Nucala & Fasenra - NC Standard

Restricted Product(s)

• Fasenra® (benralizumab) 
• Nucala® (mepolizumab)

FDA Approved Use

Nucala:

• For add-on maintenance treatment of patients with severe asthma aged 6 years and older and with an eosinophilic phenotype. 
• For the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 
• For the treatment of patients 12 years of age and older with hypereosinophilic syndrome (HES) for at least 6 months without an identifiable non-hematologic secondary cause. 
• For add-on maintenance treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) 
• Limitations of use: Not for relief of acute bronchospasm or status asthmaticus 

Fasenra:

• For add-on maintenance treatment of patients 6 years of age and older with severe asthma and with an eosinophilic phenotype. 
• Limitations of Use: 
  • Not for treatment of other eosinophilic conditions 
  • Not for relief of acute bronchospasm or status asthmaticus
    
• For the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Criteria for Approval of Restricted Product(s)

Initial Criteria for Approval

For patients that are new to the plan and currently taking the medication, the criteria pertain to when the patient started the medication.

1. ONE of the following: 
   1. The patient has a diagnosis of severe eosinophilic asthma; AND
      1. The patient is 6 years of age or older; AND 
      2. The patient has one of the following: 
         1. Eosinophil counts greater than or equal to 150 cells/microliter at initiation of therapy (i.e., within the last 6 weeks): OR 
         2. Eosinophil counts greater than or equal to 300 cells/microliter in the past 12 months; AND
      3. The patient does NOT have neoplastic disease or known/suspected parasitic infection; AND 
      4. The patient has had two or more exacerbations in the past year despite adherence to therapy with: 
         1. 12 months of high-dose inhaled corticosteroid (ICS) given in combination with a minimum of 3 months of controller medication (either a long-acting beta2-agonist [LABA], or leukotriene receptor antagonist [LTRA], or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents; OR 
         2. 6 months of ICS with daily oral glucocorticoids given in combination with a minimum of 3 months of controller medication (either a LABA, or LTRA, or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents; OR
   2. The patient has a diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA/Churg-Strauss Syndrome); AND 
      1. The patient is 18 years of age or older; AND 
      2. The patient is stable on oral corticosteroids; AND 
      3. The patient has tried and failed or has a clinical intolerance/contraindication to an oral immunosuppressant (e.g. cyclophosphamide, azathioprine, methotrexate, leflunomide, mycophenolate mofetil); OR 
   3. The patient has a diagnosis of hypereosinophilic syndrome (HES); AND 
      1. The request is for Nucala; AND 
      2. The patient is 12 years of age or older; AND 
      3. The patient has been diagnosed for six months or greater; AND 
      4. The patient does NOT have non-hematologic secondary HES (e.g., drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy) or FIP1L1-PDGFRα kinase-positive HES; AND 
      5. The patient has been on stable dosing of and will continue HES therapy (oral corticosteroids, immunosuppressive agents and/or cytotoxic therapy); AND 
      6. The patient has had at least 2 HES flares in the past 12 months (one of which was NOT related to a decrease in HES therapy within 4 weeks prior to flare) defined as: 
         1. HES-related worsening of clinical symptoms; OR
         2. Blood eosinophil count requiring escalation in therapy; AND 
      7. The patient has a blood eosinophil count ≥ 1,000 cells/mcL; OR 
   4. The patient has a diagnosis of chronic rhinosinusitis with nasal polyposis; AND 
      1. The request is for Nucala; AND 
      2. The patient is 18 years of age or older; AND 
      3. ONE of the following:
         1. The patient has tried and failed or has a clinical intolerance/contraindication to Xhance (medical record documentation required); OR 
         2. The patient has tried and failed or has a clinical intolerance/contraindication to oral systemic corticosteroids within the previous 6 months (medical record documentation required); AND
      4. The patient has had prior surgery for nasal polyps (medical record documentation required); OR 
         1. The patient is not a candidate for surgery (medical record documentation required); AND 
      5. The patient will not be using Nucala in combination with Xhance; AND 
      6. The patient is currently being treated with an over the counter intranasal steroid; OR 
         1. The patient has a clinical intolerance/contraindication to ALL intranasal steroids (medical record documentation required); AND
2. The patient will NOT be using the requested agent in combination with another biologic immunomodulator for the same indication; AND 
3. The provider is aware that if approved, any previous authorizations through Blue Cross NC for biologic agents used for the same indication as the requested agent will be terminated; AND 
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval: 365 days (1 year) 

Continuation Criteria for Approval

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND 
2. The patient will NOT be using the requested agent in combination with another biologic immunomodulator for the same indication; AND 
3. The provider is aware that if approved, any previous authorizations through Blue Cross NC for biologic agents used for the same indication as the requested agent will be terminated; AND 
4. ONE of the following: 
   1. For patients using Nucala or Fasenra for eosinophilic asthma they demonstrated one or more of the following while taking the medication: 
      1. Decreased utilization of rescue medications; 
      2. Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in ICS dose or treatment with systemic corticosteroids);
      3. Increase in predicted FEV1 from pretreatment baseline;
      4. Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing; OR
   2. For patients using Nucala for eosinophilic granulomatosis; 
      1. The member is stable on oral corticosteroid therapy; OR 
   3. For patients using Nucala for hypereosinophilic syndrome (HES) they demonstrated one or more of the following while taking the medication; 
      1. Reduction in number of flares from baseline (medical record documentation required); 
      2. Improvement in clinical symptoms (e.g., fatigue severity, cough, breathlessness) (medical record documentation required); OR 
   4. For patients using Nucala for chronic rhinosinusitis with nasal polyposis: 
      1. The patient has been on and adherent to an over-the-counter intranasal steroid since starting Nucala (medical record documentation required); OR 
      2. The patient has a clinical intolerance/contraindication to ALL intranasal steroids (medical record documentation required).

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

October 2024: Criteria change (Fasenra, Nucala): Added new indication for Fasenra to include treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) policy and updated quantity limit chart. Removed requirement for Fasenra and Nucala that patient with EGPA has been diagnosed for six months or greater.

September 2024: Criteria update: Added example length of time frame for eosinophil counts during initiation of therapy and added limitations of use to FDA section.

April 2024: Criteria update (Fasenra): Updated age to 6 years and older for patients with severe asthma and with an eosinophilic phenotype as add-on maintenance treatment.

January 2023: Criteria update: Added patient must be adherent to conventional therapies in the initial criteria for eosinophilic asthma.

June 2022: Criteria update (Nucala): Updated severe eosinophilic asthma indication for age 6 years of age and older. Added new 40 mg/0.4 mL prefilled syringe strength.

April 2022: Criteria update: Updated chronic rhinosinusitis with nasal polyposis indication to allow tried/failed Xhance OR oral systemic corticosteroids

January 2022: Criteria change: Added clause if patient is not a surgery candidate.

November 2021: Criteria change: Addition of criteria for chronic rhinosinusitis with nasal polyps. Added mycophenolate mofetil to examples of oral immunosuppressants for EGPA

October 2021: Criteria update: If approved, any authorizations for biologic agents used for the same indication as the requested agent will be terminated.

August 2021 Criteria update: Added new indication for chronic rhinosinusitis with nasal polyps to FDA approved use section.

January 2021: Criteria change: Addition of requirement that the patient will not be using the requested agent in combination with another biologic immunomodulator for the same indication.

October 2020: Criteria update: Addition of criteria for hypereosinophilic syndrome.

April 2020: Criteria change: Added requirement of a trial and failure of an oral immunosuppressant for diagnosis of EGPA/Churg-Strauss Syndrome prior to Nucala use.

November 2019: Criteria update: Added dosing for Fasenra initial therapy to Quantity Limit.

November 2019: Criteria change: Corrected age requirement of Nucala to 12 years of age.

October 2019: Criteria update: Added new to market Fasenra pen injection to criteria.

September 2019: Criteria update: Updated age criteria for eosinophilic asthma from 12 years of age to 6 years of age.

August 2019: Original utilization management criteria issued.