Subject: Antidiabetic GLP-1, GIP-GLP-1 Agonist PA with Logic Policy 5694-D UDR 05-2023

Drug

GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONIST

ADLYXIN  (lixisenatide)

BYDUREON BCISE  (exenatide extended-release)

BYETTA  (exenatide)

OZEMPIC  (semaglutide)

RYBELSUS  (semaglutide)

TRULICITY  (dulaglutide)

VICTOZA  (liraglutide)

GLUCOSE-DEPENDENT INSULINOTROPIC POLYPEPTIDE (GIP) RECEPTOR AND GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONIST

MOUNJARO  (tirzepatide)

Policy:

FDA APPROVED INDICATIONS
GLP-1 RECEPTOR AGONIST:
Adlyxin
Adlyxin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use
  •   Adlyxin 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.
  •   Adlyxin should not be used in patients with type 1 diabetes
       mellitus.
  •   Adlyxin has not been studied in patients with gastroparesis and is
       not recommended in patients with gastroparesis.

Bydureon BCise
Bydureon BCise is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.

Limitations of Use:
  •   Bydureon BCise is not recommended as first-line therapy for
       patients who have inadequate glycemic control on diet and
       exercise because of the uncertain relevance of the rat thyroid C-
       cell tumor findings to humans.
  •   Bydureon BCise is not indicated for use in patients with type 1
       diabetes mellitus.
  •   Bydureon BCise is an extended-release formulation of exenatide
       and should not be used with other products containing the active
       ingredient exenatide.
  •   Bydureon BCise has not been studied in patients with a history of
       pancreatitis. Consider other antidiabetic therapies in patients with
       a history of pancreatitis.

Byetta
Byetta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use
  •   Byetta is not indicated for use in patients with type 1 diabetes.
  •   Byetta contains exenatide and should not be used with other
       products containing the active ingredient exenatide.
       Byetta has not been studied in patients with a history of
       pancreatitis. Consider other antidiabetic therapies in patients with
       a history of pancreatitis.

Ozempic
Ozempic is indicated:
  •   as an 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
       (cardiovascular death, non-fatal myocardial infarction, or non-fatal
       stroke) in adults with type 2 diabetes mellitus and established
       cardiovascular disease.

Limitations of Use
  •   Ozempic has not been studied in patients with a history of
       pancreatitis. Consider other antidiabetic therapies in patients with
       a history of pancreatitis.
  •   Ozempic is not indicated for use in patients with type 1 diabetes
       mellitus.

Rybelsus
Rybelsus is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use
  •   Rybelsus has not been studied in patients with a history of
       pancreatitis. Consider other antidiabetic therapies in patients with
       a history of pancreatitis.
  •   Rybelsus is not indicated for use in patients with type 1 diabetes
       mellitus.

Trulicity
Trulicity is indicated:
  •   as an adjunct to diet and exercise to improve glycemic control in
       adults and pediatric patients 10 years of age and older with type 2
       diabetes mellitus.
  •    to reduce the risk of major adverse cardiovascular events
        (cardiovascular death, non-fatal myocardial infarction, or non-
        fatal stroke) in adults with type 2 diabetes mellitus who have
        established cardiovascular disease or multiple cardiovascular risk
        factors.

Limitations of Use
  •   Trulicity has not been studied in patients with a history of
       pancreatitis. Consider other antidiabetic therapies in patients with
       a history of pancreatitis.
  •   Trulicity should not be used in patients with type 1 diabetes
       mellitus.
  •   Trulicity has not been studied in patients with severe
       gastrointestinal disease, including severe gastroparesis and is
       therefore not recommended in these patients.

Victoza
Victoza is indicated:
  •   as an 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
       (cardiovascular death, non-fatal myocardial infarction, or non-fatal
       stroke) in adults with type 2 diabetes mellitus and established
       cardiovascular disease.

Limitations of Use
  •   Victoza should not be used in patients with type 1 diabetes
       mellitus.
  •   Victoza contains liraglutide and should not be coadministered with
       other liraglutide-containing products.

 

GIP/GLP-1 RECEPTOR AGONIST:
Mounjaro
Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
  •   Mounjaro has not been studied in patients with a history of
       pancreatitis.
  •   Mounjaro is not indicated for use in patients with type 1 diabetes
       mellitus.

SCREEN OUT LOGIC*
*Include Rx and OTC products unless otherwise stated.

If a claim is submitted with an ICD 10 diagnosis code indicating type 2 diabetes mellitus under a prescription benefit administered by CVS Caremark, then the requested drug will be paid under that prescription benefit.

For patients with no ICD 10 diagnosis code indicating type 2 diabetes mellitus submitted with their prescription claim:
If the patient has filled a prescription for at least a 30-day supply of an antidiabetic drug (EXCLUDING the requested drug at the same or other strengths) OR a diabetic supply within the past 730 days under a prescription benefit administered by CVS Caremark, then the requested drug will be paid under that prescription benefit. If the patient does not meet the initial screen out logic, then the claim will reject with a message indicating that a prior authorization (PA) is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
     •     The patient has a diagnosis of type 2 diabetes mellitus
     AND
            º   The patient has a history of an A1C greater than or equal to
                 6.5 percent. [NOTE: The prescriber MUST submit chart
                 notes or other documentation supporting a history of A1C
                 greater than or equal to 6.5 percent.]
                    AND
                         •   Chart notes or other documentation supporting a
                              history of A1C greater than or equal to 6.5 percent
                              have been submitted to CVS Health
     OR
            º   The patient has a history of a 2-hour plasma glucose (PG)
                 greater than or equal to 200 mg/dL during oral glucose
                 tolerance test (OGTT). [NOTE: The prescriber MUST submit
                 chart notes or other documentation supporting a history of
                 a 2-hour plasma glucose (PG) greater than or equal to 200
                 mg/dL during oral glucose tolerance test (OGTT).]
                   AND
                         •   Chart notes or other documentation supporting a
                              history of a 2-hour plasma glucose (PG) greater
                              than or equal to 200 mg/dL during oral glucose
                              tolerance test (OGTT) have been submitted to CVS
                              Health
     OR
             º   The patient has a history of symptoms of hyperglycemia
                  (e.g., polyuria, polydipsia, polyphagia) or hyperglycemic
                  crisis and a random plasma glucose greater than or equal
                  to 200 mg/dL. [NOTE: The prescriber MUST submit chart
                  notes or other documentation supporting a history of
                  symptoms of hyperglycemia (e.g., polyuria, polydipsia,
                  polyphagia) or hyperglycemic crisis and a random plasma
                  glucose greater than or equal to 200 mg/dL.]
                   AND
                   •   Chart notes or other documentation supporting a
                        history of symptoms of hyperglycemia (e.g., polyuria,
                        polydipsia, polyphagia) or hyperglycemic crisis and a
                        random plasma glucose greater than or equal to 200
                        mg/dL have been submitted to CVS Health
     OR
              º   The patient has a history of a fasting plasma glucose (FPG)
                   greater than or equal to 126 mg/dL. [NOTE: The
                   prescriber MUST submit chart notes or other
                   documentation supporting a history of a fasting plasma
                   glucose (FPG) greater than or equal to 126 mg/dL.]
                    AND
                    •   The patient fasted for at least 8 hours prior to the
                         fasting plasma glucose (FPG) greater than or equal to
                         126 mg/dL
                    AND
                    •   Chart notes or other documentation supporting a
                         history of fasting plasma glucose (FPG) greater than
                         or equal to 126 mg/dL have been submitted to CVS
                         Health.

Duration of Approval (DOA):
      •  5694-A: DOA: 36 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Adlyxin [package insert]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; June 2022.
2. Bydureon BCise [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2022.
3. Byetta [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2022.
4. Mounjaro [package insert]. Indianapolis, IN: Lilly USA, LLC; September 2022.
5. Ozempic [package insert]. Plainsboro, NJ: Novo-Nordisk Inc.; October 2022.
6. Rybelsus [package insert]. Plainsboro, NJ: Novo-Nordisk Inc.; December 2022.
7. Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; December 2022.
8. Victoza [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; June 2022.
9. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed March 16, 2023.
10. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 03/16/2023).
11. El Sayed NA, Aleppo G, Aroda VR et. al. American Diabetes Association, Standards of Care in Diabetes – 2023. Diabetes Care 2023;46(Suppl. 1):S1-S291.
12. Blonde L, Umpierrez GE, Reddy SS et. al. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan – 2022 Update. Endocrine Practice 2022; 28(10) 923-1049.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 15, 2023