CurrentUnitedHealthcarePolicy N/A

Step therapy for DPP-4 inhibitor diabetes medications

Defines step-therapy prior authorization requirements for sitagliptin and sitagliptin/metformin products (brand and authorized generics) for adults with type 2 diabetes mellitus under UnitedHealthcare pharmacy clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for DPP-4 inhibitor diabetes medications

Policy CodePolicy N/A

Change TypeUpdated product listings and authorized generics (material)

Effective DateOct 1, 2025

Next Review DateJul 1, 2025

Key ActionObtain and document a 3-month trial (30 days in CT/KY/MS) showing therapeutic failure, contraindication, or intolerance to required DPP‑4 alternatives before requesting prior authorization for sitagliptin-containing products.

SourceLink

POLICY UPDATE CHANGES

Added Zituvimet XR authorized generic and updated to generic Kombiglyze and Onglyza; updated references.

Added Zituvio and updated Nesina and Kazano to authorized generic products; added sitagliptin/ metformin products by Zydus.

Updated products typically excluded from coverage to list multiple brand and authorized generic DPP-4 agents.

10/1/2025policy effective date

3 morequired trial duration

NCapplicable state

12 mo

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Coverage Criteria for Sitagliptin Products

Initial therapy — sitagliptin (monotherapy)

Covered when ALL of the following are met:

Step requirement for sitagliptin monotherapy: History of a three-month trial resulting in therapeutic failure, contraindication (e.g., risk factors for heart failure), or intolerance to both of the following (list reason for therapeutic failure, contraindication, or intolerance): (a) Tradjenta (linagliptin); AND (b) one of: (1) Alogliptin (Nesina authorized generic) OR (2) saxagliptin (generic Onglyza).3 months (30 days for CT/KY/MS)

Authorization will be issued for 12 months

Initial therapy — sitagliptin + metformin combinations

Covered when ALL of the following are met:

Step requirement for sitagliptin+metformin combinations: History of a three-month trial resulting in therapeutic failure, contraindication (e.g., risk factors for heart failure), or intolerance to all of the following (list reason for therapeutic failure, contraindication, or intolerance): (a) Jentadueto (linagliptin/metformin immediate-release) or Jentadueto XR (linagliptin/metformin extended-release); AND (b) one of: (1) Alogliptin/Metformin immediate-release (Kazano authorized generic) OR (2) saxagliptin/metformin extended-release (generic Kombiglyze XR).3 months (30 days for CT/KY/MS)

Authorization will be issued for 12 months

Products that are typically excluded from coverage include brand and authorized-generic sitagliptin and sitagliptin/metformin formulations. Examples listed in the program are Januvia (sitagliptin), Janumet and Janumet XR (sitagliptin/metformin), multi-source brand Onglyza (saxagliptin) and multi-source brand Kombiglyze XR (saxagliptin/metformin XR), Kazano (alogliptin/metformin authorized generic), Nesina (alogliptin authorized generic), and Zydus-authorized generic products including Zituvio, Zituvimet, and Zituvimet XR.

Drugs Referenced, Trial Duration, and Coding Notes

Drugs referenced in step therapy programNDC|Brand

Januvia / sitagliptin	Brand and authorized generic sitagliptin products listed in program
Janumet / sitagliptin + metformin	Brand and authorized generic sitagliptin/metformin combination products listed in program
Zituvio, Zituvimet, Zituvimet XR	Zydus-authorized generic sitagliptin and sitagliptin/metformin products
Tradjenta / linagliptin	Step 1 required alternative
Jentadueto / linagliptin + metformin	Step 1 required alternative for combination products
Nesina / alogliptin (authorized generic)	Step 2 alternative
Onglyza / saxagliptin (generic)	Step 2 alternative
Kazano / alogliptin + metformin (authorized generic)	Step 2 alternative for combination products
Kombiglyze XR / saxagliptin + metformin XR (generic)	Step 2 alternative for combination products

Required trial duration

Required trial duration (general)3 months

State-specific shorter trial30 days for Connecticut, Kentucky, and Mississippi business

Authorization length after meeting trialAuthorization will be issued for 12 months

Provider Requirements and Prior Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required and includes step therapy. Providers must document trials of first-line alternatives before approval will be issued.

Authorization duration: 12 months
State-specific trial length: 30 days required in CT, KY, MS business

Step Therapy

Step Therapy Requirements

Step therapy requires a documented trial and therapeutic failure, intolerance, or contraindication to specified first-line DPP‑4 alternatives before coverage of non-preferred DPP‑4 agents will be approved.

Required first-line alternatives include: linagliptin (Tradjenta/Jentadueto) and one of alogliptin (Nesina) or saxagliptin (Onglyza) — for single-agent sitagliptin products
For combination sitagliptin/metformin products, required trials include linagliptin/metformin (Jentadueto/Jentadueto XR) and one of alogliptin/metformin (Kazano) or saxagliptin/metformin (Kombiglyze XR)

Initial Therapy Requirements

Initial therapy requirements — Initial coverage requires step trials

Initial coverage requires documented step trials as follows:

Initial coverage — sitagliptin monotherapy: See coverage criteria: documented history of required prior trials (Tradjenta then one of Nesina or generic Onglyza) with therapeutic failure, contraindication, or intolerance before approval of sitagliptin monotherapy.3 months (30 days for CT/KY/MS)

Authorization will be issued for 12 months; state mandates may apply.

Initial coverage — sitagliptin + metformin combinations: See coverage criteria: documented history of required prior trials (Jentadueto/Jentadueto XR then one of Kazano or Kombiglyze XR) with therapeutic failure, contraindication, or intolerance before approval of sitagliptin/metformin products.3 months (30 days for CT/KY/MS)

Authorization will be issued for 12 months; state mandates may apply.

Step Therapy Agent Requirements

Step	Required prior agent(s) and trial details	Authorization duration
Monotherapy sitagliptin (Januvia, Zituvio, authorized generics)	History of a three-month trial resulting in therapeutic failure, contraindication (e.g., risk factors for heart failure), or intolerance to BOTH of the following (list reason): (a) Tradjenta (linagliptin); AND (b) one of: (1) Alogliptin (Nesina authorized generic) OR (2) saxagliptin (generic Onglyza). (For CT/KY/MS business, a 30‑day trial is acceptable)	Authorization will be issued for 12 months
Sitagliptin + metformin combinations (Janumet, Janumet XR, Zituvimet, Zituvimet XR, authorized generics)	History of a three-month trial resulting in therapeutic failure, contraindication (e.g., risk factors for heart failure), or intolerance to ALL of the following (list reason): (a) Jentadueto (linagliptin/metformin immediate‑release) or Jentadueto XR (linagliptin/metformin extended‑release); AND (b) one of: (1) Alogliptin/Metformin immediate‑release (Kazano authorized generic) OR (2) saxagliptin/metformin extended‑release (generic Kombiglyze XR). (For CT/KY/MS business, a 30‑day trial is acceptable)	Authorization will be issued for 12 months

Re-authorization Rules

Re-authorization — rules for continuation of therapy

Re-authorization is permitted when one of the following applies:

Re-authorization possibility: UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic per program automation.

Use of automated approval and re-approval processes varies by program/therapeutic class; supply limits may apply.

Definitions and Indications

Adjunct to diet and exercise — clinical indication

IndicationAdjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Relevant productsJanuvia, Janumet, Janumet XR, Zituvio, Zituvimet, Zituvimet XR and authorized generics

Use context for combinationsSitagliptin/metformin products indicated when treatment with both sitagliptin and metformin/metformin extended‑release is appropriate

Background

Sitagliptin and sitagliptin/metformin combination products are oral DPP-4 inhibitor therapies indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The policy implements a step-therapy approach requiring prior use and documented therapeutic failure, contraindication (for example, clinical features such as risk factors for heart failure), or intolerance to specified alternative DPP-4 agents before sitagliptin-containing products will be approved.

When prior authorization is granted, coverage is typically issued for 12 months. State-specific rules may modify requirements; for example, Connecticut, Kentucky, and Mississippi require only a 30-day prior trial in lieu of the standard 3-month trial duration used elsewhere.