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DPP-4 Inhibitors and Combinations Step Therapy with Quantity Limit Program Summary
Policy Number: PH-1139
This program applies to Blue Partner, Commercial, GenPlus, Health Insurance Marketplace, NetResults A series, and SourceRx formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Janumet® (sitagliptin/metformin) Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
|
5 |
Janumet® XR (sitagliptin-metformin HCl Tab ER) Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
|
6 |
Januvia® (sitagliptin) Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
|
1 |
Jentadueto® (linagliptin/metformin) Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
|
7 |
Jentadueto XR® (linagliptin/metformin ER) Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
|
8 |
Kazano®, Alogliptin/metformin Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
|
10 |
Kombiglyze™ XR (saxagliptin/metformin)* Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate Limitations of use:
|
*- generic available |
9 |
Nesina®, Alogliptin Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
|
2 |
Onglyza® (saxagliptin)* Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
*-generic available |
3 |
Oseni®, Alogliptin/pioglitazone Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
|
11 |
Sitagliptin/metformin Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:
|
|
15 |
Tradjenta® (linagliptin) Tablet |
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
|
4 |
Zituvio™ (sitagliptin) Tablet |
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use:
|
|
14 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Diabetes |
The American Diabetes Association (ADA) states that first-line therapy depends on comorbidities, patient-centered treatment factors, and management needs and generally includes metformin and comprehensive lifestyle modification. Because type 2 diabetes is a progressive disease in many patients, maintenance of glycemic targets with monotherapy is often possible for only a few years, after which combination therapy is necessary. Traditional recommendations have been to use stepwise addition of medications to metformin to maintain A1C at target.(12,13) Metformin is effective and safe, is inexpensive, and may reduce risk of cardiovascular events and death. Metformin is available in an immediate-release form for twice-daily dosing or as an extended-release form that can be given once daily. Compared with sulfonylureas, metformin as first-line therapy has beneficial effects on A1C, weight, and cardiovascular mortality.(13) |
Safety |
Janumet, Jentadueto, Jentadueto XR, Kazano, Kombiglyze XR, and Sitagliptin/metformin carry a black box warning for lactic acidosis:(7-10,15)
Oseni carries a black box warning for congestive heart failure:(11)
Janumet, Janumet XR, Kombiglyze XR, and Sitagliptin/metformin have the following contraindications:(5,6,9,15)
Jentadueto, Jentadueto XR, and Kazano have the following contraindications:(7,8,10)
Januvia, Nesina, Onglyza, and Tradjenta have the following contraindication:(1-4)
Oseni has the following contraindication:(11)
Zituvio has the following contraindication:(14)
|
REFERENCES
Number |
Reference |
1 |
Januvia prescribing information. Merck & Co., Inc. July 2022. |
2 |
Nesina prescribing information. Takeda Pharmaceuticals America, Inc. July 2023. |
3 |
Onglyza prescribing information. Astra Zeneca. October 2019. |
4 |
Tradjenta prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. June 2023. |
5 |
Janumet prescribing information. Merck & Co., Inc. July 2022. |
6 |
Janumet XR prescribing information. Merck & Co., Inc. July 2022. |
7 |
Jentadueto prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. June 2023. |
8 |
Jentadueto XR prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. June 2023. |
9 |
Kombiglyze XR prescribing information. Bristol-Meyers Squibb Company/AstraZeneca Pharmaceuticals LP. October 2019. |
10 |
Kazano prescribing information. Takeda Pharmaceuticals America, Inc. July 2023. |
11 |
Oseni prescribing information. Takeda Pharmaceuticals America, Inc. March 2022. |
12 |
American Diabetes Association. Standards of Medical Care in Diabetes-2022. Available at https://diabetesjournals.org/care/issue/45/Supplement_1. |
13 |
Nuha A. ElSayed, et. al, American Diabetes Association, 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care 1 January 2023; 46 (Supplement_1): S140–S157. https://doi.org/10.2337/dc23-S009. |
14 |
Zituvio prescribing information. Zydus Pharmaceuticals (USA) Inc. October 2023. |
15 |
Sitagliptin/metformin prescribing information. Zydus Pharmaceuticals (USA) Inc. June 2024. |
POLICY AGENT SUMMARY STEP THERAPY
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
1-Step Through Preferred |
||||||
|
sitagliptin free base-metformin hcl tab |
50-1000 MG ; 50-500 MG |
M ; N ; O |
N |
|
|
Jentadueto ; Jentadueto xr |
linagliptin-metformin hcl tab ; linagliptin-metformin hcl tab er |
2.5-1000 MG ; 2.5-500 MG ; 2.5-850 MG ; 5-1000 MG |
M ; N ; O |
N |
|
|
Kazano |
alogliptin-metformin hcl tab |
12.5-1000 MG ; 12.5-500 MG |
M ; N ; O |
M ; N |
|
|
Kombiglyze xr |
saxagliptin-metformin hcl tab er |
2.5-1000 MG ; 5-1000 MG ; 5-500 MG |
M ; N ; O |
O ; Y |
|
|
Nesina |
alogliptin benzoate tab |
12.5 MG ; 25 MG ; 6.25 MG |
M ; N ; O |
M ; N |
|
|
Onglyza |
saxagliptin hcl tab |
2.5 MG ; 5 MG |
M ; N ; O |
O ; Y |
|
|
Oseni |
alogliptin-pioglitazone tab |
12.5-15 MG ; 12.5-30 MG ; 12.5-45 MG ; 25-15 MG ; 25-30 MG ; 25-45 MG |
M ; N ; O |
M ; N |
|
|
Tradjenta |
linagliptin tab |
5 MG |
M ; N ; O |
N |
|
|
Zituvio |
sitagliptin tab |
100 MG ; 25 MG ; 50 MG |
M ; N ; O |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
|
sitagliptin free base-metformin hcl tab |
50-500 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
|
sitagliptin free base-metformin hcl tab |
50-1000 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Janumet |
sitagliptin-metformin hcl tab |
50-1000 MG ; 50-500 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Janumet xr |
Sitagliptin-Metformin HCl Tab ER 24HR 100-1000 MG |
100-1000 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Janumet xr |
Sitagliptin-Metformin HCl Tab ER 24HR 50-1000 MG |
50-1000 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Janumet xr |
Sitagliptin-Metformin HCl Tab ER 24HR 50-500 MG |
50-500 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Januvia |
sitagliptin phosphate tab |
100 MG ; 25 MG ; 50 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Jentadueto |
linagliptin-metformin hcl tab |
2.5-1000 MG ; 2.5-500 MG ; 2.5-850 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Jentadueto xr |
Linagliptin-Metformin HCl Tab ER 24HR 2.5-1000 MG |
2.5-1000 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Jentadueto xr |
Linagliptin-Metformin HCl Tab ER 24HR 5-1000 MG |
5-1000 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Kazano |
alogliptin-metformin hcl tab |
12.5-1000 MG ; 12.5-500 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Kombiglyze xr |
Saxagliptin-Metformin HCl Tab ER 24HR 2.5-1000 MG |
2.5-1000 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Kombiglyze xr |
Saxagliptin-Metformin HCl Tab ER 24HR 5-1000 MG |
5-1000 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Kombiglyze xr |
Saxagliptin-Metformin HCl Tab ER 24HR 5-500 MG |
5-500 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Nesina |
alogliptin benzoate tab |
12.5 MG ; 25 MG ; 6.25 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Onglyza |
saxagliptin hcl tab |
2.5 MG ; 5 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Oseni |
alogliptin-pioglitazone tab |
12.5-15 MG ; 12.5-30 MG ; 12.5-45 MG ; 25-15 MG ; 25-30 MG ; 25-45 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Tradjenta |
linagliptin tab |
5 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Zituvio |
sitagliptin tab |
25 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Zituvio |
sitagliptin tab |
50 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Zituvio |
sitagliptin tab |
100 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – STEP THERAPY
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
sitagliptin free base-metformin hcl tab |
50-1000 MG ; 50-500 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Jentadueto ; Jentadueto xr |
linagliptin-metformin hcl tab ; linagliptin-metformin hcl tab er |
2.5-1000 MG ; 2.5-500 MG ; 2.5-850 MG ; 5-1000 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Kazano |
alogliptin-metformin hcl tab |
12.5-1000 MG ; 12.5-500 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Kombiglyze xr |
saxagliptin-metformin hcl tab er |
2.5-1000 MG ; 5-1000 MG ; 5-500 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Nesina |
alogliptin benzoate tab |
12.5 MG ; 25 MG ; 6.25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Onglyza |
saxagliptin hcl tab |
2.5 MG ; 5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Oseni |
alogliptin-pioglitazone tab |
12.5-15 MG ; 12.5-30 MG ; 12.5-45 MG ; 25-15 MG ; 25-30 MG ; 25-45 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Tradjenta |
linagliptin tab |
5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zituvio |
sitagliptin tab |
100 MG ; 25 MG ; 50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
sitagliptin free base-metformin hcl tab |
50-1000 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
sitagliptin free base-metformin hcl tab |
50-500 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Janumet |
sitagliptin-metformin hcl tab |
50-1000 MG ; 50-500 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Janumet xr |
Sitagliptin-Metformin HCl Tab ER 24HR 100-1000 MG |
100-1000 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Janumet xr |
Sitagliptin-Metformin HCl Tab ER 24HR 50-1000 MG |
50-1000 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Janumet xr |
Sitagliptin-Metformin HCl Tab ER 24HR 50-500 MG |
50-500 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Januvia |
sitagliptin phosphate tab |
100 MG ; 25 MG ; 50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Jentadueto |
linagliptin-metformin hcl tab |
2.5-1000 MG ; 2.5-500 MG ; 2.5-850 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Jentadueto xr |
Linagliptin-Metformin HCl Tab ER 24HR 2.5-1000 MG |
2.5-1000 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Jentadueto xr |
Linagliptin-Metformin HCl Tab ER 24HR 5-1000 MG |
5-1000 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Kazano |
alogliptin-metformin hcl tab |
12.5-1000 MG ; 12.5-500 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Kombiglyze xr |
Saxagliptin-Metformin HCl Tab ER 24HR 2.5-1000 MG |
2.5-1000 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Kombiglyze xr |
Saxagliptin-Metformin HCl Tab ER 24HR 5-1000 MG |
5-1000 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Kombiglyze xr |
Saxagliptin-Metformin HCl Tab ER 24HR 5-500 MG |
5-500 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Nesina |
alogliptin benzoate tab |
12.5 MG ; 25 MG ; 6.25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Onglyza |
saxagliptin hcl tab |
2.5 MG ; 5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Oseni |
alogliptin-pioglitazone tab |
12.5-15 MG ; 12.5-30 MG ; 12.5-45 MG ; 25-15 MG ; 25-30 MG ; 25-45 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Tradjenta |
linagliptin tab |
5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zituvio |
sitagliptin tab |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zituvio |
sitagliptin tab |
25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zituvio |
sitagliptin tab |
100 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
STEP THERAPY CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||
1-Step Through Preferred |
Target Agent(s) will be approved when ALL of the following is met:
Length of Approval: 12 months NOTE: If Quantity Limit program also applies, please refer to Quantity Limit criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months |
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 Blue Cross and Blue Shield of Alabama’s 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.
ALBP _ Commercial _ CSReg _ DPP-4_Inhibitors_and_Combinations_STQL _ProgSum_ 10-01-2024 _
© Copyright Prime Therapeutics LLC. July 2024 All Rights Reserved