Tezepelumab-ekko (Tezspire)

Policy ID: I-9023-003

Section: Injections

Effective Date: April 01, 2022

Revised Date: May 18, 2023

Revision Effective Date: July 01, 2023

Last Reviewed: May 23, 2023

Applies To: Commercial and Medicaid Expansion

Description

Tezepelumab-ekko (Tezspire™) is a thymic stromal lymphopoietin (TSLP) blocker. TSLP is a cytokine derived from epithelial cells which occupies an upstream position in the asthma inflammatory cascade.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Initial Evaluation

Tezepelumab-ekko (Tezspire) may be considered medically necessary when an individual meets ALL of the following criteria:

ONE of the following:
- Information has been provided that indicates the individual has been treated with tezepelumab-ekko (Tezspire) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tezepelumab-ekko (Tezspire) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has an FDA labeled indication or a compendia supported indication for tezepelumab-ekko (Tezspire) AND ONE of the following:
  - The individual has a diagnosis of severe asthma AND ALL of the following:
    - The individual has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:
      - Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months; or
      - Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months; or
      - Controlled asthma that worsens when the doses of inhaled and/or systemic corticosteroids are tapered; or
      - The individual has baseline (prior to therapy with tezepelumab-ekko (Tezspire)) Forced Expiratory Volume (FEV1) that is less than 80% of predicted; and
    - ONE of the following:
      - The individual is NOT currently being treated with tezepelumab-ekko (Tezspire) AND is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months; or
      - The individual is currently being treated with tezepelumab-ekko (Tezspire) AND ONE of the following:
        Is currently treated with an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms; or
        Is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months; or
      - The individual has an intolerance or hypersensitivity to inhaled corticosteroid therapy; or
      - The individual has an FDA labeled contraindication to ALL inhaled corticosteroids; and
    - ONE of the following:
      - The individual is currently being treated for at least 3 months with ONE of the following:
        A long-acting beta-2 agonist (LABA); or
        A leukotriene receptor antagonist (LTRA); or
        Long-acting muscarinic antagonist (LAMA); or
        Theophylline; or
      - The individual has an intolerance or hypersensitivity to therapy with LABA, LTRA, LAMA, or theophylline; or
      - The individual has an FDA labeled contraindication to ALL LABA, LTRA, LAMA, AND theophylline therapies; and
    - ONE of the following:
      - If the individual has a diagnosis of allergic type asthma, then ONE of the following:
        The individual has tried and had an inadequate response to omalizumab (Xolair) used for a minimum of 4 months for the treatment of allergic asthma; or
        The individual has an intolerance or hypersensitivity to omalizumab (Xolair); or
        The individual has an FDA labeled contraindication to omalizumab (Xolair); or
      - If the individual has a diagnosis of oral corticosteroid dependent type asthma, then ONE of the following:
        The individual has tried and had an inadequate response to dupilumab (Dupixent) used for a minimum of 4 months for the treatment of asthma; or
        The individual has an intolerance or hypersensitivity to dupilumab (Dupixent); or
        The individual has an FDA labeled contraindication to dupilumab (Dupixent); or
      - If the individual has a diagnosis of eosinophilic type asthma, then ONE of the following:
        The individual has tried and had an inadequate response to dupilumab (Dupixent) AND an IL-5 inhibitor (e.g., benralizumab (Fasenra), mepolizumab (Nucala)) used for a minimum of 4 months for the treatment of asthma; or
        The individual has an intolerance or hypersensitivity to dupilumab (Dupixent) AND an IL-5 inhibitor; or
        The individual has an FDA labeled contraindication to dupilumab (Dupixent) AND IL-5 inhibitors; or
      - The prescriber has provided information indicating the individual has severe asthma that is not allergic type, eosinophilic type, or oral corticosteroid dependent type; and
    - The individual will continue asthma control therapy (e.g., ICS, LABA, LTRA, LAMA, theophylline) in combination with tezepelumab-ekko (Tezspire); or
  - The individual has a diagnosis other than asthma; and
If the individual has an FDA labeled indication, then ONE of the following:
- The individual is twelve (12) years of age or older; or
- The prescriber has provided information in support of using tezepelumab-ekko (Tezspire) for the individual's age for the requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., allergist, immunologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
ONE of the following (Please refer to 'Agents NOT to be used Concomitantly' table):
- The individual will NOT be using tezepelumab-ekko (Tezspire) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tezepelumab-ekko (Tezspire) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tezepelumab-ekko (Tezspire) does NOT limit the use with another immunomodulatory agent; and
  - The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).

Compendia Allowed: DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

The use of tezepelumab-ekko (Tezspire) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J2356

Reauthorization Criteria

Continuation of therapy with tezepelumab-ekko (Tezspire) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for tezepelumab-ekko (Tezspire) through Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has an FDA labeled indication or a compendia supported indication for tezepelumab-ekko (Tezspire) AND ONE of the following:
- The individual has a diagnosis of severe asthma AND BOTH of the following:
  - The individual has had improvements or stabilization with tezepelumab-ekko (Tezspire) from baseline (prior to therapy with tezepelumab-ekko (Tezspire)) as indicated by ONE of the following:
    - The individual has had an increase in percent predicted Forced Expiratory Volume (FEV1); or
    - The individual has had a decrease in the dose of inhaled corticosteroids required to control the individual's asthma; or
    - The individual has had a decrease in need for treatment with systemic corticosteroids due to exacerbations of asthma; or
    - The individual has had a decrease in number of hospitalizations, need for mechanical ventilation, or visits to urgent care or emergency room due to exacerbations of asthma; and
  - The individual is currently treated and is compliant with asthma control therapy [e.g., inhaled corticosteroids, long-acting beta-2 agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), theophylline]; or
- The individual has a diagnosis other than asthma AND the individual has had clinical benefit with tezepelumab-ekko (Tezspire); and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., allergist, immunologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
ONE of the following (Please refer to 'Agents NOT to be used Concomitantly' table):
- The individual will NOT be using tezepelumab-ekko (Tezspire) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tezepelumab-ekko (Tezspire) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tezepelumab-ekko (Tezspire) does NOT limit the use with another immunomodulatory agent; and
  - The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).

Compendia Allowed: DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

Procedure Codes

J2356

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

J45.50

J45.51

J45.52

Professional Statements and Societal Positions Guidelines

Agents NOT to be used Concomitantly

Adbry (tralokinumab-ldrm)

Actemra (tocilizumab)

Amjevita (adalimumab-atto)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Dupixent (dupilumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Humira (adalimumab)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Nucala (mepolizumab)

Olumiant (baricitinib)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Siliq (brodalumab)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Sotyktu (deucravacitinib)

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Zeposia (ozanimod)

ND Committee Review

Internal Medical Policy Committee 3-23-2022 Adopted new precertification drug policy effective April 1, 2022

Internal Medical Policy Committee 7-01-2022 Coding update - Effective July 01, 2022

Removed Procedure code: 3590
Added Procedure code J2356

Internal Medical Policy Committee 5-23-2023 - Effective July 01, 2023

Updated criteria
Removed FDA labeled contraindications criteria
Updated E/I statement
Added Agents NOT to be used Concomitantly information

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-9023-002

Section: Injections

Effective Date: April 01, 2022

Revised Date: June 23, 2022

Revision Effective Date: July 01, 2022

Last Reviewed: July 21, 2022

Archived Date: June 30, 2023

Applies To: Commercial and Medicaid Expansion

Description

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Initial Evaluation

Tezepelumab-ekko (Tezspire) may be considered medically necessary when an individual meets ALL of the following criteria:

ONE of the following:
- Information has been provided that indicates the individual has been treated with tezepelumab-ekko (Tezspire) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tezepelumab-ekko (Tezspire) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed
- The individual has a diagnosis of severe asthma AND ALL of the following:
  - The individual has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:
    - Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months; or
    - Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months; or
    - Controlled asthma that worsens when the doses of inhaled and/or systemic corticosteroids are tapered; or
    - The individual has baseline (prior to therapy with tezepelumab-ekko (Tezspire)) Forced Expiratory Volume (FEV1) that is less than 80% of predicted; and
  - ONE of the following:
    - The individual is NOT currently being treated with tezepelumab-ekko (Tezspire) AND is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months; or
    - The individual is currently being treated with tezepelumab-ekko (Tezspire) AND ONE of the following:
      - Is currently treated with an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms; or
      - Is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months; or
    - The individual has an intolerance or hypersensitivity to inhaled corticosteroid therapy; or
    - The individual has an FDA labeled contraindication to ALL inhaled corticosteroids; and
  - ONE of the following:
    - The individual is currently being treated for at least 3 months with ONE of the following:
      - A long-acting beta-2 agonist (LABA); or
      - A leukotriene receptor antagonist (LTRA); or
      - Long-acting muscarinic antagonist (LAMA); or
      - Theophylline; or
    - The individual has an intolerance or hypersensitivity to therapy with LABA, LTRA, LAMA, or theophylline; or
    - The individual has an FDA labeled contraindication to ALL LABA, LTRA, LAMA, AND theophylline therapies; and
  - ONE of the following:
    - If the individual has a diagnosis of allergic type asthma, then ONE of the following:
      - The individual has tried and had an inadequate response to omalizumab (Xolair) used for a minimum of 4 months for the treatment of allergic asthma; or
      - The individual has an intolerance or hypersensitivity to omalizumab (Xolair); or
      - The individual has an FDA labeled contraindication to omalizumab (Xolair); or
    - If the individual has a diagnosis of oral corticosteroid dependent type asthma, then ONE of the following:
      - The individual has tried and had an inadequate response to dupilumab (Dupixent) used for a minimum of 4 months for the treatment of asthma; or
      - The individual has an intolerance or hypersensitivity to dupilumab (Dupixent); or
      - The individual has an FDA labeled contraindication to dupilumab (Dupixent); or
    - If the individual has a diagnosis of eosinophilic type asthma, then ONE of the following:
      - The individual has tried and had an inadequate response to dupilumab (Dupixent) or an IL-5 inhibitor (e.g., benralizumab (Fasenra), mepolizumab (Nucala)) used for a minimum of 4 months for the treatment of asthma; or
      - The individual has an intolerance or hypersensitivity to dupilumab (Dupixent) or an IL-5 inhibitor; or
      - The individual has an FDA labeled contraindication to dupilumab (Dupixent) AND IL-5 inhibitors; or
    - The prescriber has provided information indicating the individual has severe asthma that is not allergic type, eosinophilic type, or oral corticosteroid dependent type; and
  - The individual will continue asthma control therapy (e.g., ICS, LABA, LTRA, LAMA, theophylline) in combination with tezepelumab-ekko (Tezspire); or
- The individual has another FDA approved indication for tezepelumab-ekko (Tezspire) and route of administration; or
- The individual has another indication that is supported in compendia for tezepelumab-ekko (Tezspire) and route of administration; and
ONE of the following:
- The individual is twelve (12) years of age or older; or
- The prescriber has provided information in support of using tezepelumab-ekko (Tezspire) for the individual’s age for the requested indication; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., allergist, immunologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual will NOT be using tezepelumab-ekko (Tezspire) in combination with another biologic agent for the requested indication [e.g., omalizumab (Xolair), IL-5 inhibitor (reslizumab (Cinqair), benralizumab (Fasenra), mepolizumab (Nucala)), dupilumab (Dupixent)]; and
The individual does NOT have any FDA labeled contraindications to tezepelumab-ekko (Tezspire).

Compendia Allowed: DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

Tezepelumab-ekko (Tezspire) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Codes

J2356

Reauthorization Criteria

Continuation of therapy with tezepelumab-ekko (Tezspire) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for tezepelumab-ekko (Tezspire) through Blue Cross Blue Shield of North Dakota's precertification process; and
ONE of the following:
- The individual has a diagnosis of severe asthma AND BOTH of the following:
  - The individual has had improvements or stabilization with tezepelumab-ekko (Tezspire) from baseline (prior to therapy with tezepelumab-ekko (Tezspire)) as indicated by ONE of the following:
    - The individual has had an increase in percent predicted Forced Expiratory Volume (FEV1); or
    - The individual has had a decrease in the dose of inhaled corticosteroids required to control the individual’s asthma; or
    - The individual has had a decrease in need for treatment with systemic corticosteroids due to exacerbations of asthma; or
    - The individual has had a decrease in number of hospitalizations, need for mechanical ventilation, or visits to urgent care or emergency room due to exacerbations of asthma; and
  - The individual is currently treated and is compliant with asthma control therapy [e.g., inhaled corticosteroids, long-acting beta-2 agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), theophylline]; or
- The individual has another FDA approved indication for tezepelumab-ekko (Tezspire) and route of administration AND has had clinical benefit with tezepelumab-ekko (Tezspire); or
- The individual has another indication that is supported in compendia for tezepelumab-ekko (Tezspire) and route of administration AND has had clinical benefit with tezepelumab-ekko (Tezspire); and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., allergist, immunologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual will NOT be using tezepelumab-ekko (Tezspire) in combination with another biologic agent for the requested indication [e.g., omalizumab (Xolair), IL-5 inhibitor (reslizumab (Cinqair), benralizumab (Fasenra), mepolizumab (Nucala), dupilumab (Dupixent)]; and
The individual does NOT have an FDA labeled contraindications to tezepelumab-ekko (Tezspire).

Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

Procedure Codes

J2356

Diagnosis Codes

J45.50

J45.51

J45.52

Professional Statements and Societal Positions Guidelines

FDA Labeled Contraindication(s)

Known hypersensitivity to tezepelumab-ekko or excipients.

ND Committee Review

Internal Medical Policy Committee 3-23-2022 Adopted new precertification drug policy effective April 1, 2022

Internal Medical Policy Committee 7-01-2022 Coding update - Effective July 01, 2022

Removed Procedure code: 3590
Added Procedure code J2356

Links

References (PDF)

Disclaimer

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Medical Policies Quick Search

Tezepelumab-ekko (Tezspire)

Description

Criteria

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer