Prior authorization and site-of-service medical necessity review required

Prior authorization and site-of-service review are required for Cinqair (reslizumab), Fasenra (benralizumab), Nucala (mepolizumab), and Exdensur (depemokimab) per the policy; site-of-service medical necessity rules for injections/infusions apply and exceptions (e.g., Alaska fully‑insured members, CRS criteria) are noted. Providers should expect an explicit site-of-service review when requesting authorization for these agents.

• Site-of-service review added for Fasenra and Nucala; applies to injection drugs (History, chunk 83-84).
• Site-of-service medical necessity exceptions include Alaska fully-insured members and specified CRS criteria (chunks 9, 68).

Authorization period — approvals up to 12 months with required documentation

Initial and reauthorization approvals may be granted for up to 12 months when medical necessity criteria are met and chart notes document continued clinical benefit; reauthorization should include evidence of reduced steroid use, fewer exacerbations/ED visits/hospitalizations, symptom improvement, or improved quality of life.

• All listed drugs may be approved up to 12 months when criteria met (chunk 22).
• Reauthorization requires chart notes showing continued positive clinical response (decreased steroid requirement, fewer exacerbations/ED visits/hospitalizations, improved symptoms or QoL) (chunks 22–24).

Provide eosinophil counts, exacerbation history, lung function, and prior therapy

Prior authorization requests must include objective eosinophil measurements, prior exacerbation history or lung function data, and prior therapy trials to demonstrate severe eosinophilic disease and inadequate control on standard therapies.

• Blood eosinophil count (commonly ≥150 or ≥300 cells/mcL depending on indication) or sputum eosinophils ≥3% as applicable (chunks 11, 17, 38).
• Exacerbation history (e.g., ≥2 exacerbations requiring systemic corticosteroids in prior 12 months or ≥1 exacerbation requiring hospitalization/ED) or FEV1 <80% predicted / FEV1/FVC <0.80 (chunks 11, 17, 39).
• Documentation of trials and inadequate control on maximum tolerated inhaled corticosteroid ± LABA or other controller therapies (chunks 17, 36).

Prior authorization, quantity limits, and site-of-service coding review

Prior authorization decisions and site-of-service reviews will include assessment of quantity limits and applicable HCPCS coding; new agents and HCPCS codes (e.g., Exdensur and J2361) have been added and are subject to authorization and quantity limits per prescribing information.

• Policy updates added Exdensur and new HCPCS code J2361 effective July 1, 2026 (chunks 85–86).
• HCPCS codes for reviewed biologics are listed and subject to medical necessity review and quantity limits (chunk 30).

Use updated HCPCS coding and obtain prior authorization for new agents

Prior authorization must use the drug-specific HCPCS/CPT/administration coding and prescriber/setting documentation; Exdensur and other new agents require coding per updated HCPCS listings and authorization.

• HCPCS code J2361 was added (chunk 86).
• Reviewed HCPCS entries include J2182 (mepolizumab), J2786 (reslizumab), J0517 (benralizumab), and J2361 (depemokimab) as applicable (chunk 30).
• Prior authorization is required for all listed agents (chunk 70).

Confirm maximum tolerated inhaled corticosteroid + LABA prior to IL‑5 therapy

For asthma indications, members must be using maximum tolerated inhaled corticosteroid therapy plus an inhaled long-acting beta‑agonist (LABA) before initiating IL‑5 inhibitor therapy; documentation of maximum tolerated dose is required in the record.

• Policy language requires use of maximum tolerated inhaled corticosteroid and an inhaled LABA for asthma (chunk 17).
• Policy updates clarified 'maximum tolerated dose' rather than absolute maximum dosing (chunks 83–84).

Document background inhaled/maintenance therapy (LAMA/LABA, ICS) before biologic

For COPD and other indications, document prior maintenance inhaled therapy (e.g., LAMA/LABA for ≥90 days unless not tolerated) and specialist involvement prior to initiation of IL‑5 therapy; include prior systemic corticosteroid use where required.

• Nucala COPD criteria require trial of LAMA/LABA ≥90 days unless not tolerated (chunk 18).
• COPD and other indications require documentation of prior maintenance therapies and specialist prescribing/consultation (chunks 18–19).
• Background controller therapies (ICS, LABA, leukotriene modifiers) are described as step therapy prior to biologic use (chunk 36).

Background step‑therapy: document trials of inhaled corticosteroids and other controllers

Policy describes standard controller and alternative therapies (inhaled corticosteroids, LABAs, leukotriene modifiers) as first‑line before biologic agents; include documentation of trials and intolerance if applicable.

• Controller therapies are described as cornerstone prior to biologic consideration (chunk 36).
• Policy history and updates reference prior controller therapy requirements and changes over time (chunk 83).

Ensure indications align with GINA 2024 step‑5 add‑on therapy

Policy criteria align IL‑5 inhibitor use with GINA 2024 guidance: IL‑5 inhibitors are add‑on treatments at step 5 for severe, refractory asthma; authorization should reflect high‑step disease management.

• GINA 2024 recommends IL‑5 inhibitors as add‑on therapy in step 5 (chunk 60).

Document prior trial of high‑dose or maximum tolerated inhaled corticosteroid

Historically, the policy required trials of high‑dose inhaled corticosteroid; current wording requires 'maximum tolerated' inhaled corticosteroid prior to biologic initiation—document the dose tried and any intolerance.

• Policy changed from 'maximum doses' to 'maximum tolerated doses' (chunks 83–84).
• Providers must document dosage and tolerance in the medical record per updated criteria (chunk 84).

Follow 'Policy Criteria' and 'Documentation Requirements' sections when submitting requests

Use the policy's 'Policy Criteria' and 'Documentation Requirements' sections to guide the specific clinical and administrative information to submit with authorization requests.

• The policy includes explicit sections titled 'POLICY CRITERIA' and 'DOCUMENTATION REQUIREMENTS' (chunk 1).
• Documentation requirements list office visit notes, relevant history, laboratory values, physical exam, and medication history (chunk 24).

Ensure medical records document diagnosis, history, labs, exam, medication history, and prescriber specialty

Medical records must document that all medical necessity criteria are met and include office visit notes with diagnosis, relevant history, labs, physical exam, and medication history; prescriber specialty (allergist/immunologist/pulmonologist/hematologist/otolaryngologist) should be included when required by the drug criteria.

• Records should include office visit notes with diagnosis, history, lab values, physical exam, and medication history (chunk 24).
• Drug-specific criteria require prescriber specialty or consultation (e.g., allergist/immunologist, pulmonologist, hematologist, otolaryngologist) (chunks 17, 21).

Chart notes for reauthorization must show continued clinical benefit

For reauthorization, chart notes must document continued positive clinical response using parameters such as decreased oral steroid requirement, fewer exacerbations/ED visits/hospitalizations, symptom frequency/severity reduction, or improved quality of life; for CRSwNP, document decreased polyp size and improved nasal congestion score.

• Reauthorization criteria list decreased steroid needs, fewer exacerbations/ED visits/hospitalizations, symptom improvement, or QoL gains as acceptable evidence (chunks 22–24).
• CRSwNP reauthorization requires both decrease in nasal polyp size and improvement in nasal congestion score (chunk 24).

Document baseline eosinophils, exacerbation history, and lung function

Key clinical parameters to include in the record are baseline and on‑therapy blood eosinophil counts (commonly ≥150 or ≥300 cells/µL as drug/indication-specific), prior exacerbation history, and lung function (e.g., FEV1, FEV1/FVC) where applicable.

• Baseline blood eosinophil counts (≥150 or ≥300 cells/µL depending on indication/trial) are frequently cited (chunks 38–39).
• Prior exacerbation history and lung function measures such as FEV1 or FEV1/FVC are used in eligibility determinations (chunk 11).

Required clinical documentation summary to include prescriber, labs, thresholds, exacerbations, prior therapy/surgery

Summarize required clinical documentation in the request: prescriber identity/specialty; indication and diagnosis confirmation; eosinophil thresholds and dates; exacerbation history or lung function metrics; prior controller/systemic steroid trials; prior surgical history for nasal polyps where applicable.

• Prescriber requirements and eosinophil thresholds have been added/updated in policy modifications (chunks 67, 83).
• Diagnosis confirmation (e.g., CRSwNP by exam/CT/endoscopy) and prior therapy/surgery history are required where specified (chunk 21).
• Include dates for labs and documentation of prior controller and systemic steroid trials (chunk 24).

Include diagnosis confirmation and prior therapy/specialist documentation per indication

For diagnosis‑specific documentation, follow the policy examples: CRSwNP needs confirmation by physical exam, sinus CT, or nasal endoscopy and record of prior intranasal corticosteroid trial and prior systemic steroid use or surgery; EGPA/HES require eosinophil thresholds and specialty documentation per respective drug sections.

• CRSwNP requires confirmation by exam, sinus CT, or endoscopy and prior intranasal steroid failure plus prior systemic corticosteroid use or prior surgery (chunk 21).
• EGPA requires eosinophil ≥10% or absolute ≥1000 cells/µL and presence of vasculitic features; HES requires ≥1000 cells/µL and background therapy for ≥4 weeks with hematology involvement (chunks 19–21).

Avoid hospital outpatient or non‑preferred site administration unless medical necessity criteria are met

Do not request administration in hospital outpatient departments or other non‑preferred sites unless site‑of‑service medical necessity criteria are met; such site‑of‑service administration is considered not medically necessary when criteria are not satisfied and may result in denial.

• Hospital outpatient sites and other non‑preferred sites are considered not medically necessary when site‑of‑service criteria are not met (chunk 9).
• Site‑of‑service criteria outline when hospital administration is medically necessary (chunk 9).

Do not combine Nucala with other specified biologics for asthma — may trigger denial

Do not prescribe Nucala concurrently with other biologics listed for asthma (Cinqair, Dupixent, Exdensur, Fasenra, Tezspire, omalizumab); concurrent use is prohibited and may trigger denial.

• Nucala will not be used in combination with the listed biologics when treating asthma (chunk 18).
• Policy changes reiterated combination therapy prohibition across IL‑5 agents and other biologics (chunk 67).

Combination biologic therapy for CRSwNP (Nucala + Dupixent/Tezspire/omalizumab) prohibited

Do not combine Nucala with Dupixent, Tezspire, or omalizumab for CRSwNP; concurrent use for this indication is prohibited and may result in denial.

• Nucala is not to be used in combination with Dupixent, Tezspire, or omalizumab for CRSwNP (chunk 21).
• Combination therapy exclusions are reiterated in the policy exclusions (chunk 18).

Avoid concurrent Nucala with Dupixent or Ohtuvayre in COPD — may trigger denial

Do not combine Nucala with Dupixent or Ohtuvayre for COPD; such concurrent use is prohibited and may trigger denial for COPD indications.

• Nucala will not be used in combination with Dupixent or Ohtuvayre for COPD (chunk 19).
• Concurrent biologic use for COPD is specifically disallowed and may result in denial (chunk 18).

Note subgroup efficacy limitations for reslizumab — may affect authorization

Be aware that subgroup analyses for reslizumab showed no meaningful benefit in adolescents, blacks, and US residents; lack of demonstrated benefit in these subgroups may require additional justification or could lead to denial.

• Pooled pivotal trials and FDA/post‑hoc analyses showed no meaningful benefit in adolescents and certain racial/geographic subgroups; efficacy in adolescents was not established (chunk 52).

Concurrent therapy prohibition — Exdensur and other biologics not to be used together

Do not initiate Exdensur concurrently with other IL‑5 biologics or with Dupixent, Xolair, or Tezspire; concurrent therapy is not allowed and may trigger denial.

• Policy update added Exdensur to the list of medications not to be used concurrently with other biologics (chunk 70).
• Concurrent use prohibition includes Dupixent, Xolair, and Tezspire among others (chunk 59).

Combination therapy exclusion — IL‑5 biologics must not be used together or with specified biologics

Combination use of IL‑5 biologics with each other or with Dupixent, Xolair, or Tezspire is excluded by policy and may result in denial; verify no concurrent biologic therapy is being prescribed before authorizing treatment.

• Policy exclusions state that concurrent use of listed IL‑5 biologics with each other or with Dupixent, Xolair, or Tezspire is not allowed (chunks 82, 18).
• Recent updates added Exdensur to the non‑concurrent list (chunk 70).