ModifiedColorado Rocky Mountain Health PlansPolicy P 2245-13

DPP-4 inhibitors (sitagliptin and sitagliptin/metformin products) prior authorization

Prior authorization/medical necessity criteria for sitagliptin (Januvia, Zituvio) and sitagliptin/metformin combination products (Janumet, Janumet XR, Zituvimet, Zituvimet XR) for treatment of adults with type 2 diabetes mellitus under UnitedHealthcare Pharmacy Clinical Programs (Oxford effective 2025-10-01).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyDPP-4 inhibitors (sitagliptin and sitagliptin/metformin products) prior authorization

Policy CodePolicy P 2245-13

Change TypeModified (product additions and comparator updates)

Effective DateOct 1, 2025

Next Review Date

Key ActionProvider must document a trial (3 months; 30 days for CT) with therapeutic failure, contraindication, or intolerance to required comparator agents and list reasons to obtain approval.

POLICY UPDATE CHANGES

Oxford effective date set to 10/1/2025 and additions of authorized generic products (Zituvio, Zituvimet, Zituvimet XR) were made in 2024-2025 updates.

Updated comparator/generic references to generic Kombiglyze and Onglyza.

Note that for Connecticut business only a 30 day trial requirement applies (state-specific variation).

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

Language that several named products are typically excluded from coverage was added (5/2020 and updated subsequently).

12Authorization duration

3 monthsRequired trial (standard)

multipleProducts referenced/updated

Coverage Summary & Scope

Scope: Prior authorization/medical necessity criteria for sitagliptin (Januvia, Zituvio) and sitagliptin/metformin combination products (Janumet, Janumet XR, Zituvimet, Zituvimet XR) for treatment of adults with type 2 diabetes mellitus under UnitedHealthcare Pharmacy Clinical Programs (Program Number P 2245-13). The policy effective date for Oxford is 2025-10-01 and applies in the payer/program context of Prior Authorization/Medical Necessity for Diabetes Medications - DPP-4 Inhibitors. Coverage stance: covered_with_criteria. Policy number: P 2245-13.

Quick Facts

Authorization duration12 months

Required trial duration (standard)3 months

Required trial duration (Connecticut)30 days

Products referenced/updatedMultiple sitagliptin and sitagliptin/metformin products (Januvia, Janumet, Janumet XR, Zituvio, Zituvimet, Zituvimet XR and others)

Step therapy requirementTrial with specified DPP-4 comparators (e.g., linagliptin, alogliptin, saxagliptin or their combos) required before approval

Initial Therapy Criteria

A. Januvia / sitagliptin products - Initial approval criteria

Covered when ALL of the following are met:

ALL of the following

Indication: adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Background indication from product labeling
Therapy history requirement
- Tradjenta (linagliptin)
- One of the following:
  - Alogliptin (Nesina authorized generic)

Provider Actions & Operational Rules

Prior Authorization

Prior authorization required with documented trial history

Provider must document a history of a trial (3 months; 30 days for CT) with therapeutic failure, contraindication, or intolerance to required comparator agents and list reasons for failure/contraindication/intolerance to obtain approval.

Documentation Required

List reasons for therapeutic failure/contraindication/intolerance

Providers must include the reason(s) for therapeutic failure, contraindication, or intolerance when requesting authorization.

Referenced Products / Codes

Referenced brand/generic products and noted exclusionsmixedExperimental

Januvia	sitagliptin (typically excluded from coverage as noted)
Janumet	sitagliptin/metformin (typically excluded from coverage as noted)
Janumet XR	sitagliptin/metformin extended-release (typically excluded from coverage as noted)
Zituvio	sitagliptin authorized generic (typically excluded from coverage as noted/added 7/2024/11/2024/7/2025 updates)
Zituvimet	sitagliptin/metformin authorized generic (typically excluded from coverage as noted/added)
Zituvimet XR	sitagliptin/metformin extended-release authorized generic (typically excluded from coverage as noted/added)
Onglyza	saxagliptin (multi-source brand/generic referenced as comparator)
Kombiglyze XR	saxagliptin/metformin extended-release (multi-source brand/generic referenced as comparator)
Tradjenta	linagliptin (step therapy comparator)
Jentadueto	linagliptin/metformin (step therapy comparator)

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Clinical Evidence & Background

Background: Sitagliptin (Januvia, Zituvio) and sitagliptin/metformin products (Janumet, Janumet XR, Zituvimet, Zituvimet XR) are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This policy establishes step therapy requiring documented trials of alternative DPP-4 inhibitors or DPP-4/metformin combinations before sitagliptin or sitagliptin/metformin products will be approved. Specifically, initial approval for sitagliptin products requires a history of a three-month trial resulting in therapeutic failure, contraindication, or intolerance to required comparator agents (e.g., linagliptin and either alogliptin or saxagliptin); approval for sitagliptin/metformin products requires a three-month trial resulting in therapeutic failure, contraindication, or intolerance to required comparator combination options (e.g., linagliptin/metformin and either alogliptin/metformin or saxagliptin/metformin). Authorization will be issued for 12 months.

Definitions: Therapeutic failure — Lack of adequate glycemic control after an adequate trial of a comparator product; the provider must list the reason for therapeutic failure.

Evidence and references: Product labeling and guideline sources cited in the policy include the package inserts for Januvia, Janumet, Janumet XR, Zituvimet/Zituvimet XR, and Zituvio (package insert dates 2022–2025) and the American Diabetes Association. Standards of Medical Care in Diabetes — 2025.

Policy Revision History

5/2020policy update

Added language that several named products (Januvia, Janumet, Janumet XR and related authorized generics) are typically excluded from coverage; exclusion language established and recorded.

7/2021operational

Program type changed from Prior Authorization/Notification to Prior Authorization/Medical Necessity (operational classification change).

4/2024policy update

Product list and references updated (P&T/program update reflected an April 2024 update to products typically excluded and references).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyDPP-4 inhibitors (sitagliptin and sitagliptin/metformin products) prior authorization

Policy CodePolicy P 2245-13

Change TypeModified (product additions and comparator updates)

Effective DateOct 1, 2025

Next Review Date

Key ActionProvider must document a trial (3 months; 30 days for CT) with therapeutic failure, contraindication, or intolerance to required comparator agents and list reasons to obtain approval.

On This Page

saxagliptin (generic Onglyza)

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B. Janumet / sitagliptin+metformin products - Initial approval criteria

Covered when ALL of the following are met:

ALL of the following

Indication: adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin/metformin extended-release is appropriate
Background indication from product labeling
Therapy history requirement
- Jentadueto (linagliptin/metformin immediate-release) or Jentadueto XR (linagliptin/metformin extended-release)
- One of the following:
  - Alogliptin/Metformin immediate-release (Kazano authorized generic)
  - saxagliptin/metformin extended-release (generic Kombiglyze XR)

Authorization duration

Authorization will be issued for 12 months

Applies to both sections A and B

State-specific variation

For Connecticut business only a 30 day trial will be required

Alters the 3-month trial requirement for CT

Documentation Required

Automated/claims-based approval potential

UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic. Use of automated approval and re-approval processes varies by program.

Denial Risk

Typical product exclusions may affect coverage

Several brand and authorized generic products are typically excluded from coverage; claims for excluded products may be denied per the member's benefit plan.

Documentation Required

Supply limits and medical records

Supply limits may be in place. Prior versions of the program added a requirement for submission of medical records; the operational program may require medical records to be submitted.

Billing Rule

Authorization duration

Authorizations will be issued for 12 months.

7/2024policy update

Added Zituvio and updated Nesina and Kazano to authorized generic designations; product list and references updated.

11/2024policy update

Added Sitagliptin (Zituvio authorized generic) and Sitagliptin/Metformin (Zituvimet and Zituvimet XR by Zydus) to the product list and updated references.

7/2025policy update

Added Zituvimet XR authorized generic and revised comparator naming to reference generic Kombiglyze and Onglyza; product list and references updated.

2025-10-01policy updateLatest

Oxford-specific effective date for the policy set to 2025-10-01 (policy effective for Oxford: October 1, 2025).

state-specific (Connecticut)policy update

Clarification that for Connecticut business only a 30-day trial requirement applies instead of the standard three-month trial for required comparator agents.