Nucala (mepolizumab) prior authorization and coverage criteria
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This policy describes prior authorization, dosing limits, initial and renewal clinical criteria, and concomitant therapy restrictions for coverage of subcutaneous mepolizumab (Nucala) for Viva Health members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Initial Approval Criteria
Target agent(s) will be approved when ALL of the following are met:
Initial overall
- Continuation of therapy or new request: Either continuation of therapy within past 90 days OR meet new-request diagnostic/treatment criteria
Continuation includes prior use within 90 days or prescriber attestation of recent use and risk if changed
Severe eosinophilic asthma criteria
- Diagnostic confirmation: One of: baseline blood eosinophils >=150 cells/microliter; FeNO >=20 ppb while on high-dose ICS or daily OCS; sputum eosinophils >=2% while on high-dose ICS or daily OCS; or systemic corticosteroid dependence
- Uncontrolled disease or prior biologic: One of: >=2 severe exacerbations requiring systemic steroid in past 12 months; >=1 serious exacerbation requiring hospitalization/ventilation/ED/UC in past 12 months; controlled asthma that worsens with steroid taper; baseline FEV1 <80% predicted; OR prior use of an FDA‑labeled/compendia‑supported biologic in past 12 months
- Concomitant controller therapy and specialist: Member must be on/continue controller therapy (e.g., maximally tolerated inhaled corticosteroid for >=3 months with 90 days adherence plus LABA/LAMA as applicable) and prescriber is a relevant specialist or has consulted one
COPD criteria
- Diagnosis confirmation: Spirometry with post‑bronchodilator FEV1/FVC <0.7
- Eosinophilic phenotype: Baseline blood eosinophils >=300 cells/microliter
- Inadequate control or prior biologic: One of: >=2 moderate COPD exacerbations in past 12 months; >=1 severe COPD exacerbation requiring hospitalization/observation >24 hrs in past 12 months; OR prior biologic use for COPD in past 12 months
- Treatment trials and continuation: Member must have trials/adherence to ICS and LAMA/LABA (or triple therapy as appropriate) for >=3 months with 90 days adherence and will continue COPD inhaled maintenance therapy with the agent
EGPA criteria
- Eosinophil threshold: Baseline blood eosinophils >=1000 cells/microliter OR >=10% on WBC differential
- Asthma and non‑severe disease: Member has history/presence of asthma AND does NOT have organ‑ or life‑threatening manifestations (e.g., alveolar hemorrhage, glomerulonephritis, CNS vasculitis, cardiac involvement)
- OCS use: Either currently treated with OCS >=4 weeks within past 90 days and will use OCS with the agent, OR intolerance to one OCS, OR contraindication to all OCS
- Indication usage: Agent will be used for relapsing/refractory disease or maintenance of remission
HES criteria
- Duration and eosinophils: Diagnosis for >=6 months AND baseline blood eosinophils >=1000 cells/microliter
- Organ evaluation and exclusions: Evaluation of organ involvement performed AND no identifiable non‑hematologic secondary (reactive) cause AND FIP1L1‑PDGFRA negative
- Disease activity or prior therapy failure: At least 2 HES flares in past 12 months OR active signs/symptoms AND tried and had inadequate response to one of: OCS, hydroxyurea, interferon‑alfa, or immunosuppressive agent; or corticosteroid‑dependent; or intolerance/contraindication to listed agents
- Concurrent therapy: Member will continue existing HES therapy (e.g., OCS, hydroxyurea, interferon‑alfa, cyclosporine, methotrexate) in combination with the agent
CRSwNP criteria
- Symptom requirement: At least TWO CRS symptoms: nasal discharge, nasal obstruction, hyposmia, facial pressure/pain
- Duration and confirmation: Symptoms for >=12 consecutive weeks AND diagnosis confirmed by anterior rhinoscopy, nasal endoscopy, or CT of sinuses
- Intranasal steroid trial: Tried and had inadequate response to one intranasal corticosteroid for >=4 weeks OR intolerance to one intranasal corticosteroid OR contraindication to all intranasal corticosteroids
- Maintenance therapy: Member is currently treated with and will continue standard nasal polyp maintenance therapy in combination with the agent
- General requirements: Prescriber is a specialist in the member's diagnosis area or has consulted one; agent will not be used with contraindicated immunomodulators unless prescribing information permits and supporting evidence is provided; no FDA‑labeled contraindications to the agent
Compendia allowed: AHFS, DrugDex 1 or 2a, or NCCN 1 or 2a
Renewal Criteria
Target Agent(s) will be approved when ALL of the following are met:
Renewal overall
- Prior approval: Member was previously approved through the plan's prior authorization process
- Clinical benefit: Member has had clinical benefit with the requested agent
- Ongoing adherence and concomitant therapy: If asthma/COPD/CRSwNP, member remains on and adherent to required control/maintenance therapies within past 90 days; prescriber is a relevant specialist or consulted one
- Concomitant immunomodulator use: Either member is NOT using the agent with another immunomodulatory agent OR if used in combination, prescribing information must not limit use and supporting evidence must be submitted
- No contraindications: Member does not have any FDA‑labeled contraindications to the requested agent
Renewal contraindicated with listed concomitant therapies
Renewal is contraindicated when ANY of the following concomitant therapies are present
The policy lists a long roster of specific products by brand and generic names across chunks 18–37.
Renewal: Prohibited Concomitant Therapies
Renewal is subject to confirmation that NONE of the following concomitant therapies are being used:
The policy text repeats the list across multiple lines; renewal requires absence of these therapies.
Renewal and Dosing Criteria
Policy renewal and dosing guidance (extracted items present in this portion):
Multiple pages repeat the contraindicated list.
Administer separate injections at least 2 inches apart when multiple injections required.
Covered Diagnoses
Covered diagnoses (policy requires diagnosis matching one of the listed codes):
See Appendix 1 for full code list
For hypereosinophilic syndrome (HES) the policy requires that the member does NOT have an identifiable non-hematologic secondary (reactive) cause of HES (examples include infection, allergy/atopy, autoimmune disease, drug reaction, metabolic condition, solid tumor/lymphoma) and does NOT have FIP1L1-PDGFRA-positive disease. These exclusion conditions are part of the HES-specific initial approval criteria and must be documented prior to approval.
Within the extracted renewal material there are no explicit clinical exclusions by diagnosis beyond the listed medication prohibitions. The renewal criteria are presented primarily as a prohibition of specific concomitant therapies rather than additional diagnosis-based exclusions.
Renewal requires that the member is not receiving concomitant treatment with the numerous biologic and immunomodulatory agents enumerated in the policy. Examples repeatedly listed in the renewal section include adalimumab products (Humira, Hadlima, Hulio, Hyrimoz, Idacio), infliximab/Inflectra/Remicade, benralizumab (Fasenra), sarilumab (Kevzara), anakinra (Kineret), deuruxolitinib (Leqselvi), ritlecitinib (Litfulo), and nemolizumab (Nemluvio) among many others listed across the renewal tables.
The policy explicitly states that concurrent use with any medication listed under the heading "Contraindicated as Concomitant Therapy" is not allowed. The renewal criteria present an extensive list (e.g., apremilast, ustekinumab products, multiple infliximab and rituximab formulations, JAK inhibitors such as tofacitinib/Xeljanz and upadacitinib/Rinvoq, tezepelumab, omalizumab, and many others) which are identified as contraindicated when used concomitantly with mepolizumab for the purpose of renewal consideration.
For Medicare members, applicable Medicare coverage rules apply: providers must follow Medicare Benefit Policy guidance and any relevant National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). The policy notes that Medicare-specific determinations may exist and compliance with those documents is required where applicable.
Use of mepolizumab is not permitted when the member has any FDA-labeled contraindication to the agent. The policy requires that the member does NOT have any FDA-labeled contraindications as a condition of approval or renewal.
The policy specifies that renewal will be considered not medically necessary if the member is concurrently receiving one or more agents listed as "Contraindicated as Concomitant Therapy". Documentation at renewal must confirm the absence of these concomitant agents; presence of any listed contraindicated medication may render renewal not medically necessary.
Consistent with the renewal rules, the policy states that concurrent use of mepolizumab with medications listed as contraindicated would render the requested therapy inappropriate. The extensive enumerated list of biologics, JAK inhibitors, and other immunomodulators in the renewal section is cited as making concurrent therapy contraindicated for renewal or ongoing coverage.
Billing, Dosing Limits, and Codes
| HCPCS units: 100/28 days | Max billable units per 28 days for COPD, CRSwNP, Severe Eosinophilic Asthma |
| HCPCS units: 300/28 days | Max billable units per 28 days for EGPA, HES |
| J2182 | Injection, mepolizumab, 1 mg; 1 billable unit = 1 mg |
| 00173-0881-xx | Nucala 100 mg/mL lyophilized powder single-dose vial |
| 00173-0892-xx | Nucala 100 mg/mL single-dose prefilled autoinjector or syringe (cartons of 1) |
| 00173-0904-xx | Nucala 40 mg/0.4 mL single-dose prefilled syringe (cartons of 1) |
| 00173-0881-xx | Nucala 100 mg/mL lyophilized powder single-dose vial |
| 00173-0892-xx | Nucala 100 mg/mL single-dose prefilled autoinjector or syringe (cartons of 1) |
| 00173-0904-xx | Nucala 40 mg/0.4 mL single-dose prefilled syringe (cartons of 1) |
| D72.110 | Idiopathic hypereosinophilic syndrome [IHES] |
| D72.111 | Lymphocytic Variant Hypereosinophilic Syndrome [LHES] |
| D72.119 | Hypereosinophilic syndrome [HES], unspecified |
| J33.0 | Polyp of nasal cavity |
| J33.1 | Polypoid sinus degeneration |
| J33.8 | Other polyp of sinus |
| J33.9 | Nasal polyp, unspecified |
| J40 | Bronchitis, not specified as acute or chronic |
| J41.0 | Simple chronic bronchitis |
| J41.1 | Mucopurulent chronic bronchitis |
What Providers Must Do
Prior authorization validity (initial 12 months; renew every 12 months)
Prior authorization is required; initial authorizations are valid for 12 months (365 days) and may be renewed every 12 months (365 days) thereafter.
Renewal requires absence of listed concomitant biologic/immunomodulatory agents
Renewal authorizations require that the member is not receiving any biologic or immunomodulatory agents named in the policy's 'Contraindicated as Concomitant Therapy' list; renewal will not be approved if concurrent use of listed agents is present.
Renewal: confirm absence of contraindicated concomitant therapies
Prior authorization renewals must confirm the member is not concurrently receiving any agent explicitly listed as 'Contraindicated as Concomitant Therapy'; confirmation is required at each renewal.
Contraindicated concomitant therapies must be absent for renewal
Renewal reviews must verify that the member is not receiving any medications explicitly listed under 'Contraindicated as Concomitant Therapy' with Nucala; absence of those agents is required for renewal.
Prior authorization/renewal must confirm no contraindicated concomitant therapy
Prior authorization and renewal decisions must confirm that no concomitant therapy listed as contraindicated is being used; the renewal criteria explicitly reference the enumerated contraindicated concurrent medications.
Prior authorization required for Nucala — submit Appendix 1 diagnosis code
Prior authorization is required for Nucala; supporting diagnosis codes submitted for approval should match one of the covered ICD-10 codes listed in Appendix 1.
Controller therapy trials and documented adherence required for asthma/COPD
For asthma and COPD indications, prior authorization requires documented trials of and adherence to inhaled controller therapies (e.g., ≥3 months of appropriately dosed ICS with 90 days adherence and required LABA/LAMA/LTRA/theophylline as applicable) before approval.
- Asthma: maximally tolerated inhaled corticosteroid for ≥3 months with 90 days adherence within past 120 days.
- COPD: ICS plus LAMA/LABA dual therapy for ≥3 months with 90 days adherence within past 120 days.
Step therapy — none specified
No explicit step therapy sequencing (a formal step-therapy prerequisite pathway) is specified in this policy section.
Required clinical documentation (labs, diagnostics, specialist involvement)
Required clinical documentation for initial and renewal requests should include baseline laboratory and diagnostic results (for example, blood eosinophil counts, spirometry, CT or nasal endoscopy as appropriate) and specialist documentation when applicable.
- Baseline blood eosinophil count and other objective diagnostic tests cited in the criteria.
- Spirometry, CT or nasal endoscopy results when relevant to the indication.
- Prescriber specialty or documentation of specialist consultation.
Documentation must confirm no listed concomitant agents at renewal
Renewal documentation must explicitly confirm the member is not concurrently using any medication listed as 'Contraindicated as Concomitant Therapy'; providers must ensure renewal requests do not indicate concurrent use.
Medication history required at renewal — must show absence of contraindicated agents
Medication history is required for renewal and must show absence of listed contraindicated concomitant biologic or immunomodulatory agents (e.g., adalimumab products, infliximab, benralizumab, baricitinib, and others named in the policy).
- Include medication history covering recent biologic and immunomodulator use.
- Document absence of any agent named under 'Contraindicated as Concomitant Therapy.'
Renewal requests must document absence of listed contraindicated concomitant therapies
Renewal requests should document absence of concomitant use of therapies listed as 'Contraindicated as Concomitant Therapy' with Nucala; this verification should be included in renewal submissions.
Concomitant therapy documentation — verify Nucala not used concurrently with listed agents
Documentation must support that Nucala is not being used concurrently with any agents enumerated under 'Contraindicated as Concomitant Therapy'; submissions should explicitly address concomitant therapy status.
Required documentation — Nucala NDC/formulation and Appendix 1 diagnosis code
Providers must document the specific Nucala NDC/formulation administered and include an appropriate covered diagnosis code from Appendix 1 with the authorization request.
- Include NDC (e.g., 00173-0881-xx, 00173-0892-xx, or 00173-0904-xx) for the product/formulation administered.
- Include a covered ICD-10 diagnosis code from Appendix 1.
Provider action if initial criteria unmet — risk of denial or need for more documentation
Requests that do not meet the initial approval criteria (for example, missing required diagnostic confirmation, medication history, or specialist involvement) may be denied or will require additional documentation to be considered.
Contraindicated concomitant therapies may trigger denial of renewal
Renewal may be denied if the patient is receiving any therapy named in the policy's 'Contraindicated as Concomitant Therapy' list; concurrent use of those agents may trigger denial of renewal.
Contraindicated concomitant therapy may trigger denial
Renewal may be denied if the member is receiving any agent identified as 'Contraindicated as Concomitant Therapy' with Nucala (mepolizumab); concurrent use is a basis for non‑renewal.
Concomitant contraindicated therapy may trigger denial of coverage/renewal
Use of listed contraindicated concomitant therapies with Nucala (mepolizumab) may trigger denial of renewal or coverage; providers should avoid concurrent prescribing of listed agents.
Contraindicated concomitant therapy — significant denial risk
Use of the extensive list of contraindicated concomitant therapies (including multiple biologics, JAK inhibitors, and related agents named in the policy) poses a denial risk for renewal or coverage when used concurrently with Nucala.
Prior authorization rationale — NQTL and drug cost considerations
Prior authorization is applied as a utilization management NQTL; the policy notes prior authorization may be considered due to indication and drug cost per the NQTL checklist.
Background and Drug Information
Mepolizumab (Nucala) is an anti–interleukin‑5 (IL‑5) monoclonal antibody indicated for eosinophil‑driven diseases. The policy addresses its labeled uses and associated requirements: for severe eosinophilic asthma, dosing and objective confirmation of eosinophilic phenotype and inadequate control on standard therapies are required; other labeled indications addressed in the policy include eosinophilic COPD phenotype, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and chronic rhinosinusitis with nasal polyps (CRSwNP). The document references the prescribing information and guideline sources for clinical context and requires appropriate diagnostic confirmation and specialist involvement for approval.
Definitions and Clinical Thresholds
Policy Revision History
Policy IC-P0260 last reviewed and effective date set; references and appendices updated (Last review 2026-07-01).
Updated prescribing information for Nucala (mepolizumab) cited from GlaxoSmithKline LLC, May 2025.
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