Centene DPP-4 Inhibitors Prior Auth Policy Update

Coverage Criteria for DPP-4 Inhibitors

Initial Therapy

Covered when ALL of the following are met:

Initial Approval: 1. Diagnosis of type 2 diabetes mellitus.

Age: 2. Age >= 18 years.

Prior metformin trial: 3. Failure of >= 3 consecutive months of metformin unless contraindicated or clinically significant adverse effects are experienced.>= 3 consecutive months

Clinical pathway options: 4. Member meets one of the following options:

4a or 4b: a) For antidiabetic medication‑naive members: intended for concurrent use with metformin due to HbA1c >= 8.5% (drawn within the past 3 months). b) Other approval pathways per policy (e.g., failure of a preferred sitagliptin‑containing product or documented inability to take tablets for product‑specific circumstances).HbA1c >= 8.5% (when medication‑naive)

Preferred sitagliptin‑containing product requirement applies where specified.

Dose limit: 5. Requested dose does not exceed the FDA‑approved maximum recommended dose.see Section V in policy for FDA max doses

Approval duration: 12 months.

Continuation

Continued therapy approved when ONE of the following is met:

Continued Therapy: a) Member is currently receiving the medication via the Centene benefit or has previously met the initial approval criteria and continues therapy.

Member must be responding positively to therapy; approval duration: 12 months.

Continuity of care: b) Member is currently receiving the medication and is enrolled in a state/product with continuity of care regulations (refer to state‑specific addendums).

If request is for a dose increase, new dose must not exceed FDA maximum recommended dose.

Non‑standard Uses

If requested use is outside criteria:

Non‑standard Uses: For indications, ages, or dosing regimens not specifically listed in this policy, follow the applicable line‑of‑business policies: no‑coverage criteria policy (HIM.PA.33) or non‑formulary policy (HIM.PA.103) for formulary status, or the off‑label use policy (HIM.PA.154) when appropriate.

Non‑FDA approved indications are not authorized here unless sufficient documentation of efficacy and safety is provided per off‑label policy.

Policy revision history / implied coverage logic

Policy history and editing notes indicating criteria changes over time (edits refer to initial approval criteria, redirection, and addition of new agents).

policy_history: Series of reviews and edits: removed criteria for combination DPP‑4/SGLT2 products and directed requests to the SGLT2 policy; clarified initial approval to reference preferred sitagliptin‑containing products; added newly approved non‑preferred agents (Zituvio, Zituvimet, Zituvimet XR, and later Brynovin) to criteria across 2021–2025 reviews.

This node represents the change log and implied redirection/preference logic rather than clinical eligibility criteria.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized under this document. Requests for therapy for off‑label uses must include sufficient documentation of efficacy and safety consistent with the plan’s off‑label use policy (HIM.PA.154) or other applicable evidence of coverage documentation to be considered for authorization.

Combination products that include both a DPP‑4 inhibitor and an SGLT2 inhibitor were removed from this DPP‑4 policy. Requests for those combination DPP‑4/SGLT2 agents should be submitted and reviewed under the SGLT2 Inhibitors policy (see related policy HIM.PA.91), per the 1Q 2021 revision directing such requests to the SGLT2 policy.

DPP‑4 inhibitors are not indicated for the treatment of diabetic ketoacidosis or for patients with type 1 diabetes and should not be used in these settings. Additionally, certain products (for example, Brynovin, Jentadueto, Jentadueto XR, Tradjenta, Zituvimet, Zituvimet XR, and Zituvio) have not been studied in patients with a history of pancreatitis. Contraindications described in product labeling — such as severe renal impairment for metformin‑containing combination products, NYHA Class III/IV heart failure for select agents (Oseni), and history of serious hypersensitivity to the requested drug — must be considered when evaluating requests.

This clinical policy is provided as a guide to medical necessity to assist in coverage determinations and benefit administration. It does not constitute a guarantee of payment, a substitute for clinical judgment, or medical advice. Coverage decisions remain subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents and applicable laws and regulations.

Products, Formulations, and Key Clinical Thresholds

DPP-4 inhibitor productsmixed

Nesina	alogliptin
Kazano	alogliptin/metformin
Oseni	alogliptin/pioglitazone
Tradjenta	linagliptin
Jentadueto	linagliptin/metformin
Jentadueto XR	linagliptin/metformin (extended release)
Onglyza	saxagliptin
Kombiglyze XR	saxagliptin/metformin (extended release)
Brynovin	sitagliptin
Zituvio	sitagliptin (brand variant)

1–10 of 12

1/2

Product formulations and strengths (selected)mixed

Brynovin	Oral solution: 25 mg/mL; tablet formulation (sitagliptin) also available per manufacturer
Tradjenta	Tablets: 5 mg (linagliptin)
Jentadueto / Jentadueto XR	Tablets: linagliptin/metformin combinations; XR formulations available; strengths individualized
Kazano	Alogliptin/metformin combination; strengths individualized
Kombiglyze XR	Tablets: 2.5/1000 mg, 5/500 mg, 5/1000 mg (saxagliptin/metformin XR)
Nesina	Tablets: 6.25 mg, 12.5 mg, 25 mg (alogliptin)
Onglyza	Tablets: saxagliptin available; typical max dose 5 mg/day
Oseni	Tablets: alogliptin/pioglitazone combinations (e.g., 12.5/15 mg, 12.5/30 mg, 12.5/45 mg)
Zituvimet / Zituvimet XR	Tablets: sitagliptin/metformin combinations; XR strengths include 50/500 mg; other strengths individualized

Key Clinical Thresholds

HbA1c threshold for antidiabetic medication–naive members>= 8.5% (drawn within the past 3 months)

Prior metformin trial requirementFailure of at least 3 consecutive months of metformin unless contraindicated or clinically significant adverse effects are experienced

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required for the DPP-4 inhibitors listed in this policy (e.g., alogliptin [Nesina], alogliptin/metformin [Kazano], alogliptin/pioglitazone [Oseni], linagliptin [Tradjenta], linagliptin/metformin [Jentadueto, Jentadueto XR], saxagliptin [Onglyza], saxagliptin/metformin [Kombiglyze XR], sitagliptin [Brynovin, Zituvio, Zituvio XR], sitagliptin/metformin [Zituvimet, Zituvimet XR], and newly added branded products such as Brynovin). Providers must obtain prior authorization before dispensing these agents.

Affected agents: alogliptin, alogliptin/metformin, alogliptin/pioglitazone, linagliptin, linagliptin/metformin, saxagliptin, saxagliptin/metformin, sitagliptin, sitagliptin/metformin, branded additions (e.g., Brynovin, Zituvimet, Zituvimet XR).
Prior authorization applies to single-agent and combination products listed under this DPP-4 policy unless specifically redirected (see product redirection callout).

Note

Product Redirection / Preferred Products

Product Redirection / Preferred Product Specification — Requests for combination products that include both a DPP-4 inhibitor and an SGLT2 inhibitor are redirected to the SGLT2 Inhibitors policy (HIM.PA.91). For sitagliptin-containing requests, preferred sitagliptin-containing products are specified in the criteria; non-preferred branded sitagliptin products (for example, newly added non-preferred brands) may be redirected to a preferred sitagliptin product or require additional justification per formulary status.

Background and Scope

Dipeptidyl peptidase‑4 (DPP‑4) inhibitors are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin is recommended as first‑line therapy; DPP‑4 inhibitors are used for escalation of therapy when additional glycemic control is needed, typically guided by HbA1c targets and treatment response.

Key Terms and Product Availability

inv-22: dipeptidyl peptidase-4 (DPP-4) definition

DefinitionDipeptidyl peptidase-4 (DPP-4): an enzyme targeted by DPP-4 inhibitor medications used as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Role in therapyDPP-4 inhibitors may be used as part of dual or combination therapy when metformin alone is inadequate or when guidelines support initial combination therapy based on HbA1c level

LimitationsNot indicated for diabetic ketoacidosis or type 1 diabetes; use for non‑FDA indications requires sufficient documentation per off-label policies

inv-23: glycated hemoglobin (HbA1c) definition

DefinitionGlycated hemoglobin (HbA1c): a laboratory measure of average blood glucose over ~3 months used to guide diabetes therapy decisions

Policy Revision History

2021-10-27annual_review

Removed criteria for combination DPP-4/SGLT2 products and directed requests to the SGLT2 policy; references reviewed and updated.

2021-02-21P&T_approval

P&T approval recorded for 1Q 2021 annual review reflecting removal of combination DPP-4/SGLT2 criteria.

2022-09-16annual_review

1Q 2022 annual review: no significant clinical changes; references reviewed and updated.

OpenPayer

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors prior authorization