HCPCS Code J2356: Injection, Tezepelumab-Ekko, 1 mg

## **Documentation and billing requirements for HCPCS code J2356** You can't just prescribe or administer tezepelumab-ekko to patients, and by extension, can't file for claims, if patients don't meet the following criteria to be eligible for the medicine. You must confirm and document the following: - The patient must be aged 12 or older. - The medicine must be prescribed by, or in consultation with a pulmonologist, allergist, or immunologist. - Patient's documentation of the patient having severe asthma. - Documentation of the patient being adherent to current treatment with both of the following medications at optimized doses for at least 3 months with or without oral corticosteroids: high-dose inhaled corticosteroid and additional controller medication (e.g., long acting beta2-agonist, long-acting muscarinic antagonist, leukotriene modifier). - Documentation of the patient having inadequate asthma control with two or more asthma exacerbations in the previous year, requiring systemic corticosteroid treatment in addition to the regular maintenance therapy, or one asthma exacerbation resulting in hospitalization. - Confirmed and documented agreement that the patient will use Tezspire as add-on maintenance treatment (not as monotherapy). - Documentation of the patient's baseline blood eosinophil. - If the baseline blood eosinophil level is ≥150 cells/µL, there must be documentation of the patient indicating they've had an inadequate treatment response or intolerance to treatment with at least one biologic indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Nucala, Xolair). - Confirmed and documented agreement that the patient will not use Tezspire in combination with another biologic agent indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Nucala, Xolair). This also means that, if the medicine will be administered with your direct supervision, it can't be administered concurrently with the aforementioned biologic agents. - Confirmation and documentation of baseline measurement of at least one of the following for assessment of the patient's clinical status: use of systemic corticosteroids, use of inhaled corticosteroids, or the number of hospitalizations, ER visits, or unscheduled visits to healthcare provider(s) due to asthma condition. - Documented agreement that the patient will not receive the medicine concurrently with live vaccines. - Confirmation and documentation that the patient does not have an active or untreated parasitic (helminth) infection. - Documented agreement that the medicine will not be used for the relief of acute bronchospasm or status asthmaticus.

## **Criteria for continuing the use of tezepelumab-ekko** - The patient must be aged 12 or older. - The medicine must be prescribed by, or in consultation with a pulmonologist, allergist, or immunologist. - Patient's documentation of the patient having severe asthma. - Patient is tolerating their treatment. - The patient has achieved and maintained a positive clinical response with Tezspire therapy for asthma with documentation of improvement as evidenced by: 1. A decrease in one or more of the following: use of systemic corticosteroids, hospitalizations, ER visits, or unscheduled visits to healthcare provider. 2. Improvement from baseline in forced expiratory volume in 1 second (FEV1). - Confirmed and documented agreement that the patient will use Tezspire as add-on maintenance treatment (not as monotherapy). - Confirmed and documented agreement that the patient will not use Tezspire in combination with another biologic agent indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Nucala, Xolair).

## **Other similar HCPCS codes** - J2357 - Injection, omalizumab, 5 mg - J2506 - Injection, pegfilgrastim, 0.5 mg - J2507 - Injection, pegloticase, 1 mg - J2777 - Injection, faricimab-svoa, 0.1 mg - 96372 - Therapeutic subcutaneous injection

## **Reference** TEZSPIRE® (n.d.). TEZSPIRE® (tezepelumab-ekko) for severe asthma | For HCPs. https://www.tezspirehcp.com/