Pharmacy Prior Authorization Criteria

Authorized Brand Alternative (ABA) Policy

Indications for Prior Authorization

Fluticasone and Vilanterol inhalation powder

• For diagnosis of Asthma
  Indicated for once-daily treatment of asthma in patients aged 18 years and older. Limitation of Use: Fluticasone Furoate/Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm.

• For diagnosis of Chronic Obstructive Pulmonary Disease
  Indicated for long-term, once-daily, maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Limitation of Use: Fluticasone Furoate/Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm.

Fluticasone and Salmeterol HFA inhalation aerosol

• For diagnosis of Asthma
  For treatment of asthma in adult and adolescent patients aged 12 years and older. Limitations of Use: Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm.

Insulin Glargine Injection Solution, Insulin Glargine Solostar Injection

• For diagnosis of Diabetes Mellitus
  Indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Limitations of use: Insulin glargine is not recommended for the treatment of diabetic ketoacidosis.

Insulin Degludec Injection Solution, Insulin Degludec Flextouch Injection

• For diagnosis of Diabetes Mellitus
  Indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis.

Insulin Aspart Injection Solution, Insulin Aspart Flexpen, Insulin Aspart Penfill, Novolog Relion, Novolog Relion Flexpen

• For diagnosis of Diabetes Mellitus
  Indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Insulin Aspart 70/30 Injection Solution, Insulin Aspart 70/30 Flexpen, Novolog Relion 70/30, Novolog Relion 70/30 Flexpen

• For diagnosis of Diabetes Mellitus
  Indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: 1) Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 and Novolog Mix 70/30 are not recommended for the treatment of diabetic ketoacidosis. 2) The proportions of rapid-acting and long-acting insulins in Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 and Novolog Mix 70/30 are fixed and do not allow for basal versus prandial dose adjustments.

Insulin Lispro Kwikpen, Insulin Lispro Jr Kwikpen, Insulin Lispro 75/25 Kwikpen

• For diagnosis of Diabetes Mellitus
  Indicated to improve glycemic control in adults and children with diabetes mellitus.

  Limitations of Use: the proportions of rapid-acting and intermediate-acting insulins in Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are fixed and do not allow for basal versus prandial dose adjustments.

Dapagliflozin-Metformin hydrochloride Extended-Release

• For diagnosis of Type 2 Diabetes Mellitus
  Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin is indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. Limitations of Use: Dapagliflozin and Metformin HCl extended-release tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. Because of the metformin component, the use of Dapagliflozin and Metformin HCl extended-release tablets are limited to adults with type 2 diabetes mellitus for all indications.

• For diagnosis of Heart Failure
  Dapagliflozin is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. Limitations of Use: Because of the metformin component, the use of Dapagliflozin and Metformin HCl extended-release tablets are limited to adults with type 2 diabetes mellitus for all indications.

• For diagnosis of Chronic Kidney Disease
  Dapagliflozin is indicated to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Limitations of Use: Dapagliflozin and Metformin HCl extended-release tablets are not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. Dapagliflozin and Metformin HCl extended-release tablets not expected to be effective in these populations. Because of the metformin component, the use of Dapagliflozin and Metformin HCl extended-release tablets are limited to adults with type 2 diabetes mellitus for all indications.

Dapagliflozin

• For diagnosis of Type 2 Diabetes Mellitus
  Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. Limitations of Use: DAPAGLIFLOZIN TABLETS are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. DAPAGLIFLOZIN TABLETS are not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. DAPAGLIFLOZIN TABLETS are likely to be ineffective in this setting based upon its mechanism of action.

• For diagnosis of Heart Failure
  Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.

• For diagnosis of Chronic Kidney Disease
  Indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Limitations of Use: DAPAGLIFLOZIN TABLETS are not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. DAPAGLIFLOZIN TABLETS are not expected to be effective in these populations.

Insulin Glargine U-300 Solostar Injection Solution, Insulin Glargine U-300 Max Solostar Injection

• For diagnosis of Diabetes Mellitus
  Indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. Limitations of Use: INSULIN GLARGINE U-300 is not recommended for the treatment of diabetic ketoacidosis.

Criteria

Brand Insulin Glargine, Brand Insulin Glargine Solostar, Brand Fluticasone-Vilanterol, Brand Insulin Degludec, Brand Insulin Aspart, Brand Insulin Lispro, Novolog Relion, Brand Fluticasone-Salmeterol HFA, Brand Dapagliflozin-Metformin hydrochloride Extended-Release, Brand Dapagliflozin, Brand Insulin Glargine Max Solostar

*See table in background section for a list of the target ABAs and their associated Brand products.

Prior Authorization

Length of Approval: 12 Month(s)

• One of the following:
• Requested drug is FDA-approved for the condition being treated
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met
AND
• At least 6 months use of the Brand product* within the previous 365 days (document drug, duration, dose and date of use)
AND
• Both of the following:
• Documentation provided stating the Brand product has not been effective
AND
• Justification provided for why the authorized brand alternative (ABA) is expected to provide benefit when the Brand product has not been shown to be effective

P & T Revisions

2024-03-06, 2024-02-02, 2023-11-23, 2023-08-10, 2023-06-06, 2023-03-09, 2023-02-10, 2023-01-06, 2022-10-18, 2022-05-27, 2022-05-16, 2022-01-27, 2021-09-28, 2021-05-20, 2021-01-19, 2020-02-25, 2020-01-30

References

1. Insulin Glargine/Insulin Glargine Solostar. Winthrop U.S. Bridgewater, New Jersey. June 2023.
2. Fluticasone-Vilanterol Prescribing Information. Prasco Laboratories. Mason, Ohio. February 2022.
3. Insulin Degludec/Insulin Degludec Flextouch Prescribing Information. Novo Nordisk Pharma, Inc. Plainsboro, NJ. July 2022.
4. Insulin Aspart Protamine & Insulin Aspart Mix 70/30. Novo Nordisk Pharma, Inc. Plainsboro, New Jersey. February 2023.
5. Insulin Aspart Injection/Flexpen/Penfill. Novo Nordisk Pharma, Inc. Plainsboro, New Jersey. February 2023.
6. Insulin Lispro Injection/Kwikpen/Jr Kwikpen. Eli Lilly and Company. Indianapolis, IN. September 2023
7. Insulin Lispro Protamine & Insulin Lispro Mix 75/25 Kwikpen. Eli Lilly and Company. Indianapolis, IN. July 2023.
8. Fluticasone and Salmeterol HFA Prescribing Information. Prasco Laboratories. Mason, Ohio. August 2022.
9. Novolog- insulin aspart injection, solution. Novo Nordisk Pharma, Inc. Plainsboro, New Jersey. February 2023
10. Novolog Mix 70/30- insulin aspart injection, suspension. Novo Nordisk Pharma, Inc. Plainsboro, New Jersey. February 2023
11. Dapagliflozin and Metformin Hydrochloride tablet, film coated, extended release. Prescribing Information. Prasco Laboratories. Mason, Ohio. September 2023.
12. Dapagliflozin tablet, film coated. Prescribing Information. Prasco Laboratories. Mason, Ohio. September 2023.
13. Insulin Glargine U-300 SoloStar/ Insulin Glargine U-300 Max SoloStar. Winthrop U.S. Bridgewater, New Jersey. August 2022.

---

Revision History

• 2024-03-06: Added Insulin Glargine U-300 as target to guideline. Updated indications and reference sections.
• 2024-02-02: Added Dapagliflozin-Metformin hydrochloride Extended-Release and Dapagliflozin as targets to guideline. Updated indication and references sections.
• 2023-11-23: Removed Brand Fluticasone HFA as target from GL.
• 2023-08-10: Removed Brand Budesonide/Formoterol as target from guideline.
• 2023-06-06: Removed Brand Insulin Lispro (Humalog ABA) GPI 27104005002022. Updated background.
• 2023-03-09: Added new ABA for Advair HFA.
• 2023-02-10: Annual Review
• 2023-01-06: Removed Dexlansoprazole 60 mg from guideline as product is no longer an authorized brand alternative.
• 2022-10-18: Added new ABAs for insulin lispro, insulin aspart, dexlansoprazole and insulin degludec. Updated background and references.
• 2022-05-27: Added new ABAs for fluticasone-vilanterol and fluticasone HFA inhaler. Updated background and references.
• 2022-05-16: Added new ABA insulin glargine. Removed SP formulary.
• 2022-01-27: Annual Review
• 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2021-01-19: Annual Review: references updated
• 2020-02-25: Updated to add a diagnosis check criterion to ensure the product is being used for a medically accepted indication.
• 2020-01-30: New Program.

---