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Dipeptidyl Peptidase-4 (DPP-4) Inhibitors and Combinations Step Therapy and 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 

4/1/2023

FDA APPROVED 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 adult patients with type 2 diabetes mellitus

Limitations of use:

  • Should not be used in patients with type 1 diabetes. 
  • Has not been studied in patients with a history of pancreatitis

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:

  • Should not be used in patients with type 1 diabetes.
  • Has not been studied in patients with a history of pancreatitis

 

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:

  • Should not be used in patients with type 1 diabetes. 
  • Has not been studied in patients with a history of pancreatitis.

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:

  • Should not be used in patients with type 1 diabetes 
  • Has not been studied in patients with a history of pancreatitis.

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:

  • Should not be used in patients with type 1 diabetes 
  • Has not been studied in patients with a history of pancreatitis.

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:

  • Should not be used in patients with type 1 diabetes mellitus

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:

  • Not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis

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:

  • Should not be used in patients with type 1 diabetes mellitus 

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:

  • Not used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis

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:

  • Should not be used in patients with type 1 diabetes

11

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:

  • Should not be used in patients with type 1 diabetes, as it would not be effective in these settings
  • Has not been studied in patients with a history of pancreatitis

4

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)    

 

SAFETY

Jentadueto, Jentadueto XR, Kazano, and Kombiglyze XR carry a black box warning for lactic acidosis. 

  • Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin associated lactic acidosis was characterized by elevated blood lactate levels (greater than 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/ml
  • Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
  • Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the full prescribing information
  • If metformin-associated lactic acidosis is suspected, immediately discontinue the medication and institute general supportive measures in a hospital setting.  Prompt hemodialysis is recommended.(7-10)

 

Oseni carries a black box warning for congestive heart failure.

  • Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients.
  • After initiation of Oseni and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone in Oseni must be considered.
  • Oseni is not recommended in patients with symptomatic heart failure. Initiation of Oseni in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.(11)

REFERENCES                                                                                                                                                                           

Number

Reference

1

Januvia prescribing information.  Merck & Co., Inc.  July 2022.

2

Nesina prescribing information. Takeda Pharmaceuticals America, Inc. March 2022.

3

Onglyza prescribing information. Astra Zeneca. October 2019.

4

Tradjenta prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. April 2022.

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. April 2022.

8

Jentadueto XR prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. October 2021.

9

Kombiglyze XR prescribing information. Bristol-Meyers Squibb Company/AstraZeneca Pharmaceuticals LP. October 2019.

10

Kazano prescribing information. Takeda Pharmaceuticals America, Inc. March 2022.

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

 

POLICY AGENT SUMMARY STEP THERAPY

Agent Names

Strength

Targeted MSC

Available MSC

Preferred Status

Effective Date

1-Step Through Preferred

JENTADUETO*linagliptin-metformin hcl tab  ; JENTADUETO*linagliptin-metformin hcl tab er

2.5 MG ; 5 MG

M ; N ; O

N

ALOGLIPTIN/METFORMIN*alogliptin-metformin hcl tab  ; KAZANO*alogliptin-metformin hcl tab

12.5 MG

M ; N ; O

M

KOMBIGLYZE*saxagliptin-metformin hcl tab er

2.5 MG ; 5 MG

M ; N ; O

N

ALOGLIPTIN*alogliptin benzoate tab  ; NESINA*alogliptin benzoate tab

12.5 MG ; 25 MG ; 6.25 MG

M ; N ; O

M

ONGLYZA*saxagliptin hcl tab

2.5 MG ; 5 MG

M ; N ; O

N

ALOGLIPTIN/PIOGLITAZONE*alogliptin-pioglitazone tab  ; OSENI*alogliptin-pioglitazone tab

12.5 MG ; 25 MG

M ; N ; O

M ; N

TRADJENTA*linagliptin tab

5 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

Days Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Effective Date

Janumet ; Janumet xr

sitagliptin-metformin hcl tab  ; sitagliptin-metformin hcl tab er

100 MG ; 50 MG

60.0

TABS

30

Days

Janumet xr

Sitagliptin-Metformin HCl Tab ER 24HR 100-1000 MG

100 MG

30.0

TABS

30

Days

Janumet xr

Sitagliptin-Metformin HCl Tab ER 24HR 50-500 MG

50 MG

30.0

TABS

30

Days

Januvia

sitagliptin phosphate tab

100 MG ; 25 MG ; 50 MG

30.0

TABS

30

Days

Jentadueto ; Jentadueto xr

linagliptin-metformin hcl tab  ; linagliptin-metformin hcl tab er

2.5 MG ; 5 MG

60.0

TABS

30

Days

Jentadueto xr

Linagliptin-Metformin HCl Tab ER 24HR 5-1000 MG

5 MG

30.0

TABS

30

Days

Kazano

alogliptin-metformin hcl tab

12.5 MG

60.0

TABS

30

Days

Kombiglyze xr

saxagliptin-metformin hcl tab er

2.5 MG ; 5 MG

30.0

TABS

30

Days

Kombiglyze xr

Saxagliptin-Metformin HCl Tab ER 24HR 2.5-1000 MG

2.5 MG

60.0

TABS

30

Days

Nesina

alogliptin benzoate tab

12.5 MG ; 25 MG ; 6.25 MG

30.0

TABS

30

Days

Onglyza

saxagliptin hcl tab

2.5 MG ; 5 MG

30.0

TABS

30

Days

Oseni

alogliptin-pioglitazone tab

12.5 MG ; 25 MG

30.0

TABS

30

Days

Tradjenta

linagliptin tab

5 MG

30.0

TABS

30

Days

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Jentadueto ; Jentadueto xr

linagliptin-metformin hcl tab  ; linagliptin-metformin hcl tab er

2.5 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kazano

alogliptin-metformin hcl tab

12.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kombiglyze xr

saxagliptin-metformin hcl tab er

2.5 MG ; 5 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 MG ; 25 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

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Janumet ; Janumet xr

sitagliptin-metformin hcl tab  ; sitagliptin-metformin hcl tab er

100 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Janumet xr

Sitagliptin-Metformin HCl Tab ER 24HR 100-1000 MG

100 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Janumet xr

Sitagliptin-Metformin HCl Tab ER 24HR 50-500 MG

50 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 ; Jentadueto xr

linagliptin-metformin hcl tab  ; linagliptin-metformin hcl tab er

2.5 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Jentadueto xr

Linagliptin-Metformin HCl Tab ER 24HR 5-1000 MG

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kazano

alogliptin-metformin hcl tab

12.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kombiglyze xr

saxagliptin-metformin hcl tab er

2.5 MG ; 5 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 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 MG ; 25 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

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

1-Step Through Preferred

Preferred Agents

Non-preferred Agents

Januvia® (sitagliptin)     
Janumet® (sitagliptin/metformin)
Janumet® XR (sitagliptin/metformin extended-release)

Alogliptin
Alogliptin/metformin
Alogliptin/pioglitazone
Jentadueto® (linagliptin/metformin)
Jentadueto XR® (linagliptin/metformin ER)
Kazano (alogliptin/metformin)
Kombiglyze® XR (saxagliptin/metformin ER)
Nesina (alogliptin)
Onglyza® (saxagliptin)
Oseni (alogliptin/pioglitazone)
Tradjenta® (linagliptin)

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

  1. The patient’s medication history includes use of one or more of the following: Januvia, Janumet, Janumet XR OR
  2. The patient has an intolerance or hypersensitivity to sitagliptin OR
  3. The patient has an FDA labeled contraindication to sitagliptin that is not expected to occur with the requested agent

Length of approval: 12 months

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

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:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) is greater than the program quantity limit AND ONE of the following:
    1. BOTH of the following:
      1. The requested agent does not have a maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support therapy with a higher dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
    3. BOTH of the following:
      1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support therapy with a higher dose for the requested indication

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.

 

 

Commercial _ PS _ DPP-4 Inhibitors and Combinations Step Therapy with Quantity Limit _ProgSum_ 4/1/2023