Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Interleukin-5 (IL-5) Antagonist (e.g., Cinqair®, Nucala®) and IL-5 Receptor Antagonist (e.g., Fasenra™)

Policy #:08.01.23e

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

BENRALIZUMAB (FASENRA™)
Benralizumab (Fasenra™) is considered medically necessary and, therefore, covered for the treatment of severe eosinophilic asthma when all of the following criteria are met:
  • The individual is 12 years of age or older.
  • The blood eosinophil count at the initiation of treatment is at least:
    • 150 cells/μL, if dependent on concurrent daily oral corticosteroid therapy for at least 6 continuous months, or
    • 300 cells/μL, if naive of daily oral corticosteroid therapy
  • The individual is currently receiving treatment that does not maintain adequate control of his/her asthma and benralizumab (Fasenra™) is being used as additional maintenance therapy.
    • Current treatment must include high-dose inhaled corticosteroids (ICS), long-acting beta agonist (LABA), and if required, additional asthma controller medication (e.g., oral corticosteroids, leukotriene inhibitor, theophylline), unless the individual is intolerant of or has a contraindication to these agents.

The dosage, frequency, and route of administration for benralizumab (Fasenra™) is 30 mg administered once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter, by subcutaneous injection.

MEPOLIZUMAB (NUCALA®)
Mepolizumab (Nucala®) is considered medically necessary and, therefore, covered for the treatment of severe eosinophilic asthma when all of the following criteria are met:
  • The individual is 12 years of age or older.
  • The individual has one of the following blood eosinophil counts:
    • Blood eosinophils of at least 150 cells/microliter* at the initiation of treatment
    • Blood eosinophils of at least 300 cells/microliter* in the past 12 months
  • The individual is currently receiving treatment that does not maintain adequate control of his/her asthma and mepolizumab (Nucala®) is being used as additional maintenance therapy.
    • Current treatment must include high-dose inhaled corticosteroids (ICS) (with or without oral corticosteroids) plus an additional controller (e.g., long-acting beta agonist [LABA], leukotriene inhibitor, theophylline) medication, unless the individual is intolerant of or has a contraindication to these agents.

The dosage, frequency, and route of administration for mepolizumab (Nucala®) for the treatment of severe eosinophilic asthma is 100 mg administered once every 4 weeks by subcutaneous injection.

Mepolizumab (Nucala®) is considered medically necessary and, therefore, covered for the treatment of relapsed or refractory eosinophilic granulomatosis with polyangiitis (EGPA) when all of the following criteria are met:
  • The individual is 18 years of age or older
  • The individual has a history of asthma or a current asthma condition
  • The individual has eosinophilia, characterized by >10% of leukocytes or an absolute eosinophil count >1000 cells/mm3 (or >1 x109/L) in the past 6 months
  • The individual has symptoms despite treatment with oral corticosteroids, unless the individual is intolerant of or has a contraindication to these agents
  • Presence of two or more of the following features typical of EGPA:
    • biopsy showing histopathological evidence of one of the following:
      • eosinophilic vasculitis
      • perivascular eosinophilic infiltration
      • eosinophil-rich granulomatous inflammation
    • neuropathy
    • pulmonary infiltrates
    • sinonasal abnormality
    • cardiomyopathy
    • glomerulonephritis
    • alveolar hemorrhage
    • palpable purpura
    • positive test for antineutrophil cytoplasmic antibody (ANCA)

The dosage, frequency, and route of administration for mepolizumab (Nucala®) for the treatment of EGPA is 300 mg (i.e., 3 separate 100-mg injections) administered once every 4 weeks by subcutaneous injection.

RESLIZUMAB (CINQAIR®)

Reslizumab (Cinqair®) is considered medically necessary and, therefore, covered for the treatment of severe eosinophilic asthma when all of the following criteria are met:
  • The individual is 18 years of age or older
  • Blood eosinophils of at least 400 cells/microliter* at the initiation of treatment (within 3-4 weeks of the first dose)
  • The individual is currently receiving treatment that does not maintain adequate control of his/her asthma and reslizumab (Cinqair®) is being used as additional maintenance therapy.
    • Current treatment must include high-dose inhaled corticosteroids (ICS) (with or without oral corticosteroids) plus an additional controller (e.g., long-acting beta agonist [LABA], leukotriene inhibitor, theophylline) medication, unless the individual is intolerant of or has a contraindication to these agents.

The dosage, frequency, and route of administration of reslizumab (Cinqair®) is 3 mg/kg once every 4 weeks by intravenous infusion.

* Note: 1 microliter is equal to 1 cubic millimeter (mm3)

EXPERIMENTAL/INVESTIGATIONAL

All other uses for benralizumab (Fasenra™), mepolizumab (Nucala®), reslizumab (Cinqair®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Guidelines

BLACK BOX WARNINGS

RESLIZUMAB (CINQAIR®)
Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, interleukin-5 (IL-5) Antagonist (e.g., Cinqair®, Nucala®) and IL-5 receptor antagonist (e.g., Fasenra™) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Benralizumab (Fasenra™) was approved by the FDA on November 14, 2017 for the add-on maintenance treatment of individuals with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Mepolizumab (Nucala®) was approved by the FDA on November 4, 2015 for the add-on maintenance treatment of individuals with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Supplemental approvals for mepolizumab (Nucala®) have since been issued by the FDA.

Reslizumab (Cinqair®) was approved by the FDA on March 23, 2016 for the add-on maintenance treatment of individuals with severe asthma aged 18 years and older with an eosinophilic phenotype.

PEDIATRIC USE

BENRALIZUMAB (FASENRA™)
The safety and efficacy in pediatric individuals younger than 12 years have not been established.

MEPOLIZUMAB (NUCALA®)
The safety and efficacy in pediatric individuals younger than 12 years have not been established.

RESLIZUMAB (CINQAIR®)
Reslizumab (Cinqair®) is not indicated for use in pediatric individuals less than 18 years of age. The safety and effectiveness in pediatric individuals (aged 17 years and younger) have not been established.

Description

Asthma is a chronic respiratory disorder characterized by variable and recurring symptoms of airflow obstruction, bronchial hyper-responsiveness, and airway inflammation that can be triggered by environmental allergens, upper respiratory infections, or other stimuli. Eosinophilic asthma is a phenotype of asthma that is associated with tissue and sputum eosinophilia, thickening of the basement membrane zone, and often corticosteroid responsiveness. Sputum cell counts range from 1% to 3% of eosinophils. Reducing the sputum eosinophil count has been shown to be an effective method for preventing severe asthma exacerbations and hospitalizations.

Eosinophilic granulomatosis with polyangiitis (EGPA) (formerly known as the Churg–Strauss syndrome) is a type of vasculitis of the small and medium sized arteries. Symptoms of EGPA include allergic rhinitis, asthma, and peripheral blood eosinophilia. Any organ can be affected, but EGPA more commonly affects the lung and skin. Initial treatment begins with systemic glucocorticoids. Immunosuppressants, such as methotrexate, azathioprine, rituximab, and IVIG may be added to control this disease.

BENRALIZUMAB (FASENRA™)

IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils, a type of white blood cell that contributes to the development of allergic conditions. Benralizumab (Fasenra™) is a humanized monoclonal antibody (IgG1 kappa) produced by recombinant DNA technology in Chinese hamster ovary cells that directly binds to the alpha subunit of interleukin-5 receptor (IL-5Ra) expressed on the surface of eosinophils and basophils. Benralizumab (Fasenra™) recruits natural killer (NK) cells to induce cell death (apoptosis) of eosinophils and basophils, reducing their quantity in the body.

On November 14, 2017, benralizumab (Fasenra™) was approved by the US Food and Drug Administration (FDA) for the add-on maintenance treatment of individuals with severe asthma with an eosinophilic phenotype, aged 12 years and older.

The safety and efficacy of benralizumab (Fasenra™) was studied in three Phase 3 trials.

TRIALS 1 AND 2
SIROCCO (a 48-week trial) and CALIMA (a 56-week trial) were both Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter studies in a total of 2511 subjects. Subjects were 12-75 years of age with asthma for at least 1 year, and at least two exacerbations of asthma (requiring a new or increased dose of oral corticosteroids) in within the year while taking medium-to-high-dose inhaled corticosteroids (ICS) and long-acting beta agonist (LABA) with or without oral corticosteroids and additional asthma controllers. Subjects were randomized (1:1:1) to receive the add-on treatment of one of the following:
  • benralizumab (Fasenra™) 30 mg every 4 weeks (Q4W)
  • benralizumab (Fasenra™) 30 mg every 4 weeks for 3 doses, then every 8 weeks thereafter (Q8W)
  • placebo every 4 weeks

Subjects were stratified 2:1 according to blood eosinophil counts of at least 300 cells/μL and less than 300 cells/μL. The primary endpoint was annual exacerbation rate ratio versus placebo, which is the total number of exacerbations X 365.25 divided by total duration of follow-up within the treatment group (days).

In the SIROCCO trial, subjects with blood eosinophil counts of at least 300 cells/μL who received benralizumab (Fasenra™) had a statistically significant reduction in the annual exacerbation rate ratio by 45% (Q4W) and 51% (Q8W) compared with placebo. Subjects with blood eosinophil counts of less than 300 cells/μL who received benralizumab (Fasenra™) Q4W also had a statistically significant reduction in the annual exacerbation rate ratio compared with placebo (30%), although Q8W did not (17%). Adverse events were similar between all treatment groups.

In the CALIMA trial, subjects with blood eosinophil counts of at least 300 cells/μL who received benralizumab (Fasenra™) had a statistically significant reduction in the annual exacerbation rate ratio by 36% (Q4W) and 28% (Q8W) compared with placebo. Although not a primary endpoint, subjects with blood eosinophil counts of less than 300 cells/μL who received benralizumab (Fasenra™) also had a statistically significant reduction in the annual exacerbation rate ratio by 36% (Q4W) and 40% (Q8W) compared with placebo. Adverse events were similar between all treatment groups.

A subanalysis of the SIROCCO and CALIMA trials was performed to compare the primary endpoint in those with blood eosinophil counts of at least 150 cells/μL versus <150 cells/μL. The Q4W group was not included in the analysis. In those with blood eosinophil counts of at least 150 cells/μL, the benralizumab (Fasenra™) Q8W had a statistically significant reduction in the annual exacerbation rate ratio by 42% (SIROCCO) and 36% (CALIMA) compared with placebo. In those with blood eosinophil counts <150 cells/μL, the benralizumab (Fasenra™) Q8W had favorable, but not statistically significant reduction in the annual exacerbation rate ratio by 24% (SIROCCO) and 35% (CALIMA) compared with placebo.

A pooled analysis of the SIROCCO and CALIMA trials was performed to compare the primary endpoint analyzed by blood eosinophil counts of at least (≥0, ≥150, ≥300, or ≥450 cells/μL). Researchers found that those with higher baseline blood eosinophil counts treated with benralizumab (Fasenra™) had an increased degree of improvement in annual exacerbation rate ratio, compared to those with lower baseline blood eosinophil counts. When annual exacerbation rate ratio was stratified by blood eosinophil counts (i.e., as less than 150, 150–299, 300–449, ≥450 cells/μL), those with counts <150 cells/μL who had benralizumab (Fasenra™) Q4W or Q8W, had favorable, but not statistically significant reductions in the annual exacerbation rate ratio compared to placebo. Similarly, in those with baseline blood eosinophil counts of 150-299 cells/μL, Q8W, had favorable, but not statistically significant reduction in the annual exacerbation rate ratio compared to placebo.

TRIAL 3
The ZONDA trial assessed the safety and efficacy of benralizumab (Fasenra™) as an oral glucocorticoid-sparing therapy in this 28-week randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial. Subjects were 220 adults who required oral glucocorticoid to manage their severe eosinophilic asthma. Inclusion criteria included blood eosinophil counts of 150 cells/μL or more, one exacerbation of asthma in the previous 12 months, and were on a regimen containing high dose ICS, LABA, oral glucocorticoid therapy for at least 6 months (equivalent to predisone 7.5-40 mg/day), and, if needed, additional asthma controller (e.g., leukotriene inhibitor, theophylline) medication.

During the run-in phase (Week -8), the dose of the oral glucocorticoid was reduced to the minimum dose required to control asthma. At Week 0, subjects were randomized (1:1:1) similarly to the prior trials, benralizumab (Fasenra™) Q4W, Q8W, or placebo every 4 weeks for 28 weeks. Weeks 0-4, the oral glucocorticoid dose remained unchanged. Weeks 4-24 was the oral glucocorticoid reduction phase where daily doses were reduced every 4 weeks by 2.5-5 mg; in those who had worsening asthma, the dose was increased to the most recent effective dose and maintained. Weeks 24-28, the oral glucocorticoid dose was maintained.

The primary end point was the percentage reduction in the oral glucocorticoid dose from baseline (randomization at week 0) to the final dose at the end of the maintenance phase (week 28) while asthma control was maintained. Results showed a statistically significant median reduction from baseline of 75% in those who received benralizumab (Fasenra™) Q4W or Q8W, as compared with a reduction of 25% in those who received placebo (P<0.001 for both comparisons). Approximately 85% of the subjects had a median blood eosinophil count ≥300 cells/μL; however the results were not stratified to median blood eosinophil counts of both 150-299 and ≥300 cells/μL.

MEPOLIZUMAB (NUCALA®)

Mepolizumab (Nucala®) is a humanized interleukin-5 antagonist monoclonal antibody (IgG1 kappa) produced by recombinant DNA technology in Chinese hamster ovary cells. IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils, a type of white blood cell that contributes to the development of asthma. Mepolizumab (Nucala®) binds to IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface.

SEVERE ASTHMA WITH EOSINOPHILIC PHENOTYPE
On November 4, 2015, mepolizumab (Nucala®) was approved by the US Food and Drug Administration (FDA) for the add-on maintenance treatment of individuals with severe asthma with an eosinophilic phenotype, aged 12 years and older.

A total of 1,327 subjects with asthma were evaluated in three randomized, placebo-controlled multicenter trials of 24 to 52 weeks duration. Of these, 1,192 subjects had a history of two or more exacerbations in the year prior to enrollment despite regular use of high-dose inhaled corticosteroids plus an additional controller(s), and 135 subjects required daily oral corticosteroids in addition to regular use of high-dose inhaled corticosteroids plus an additional controller(s) to maintain asthma control. All subjects had markers of eosinophilic airway inflammation and blood eosinophils of at least 150 cells/microliter at initiation of treatment or blood eosinophils of at least 300 cells/microliter in the last 12 months. Of the subjects enrolled, 59% were female, 85% were white, and subjects ranged in age from 12 to 82 years. Mepolizumab (Nucala®) was administered subcutaneously or intravenously once every four weeks; 263 subjects received mepolizumab (Nucala®) by subcutaneous route for at least 24 weeks. Compared with placebo, individuals with severe asthma receiving mepolizumab (Nucala®) had fewer exacerbations requiring hospitalization and/or emergency department visits, and a longer time to the first exacerbation. In addition, individuals with severe asthma receiving mepolizumab (Nucala®) experienced greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control, compared with individuals receiving placebo. Treatment with mepolizumab (Nucala®) did not result in a significant improvement in lung function, as measured by the volume of air exhaled by patients in one second.

Serious adverse events that occurred in more than one subject and in a greater percentage of subjects treated with mepolizumab (Nucala®) (n=263) than placebo (n=257) included one event, herpes zoster (2 subjects vs. 0 subjects, respectively). Approximately 2% of subjects withdrew from clinical trials due to adverse events (e.g., headache, injection site reaction) compared with 3% of subjects receiving placebo.

EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS (EGPA)
On December 12, 2017, mepolizumab (Nucala®) was approved by the US Food and Drug Administration (FDA) for the treatment adults with eosinophilic granulomatosis with polyangiitis (EGPA) (formerly known as the Churg–Strauss syndrome).

The safety and efficacy of mepolizumab (Nucala®) was studied in 136 adults with relapsing or refractory EGPA in a Phase 3, randomized (1:1), double-blind, placebo-controlled, multi-center trial over 52 weeks. Participants had a history or presence of asthma, a blood eosinophil level of 10% or an absolute eosinophil count of more than 1000 cells per cubic millimeter, and the presence of two or more criteria that are typical of eosinophilic granulomatosis with polyangiitis (biopsy showing histopathological evidence of eosinophilic vasculitis, perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation; neuropathy; pulmonary infiltrates; sinonasal abnormality; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; or antineutrophil cytoplasmic antibody [ANCA] positivity).

Participants received 300 mg mepolizumab (Nucala®) or placebo subcutaneously every 4 weeks. They were required to be on a stable dose of oral corticosteroids 4 weeks prior to baseline; doses could be tapered during the study. If required, those who were taking immunosuppressives were required to remain at a stable dose 4 weeks prior to baseline and continue throughout the study.

The first primary end point was the total accrued weeks of remission, defined as a Birmingham Vasculitis Activity Score (BVAS, version 3) of 0 on a scale from 0 to 63 (with 0 meaning no disease activity and higher scores indicating greater disease activity) and the receipt of prednisolone or prednisone at a dose of 4 mg or less per day over the 52-week period. Those who received mepolizumab (Nucala®) had a greater percentage of participants who had remission over the 52-week period, measured at 0 weeks, 0 to less than 12 weeks, 12 to less than 24 weeks, 24 to less than 36 weeks, and for at least 36 weeks (Odds ratio, p<0.001). The second primary end point was the percentage of participants who had remission at both week 36 and week 48. Those who received mepolizumab (Nucala®) had a statistically significant greater percentage of participants achieving remission at both 36 and 48 weeks (32% vs 3%) (Odds ratio, p<0.001). There was no significant differences between the two groups in the occurrence of adverse reactions; however there was a greater percentage of serious adverse events in those in the placebo group (26%) when compared to the mepolizumab (Nucala®) group (18%). This observation could be related to relapsing disease.

RESLIZUMAB (CINQAIR®)

On March 23, 2016, reslizumab (Cinqair®) was FDA-approved for the add-on maintenance treatment of individuals with severe asthma with an eosinophilic phenotype who are aged 18 years and older. Reslizumab (Cinqair®) is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant technology in murine myeloma non-secreting 0 cells.

Reslizumab (Cinqair®) approval was based on four randomized, double-blind, placebo-controlled studies. Studies I and II were 52-week studies in 953 individuals with severe asthma who were required to have a blood eosinophil count of at least 400 cells/microliter, and at least 1 asthma exacerbation requiring systemic corticosteroid use over the past 12 months. The majority of individuals (82%) were on medium-high dose inhaled corticosteroids plus a long-acting beta agonist (ICS/LABA) at baseline. Maintenance oral corticosteroids were allowed. The primary endpoint was the frequency of asthma exacerbations. In both studies, individuals on reslizumab (Cinqair®) had a statistically significant reduction in the rate of all asthma exacerbations (episodes requiring systemic corticosteroid use and exacerbations resulting in hospitalization and/or emergency room visit) compared to the placebo. The forced expiration volume in 1 second (FEV1) was also observed during the studies. Improvements were observed at 4 weeks after the first dose of reslizumab (Cinqair®) an maintained through Week 52.

Study 3 was a 16-week study on 315 individuals with severe asthma with a blood eosinophil count of at least 400 cells/microliter at screening. Maintenance oral corticosteroids were not allowed. Individuals received 3 mg/kg or 0.3 mg/kg of reslizumab (Cinqair®) once every 4 weeks for a total of 4 doses compared to placebo. Reslizumab (Cinqair®) at 3 mg/kg is the recommended dose. The primary endpoint was FEV1. Improvements in FEV1 were observed at 4 weeks following the first dose of reslizumab (Cinqair®).

Study 4 was a 16-week study on 496 individuals with severe asthma. Baseline blood eosinophil levels were not taken into account for selection. The majority of the participants had a blood eosinophil level of less than 400 cells/microliter at screening. Maintenance oral corticosteroids were not allowed. Individuals were randomized to receive either reslizumab (Cinqair®) 3 mg/kg once every 4 weeks or placebo for a total of 4 doses. The primary endpoint was FEV1. There was no association of treatment effect and baseline blood eosinophils observed in asthma individuals unselected for blood eosinophils. In the subgroup of individuals with eosinophil count at least 400 cells/microliter, the treatment of reslizumab (Cinqair®) was associated with a significant improvement in FEV1 compared to the placebo.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
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US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Benralizumab (Fasenra™). Labeling and approval letter. [FDA Web site]. 11/14/17. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed January 17, 2018.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Mepolizumab (Nucala®). Labeling and approval letter. [FDA Web site]. 12/12/17. Available at:
https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed January 17, 2018.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Reslizumab (Cinqair®). Labeling and approval letter. [FDA Web site]. 03/2016. Available at:
https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed January 17, 2018.

Walford HH, Doherty TA. Diagnosis and management of eosinophilic asthma: a US perspective. J Asthma Allergy.2014;7:53-65.

Wagner AH, Nijs S, Lutter R, et al. External validation of blood eosinophils, FEno, and serum periostin as surrogates for sputum eosinophils in asthma. Thorax. 2015;70(2):115-120.

Wechsler ME, Akuthota P, Jayne D, et al; EGPA Mepolizumab Study Team. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017;376(20):1921-1932.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

J82 Pulmonary eosinophilia, not elsewhere classified


M30.1 Polyarteritis with lung involvement [Churg-Strauss]



HCPCS Level II Code Number(s)

J0517 Injection, benralizumab, 1 mg


J2182 Injection, mepolizumab, 1 mg

J2786 Injection, reslizumab, 1 mg



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 08.01.23e
01/01/2019This policy has been identified for the HCPCS code update, effective 01/01/2019.

The following HCPCS code has been added to this policy:
J0517 Injection, benralizumab, 1 mg

The following HCPCS codes have been removed from this policy:
C9466 Injection, benralizumab, 1 mg
J3590 Unclassified biologics

Revisions from 08.01.23d
04/09/2018This policy has undergone a routine review, and the medical necessity criteria have been revised as follows:

The coverage criteria was included for the newly FDA-approved drug, benralizumab (Fasenra™) for the treatment of severe asthma with an eosinophilic phenotype.

The coverage criteria was also included for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) with mepolizumab (Nucala®).

Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 01/01/2019
Version Issued Date: 01/03/2019
Version Reissued Date: N/A

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