Tezspire (tezepelumab-ekko) medical benefit drug policy
Policy governing medical-benefit administration (vial and prefilled syringe for provider administration) of Tezspire for Individual Exchange benefit plans (excludes MA, NV, NY), covering indications, authorization criteria, reauthorization, and applicable codes.
Policy now specifies that Tezspire vial and pre-filled syringe for administration by a healthcare professional are covered under the medical benefit while the prefilled pen for self-administration is obtained under the pharmacy benefit, unless member plan specifies otherwise.
Replaced language requiring listed criteria 'must be met' for continuation with language that 'authorization for continued use will be approved for patients currently on Tezspire for the treatment of severe asthma based on the [listed] criteria.'
Added detailed initial and continuation authorization criteria for CRSwNP including diagnostic requirements, prior therapy trials, contraindication to combination biologic therapy, prescribing specialist requirement, and 12-month initial authorization limit.
Added specific ICD-10 diagnosis codes for CRSwNP to the policy.
Coverage Criteria
Initial Therapy (Severe Asthma)
Covered when ALL of the following are met
Maintains requirement for combination background therapy and specialist prescriber.
Reauthorization/Continuation (Severe Asthma)
Covered when ALL of the following are met
Authorization for continued use will be approved for patients currently on Tezspire based on these criteria.
Initial Therapy (CRSwNP)
Covered when ALL of the following are met
Requires objective diagnostic findings and prior therapy trials or surgical history unless prior bilateral polypectomy present.
Reauthorization/Continuation (CRSwNP)
Covered when ALL of the following are met
Response documentation required for continued coverage.
Initial Therapy (CRSwNP)
Covered when ALL of the following are met for initial provider-administered Tezspire for CRSwNP:
Operationalizes detailed diagnostic and prior-therapy requirements for provider-administered Tezspire in CRSwNP.
Continuation Therapy (CRSwNP)
Authorization for continued use (provider-administered Tezspire for CRSwNP) approved when ALL of the following are met:
Continuation requires ongoing intranasal corticosteroid use and documentation of benefit.
Severe Asthma - Continuation
Severe asthma coverage note:
Clinical efficacy established in pivotal trials (PATHWAY, NAVIGATOR) supports add-on maintenance use in patients ≥12 years.
Tezspire must not be used concurrently with other biologic therapies for the same indication. Specifically, patients must not be receiving Tezspire in combination with any anti‑interleukin‑5 agents (e.g., reslizumab/Cinqair, benralizumab/Fasenra, mepolizumab/Nucala), anti‑IgE therapy (omalizumab/Xolair), or anti‑interleukin‑4 therapy (dupilumab/Dupixent) when seeking coverage under this policy. Requests may be denied if documentation shows concomitant use of these listed biologics for the same condition.
For chronic rhinosinusitis with nasal polyps (CRSwNP), Tezspire is not permitted in combination with other biologic agents for the same indication. Coverage requires that the patient is not receiving Tezspire concurrently with anti‑IL‑5 therapies (e.g., reslizumab, benralizumab, mepolizumab), anti‑IgE therapy (omalizumab), or anti‑IL‑4 therapy (dupilumab). Requests for CRSwNP will be denied if the patient is documented to be on any of these biologics for the same diagnosis.
Operationally, product presentation determines benefit routing: the Tezspire vial and prefilled syringe for administration by a healthcare professional are processed under the medical benefit, while the Tezspire prefilled pen for self‑administration is obtained under the pharmacy benefit, unless the member’s specific benefit plan specifies otherwise.
In the randomized OCS‑dependent severe asthma study, Tezspire did not demonstrate a statistically significant reduction in maintenance oral corticosteroid dose versus placebo (cumulative odds ratio 1.28, 95% CI: 0.69–2.35). Therefore, coverage decisions should account for the lack of a statistically significant OCS‑sparing effect in that maintenance OCS‑dependent subgroup rather than assume guaranteed steroid dose reduction.
Coding
| J2356 | Injection, tezepelumab-ekko, 1 mg. |
| J31.0 | Chronic rhinitis. |
| J32.0 | Chronic maxillary sinusitis. |
| J32.1 | Chronic frontal sinusitis. |
| J32.2 | Chronic ethmoidal sinusitis. |
| J32.3 | Chronic sphenoidal sinusitis. |
| J32.4 | Chronic pansinusitis. |
| J32.8 | Other chronic sinusitis. |
| J32.9 | Chronic sinusitis, unspecified. |
| J33.0 | Polyp of nasal cavity. |
| J33.1 | Polypoid sinus degeneration. |
| J31.0 | |
| J32.0 | |
| J32.1 | |
| J32.2 | |
| J32.3 | |
| J32.4 | |
| J32.8 | |
| J32.9 | |
| J33.0 | |
| J33.1 |
Provider Actions and Authorization
Prior Authorization Required
Prior authorization is required for provider-administered Tezspire (tezepelumab-ekko). Initial approvals are limited to no more than 12 months. Requests may be denied if the submitted documentation does not meet the policy criteria, the requested use is not a covered indication, required prior therapies are not documented, or the patient is receiving a contraindicated combination biologic for the same indication.
- Prior authorization required for provider-administered Tezspire; initial approvals limited to ≤ 12 months
- Requests may be denied if: lack of covered indication, inadequate documentation of required criteria, or prohibited biologic combinations present
CRSwNP Authorization Denial Triggers
For chronic rhinosinusitis with nasal polyps (CRSwNP), authorization should be denied when diagnostic or prior-therapy criteria are not met. Denial triggers include absence of symptoms >12 weeks, lack of objective findings on nasal endoscopy or CT (e.g., polyps or mucosal disease), absence of bilateral nasal polyposis or history of surgical removal of bilateral polyps, or missing documentation of required prior therapies (sinus surgery, systemic corticosteroids in the prior 2 years, or trials of two classes such as intranasal corticosteroids and nasal saline/antileukotriene agents).
- Deny if CRSwNP diagnostic criteria not met: symptoms >12 weeks PLUS objective endoscopy or CT findings and bilateral polyps or prior bilateral polyp surgery
- Deny if required prior therapies for CRSwNP are not documented (prior sinus surgery, systemic corticosteroids in prior 2 years, or trials of two classes such as intranasal corticosteroids and nasal saline/antileuktriene agents)
Reauthorization Documentation Requirements
For reauthorization (continuation of care), documentation must show a positive clinical response to Tezspire. Examples of acceptable evidence include reduction in exacerbation frequency, decreased rescue medication use, increased percent predicted FEV1 from pretreatment baseline, or reduction in severity/frequency of disease-related symptoms. For CRSwNP, documentation must also show continued use as add-on maintenance therapy with intranasal corticosteroids.
- Reauthorization requires documentation of positive clinical response (e.g., fewer exacerbations, decreased rescue use, improved % predicted FEV1, or reduced symptom severity/frequency)
- For CRSwNP reauthorization, document continued add-on maintenance use with intranasal corticosteroids
Required Prior Therapies and Prohibited Combinations
Required prior therapies must be documented before initial approval and certain biologic combinations are prohibited. For severe asthma, Tezspire must be used in combination with a maximally-dosed ICS/LABA product or the specified alternative combination of a maximally-dosed ICS plus an additional controller. For CRSwNP, document inadequate response to prior therapies such as prior sinus surgery, systemic corticosteroids in the previous 2 years, or trials of two classes (nasal saline irrigations, intranasal corticosteroids, antileukotriene agents). Tezspire must not be used in combination with other biologics for the same indication (anti-IL-5 agents, anti-IgE, or anti-IL-4 agents).
- Severe asthma: must be used with one of the following — a maximally-dosed ICS/LABA combination product OR a maximally-dosed ICS plus one additional controller medication
- CRSwNP: prior therapies required — prior sinus surgery OR systemic corticosteroids for CRSwNP in the past 2 years OR trial of two classes (nasal saline irrigations, intranasal corticosteroids, antileukotriene agents)
- Prohibited combination biologic therapy for the same indication: anti-interleukin-5 agents (reslizumab, benralizumab, mepolizumab), anti-IgE (omalizumab), anti-interleukin-4 (dupilumab)
Background
Asthma is a chronic inflammatory airway disease; a severe subset (approximately 5–10% of patients) remains uncontrolled despite optimized inhaled therapy and contributes disproportionately to morbidity. Chronic rhinosinusitis with nasal polyps (CRSwNP) is an inflammatory condition of the paranasal sinuses with symptoms persisting for longer than 12 weeks and often objective findings on endoscopy or CT; when intranasal corticosteroids and other standard measures fail, biologic therapy or surgery are considered.
Definitions
Revision History
Policy revised coverage rationale to specify that Tezspire vial and prefilled syringe for administration by a healthcare professional are covered under the medical benefit while the prefilled pen for self-administration is obtained under the pharmacy benefit unless the member's plan specifies otherwise; clarified continuation language for severe asthma to approve ongoing patients based on listed criteria; added CRSwNP-related coverage language.
Added ICD-10 diagnosis codes for CRSwNP to the policy.
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