CurrentNeighborhood Health Plan of Rhode IslandPolicy 1009-D

DPP‑4 Inhibitor Coverage Criteria (Type 2 Diabetes)

Covers DPP‑4 inhibitor drugs (brand and generic, all dosage forms/strengths) used as adjuncts to diet and exercise for glycemic control in adults with type 2 diabetes; governs coverage for Neighborhood Health Plan of Rhode Island members. This brief reflects the portion of the policy document provided (product listings and FDA‑approved indications/limitations).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDPP‑4 Inhibitor Coverage Criteria (Type 2 Diabetes)

Policy CodePolicy 1009-D

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionDocument diagnosis of type 2 diabetes and confirm metformin step (≥30‑day fill in past 180 days) or provide clinical rationale for authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~18drug entries listed

Adults with T2DMFDA‑approved indication

Type 1 diabetes/DKAExplicit limitation

≥7.5%A1C threshold

30d/180dMetformin fill check

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Coverage Criteria for DPP-4 Inhibitors

Indication for use (Type 2 diabetes)

Covered when ALL of the following are met

FDA‑approved indication: Medication is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Applies to listed DPP‑4 inhibitor products

Type 2 Diabetes Mellitus - Initial and Continuation Authorization

Authorization may be granted for a diagnosis of type 2 diabetes mellitus when the following is met:

Overall requirement: Patient has a diagnosis of type 2 diabetes mellitus and meets either initial or continuation criteria below

Initial therapy pathway: Patient has NOT been receiving a stable maintenance dose of the requested drug for at least 3 months AND one of the following is met:

Initial pathway options: (1) Patient experienced inadequate treatment response, intolerance, or has a contraindication to metformin; OR (2) Patient requires combination therapy AND has an A1C >= 7.5%

Continuation pathway: Patient HAS been receiving a stable maintenance dose of the requested drug for at least 3 months AND has demonstrated a reduction in A1C since starting this therapy

The DPP‑4 inhibitor products listed in this policy have an explicit limitation across multiple agent labeling: they are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Several product entries also state that the agent has not been studied in patients with a history of pancreatitis and that it is unknown whether such patients are at increased risk for pancreatitis when using these drugs.

Use of DPP‑4 inhibitors is not indicated or recommended for treatment of type 1 diabetes mellitus. Product-specific labeling calls out this limitation for multiple agents (for example, Onglyza, Oseni, Tradjenta, Zituvimet/Zituvimet XR, and Zituvio), noting these medications would not be effective or are not recommended in type 1 diabetes.

Prescribing DPP‑4 inhibitors for type 1 diabetes mellitus or diabetic ketoacidosis is outside the indicated uses for these products and therefore would be considered not medically necessary under this policy when used for those conditions.

Multiple DPP‑4 product labels state they have not been studied in patients with a history of pancreatitis, and the labels indicate it is unknown whether patients with prior pancreatitis are at increased risk of developing pancreatitis while using these agents. Use in this population is therefore not supported by study data.

Products and Clinical Thresholds

Products referencedmixed

Brynovin	sitagliptin
Janumet / Janumet XR	sitagliptin/metformin (and XR)
Januvia	sitagliptin
Jentadueto / Jentadueto XR	linagliptin/metformin (and XR)
Kazano	alogliptin/metformin
Kombiglyze XR	saxagliptin/metformin extended-release
Nesina	alogliptin
Onglyza	saxagliptin
Oseni	alogliptin/pioglitazone
Tradjenta	linagliptin

1–10 of 12

1/2

A1C threshold for combination therapy

A1C threshold for combination therapyA1C ≥ 7.5%

ContextApplies when patient requires combination therapy as part of initial authorization pathway

Use for continuationNot applicable — continuation requires demonstrated A1C reduction after ≥3 months on therapy

Metformin fill requirement

Metformin fill requirementPatient has filled ≥30-day supply of metformin within the past 180 days under a CVS Caremark-administered prescription benefit

Consequence if not metClaim will reject with message that prior authorization is required

Provider Actions, Prior Authorization, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization applies to the DPP‑4 inhibitor products listed in this policy (all brand and generic names, all dosage forms and strengths unless otherwise stated). Examples include sitagliptin (Januvia, Brynovin, Zituvio), sitagliptin/metformin combinations (Janumet, Zituvimet, Zituvimet XR), linagliptin (Tradjenta), linagliptin/metformin (Jentadueto, Jentadueto XR), saxagliptin (Onglyza), saxagliptin/metformin (Kombiglyze XR), alogliptin (Nesina), alogliptin/metformin (Kazano), and combination products (Oseni). OTC products are not included unless stated.

Applies to all listed DPP‑4 inhibitor drugs (brand and generic, all dosage forms/strengths).

Documentation Required

Indication Documentation

Authorization may be granted for adults with type 2 diabetes mellitus when used as an adjunct to diet and exercise. Documentation must support that the medication is being used to improve glycemic control in type 2 diabetes.

Medication must be used as an adjunct to diet and exercise for type 2 diabetes mellitus.

Background and Class Information

DPP‑4 inhibitors are oral antihyperglycemic agents indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Multiple brand and combination products are available; labeling across these products consistently notes they are not for use in type 1 diabetes or diabetic ketoacidosis and that some agents have not been studied in patients with a history of pancreatitis.

Definitions and Agent-specific Notes

DPP-4 inhibitor

DefinitionDPP-4 inhibitor: a class of oral glucose-lowering drugs that improve glycemic control in adults with type 2 diabetes by inhibiting the dipeptidyl peptidase-4 enzyme (examples include sitagliptin, saxagliptin, linagliptin, alogliptin)

Formulary examplesListed products include sitagliptin (Januvia, Brynovin), saxagliptin (Onglyza), linagliptin (Tradjenta), and alogliptin (Nesina)

Indication statementUsed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Onglyza limitation

Onglyza indication limitationOnglyza is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis

Therapeutic contextOnglyza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDPP‑4 Inhibitor Coverage Criteria (Type 2 Diabetes)

Policy CodePolicy 1009-D

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionDocument diagnosis of type 2 diabetes and confirm metformin step (≥30‑day fill in past 180 days) or provide clinical rationale for authorization.

SourceLink

On This Page

ScopeIncludes prescription and OTC products unless otherwise stated

Stable maintenance duration

Stable maintenance duration>= 3 months (patient has been receiving a stable maintenance dose of the requested drug)

Role in continuation criteriaRequired for continuation pathway, plus must demonstrate reduction in A1C since starting therapy

Role in initial criteriaInitial pathway requires patient NOT to have been on a stable maintenance dose for at least 3 months

Indication must be clearly documented in the medical record.

Denial Risk

Indication Limitations and Denial Triggers

These agents are not indicated for type 1 diabetes mellitus or for treatment of diabetic ketoacidosis. Use in those settings is a basis for denial. Many products have not been studied in patients with a history of pancreatitis; prescribing for such patients may be contraindicated or require additional justification.

Not indicated for type 1 diabetes mellitus.
Not indicated for diabetic ketoacidosis.
History of pancreatitis is not studied for several agents and may be a denial trigger.

Documentation Required

Required Clinical Documentation for Prior Authorization

For prior authorization requests, submit clinical documentation that supports the diagnosis of type 2 diabetes mellitus and the reason for using a DPP‑4 inhibitor instead of, or in addition to, metformin. Documentation should include recent A1C values, prior medication history (including fills), evidence of metformin intolerance or contraindication if claimed, and duration of therapy when applicable.

Recent A1C results (to document inadequate control or improvement).
Medication history showing metformin use or evidence of intolerance/contraindication.
If continuation: documentation of stable maintenance dose for ≥3 months and A1C reduction since starting therapy.

Step Therapy

Initial Step Therapy and Type 2 Diabetes Criteria

If the patient has filled at least a 30‑day supply of metformin within the past 180 days under the prescription benefit administered by CVS Caremark, the requested DPP‑4 agent will be paid under that prescription benefit and PA is not required. If the patient does not meet this initial step therapy criterion, the claim will reject and a prior authorization is required. For initial approvals, the patient must not have been on a stable maintenance dose of the requested DPP‑4 drug for ≥3 months and must meet one of: inadequate response/intolerance/contraindication to metformin, or require combination therapy with A1C ≥7.5%.

Initial step: ≥30‑day supply of metformin filled within past 180 days under CVS Caremark benefit exempts from PA.
If initial step not met, claim rejects and PA must be submitted.
PA initial criteria: patient not on stable maintenance dose for ≥3 months AND (metformin inadequate/intolerant/contraindicated OR requires combination therapy with A1C ≥7.5%).
PA continuation criteria: patient on stable maintenance dose ≥3 months and shows A1C reduction since starting therapy.

Implication for coverageUse for type 1 diabetes or DKA may be a basis for denial as agent would not be effective

General DPP-4 limitations

General limitationSeveral DPP-4 agents are not recommended for patients with type 1 diabetes mellitus (examples: Oseni, Tradjenta, Zituvimet/Zituvimet XR, Zituvio)

Pancreatitis safetySome agents (e.g., Tradjenta, Zituvimet/Zituvimet XR, Zituvio) have not been studied in patients with a history of pancreatitis; risk in that population is unknown

Coverage implicationUse for type 1 diabetes or diabetic ketoacidosis is not indicated and may be considered not medically necessary