ASTHMA MANAGEMENT

X.65





Preauthorization Required
X.65 ASTHMA MANAGEMENT


Policy

TARGET AGENTS

Nucala® (mepolizumab) is FDA approved:

  • For the add-on maintenance treatment of adult and pediatric patients age 6 years and older with severe asthma and with an eosinophilic phenotype
  • For the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids
  • For the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA)
  • For the treatment of adult and pediatric patients age 12 years and older with hypereosinophilic syndrome (HES) for ≥ 6 months without an identifiable non-hematologic secondary cause

Fasenra® (benralizumab) is FDA approved:

  • For the add-on maintenance treatment of patients with severe asthma age 6 years and older, and with eosinophilic phenotype
  • For the treatment of adult patients wtih eosinophilic granulomatosis with polyangiitis (EGPA).

Cinqair® (reslizumab) is FDA approved:

  • For the add-on maintenance treatment of patients with severe asthma age 18 years and older with an eosinophilic phenotype

Tezspire® (Tezepelumab-ekko) is FDA approved:

  • For the add-on maintenance treatment of adult and pediatric patients age 12 years and older with severe asthma.
  • For the add-on maintenance treatment of adult and pediatric patients age 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)

 

 

Brand (generic)

GPI (NDC)

Multisource Code

Quantity Limit (per day or as listed)

Nucala (mepolizumab)

100mg powder for injection

44604055002120

M, N, O, or Y

1 vial per 28 days

100mg/mL auto-injector

4460405500D530

M, N, O, or Y

1 auto-injector per 28 days

100mg/mL prefilled syringe

4460405500E530

M, N, O, or Y

1 syringe per 28 days

Fasenra (benralizumab)

30mg/mL prefilled syringe

4460402000E520

M, N, O, or Y

1 syringe per 56 days

30mg/mL auto-injector

4460402000D520

M, N, O, or Y

1 auto-injector per 56 days

Cinqair (reslizumab)

200mg/10mL single use vial

44604460002020

M, N, O, or Y

n/a

Tezspire (tezepelumab-ekko)

210mg/1.91mL prefilled syringe

4460807525E520

M, N, O, or Y

1 syringe per 28 days (1.910mL per 28 days)

 

 

 

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Initial Evalution

I.  Target Agent(s) may be considered medically necessary when ALL of the following are met:

A.  The requested agent is eligible for continuation of therapy and ONE of the following:

1.  Information has been provided that the patient has been treated with the requested agent within the past 90 days OR

2.  The prescriber states the patient has been treated with the requests agent within the past 90 days AND is at risk if therapy is changed.

     OR

B.  The request is for Nucala and the patient has ONE of the following diagnosis:

1.  Severe eosinophilic asthma AND

a.  The patient does not have any contraindications to the requested agent AND

b.  The patient is 6 years of age or greater AND

c.  The patient's diagnosis has been confirmed by ONE of the following eosinophilic counts:

i.  Eosinophilic blood count greater than or equal to 150cells/microliter prior to initiation (within previous 6 weeks) of therapy with requested agent OR

ii.  Eosinophilic blood count greater than or equal to 300cells/microliter within the previous 12 months OR

iii.  Sputum eosinophilic count greater than 3%

AND

d.  The patient has a baseline Forced Expiratory (Volume FEV1) less than 80%

e.  The patient has ONE of the following:

i.  Frequent severe asthma exacerbations requiring 2 or more courses of systemic corticosteroids within the past 12 months OR

ii.  Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to emergency room or urgent care within the past 12 months OR

iii. Controlled asthma that worsens when doses of inhaled or systemic corticosteroids are tapered

AND

f.  ONE of the following:

i.  The patient is currently treated with a maximally tolerated inhaled corticosteroid OR

ii.  The patient has documented intolerance, FDA labeled contraindication, or hypersensitivity to inhaled corticosteroids

AND

g.  ONE of the following:

i.  The patient is currently treated with ONE of the following:

a).  The A long acting beta-2 agnostic (LABA) OR
b).  A leukotriene receptor antagonist (LTRA) OR

c).  Long acting muscarinic antagonist (LAMA) OR

d).  Theophylline

OR

     ii.  The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to

          LABA, LRTA, LAMA, and theophylline

AND

h.  The patient will not receive the requested agent in combination with other biologic asthma therapy (Xolair, Cinqair, Fasenra, Tezspire)

OR

2.  Chronic rhinosinusitis with nasal polys

a.  ALL of the following:

                i.  The patient has at least TWO of the following symptoms consistent wtih chronic rhinosinusitis (CRS):

A. Nasal discharge (rhinorrhea or post-nasal drainage)

B. Nasal obstruction or congestion

C. Loss or decreased sense of smell (hyposmia)

D. Facial pressure or pain AND

               ii.  The patient has had symptoms consistent with chronic rhinosinusitis (CRS) for at least 12 consecutive weeks AN

              iii.  The patient's diagnosis was confirmed by ONE of the following:

A. Anterior rhinoscopy

B. Nasal endoscopy

C. Computed tomography (CT) of the sinuses AND

iv. The patient has ONE of the following:

A. Tried and had inadequate response to ONE intranasal corticosteroid (e.g. nasal saline irrigatino, intranasal corticosteroid [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) OR

B. An intolerance or hypersensitivity to ONE intranasal corticosteroid (e.g. nasal saline irrigatino, intranasal corticosteroid [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) OR

C. An FDA labeled contraindication to ALL intranasal corticosteroids OR

v. The patient is currently treated with standard nasal polyp maintenance therapy (e.g. nasal saline irrigatino, intranasal corticosteroid [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) AND

vi. The patient will continue standard nasal polyp maintenance therapy (e.g. nasal saline irrigatino, intranasal corticosteroid [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) in combination with the requested agent AND

vii. The prescriber is a specialist in the area of the patient's diagnosis (e.g., allergist, immunologist, pulmonologist) or the prescriber has consulted wiht a specialist in the area of the patient's diagnosis

viii. The patient will not receive the requested agent in combination with other biologic asthma therapy (Xolair, Cinqair, Fasenra, Nucala, Dupixent).

 

OR
C.  The request is for Cinqair and ALL of the following:

1.  The patient's age is within FDA labeling for the requested indication for the requested agent AND

2.  The patient has ONE Of the following diagnoses:

a.  Severe eosinophilic asthma OR
b.  Another FDA approved indication

AND

3.  For diagnosis of severe eosinophilic asthma ALL of the following:

 a. The patient is 18 years of age or older AND

 b.  The patient's diagnosis has been confirmed by ONE of the following eosinophilic counts

i.  Eosinophilic blood count ≥400cells/microliter within the previous month OR
ii.  Sputum eosinophilic count greater than 3%

     AND

       c.  The patient is receiving at least a medium dose of inhaled corticosteroid (fluticasone

            propionate ≥440mcg/day or equivalent) with or without controller drug (including oral corticosteroids) AND

       d.  The patient has been stable for ≥30 days on current regimen AND

       e.  Patient has to have at least one asthma exacerbation needing systemic corticosteroids within the past 12 

            months

AND

4. The patient has been previously approved and inadequate response to Fasenra OR Nucala AND

5.  The patient will not receive the requested agent in combination with other biologic asthma therapy (Xolair, Nucala, Fasenra, Tesprie, Dupixent)

 

D.  The request is for Fasenra and ALL of the following are met:

1.  The patient does not have any FDA labeled contraindications to the requested agent AND

2.  The patient has ONE of the following diagnoses:

a.  Severe eosinophilic asthma OR

b.  Another FDA approved indication

AND

3.  For the diagnosis of severe eosinophillic asthma ALL of the following:

a.  The patient is 6 years of age or over AND

b. ONE of the following:

i.  Eosinophilic blood count ≥150cell/microliter prior to initiation (within the previous 6 weeks) of therapy with the requested agent OR

ii.  Eosinophilic blood count greater than or equal to 300cells/microliter within the previous 12 months AND

c.  The patient has a baseline FEV1 <80% predicted (less than 90% predicted for patients age 12-17 years) AND

d.  Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months AND

e.  ONE of the following:

i.  The patient is currently treated with medium to high dose inhaled corticosteroids (>250ug (medium) or  > 500 (high) fluticasone dry powder formulation or equivalent AND LABA for 12 months or more (with or without the use of oral corticosteroids) OR

ii.  The patient is currently treated with high dose inhaled corticosteroids (>500 fluticasone dry powder formulation or equivalent and LABA for 3 months or more (with or without the use of oral corticosteroids) OR
iii. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to inhaled corticosteroids or LABA therapy

AND

4.  The patient will not receive the requested agent in combination with other biologic asthma therapy (Xolair, Cinqair, Nucala, Tezspire, Dupixent)

OR

E.  The request is for Tezspire and ALL of the following:

1.  The patient has a diagnosis of severe asthma and ALL of the following:

a.  The patient has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:

i.  Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months OR

ii.  Serious asthma exacerbations requiring hopsitialization, mechanical ventilation, or visit to emergency room or urgent care within the past 12 months OR
iii.  Controlled asthma that worsens when the dose of inhaled and/or systemic corticosteroids are tapered OR
iv.  The patient has baseline (prior to therapy with the requested agent) Forced Expiratory Volume (FEV1) that is less than 80% predicted

AND

b.  ONE of the following:

i.  The patient is NOT currently being treated with the requested agent and currently treated with maximally tolerated inhaled corticosteroid for at least 3 months following:

a). Is currently treated with an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms OR

b). Is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months

OR

ii.  The patient has an FDA labeled contraindication, intolerance, or hypersensitivity to inhaled corticosteroid therapy

OR

c.  ONE of the following:

i.  The patient is currently being treated for at least 3 months with ONE Of the following:

a).  A long acting beta-2 agonist (LABA) OR

b).  A leukotriene receptor antagonist (LTRA) OR

c).  A long acting muscarinic antagonist (LAMA) OR

d).  Theophylline

OR

ii.  The patient has a FDA contraindication, intolerance, or hypersensitivity to therapy with LABA, LTRA, LAMA, or theophylline

AND

d.  The patient will continue asthma control therapy (e.g., ICS, LABA, LTRA, LAMA, therophylline) in combination with the requested agent.

OR

2.  The patient has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) AND ALL of the following:

a. The patient has at least TWO of the following symptoms consistent with chronic rhinosinusitis (CRS):

i. Nasal discharge (rhinorrhea or post-nasal drainage) 

ii. Nasal obstruction or congestion

iii. Loss or decreased sense of smell (hyposmia)

iv. Facial pressure or pain AND

b. The patient has had symptoms consistent with chronic rhinosinusitis (CRS) for at least 12 consecutive weeks AND

c. The patient's diagnosis was confirmed by ONE of the following:

i. Anterior rhinoscopy OR

ii. Nasal endoscopy OR

iii. Computed tomography (CT) of the sinuses AND

d. The patient has ONE of the following: 

i. Tried and had an inadequate response to ONE intranasal corticosteroid (e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva) after at least a 4-week duration of therapy OR

ii. An intolerance or hypersensitivity to ONE intranasal corticosteroid (e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva) OR

iii. An FDA labeled contraindication to ALL intranasal corticosteroids OR

e. The patient is currently treated with standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroid [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) AND

f. The patient will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroid [e.g., fluticasone nasal spray, mometasone nasal spray, Sinuva]) in combination with the requested agent.

3.  The patient has another FDA approvedapproved indication for the requested agent AND

4.  ONE of the following:

a.  The patient's age is within FDA labeling for the requested indication for the requested agent OR
b.  The prescriber has provided information in support of using the requested agent for the patient's age for the requested indication

AND

5.  The prescriber is a specialist in the area of the patient's diagnosis (e.g., allergist, immunologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient's diagnosis  AND

6.  The patient will not receive the requested agent in combination with other biologic asthma therapy (Xolair, Cinqair, Fasenra, Nucala, Dupixent)  AND

7.  The patient does NOT have any FDA labeled contraindications to the requested agent AND

8.  The requested quantity dose does NOT exceed the program quantity limit

AND

F. If request is for healthcare administered formulation, the patient has had failure, intolerance, or contraindication to self-administered formulation.

AND

G.  ALL of the following:

1. The requested quantity dose is greater than the program quantity limit AND

2. The requested quantity dose dose NOT exceed the maximum FDA labeled dose for the requested indication AND

3. The requested quantity dose cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

H.  ALL of the following:

1.  The requested quantity dose is greater than the program quantity limit AND

2.  The requested quantity dose is greater than the maximum FDA labeled dose for the requested indication AND

3.  The prescriber has provided information in support of therapy with a higher dose for the requested indication.

Length of Approval:  12 months

 

Renewal Evaluation

I.  Target agent(s) may be considered medically necessary when ALL of the following are met:

A.  The patient has been previously approved for the requested agent through the plan's prior authorization process AND

B.  The patient has had clinical benefit with the requested agent AND

C.  The patient does NOT have any FDA labeled contraindications to the requested agent AND

D.  ONE of the following:

1.  The requested quantity dose does not exceed the program quantity limit OR
2.  ALL of the following:

a.  The requested quantity dose is greater than the program quantity limit AND

b.  The requested quantity dose does not exceed the maximum FDA labeled dose for the requested indication AND

c.  The requested quantity dose cannot be achieved with a lower quantity of higher strength that dose not exceed the program quantity limit

OR
3.  ALL of the following:

a.  The requested quantity dose is greater than the program quantity limit AND

b.  The requested quantity dose is greater than the maximum FDA labeled dose for the requested indication AND

c.  Information has been provided in support of therapy with a higher dose for the requested indication.

Length of Approval:   12 months

 



Dates

  • Original Effective
    11-11-2015
  • Last Review
    11-05-2025
  • Next Review
    11-12-2026

Background

Nucala:  Approved based on the results of 3 randomized, double-blind, placebo-controlled trials.

Study 1 was a 52-week dose-ranging and exacerbation-reduction trial in asthmatic subjects with a history of ≥ 2 exacerbations in the previous year despite regular high-dose inhaled corticosteroids plus an additional controller(s). The trial randomized the subjects to either the mepolizumab or placebo arms. Those in the mepolizumab arm received one of three intravenous (IV) doses: 75 mg, 250 mg, and 750 mg each dosed once every four weeks. The primary endpoint for this trial was the frequency of exacerbations. Results from this trial and the pharmacodynamic study supported the evaluation of mepolizumab 75 mg IV and 100 mg SC in the subsequent trials.

Study 2 was a phase 3 double-blind, placebo-controlled trial which enrolled 576 patients with recurrent asthma exacerbations (at least 2 in the previous year which were treated with systemic glucocorticoids) and evidence of eosinophilic inflammation (eosinophil count of at least 150 cells/µL in the peripheral blood at screening or at least 300 cells/ µL at some time during the previous year) despite high doses of inhaled glucocorticoids.  Patients were assigned to one of three study groups upon enrollment (mepolizumab 75mg IV, mepolizumab 100mg subq, or placebo; every 4 weeks for 32 weeks).  The primary outcome was rate of exacerbations.  Results of the study demonstrated the rate of exacerbations was reduced by 47% among patients receiving IV mepolizumab (0.93/patient/year) and by 53% among patients receiving subcutaneous mepolizumab (0.83/patient/year) compared to placebo (1.74/patient/year).

Study 3 was a 24 week oral corticosteroid reduction trial in subjects who required oral corticosteroids in addition to high dose inhaled corticosteroids and additional controller(s) to control asthma symptoms. The primary end point for trial 3 was the percent reduction of oral corticosteroid dose during weeks 20 to 24 compared to baseline dose, while maintaining asthma control. Compared to placebo, subjects receiving Nucala achieved greater reductions in daily maintenance oral corticosteroid dose, while maintaining asthma control. 

 

Cinqair: Approved based on the results of 4 randomized, double-blind, placebo-controlled studies.

 

Studies 1 & 2 were 52 week, double-blind, randomized, placebo-controlled studies; conducted in 953 patients with asthma who were required to have a blood eosinophil count of at least 400 cells/µL (w/i 3-4 weeks of dosing), inadequately controlled asthma, receiving at least a medium dose of inhaled corticosteroids, and have at least 1 asthma exacerbation requiring systemic corticosteroid use over the previous 12 months (as well as an FEV1 reversibility of 12% or more w/ albuterol). Patients were randomized in a 1:1 ratio to receive either reslizumab 3mg/kg or matching placebo every 4 weeks for 13 doses. The primary endpoint of these studies was frequency of Clinical asthma exacerbations per patient during the 52 week treatment period. The results of the studies indicates the proportion of patients who did not experience an asthma exacerbation was higher in the reslizumab group (~78%) compared with placebo (~50%). Only the number of exacerbations requiring the use of systemic corticosteroids was significantly lower in the reslizumab group over the placebo.

 

The primary endpoint for studies 3 & 4 was change from baseline to week 16 in FEV1. Study 3 looked at 2 doses of reslizumab (0.3 or 3 mg/kg every 4 weeks) and compared them to placebo to determine which was more effective in improving lung function in patients with asthma with an eosinophilic phenotype. Significant improvements in FEV1 were seen in patient in both reslizumab groups compared to placebo, but the overall treatment effect was larger for patients in the 3mg/kg dosing group. Study 4 included patients with moderate-severe asthma who were unselected for baseline blood eosinophils. The results did not show a significant interaction between baseline blood eosinophil count and change in FEV1 at week 16.

 

Fasenra: Approved based on the results from 2 randomized, double-blind, placebo-controlled phase 3 studies.


Study 1 (SIROCCO) was a 48 week, randomized, double-blind, parallel-group, placebo-controlled, phase 3 study.  The study enrolled 2,681 patients with a minimum weight of 40 kg, severe asthma uncontrolled by medium to high dose inhaled corticosteroids (ICS) plus long-acting β2-agonists (LABA) and a history of two or more exacerbations in the previous year.  Of the 2,681 only 1,205 were randomized in a 1:1:1 ratio to 1 of 3 groups.  The 3 groups were benralizumab 30 mg every 4 weeks (n = 400), benralizumab 30 mg every 8 weeks (with first 3 doses given 4 weeks apart; n = 398) and placebo (n = 407).  The study demographic consisted of patients aged 12 – 75 with a mean age of 49, 66% were female, 73% were white, 80% never smoked and the mean baseline eosinophil count was 472 cells/microliter.  The primary end point was the annual rate ratio versus placebo of asthma exacerbations for patients receiving high dose ICS plus LABA therapy with a blood eosinophil baseline of 300 cells/microliter or greater.  The results of the study indicated that benralizumab given every 4 weeks and benralizumab given every 8 weeks (with first 3 doses given 4 weeks apart) significantly reduced the annual rate of asthma exacerbations by 45% and 51% respectively compared to placebo (Q4W p<0.0001; Q8W p<0.0001). 

Study 2 (CALIMA) was a 52 week, randomized, double-blind, parallel-group, placebo-controlled, phase 3 study.  The study enrolled 2,505 patients with a minimum weight of 40 kg, severe asthma uncontrolled by medium to high dose inhaled corticosteroids (ICS) plus long-acting β2-agonists (LABA) and a history of two or more exacerbations in the previous year.  Of the 2,505 only 1,306 were randomized in a 1:1:1 ratio to 1 of 3 groups.  The 3 groups were benralizumab 30 mg every 4 weeks (n = 425), benralizumab 30 mg every 8 weeks (with first 3 doses given 4 weeks apart; n = 441) and placebo (n = 440).  The study demographic consisted of patients aged 12 – 75 with a mean age of 49, 62% were female, 84% were white, 78% never smoked and the mean baseline eosinophil count was 472 cells/microliter.  The primary end point was the annual rate ratio versus placebo of asthma exacerbations for patients receiving high dose ICS plus LABA therapy with a blood eosinophil baseline of 300 cells/microliter or greater.  Only 728 of the 1,306 randomized patients were included in the primary end point.  The remaining 363 randomized patients had a blood eosinophil baseline of less than 300 cells/microliter.  The results of the study indicate that benralizumab given every 4 weeks and benralizumab given every 8 weeks (with first 3 doses given 4 weeks apart) significantly reduced the annual rate of asthma exacerbations by 36% and 28% respectively compared to placebo (Q4W p=0.0018; Q8W p=0.0188). 



Guidelines

Initial Evaluation:

If deemed medically necessary, mepolizumab 100mg subq every 4 weeks is approved for 6 months.

If deemed medically necessary, reslizumab 3mg/kg IV every 4 weeks is approved for 6 months.

If deemed medically necessary, benralizumab 30mg/mL subq every 4 weeks for the first 3 doses followed by 30mg/mL subq every 8 weeks is approved for 6 months.

 

Renewal Evaluation:

If deemed medically necessary, mepolizumab 100mg subq every 4 weeks is approved for 12 months.

If deemed medically necessary, reslizumab 3mg/kg IV every 4 weeks is approved for 12 months.

If deemed medically necessary, benralizumab 30mg/mL subq every 8 weeks is approved for 12 months.

*Current use of inhaled corticosteroids is defined as being compliant to prescribed therapy.

 

Contraindications:

*Mepolizumab is contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in its formulation.

*Reslizumab is contraindicated in patients with a history of hypersensitivity to reslizumab or excipients in its formulation.

*Benralizumab is contraindicated in patients with a history of hypersensitivity to benralizumab or excipients in its formulation.



Quick Code Search

Use this feature to find out if a procedure and diagnosis code pair will be approved, denied or held for review. Simply put in the procedure code, then the diagnosis code, then click "Add Code Pair". If the codes are listed in this policy, we will help you by showing a dropdown to help you.

Procedure

Enter at least the first 3 characters of the code


Diagnosis

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Codes

      
          Full Description
            INJECTION, BENRALIZUMAB, 1 MG
      
          Full Description
            Injection, benralizumab, 1 mg
      
          Full Description
            Injection, mepolizumab, 1 mg
      
          Full Description
            Injection, tezepelumab-ekko, 1 mg
      
          Full Description
            Injection, reslizumab, 1 mg




References

2014

Bel EH, Wenzel SE, Thompson PJ, et al. Oral Glucocorticoid-Sparing Effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014; 371(13): 1189-1197. DOI: 10.1056/NEJMoa1403291
2014

Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-207. doi:10.1056/NEJMoa1403290
2015

Nucala package insert. GlaxoSmithKline LLC. November 2015. Available at https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL.PDF Accessed May 2016
2015

Castro M, Zanfrilli J, Wechsler ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicenter, parallel, double-blind, randomized, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015; 3: 355-366. 
2016

Cinqair package insert. Teva Pharmaceuticals LLC. March 2016. Available at http://www.cinqair.com/pdf/PrescribingInformation.pdf Accessed May 2016
2017

 Fasenra (benralizumab) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017.
2016

Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomized, multicenter, placebo-controlled phase 3 trial. Lancet 2016; 388:2115.
2016

FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomized, double-blind, placebo-controlled phase 3 trial. Lancet 2016; 388:2128.

Revisions

07-05-2026

Updated CRSwNP for Nucala per Prime Trade contract.
04-13-2026

Added criteria for FDA approved diagnosis of CRSwNP for Tezspire per Trade requirements.
01-13-2025

Update to require step through Fasenra or Nucala prior to approval of Cinqair, per trade.
11-19-2024

Updated Fasenra indication and blood eosinophil count within 12 months per Prime.
08-21-2024

Updated FDA approved age of use for Fasenra to 6yr.
04-07-2024

Removed weight criteria for Fasenra.
11-30-2023

Removed biologic step through criteria for Tezspire and added criteria requiring use of self-administered product before health-care administered product.
06-16-2022

Added new code for 07/01/2022: J2356
01-17-2022

Addition of criteria for use of Nucala for chronic rhinosinusitis with nasal polyps.
03-01-2021

Changed minimum age of use of Nucala
01-03-2019

Added new code for 2019 J0517
03-15-2018

Added Fasenra to policy
12-07-2016

Added new 2017 HCPCS codes J2182 J2786
09-19-2016

New 10/01/2016 HCPCS code C9481 added to policy. 
06-09-2016

Added new indication for Nucala and Cinqair
03-15-2016

Added new HCPCS code C9473 to policy.