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Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Antidiabetic Agents

Drug
Glyxambi®  (empagliflozin/linagliptin)
Jardiance®  (empagliflozin)
Synjardy®  (empagliflozin/metformin HCl)
Synjardy XR®  (empagliflozin/metformin HCL extended-release)
Trijardy XR  (empaglifozin / linagliptin / metformin HCL extended-release)


Policy:

Note: The provision of physician samples does not guarantee coverage under the provisions of the pharmacy benefit. All criteria below must be met in order to obtain coverage of Glyxambi (empagliflozin / linagliptin), Jardiance (empagliflozin), Synjardy (empagliflozin / metformin HCl), Synjardy (empagliflozin / metformin HCL extended-release), Trijardy XR (empaglifozin / linagliptin / metformin HCL extended-release).

To determine formulary coverage applicable to the specific benefit plan please refer to the formulary specific Aetna Pharmacy Drug Guide.

 

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary, Trijardy XR (empaglifozin / linagliptin / metformin HCL extended-release) is subject to precertification. If precertification requirements apply Aetna considers this drug to be medically necessary for those members who meet the following precertification criteria:

    • The patient has been receiving the requested drug for at least 3 months
      AND
      • The patient has demonstrated a reduction in A1c (hemoglobin A1c) since starting this therapy

    OR

    • Patient has the diagnosis of type 2 diabetes mellitus
      AND
      • The patient has experienced an inadequate treatment response, intolerance, or contraindication to metformin
        OR
      • The patient requires combination therapy AND has an A1c (hemoglobin A1c) of 7.5 percent or greater

     

    Quantity Limits

    The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

    According to the manufacturers, Glyxambi (empagliflozin / linagliptin), Jardiance (empagliflozin), Synjardy (empagliflozin / metformin HCl), Synjardy XR (empagliflozin / metformin HCL extended-release) Trijardy XR (empaglifozin / linagliptin / metformin HCL extended-release), can be dosed to a maximum daily dose as indicated below.  A quantity of Glyxambi (empagliflozin / linagliptin), Jardiance (empagliflozin), Synjardy (empagliflozin / metformin HCl), Synjardy XR (empagliflozin / metformin HCL extended-release) Trijardy XR (empaglifozin / linagliptin / metformin HCL extended-release) will be considered medically necessary, if the above criteria are met, as indicated in the table below:

      Medication 30-Day Limit*

    Glyxambi Tablet 10-5 Mg Oral

    30 tablets

     Glyxambi Tablet 25-5 Mg Oral

    30 tablets 

    Jardiance Tablet 10 Mg Oral 

    30 tablets

    Jardiance Tablet 25 Mg Oral 

    30 tablets 

    Synjardy Tablet 12.5-1000 Mg Oral 

     60 tablets

    Synjardy Tablet 12.5-500 Mg Oral 

     60 tablets

    Synjardy Tablet 5-1000 Mg Oral

    60 tablets

    Synjardy Tablet 5-1000 Mg Oral 

     60 tablets

    Synjardy Xr Tablet Extended Release 24 Hour 10-1000 Mg Oral 

    60 tablets 

     Synjardy Xr Tablet Extended Release 24 Hour 12.5-1000 Mg Oral

    60 tablets 

     Synjardy Xr Tablet Extended Release 24 Hour 25-1000 Mg Oral

    30 tablets

     Synjardy Xr Tablet Extended Release 24 Hour 5-1000 Mg Oral  60 tablets
    Trijardy XR Tablet Extended Release 5-2.5-1000 mg 60 tablets
    Trijardy XR Tablet Extended Release 10-5-1000 mg 30 tablets
    Trijardy XR Tablet Extended Release 12.5-2.5-1000 mg 60 tablets
    Trijardy XR Tablet Extended Release 25-5-1000 mg 30 tablets

     

  3. Step Therapy Criteria
  4. Under some plans, including plans that use an open or closed formulary, Glyxambi (empagliflozin / linagliptin) and Trijardy XR (empaglifozin / linagliptin/ metformin HCL extended-release) are subject to step therapy. Aetna considers these medications to be medically necessary for those members who meet step therapy criteria listed below:

    Formulary specific step therapy:

    • SG-ACA Formulary (Glyxambi Only): A documented contraindication, intolerance, allergy, or failure of Tradjenta or Jentadueto and either Januvia or Janumet
    • Value Plus and Premier Formulary (Trijardy XR Only): A documented contraindication, intolerance, allergy, or failure to metformin/XR and Xigduo XR, or Synjardy XR

    If it is medically necessary for a member to be treated initially with a medication subject to step therapy, the member, a person appointed to manage the member’s care, or the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-855-240-0535.

     

    Duration of Approval
    12 months

     


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Glyxambi [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2018,
  2. Jardiance [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2018.
  3. Synjardy [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2018.
  4. Synjardy XR [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2018.
  5. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. Accessed June 2019. .
  6. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed June 2019.
  7. American Diabetes Association. Standards of Medical Care in Diabetes-2019: Diabetes Care January 2019;42(Supplement1).
  8. Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm 2019, Endocr Pract. January 2019; 25 (No 1); 69-100
  9. Trijardy XR [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; January 2020
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.

December 10, 2020
Aetna
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