CurrentViva HealthPolicy IC-P0260

Nucala (mepolizumab) (Subcutaneous)

Defines prior authorization, renewal, dosing, contraindications for mepolizumab (Nucala) for Viva Health members; applies to providers requesting coverage for indicated eosinophilic conditions.

Policy Summary

PayerViva Health

PolicyNucala (mepolizumab) (Subcutaneous)

Policy CodePolicy IC-P0260

Change TypeNo material changes

Effective Date

Next Review DateMar 3, 2026

Key ActionObtain prior authorization from a specialist (or documented specialist consultation) and confirm no FDA-labeled contraindications before approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J2182HCPCS code

100 mg q4wStandard dose

300 mg q4wEGPA/HES dose

presentNDCs

appendixCovered ICD-10s

Coverage Criteria for Mepolizumab (Nucala)

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Renewal / Continued Authorization

Renewal is allowed when ALL of the following are met:

Renewal criteria: The prescriber is a specialist in the area of the member's diagnosis or the prescriber has consulted with a specialist.

Examples: asthma/COPD = allergist, immunologist, pulmonologist; CRSwNP = otolaryngologist, allergist, immunologist, pulmonologist; EGPA/HES = allergist, immunologist, pulmonologist, rheumatologist.

Concomitant-immunomodulatory therapy

A: The member will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors).
Refer to 'Agents NOT to be used Concomitantly' table for examples.
B
- B.1: The prescribing information for the requested agent does NOT limit use with another immunomodulatory agent.
  Submit prescribing information showing permissive combination use.
- B.2: There is support for the use of combination therapy (submit copy of clinical trials, phase III studies, or guidelines).
  Clinical evidence must be supplied to justify combination use.

Contraindications: The member does NOT have any FDA-labeled contraindications to the requested agent.

Use of agents listed under 'Contraindicated as Concomitant Therapy' (e.g., infliximab, rituximab, tofacitinib, omalizumab, and others) is considered contraindicated for concomitant therapy unless policy conditions for combination use are satisfied.

Concomitant use of mepolizumab with other immunomodulatory agents is restricted. The policy does not permit concurrent administration with products listed in the "Agents NOT to be used Concomitantly" or the "Contraindicated as Concomitant Therapy" lists unless the policy's combination-use conditions are satisfied. For renewal, the prescriber must be a specialist (or have documented specialist consultation), and either the member will not receive the requested agent with another immunomodulator, or if combination therapy is proposed both: (1) the prescribing information for the requested agent does not limit use with another immunomodulator; and (2) supporting evidence for combination therapy (clinical trials, phase III studies, or guidelines) is submitted. Additionally, the member must have no FDA-labeled contraindications to the requested agent.

The following agents are listed as Contraindicated as Concomitant Therapy with mepolizumab and concurrent use is considered not allowable: Inflectra (infliximab-dyyb) / Infliximab and its biosimilars, Kevzara (sarilumab), Kineret (anakinra), Leqselvi (deuruxolitinib), Litfulo (ritlecitinib), Nemluvio (nemolizumab-ilto), Olumiant (baricitinib), Omlyclo (omalizumab-igec), Omvoh (mirikizumab-mrkz), Opzelura (ruxolitinib), Orencia (abatacept), Otezla (apremilast), Pyzchiva/Renflexis/Remicade and other infliximab products, multiple rituximab products (e.g., Riabni, Rituxan, Ruxience, Truxima), JAK inhibitors (e.g., Tofacitinib / Xeljanz, Rinvoq), several interleukin-targeted biologics and other listed immunomodulators. Concurrent use with any product named in these Contraindicated lists will render therapy contraindicated unless explicit policy exceptions and supporting documentation are provided.

Coding, Dosing Thresholds, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J2182

Injection, mepolizumab, 1 mg; 1 billable unit = 1 mg

NDCsNDC

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)

Covered ICD-10 CodesICD-10Covered

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

1–10 of 22

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inv-07: Pediatric dosing threshold — Age 6-11 years: 40 mg every 4 weeks

Pediatric dosing (age 6–11)40 mg subcutaneously every 4 weeks

RouteSubcutaneous injection

Indication contextSevere eosinophilic asthma (pediatric)

inv-08: Adult/adolescent dosing threshold — Age >=12 years: 100 mg every 4 weeks

Adult/adolescent dosing (≥12 years)100 mg subcutaneously every 4 weeks

RouteSubcutaneous injection

IndicationsSevere eosinophilic asthma, CRSwNP, COPD

inv-09: EGPA/HES dosing threshold — 300 mg every 4 weeks as three 100 mg injections

EGPA / HES dosing300 mg subcutaneously every 4 weeks administered as three separate 100 mg injections

Injection spacingAdminister each 100 mg injection at least 2 inches apart

RouteSubcutaneous injections (three 100 mg doses)

Prescriber Requirements, Documentation, and Utilization Management

Prior Authorization

Prior Authorization Required

Prior authorization is required. The prescriber must be a specialist in the area of the member's diagnosis (for example: asthma or COPD — allergist, immunologist, pulmonologist; CRSwNP — otolaryngologist, allergist, immunologist, pulmonologist; EGPA or HES — allergist, immunologist, pulmonologist, rheumatologist) or the prescriber must document consultation with an appropriate specialist. Initial and renewal requests must include complete clinical documentation to support medical necessity, including diagnosis, prior therapies tried, response to therapy, and any relevant specialist notes or consultation reports.

Specialist prescriber or documented specialist consultation required
Complete clinical documentation required at initial and renewal submission (diagnosis, prior therapies, response, specialist notes)

Note

Utilization Management Rationale

Prior authorization is considered appropriate based on the clinical indication and the high cost of the agents. The NQTL checklist was used to ensure the utilization management approach is applied comparably and not more stringently for MH/SUD vs M/S benefits; key factors supporting PA include the drug's indication and cost, while safety/efficacy and potential for misuse were not primary drivers.

PA applied to ensure appropriate use by indication and to manage high-cost therapies
NQTL review confirms comparable application across benefit types

Documentation Required

Documentation Required for Combination Therapy

Requests proposing combination therapy must include supporting documentation: a copy of relevant clinical trials, phase III studies, or society guideline citations demonstrating safety and efficacy of the combination; and verification that the requested agent's prescribing information does not prohibit concomitant use. Use of agents listed in the 'Agents NOT to be used Concomitantly' and 'Contraindicated as Concomitant Therapy' lists is not permitted; combinations with those products are grounds for denial.

Submit published clinical evidence or guideline support when combination immunomodulatory therapy is proposed
Confirm requested agent labeling does not limit concomitant use
Combinations with agents listed in the "Agents NOT to be used Concomitantly" or "Contraindicated as Concomitant Therapy" lists will be denied

Denial Risk

Triggers for Denial

Requests may be denied if any of the following apply: prescriber is not a specialist and no specialist consultation is documented; the member has FDA-labeled contraindications to the requested agent; the requested therapy is proposed in combination with agents specifically listed as not to be used concomitantly or contraindicated; or required supporting evidence for combination therapy (labeling or clinical studies/guidelines) is not provided.

Non-specialist prescriber without documented specialist consultation — denial risk
FDA-labeled contraindications present — denial risk
Proposed concomitant use with listed agents NOT to be used or contraindicated — denial
Lack of required clinical evidence when combination therapy is proposed — denial

Dosing Definitions and Administration Notes

inv-15: EGPA dosing — 300 mg subcutaneously once every 4 weeks administered as three separate 100 mg injections, spacing guidance

Total dose for EGPA300 mg subcutaneously once every 4 weeks administered as three separate 100 mg injections

Injection technique guidanceAdminister each 100 mg injection at least 2 inches apart

Use contextEosinophilic Granulomatosis with Polyangiitis (EGPA)

inv-16: Pediatric severe eosinophilic asthma dosing — Age 6-11 years: 40 mg subcutaneously once every 4 weeks

Pediatric severe eosinophilic asthma (age 6–11)40 mg subcutaneously once every 4 weeks

RouteSubcutaneous injection

IndicationSevere eosinophilic asthma (pediatric)

inv-17: Adult/adolescent dosing — Age 12 years and older: 100 mg subcutaneously once every 4 weeks for asthma, CRSwNP, COPD

Adult/adolescent standard dose (≥12 years)100 mg subcutaneously once every 4 weeks

IndicationsSevere eosinophilic asthma, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), Chronic Obstructive Pulmonary Disease (COPD)

RouteSubcutaneous injection

OpenPayer

Nucala (mepolizumab) (Subcutaneous)

Coverage Criteria for Mepolizumab (Nucala)

Coding, Dosing Thresholds, and Diagnosis Codes

Prescriber Requirements, Documentation, and Utilization Management

Background

Dosing Definitions and Administration Notes