- ONE of
  - Decreased utilization of reliever medications
  - Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in inhaled corticosteroid dose or treatment with systemic corticosteroids)
  - Increase in percent predicted FEV1 from pretreatment baseline
  - Reduction in reported asthma-related symptoms, including asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance or wheezing
Individual continues to use Tezspire in combination with inhaled corticosteroid-based controller therapy

Provider Actions & Billing

Prior Authorization

Prior authorization required with documentation

Submit documentation demonstrating age ≥12, the diagnosis of severe asthma or CRSwNP, and required objective testing: for asthma, pretreatment FEV1 <80% predicted and FEV1 reversibility ≥12% and ≥200 mL after albuterol; for CRSwNP, confirmation of nasal polyps by anterior rhinoscopy, nasal endoscopy, or CT. Also include documentation of trials and inadequate response or intolerance to listed therapies, and exacerbation history per criteria.

Include age and diagnosis
Asthma objective testing: pretreatment FEV1 <80% predicted and reversibility ≥12% and ≥200 mL after albuterol
CRSwNP objective testing: anterior rhinoscopy, nasal endoscopy, or CT
Document trials/inadequate response or intolerance to required therapies
Document asthma exacerbation history (≥2 exacerbations in prior 12 months requiring systemic corticosteroids)

Documentation Required

Document controller therapy trials

For asthma, document a 3 month trial with inadequate response or intolerance to combination controller therapy: high-dose inhaled corticosteroids plus long-acting beta2-agonists, leukotriene modifiers, long-acting muscarinic antagonists, or oral corticosteroids. For CRSwNP, document a trial and inadequate response to maintenance intranasal corticosteroids and prior systemic corticosteroids or sinonasal surgery, or documentation of ineligibility or intolerance to those options.

Asthma: 3 month trial of combination controller therapy (high-dose ICS + LABA; alternatives include leukotriene modifiers, LAMA, or oral corticosteroids)
CRSwNP: trial of maintenance intranasal corticosteroids plus prior systemic corticosteroids or sinonasal surgery, or documentation of ineligibility/intolerance

Billing Rule

Quantity limit

Quantity limit: 1 prefilled syringe/vial per 28 days for Tezspire 210 mg/1.91 mL (HCPCS J2356).

HCPCS: J2356
Tezspire formulation: 210 mg/1.91 mL prefilled pen/prefilled syringe/vial

Denial Risk

Contraindicated combinations

Claims may be denied if Tezspire is billed in combination with Cinqair, Dupixent, Fasenra, Nucala, or Xolair.

Contraindicated combinations: Cinqair, Dupixent, Fasenra, Nucala, Xolair

Prior Authorization

Approval duration

Approval durations: initial requests authorized for 6 months; continuation requests authorized for 12 months.

Initial approval: 6 months
Continuation approval: 12 months

Clinical Evidence

Key evidence includes the PATHWAY and NAVIGATOR randomized, double-blind, placebo-controlled trials establishing Tezspire efficacy in severe asthma, demonstrating reductions in exacerbations and improvements in asthma control and quality of life measures. For CRSwNP, a randomized, double-blind, placebo-controlled trial showed a statistically significant improvement in nasal polyp score (NPS) and nasal congestion score (NCS) at week 52. Guideline and society sources referenced for context include ERS/ATS, GINA, JTFPP, and AAO-HNS.

Background & Definitions

Tezspire (tezepelumab-ekko) is a thymic stromal lymphopoietin (TSLP)-blocking human monoclonal antibody (IgG2λ) that is FDA-approved as add-on maintenance therapy for adults and pediatric individuals aged 12 years and older with severe asthma and for inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Efficacy for severe asthma was established in two randomized, double-blind, placebo-controlled trials (PATHWAY, NAVIGATOR) showing reduced exacerbations and improved asthma control and quality of life. FDA approval for CRSwNP was supported by a randomized, double-blind, placebo-controlled trial in which Tezspire added to background nasal corticosteroids produced statistically significant greater improvement in nasal polyp score (NPS) and nasal congestion score (NCS) at week 52 compared with placebo.

Definitions:

• Severe asthma: Asthma requiring treatment with high-dose inhaled corticosteroids plus another controller for the previous year to prevent uncontrolled symptoms, or systemic corticosteroid treatment for >50% of the previous year (ERS/ATS).

• Uncontrolled asthma: Poor symptom control (ACQ >1.5 or ACT <20), frequent severe exacerbations (≥2 systemic corticosteroid bursts in prior year), history of serious exacerbation (hospitalization/ICU/mechanical ventilation), or airflow limitation (post-bronchodilator FEV1 <80% predicted).

Revision History

2022-07-01effective_date

Policy effective date added; initial coverage criteria and HCPCS J2356 and ICD-10-CM J45.50-J45.52 included per 7/1/2022 updates.

2023-02-24material_change

Quantity limit added: Tezspire 210 mg/1.91 mL prefilled pen/prefilled syringe/vial limited to 1 prefilled syringe/vial per 28 days.

2024-02-23annual_review

Annual review updated continuation criteria wording and formatting; guideline references updated (non-material).

2025-11-14material_changeLatest

Select review revision added clinical criteria for the new CRSwNP indication and administrative documentation updates; ICD-10-CM codes J32.0-J32.9 and J33.0-J33.9 were added.