ph-99991007
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GLP-1 (glucagon-like peptide-1) Agonists Step Therapy and Quantity Limit Program Summary

Policy Number: PH-99991007

This program applies to Blue Partner, Commercial, GenPlus, Health Insurance Marketplace, NetResults A series, and SourceRx formularies.

GLP-1 (glucagon-like peptide-1) Agonists Step Therapy

TARGET AGENT(S)

Adlyxin™ (lixisenatide)

Byetta® (exenatide)

Bydureon™ (exenatide extended-release)

Bydureon BCise™ (exenatide extended-release)

Ozempic® (semaglutide)

Rybelsus® (semaglutide)

Trulicity™ (dulaglutide)

Victoza® (liraglutide)

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Target Agent(s) will be approved when ONE of the following is met:

  1. Information has been provided that indicates the patient is currently being treated with the requested GLP-1 within the past 90 days

OR

  1. The prescriber states the patient is currently being treated with the requested GLP-1 within the past 90 days AND is at risk if therapy is changed

OR

  1. The patient has a diagnosis of type 2 diabetes mellitus AND ONE of the following:
    1. The patient’s medication history includes use of one or more of the following: an agent containing metformin or insulin within the past 90 days

OR

    1. The patient has an intolerance or hypersensitivity to ONE of the following agents: metformin or insulin

OR

    1. The patient has an FDA labeled contraindication to ALL of the following agents: metformin AND insulin

Length of approval: 12 months

NOTE: If Quantity Limit program also applies, please refer to Quantity Limit documents.

FDA APPROVED INDICATIONS AND DOSAGE1-8

Agent(s)

Indication(s)

Dosage and Administration

 

Adlyxin

(lixisenatide)

subcutaneous injection

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of use:

  • Has not been studied in patients with chronic pancreatitis or a history of unexplained pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis
  • Not for treatment of type 1 diabetes or diabetic ketoacidosis
  • Has not been studied in combination with short acting insulin
  • Has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis.
  • Starting dose of 10 mcg subcutaneously once daily for 14 days.
  • Increase the dose to the maintenance dose of 20 mcg once daily starting on Day 15.

 

Bydureon (exenatide extended-release)

subcutaneous injection

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of use:

  • Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
  • Should not be used to treat type 1 diabetes or diabetic ketoacidosis
  • Use with prandial insulin has not been studied
  • Bydureon is an extended-release formulation of exenatide.  Do not co-administer with other exenatide containing products.
  • Has not been studied in patients with a history of pancreatitis.  Consider other antidiabetic therapies in patients with a history of pancreatitis.
  • Administer 2 mg by subcutaneous injection once every 7 days (weekly) at any time of day, with or without meals. The day of weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before.

 

Bydureon BCise

(exenatide extended release)

subcutaneous injection

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of use:

  • Not recommended as first-line therapy for patients inadequately controlled on diet and exercise.
  • Should not be used to treat type 1 diabetes or diabetic ketoacidosis.
  • Use with prandial insulin has not been studied.
  • Bydureon BCise is an extended-release formulation of exenatide. It should not be used with other products containing the active ingredient exenatide.
  • Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
  • Administer 2 mg by subcutaneous injection once every seven days (weekly), at any time of day and with or without meals.

Byetta (exenatide)

subcutaneous injection

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of use:

  • Not a substitute for insulin. Should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis.
  • Concurrent use with prandial insulin has not been studied and cannot be recommended.
  • Byetta has not been studied in patients with a history of pancreatitis.  Consider other antidiabetic therapies in patients with a history of pancreatitis.
  • Inject subcutaneously within 60 minutes prior to morning and evening meals (or before the 2 main meals of the day, approximately 6 hours or more apart).
  • Initiate at 5 mcg per dose twice daily; increase to 10 mcg twice daily after 1 month based on clinical response.

Ozempic

(semaglutide)

subcutaneous injection

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease

Limitations of use:

  • Has not been studied in patients with a history of pancreatitis. Consider another antidiabetic therapy
  • Not indicated for use in type 1 diabetes mellitus or treatment of diabetic ketoacidosis
  • Start at 0.25 mg subcutaneously once weekly for 4 weeks.  The 0.25 mg dose is intended for treatment initiation and is not effective for glycemic control
  • After 4 weeks, increase to 0.5 mg once weekly
  • If additional glycemic control is needed after at least 4 weeks on the 0.5 mg dose, the dosage may be increased to 1 mg once weekly.  The maximum recommended dosage is 1 mg once weekly

Rybelsus®

(semaglutide)

tablet

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Limitations of use:

  • Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
  • Has not been studied in patients with a history of pancreatitis
  • Not indicated for use in patients with type 1 diabetes mellitus or treatment of diabetic ketoacidosis
  • Take at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only
  • Start with 3 mg once daily for 30 days.  After 30 days on the 3 mg dose, increase the dose to 7 mg once daily.
  • Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose

Trulicity

(dulaglutide)

subcutaneous injection

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors

Limitations of use:

  • Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients
  • Not for treatment of type 1 diabetes  
  • Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis.
  • Initiate at 0.75 mg subcutaneously once weekly.  Increase to 1.5 mg once weekly for additional glycemic control.  If additional glycemic control is needed, increase to the maximum dose of 4.5 mg once weekly after at least 4 weeks on the 3 mg dose

Victoza

(liraglutide)

subcutaneous injection

Adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus.

To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease

Limitations of use:

  • Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
  • Has not been studied in combination with prandial insulin
  • Adult dosage: Initiate with 0.6 mg daily for one week.  The 0.6 mg dose is for titration and is not effective for glycemic control in adults.  After one week at 0.6 mg daily, increase to 1.2 mg daily.  If additional glycemic control is required, increase the ose to 1.8 mg daily after at least one week of treatment with the 1.2 mg dose
  • Pediatric dosage: Initiate with a dose of 0.6 mg daily.  After at least one week at 0.6 mg daily, the dose may be increased to 1.2 mg daily if additional glycemic control is required.  If additional glycemic control is required (again), increase the dose to 1.8 mg daily after at least one week of treatment with the 1.2 mg dose
 

CLINICAL RATIONALE

The American Diabetes Association (ADA) and American Association of Clinical Endocrinologists (AACE) recommend metformin as the preferred first-line drug in type 2 diabetes mellitus.9,10 Metformin has a low risk of hypoglycemia, can promote modest weight loss, and has good antihyperglycemic efficacy at doses of 1000-2000 mg/day.10 Two-drug combinations should be considered if A1c is  ≥1.5% above the glycemic target, or when metformin monotherapy fails to achieve A1c target after approximately 3 months.  The choice of the second agent (sulfonylurea, thiazolidinedione, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter 2 inhibitor, basal insulin, glucagon-like peptide 1 agonist) is based upon patient and drug characteristics, with the goal of improving glycemic control while minimizing side effects and patient burden.9

Bydureon, Bydureon BCise, Ozempic, Rybelsus, Trulicity, and Victoza all share the same black box warning:

  • Causes thyroid C-cell tumors at clinically relevant exposures in rats.  It is unknown whether these agents cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of induced rodent thyroid C-cell tumors has not been determined. 
  • Contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).2-7

REFERENCES

  1. Byetta prescribing information.  AstraZeneca Pharmaceuticals, Inc.  February 2020.
  2. Victoza prescribing information.  Novo Nordisk A/S.  August 2020.
  3. Bydureon prescribing information. AstraZeneca Pharmaceuticals, Inc. February 2020.
  4. Bydureon BCise prescribing information. AstraZeneca Pharmaceuticals, Inc. February 2020.
  5. Ozempic prescribing information. Novo Nordisk. January 2020.
  6. Rybelsus prescribing information.  Novo Nordisk A/S.  January 2020.
  7. Trulicity prescribing information. Eli Lilly and Company. September  2020.
  8. Adlyxin prescribing information. Sanofi-Aventis US. LLC. January 2019.
  9. American Diabetes Association.  Pharmacologic Approaches to Glycemia Treatment: Standards of Medical Care in Diabetes-2020.  Accessed 9/11/2020.  Available at: https://care.diabetesjournals.org/content/43/Supplement_1/S98
  10. Garber AJ, Handelsman Y, Grunberger G et, al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm-2020 Executive Summary.  Endocrine Practice, 26 (1) January 2020.  107-139.  Accessed 9/11/2020.  Available at: https://www.aace.com/disease-state-resources/diabetes/clinical-practice-guidelines-treatment-algorithms/comprehensive

 

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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