Authorization period

Prior authorization is required. Initial approvals are valid for 12 months (365 days); renewals may be granted every 12 months (365 days) thereafter.

Commercial members: document two prior biologic trials (≥3 months each)

For Commercial members, document trials of at least two of the specified biologics (mepolizumab, dupilumab, tezepelumab, omalizumab), each for a minimum of three (3) months, showing inadequate response, intolerance, or contraindication prior to approval.

• Required agents: mepolizumab (Nucala), dupilumab (Dupixent), tezepelumab-ekko (Tezspire), omalizumab (Xolair)
• Each trial must be at least three (3) months

Medicaid members: document two prior biologic trials (≥3 months each)

For Medicaid members, document trials of at least two of the specified biologics (mepolizumab, dupilumab, omalizumab), each for a minimum of three (3) months, showing inadequate response, intolerance, or contraindication prior to approval.

• Required agents: mepolizumab (Nucala), dupilumab (Dupixent), omalizumab (Xolair)
• Each trial must be at least three (3) months

Confirm no contraindicated concomitant agents

Prior authorization requires confirmation that the patient is not receiving any agent listed as 'Contraindicated as Concomitant Therapy' before approving Fasenra.

Exclude listed concomitant therapies on PA requests

Prior authorization requests must account for and exclude concomitant use of agents listed as 'Agents NOT to be used Concomitantly' or 'Contraindicated as Concomitant Therapy' when seeking approval for Fasenra.

Concomitant agent restrictions: avoid or justify excluded agents

If concomitant use of any agent on the policy's exclusion list is being considered, the prior authorization must avoid or provide justification; many listed agents are explicitly labeled 'Contraindicated as Concomitant Therapy.'

PA check: verify current concomitant medications

Prior authorization will not approve Fasenra if the patient is receiving agents listed as contraindicated for concomitant use; the PA process includes a check for current concomitant medications.

Verify no contraindicated concomitant agents for PA

As part of PA, verify the patient is not receiving any agent identified in the policy as contraindicated for concomitant use with Fasenra prior to approval.

Concomitant-agent verification required for PA

Prior authorization should verify the patient is not receiving any agent listed as 'Agents NOT to be used Concomitantly' and identify any agent specifically labeled 'Contraindicated as Concomitant Therapy.'

PA considered for indication and drug cost

PA is applied due to indication and drug cost; utilization management NQTL factors cite indication and cost as reasons to consider prior authorization.

Use covered ICD-10 diagnosis codes on PA

Prior authorization and coverage are tied to the ICD-10 diagnosis codes listed in Appendix 1; ensure the member's diagnosis matches one of the covered codes when requesting PA.

Step therapy: document required prior biologic trials

Members must have tried and had inadequate response, contraindication, or intolerance to specified alternative biologics (lists differ slightly by Commercial vs Medicaid) before Fasenra is approved.

• Commercial list includes: mepolizumab, dupilumab, tezepelumab, omalizumab
• Medicaid list includes: mepolizumab, dupilumab, omalizumab

Step therapy sequencing not specified

No specific step therapy sequencing is described in the policy chunks; PA is considered primarily for indication and cost rather than detailed step sequencing.

No specified step therapy order in policy

The policy does not state a specific sequencing order for step therapy; prior authorization focuses on documented prior trials and clinical criteria per the NQTL checklist.

Required clinical documentation (labs, exacerbations, prior meds, specialist)

Provide prior clinical documentation including baseline or prior blood eosinophil count or FeNO/sputum eosinophils, history of exacerbations or FEV1 measurements, prior biologic medication history (excluding samples), prior OCS use when applicable, and specialist involvement or consultation.

• Baseline blood eosinophil ≥150 cells/µL or FeNO ≥20 ppb or sputum eosinophils ≥2% (for severe eosinophilic asthma)
• Exacerbation history (e.g., ≥2 steroid bursts in past 12 months) or FEV1 <80% predicted
• Prior biologic medication history (samples not approvable)
• Specialist prescriber or documented specialist consultation

Medication reconciliation: document current meds and absence of excluded agents

Document the current medication list and confirm the absence of any agent listed as contraindicated for concomitant therapy before approving Fasenra.

Document absence of listed concomitant agents on PA

Documentation should demonstrate that the member is not receiving any agents listed as 'Agents NOT to be used Concomitantly' or 'Contraindicated as Concomitant Therapy' when requesting coverage for Fasenra.

If considering excluded concomitant therapy, provide justification and evidence

If a listed concomitant agent is being considered despite the policy, provide clinical rationale and supporting evidence (e.g., trials, guidelines) to justify combined use; otherwise show the prescribed therapy is not one of the excluded agents.

Concomitant medication documentation: avoid/discontinue contraindicated agents

Document current concomitant medications and avoid or discontinue agents designated 'Contraindicated as Concomitant Therapy' prior to approval; the record should clearly indicate medication history and absence of listed biologic or immunomodulatory agents.

Document absence of concurrent listed biologics/immunomodulators

Explicitly document that none of the biologic or immunomodulatory agents listed in the policy are being used concurrently with Fasenra when prescribing; if concurrent use exists, provide rationale and supporting documentation.

Document absence or provide rationale for concomitant agents

Document absence of concurrent therapy with any agent listed as 'Agents NOT to be used Concomitantly' or provide rationale and supporting evidence if used together despite the contraindication.

Dosing and billing documentation: indicate dosing, NDC, and use J0517 (1 mg/unit)

Provide indication and dosing rationale consistent with labeled dosing (including pediatric weight-based dosing) and include the product NDC when billing; use HCPCS J0517 where 1 billable unit = 1 mg.

• Pediatric dosing: <35 kg = 10 mg SC q4wk ×3 then q8wk; ≥35 kg = 30 mg SC q4wk ×3 then q8wk
• EGPA/HES dosing: 30 mg SC every 4 weeks
• Use NDC(s) from product listing when billing

Medicare documentation and coverage guidance

For Medicare patients, consult the Medicare Benefit Policy Manual Chapter 15 §50 and any applicable NCDs, LCDs, or LCAs for Part B coverage; Medicare coverage determinations may differ from this non‑Medicare policy.

Prior trial documentation: document agents tried and 3‑month durations

Document trials of the required prior biologic agents and the duration (three months each); failure to provide this documentation or to show the required duration may result in denial.

• Record dates and durations of prior biologic trials (samples are not approvable evidence)

Denial risk: concomitant biologic/targeted therapy

Requests for benralizumab will be denied if the patient is receiving any agent listed as contraindicated for concomitant therapy with Fasenra; verify and document absence of these agents.

Denial risk: concomitant use of excluded agents

Use of agents specified as 'Agents NOT to be used Concomitantly' or labeled 'Contraindicated as Concomitant Therapy' with Fasenra may trigger denial of the request.

Concomitant therapy contraindications may lead to denial

Concomitant use of listed agents may be considered contraindicated and could lead to denial of concomitant therapy requests for Fasenra; do not prescribe listed agents concurrently without justification.

Denial risk for contraindicated concomitant agents

Requests will be denied if the patient is receiving agents the policy designates as 'Contraindicated as Concomitant Therapy' with benralizumab; confirm medication list and adjust therapy as needed before PA submission.

Contraindicated concomitant agents may cause denial

Concurrent use of any listed agent with Fasenra may trigger contraindication‑based denial; ensure none of the listed biologic or immunomodulatory agents are being used concomitantly when prescribing.

Denial risk if concomitant agents are prescribed

A PA request may be denied if the patient is prescribed or will be receiving listed agents concurrently with Fasenra; verify and document plans for other biologic/immunomodulatory agents.

Concomitant agent contraindications: named biologics/JAK inhibitors may cause denial

Use of listed contraindicated immunomodulatory or biologic agents (e.g., Tremfya, Truxima, Xolair, Xeljanz, ustekinumab products and others named in the policy) may trigger denial of concomitant therapy requests.

Medicare vs Non‑Medicare coverage: follow CMS/NCD/LCD/LCA where applicable

Non‑Medicare coverage determinations follow this document; Medicare beneficiaries remain subject to applicable NCDs/LCDs/LCAs which may affect coverage and documentation requirements.