CurrentUnitedHealthcarePolicy 2025 P 2245-13

UnitedHealthcare Pharmacy Clinical Pharmacy Programs - Diabetes Medications - DPP4 Inhibitors

Policy Summary

PayerUnitedHealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs - Diabetes Medications - DPP4 Inhibitors

Policy CodePolicy 2025 P 2245-13

Change TypeProduct additions and reference updates (including authorized generics)

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit documentation of a 3-month trial (30 days for Connecticut) showing therapeutic failure, contraindication, or intolerance to required step therapy agents and list reasons; authorization issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

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

Added Sitagliptin (Zituvio authorized generic), Zituvimet and Zituvimet XR to the program.

Updated products typically excluded from coverage list and references.

For Connecticut business required trial duration is 30 days instead of three months.

Program type changed from Notification to Prior Authorization/Medical Necessity in 7/2021.

2Therapeutic classes represented

12Authorization duration (months)

Coverage summary

UnitedHealthcare prior authorization/medical necessity policy for DPP-4 inhibitor diabetes medications (sitagliptin products and sitagliptin/metformin combinations) describing required step trials, authorization duration, exclusions, and program rules for Oxford. Effective date: 2025-10-01. Scope includes sitagliptin mono products (Januvia, Zituvio/authorized generic) and sitagliptin/metformin combinations (Janumet, Janumet XR, Zituvimet, Zituvimet XR and generics).

Coverage stance: covered with criteria — products are covered when specified prior trial requirements and documentation (therapeutic failure, contraindication, or intolerance) are met per the step therapy criteria. Authorization duration: 12 months.

Key thresholds and quick facts

Required trial duration (standard)3 months

Required trial duration (Connecticut)30 days

Authorization duration12 months

Number of therapeutic classes2

Program scopePrior Authorization/Medical Necessity for sitagliptin and sitagliptin/metformin products

Initial therapy / Prior trials (sitagliptin and combinations)

A. Coverage criteria for sitagliptin (Januvia, Zituvio, generic sitagliptin)

Covered when ALL of the following are met:

ALL of the following

ALL of the following
- AND one of the following
  - Alogliptin (Nesina authorized generic) trial with therapeutic failure, contraindication, or intolerance; list reason
  - Saxagliptin (generic Onglyza) trial with therapeutic failure, contraindication, or intolerance; list reason

B. Coverage criteria for sitagliptin/metformin combination products (Janumet, Janumet XR, Zituvimet, Zituvimet XR and generics)

Covered when ALL of the following are met:

Continuation / Re-authorization criteria

Continuation/renewal: Authorization is issued for 12 months. Re-authorization may be approved based on prior claim/medication history, diagnosis codes (ICD-10), and/or automated claim-logic processes per program rules; UnitedHealthcare may approve initial and re-authorization using these automated allowances depending on the program.

Products typically excluded from coverage

Products typically excluded from coveragemixedNot Covered

Januvia	typically excluded from coverage (brand)
Janumet	typically excluded from coverage (brand)
Janumet XR	typically excluded from coverage (brand)
Onglyza (multi-source brand)	typically excluded from coverage (multi-source brand)
Kombiglyze XR (multi-source brand)	typically excluded from coverage (multi-source brand)
Kazano	typically excluded from coverage (brand/authorized generic listed as typically excluded in updates)
Nesina	typically excluded from coverage (authorized generic listed as typically excluded in updates)
Zituvio (including authorized generic)	typically excluded from coverage
Zituvimet (including authorized generic)	typically excluded from coverage
Zituvimet XR (including authorized generic)	typically excluded from coverage

Note: Many brand products and certain multi-source products are typically excluded from coverage. Exclusions were revised in 4/2024 and again updated in 7/2025.

Medications and step-therapy alternatives (codes/products)

Medications covered with criteria (listed by product name)mixedCovered

Januvia	sitagliptin — brand product included in program
Zituvio	sitagliptin authorized generic
Sitagliptin (Zituvio authorized generic)	authorized generic sitagliptin
Janumet	sitagliptin/metformin immediate-release
Janumet XR	sitagliptin/metformin extended-release
Zituvimet	sitagliptin/metformin authorized generic
Zituvimet XR	sitagliptin/metformin extended-release authorized generic
Zituvimet (by Zydus)	sitagliptin/metformin product added 11/2024

Step therapy / step 1 alternatives (required prior trials)mixedCovered

Tradjenta	linagliptin (step requirement for sitagliptin products)
Jentadueto	linagliptin/metformin immediate-release (step requirement for combos)
Jentadueto XR	linagliptin/metformin extended-release (step requirement for combos)
Nesina	alogliptin (or authorized generic) - alternate in step list
Onglyza	saxagliptin (multi-source brand/generic) - alternate in step list
Kazano	alogliptin/metformin (authorized generic) - alternate in step list for combos
Kombiglyze XR	saxagliptin/metformin extended-release (multi-source/generic) - alternate in step list for combos

Clarification: Some products may appear both on the covered-with-criteria lists and on the 'typically excluded' list depending on brand versus authorized-generic status and recent program updates; see program changes in 11/2024 and 7/2025 for examples of additions and reclassifications.

Prior authorization and documentation requirements

Prior Authorization

Prior authorization required with documentation of prior trials

Submit documentation of a 3-month trial (30 days for Connecticut) showing therapeutic failure, contraindication, or intolerance to required step therapy agents and list reasons; authorization issued for 12 months.

Authorization issued for 12 months
Connecticut exception: required prior trial duration = 30 days (instead of 3 months)

Documentation Required

List reasons for therapeutic failure/contraindication/intolerance

Provider must list the reason for therapeutic failure, contraindication, or intolerance for each required prior agent trial.

List reason for therapeutic failure, contraindication, or intolerance for each prior agent

Evidence and references

Evidence: P&T approval dates span multiple actions from 10/2016 through 7/2025.

Primary references include package inserts for Januvia, Janumet, Janumet XR, Zituvimet/Zituvimet XR, Zituvio and the American Diabetes Association Standards of Care 2025.

Definitions and background

Background: This policy governs prior authorization/medical necessity for DPP-4 inhibitors sitagliptin and sitagliptin/metformin combinations as adjuncts to diet and exercise for adults with type 2 diabetes mellitus.

Definitions:

Therapeutic failure — Insufficient clinical response after trial of medication (as determined by prescriber); reason must be documented.

Contraindication — Clinical reason medication is not appropriate (example: risk factors for heart failure); must be documented.

Intolerance — Adverse reaction or inability to tolerate medication; must be documented.

Policy changes

7/2025addedLatest

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

11/2024added

Added Sitagliptin (Zituvio authorized generic), Zituvimet and Zituvimet XR to the program; updated references.

4/2024revised

Updated products typically excluded from coverage list and updated references.