CurrentNeighborhood Health Plan of Rhode IslandPolicy 1009-D

DPP-4 Inhibitor Step Therapy (Post-PA) Policy

Step therapy criteria for dipeptidyl peptidase-4 (DPP-4) inhibitor drugs used as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; affects prescribers and pharmacy prior authorization processes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDPP-4 Inhibitor Step Therapy (Post-PA) Policy

Policy CodePolicy 1009-D

Change TypeNo material changes

Effective DateMay 1, 2023

Next Review Date

Key ActionObtain prior authorization if the patient does not meet initial step therapy criteria (including metformin fill or clinical exception).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~18brand and combination products listed

Adults with T2DMindication population

36 monthsduration of approval

>=7.5%A1C threshold

30d/180dmetformin fill required

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Coverage Criteria

Initial Therapy — Type 2 Diabetes Mellitus

Covered when ALL of the following are met:

Initial approval requirements

One of the following: 1) Patient has experienced inadequate treatment response, intolerance, or contraindication to metformin; 2) Patient requires combination therapy AND has an A1C of 7.5 percent or greater; 3) Patient has filled at least a 30-day supply of metformin within the past 180 days under the prescription benefit administered by CVS Caremark (in which case the requested drug will be paid under that prescription benefit).
If patient meets metformin fill condition, claim will be paid under prescription benefit; otherwise PA required.

Continuation of Therapy — Type 2 Diabetes Mellitus

Covered when ALL of the following are met:

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

Use of the listed DPP‑4 inhibitor products is outside their indicated populations when prescribed for type 1 diabetes mellitus or diabetic ketoacidosis. Multiple product labeling statements explicitly state these agents should not be used in patients with type 1 diabetes mellitus or, where noted, diabetic ketoacidosis, and therefore such uses are not covered under this policy.

DPP‑4 inhibitors are indicated as adjuncts to diet and exercise for adults with type 2 diabetes mellitus and are not recommended for patients with type 1 diabetes mellitus. Product labeling for several agents specifically notes lack of study and lack of efficacy in type 1 diabetes; prescribers should not use these agents for type 1 diabetes and expect coverage under the step therapy criteria.

Several DPP‑4 inhibitor product labels report they have not been studied in patients with a history of pancreatitis, and the risk of pancreatitis in such patients while using these agents is unknown. Because safety in this population is uncertain, use in patients with a history of pancreatitis may be considered not medically necessary or require additional clinical justification to obtain authorization.

Coding & Thresholds

A1C threshold for combination therapy

A1C threshold for combination therapy>= 7.5%

ContextRequired when patient 'requires combination therapy' under initial approval criteria

Use for authorizationDocumented A1C >= 7.5% supports initial approval when combination therapy is needed

Stable maintenance duration for continuation

Stable maintenance duration>= 3 months

Continuation requirementPatient must have been receiving a stable maintenance dose of the requested drug for at least 3 months to qualify for continuation approval

Supporting evidence

Provider Actions & Requirements

Prior Authorization

Prior Authorization Applies to DPP-4 Inhibitors

Prior authorization applies to DPP-4 inhibitors listed in this policy. Step therapy and post-prior-authorization rules govern coverage for these products; claims that do not meet step therapy criteria will reject and require PA review.

Applies to listed DPP-4 inhibitor brands and combination products (e.g., sitagliptin, linagliptin, alogliptin, saxagliptin and combinations with metformin or pioglitazone).
Includes both prescription and OTC products when noted in step therapy criteria.

Prior Authorization

Prior Authorization Requirement

A prior authorization is required when initial step therapy criteria are not met. If the patient has not filled a 30-day supply of metformin within the past 180 days (under the administered prescription benefit) or otherwise fails initial step criteria, the claim will reject and a PA must be submitted for evaluation against the PA criteria.

Claim rejection will include a message indicating that prior authorization is required.
PA requests will be evaluated by the PA unit using the documented PA criteria (including clinical exceptions).

Background

DPP‑4 inhibitors are oral antihyperglycemic agents used as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Multiple branded and combination products pair a DPP‑4 inhibitor with metformin or other agents; this policy defines step therapy requirements and coverage rules for those products.

Definitions

DPP-4 inhibitors

Class definitionDipeptidyl peptidase-4 (DPP-4) inhibitors: oral agents used to improve glycemic control in adults with type 2 diabetes when added to diet and exercise (examples include sitagliptin, linagliptin, saxagliptin, alogliptin)

Representative productsExamples listed in policy include JANUMET (sitagliptin/metformin), JANUVIA (sitagliptin), TRADJENTA (linagliptin), ONGLYZA (saxagliptin), NESINA (alogliptin)

FormulationsAvailable as monotherapy and multiple fixed-dose combinations with metformin or other agents

Limitations of Use

Not for type 1 diabetesDPP-4 inhibitors are not recommended for patients with type 1 diabetes mellitus (would not be effective)

Pancreatitis uncertaintyMany products have not been studied in patients with a history of pancreatitis; risk in this population is unknown

Initial Therapy Criteria

Initial therapy step requirements

Initial: Patient not on stable maintenance for >=3 months AND one of: inadequate response/intolerance/contraindication to metformin; OR requires combination therapy with A1C >=7.5%; OR has filled >=30-day supply of metformin within past 180 days under CVS Caremark benefit (this affects billing).

If initial criteria not met, claim rejects and prior authorization must be requested.

Continuation Therapy Criteria

Continuation criteria for DPP-4 inhibitors

Continuation: Patient receiving stable maintenance dose >=3 months AND demonstrated reduction in A1C since starting therapy

Duration of stable maintenance defined as at least 3 months per policy.

Step Therapy Rules

Step	Requirement / scope
1
Applies step therapy/post‑prior authorization rules to the listed DPP‑4 inhibitor products (see drug list).

Coverage condition	Policy action
Initial therapy: patient has NOT been on a stable maintenance dose of the requested drug for ≥3 months AND one of: (a) inadequate response/intolerance/contraindication to metformin; (b) requires combination therapy AND A1C ≥ 7.5%; OR (c) has filled ≥30‑day supply of metformin within the past 180 days under a CVS Caremark prescription benefit.
If initial criteria met and metformin fill condition applies, the requested drug will be paid under that prescription benefit; if initial criteria not met the claim will reject and a prior authorization is required (PA unit will apply PA criteria).
Continuation therapy: patient has been receiving a stable maintenance dose of the requested drug for ≥3 months AND has demonstrated a reduction in A1C since starting therapy.
If continuation criteria are met, authorization may be granted for the continuation period; if not met, a prior authorization request and justification (including documented A1C change) are required.