CurrentColorado Rocky Mountain Health PlansPolicy P 2245-13

DPP-4 inhibitor prior authorization for sitagliptin and sitagliptin/metformin products

Defines prior authorization and medical necessity criteria for sitagliptin (Januvia, Zituvio) and sitagliptin/metformin combination products (Janumet, Janumet XR, Zituvimet, Zituvimet XR) for adults with type 2 diabetes mellitus for Colorado Rocky Mountain Health Plans (UnitedHealthcare pharmacy programs).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyDPP-4 inhibitor prior authorization for sitagliptin and sitagliptin/metformin products

Policy CodePolicy P 2245-13

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateJul 1, 2025

Key ActionObtain prior authorization with documentation of a 3-month trial and therapeutic failure, contraindication, or intolerance to required step agents before sitagliptin or sitagliptin/metformin will be approved.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration for approved requests

3-month trialrequired trial duration of prior agents before approval

30 daystrial duration exception for Connecticut business

Multipleproducts covered

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Coverage Criteria and Covered Products

Initial Therapy Criteria

Covered when ALL of the following are met for each product group:

Group A - Sitagliptin (Januvia, Zituvio): 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 the following: (1) Alogliptin (Nesina authorized generic) OR (2) saxagliptin (generic Onglyza).3-month trial (30 days for Connecticut)

Authorization will be issued for 12 months.

Group B - Sitagliptin/Metformin combinations (Janumet, Janumet XR, Zituvimet, Zituvimet XR): 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 the following: (1) Alogliptin/Metformin immediate-release (Kazano authorized generic) OR (2) saxagliptin/metformin extended-release (generic Kombiglyze XR).3-month trial (30 days for Connecticut)

Authorization will be issued for 12 months.

Products including Januvia, Janumet, Janumet XR, Onglyza, Kombiglyze XR, Kazano, Nesina, Zituvio, Zituvimet, and Zituvimet XR (including authorized generics where noted) are listed in the plan’s formulary materials and are subject to prior authorization under this policy. The policy notes these products are typically excluded from standard coverage absent approval via the criteria described below; state mandates, federal requirements, and member-specific benefit plans may also affect coverage.

For sitagliptin monotherapy (e.g., Januvia or Zituvio), approval requires documentation of a three-month trial resulting in therapeutic failure, contraindication, or intolerance to both linagliptin (Tradjenta) and one additional DPP-4 agent (alogliptin/Nesina authorized generic or saxagliptin/generic Onglyza). For sitagliptin/metformin combination products (e.g., Janumet, Janumet XR, Zituvimet, Zituvimet XR), approval requires documentation of a three-month trial resulting in therapeutic failure, contraindication, or intolerance to all of the following: linagliptin/metformin (Jentadueto or Jentadueto XR) and one additional DPP-4/metformin comparator (alogliptin/metformin — Kazano authorized generic — or saxagliptin/metformin ER — generic Kombiglyze XR).

Initial Therapy Rules

Initial therapy rules

Initial approval requirements

Sitagliptin products: Documented history of a three-month trial resulting in therapeutic failure, contraindication, or intolerance to both: linagliptin (Tradjenta) and one of alogliptin (Nesina authorized generic) or saxagliptin (generic Onglyza).3-month trial (30 days for Connecticut)

Authorization will be issued for 12 months.

Sitagliptin/Metformin products: Documented history of a three-month trial resulting in therapeutic failure, contraindication, or intolerance to all of the following: Jentadueto/Jentadueto XR (linagliptin/metformin) and one of alogliptin/metformin (Kazano authorized generic) or saxagliptin/metformin extended-release (generic Kombiglyze XR).3-month trial (30 days for Connecticut)

Authorization will be issued for 12 months.

Step	Required prior trials	Required trial duration	Authorization duration
1
Linagliptin (Tradjenta) AND one of: alogliptin (Nesina authorized generic) OR saxagliptin (generic Onglyza)
3-month trial (30 days for Connecticut)
12 months

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization requires documented history of therapeutic failure, contraindication, or intolerance to the specified step agents. Requests must include the reason for failure/intolerance/contraindication and supporting documentation.

Prior authorization required for initial and re-authorization — Authorization issued for 12 months when criteria met
Include reason for therapeutic failure, contraindication (e.g., risk factors for heart failure), or intolerance
For Connecticut business only a 30 day trial may be acceptable (state-specific)

Step Therapy

Step Therapy Requirement

Step therapy requires prior trial and documented therapeutic failure, contraindication, or intolerance to the listed step 1 agents before higher-tier DPP‑4 products will be approved.

Step 1 agents include linagliptin (Tradjenta) or linagliptin/metformin (Jentadueto/Jentadueto XR)
Alternative step 1 options include authorized generics or listed alternatives (e.g., alogliptin/Nesina, saxagliptin/generic Onglyza, and combinations such as Kazano or generic Kombiglyze XR)
Authorization will be issued for 12 months when step therapy criteria are met

Documentation Required

Supporting Documentation

Submission of previous claim/medication history, relevant ICD-10 diagnosis codes, and medical records may be used to approve initial and re‑authorization requests. Automated approval processes may be used depending on program logic.

Supply limits may apply
Medical records should document dates and duration of prior trials (typically a three‑month trial unless state mandate specifies otherwise)
For Connecticut business only, a 30‑day trial requirement is applicable

Denial Risk

Missing Required Prior Trials — Denial Risk

Requests lacking documentation of a required trial (or a documented contraindication or intolerance) to the specified DPP‑4 agents will not meet criteria and are at risk for denial.

If required prior trials are not shown, include documentation of contraindication or intolerance to the listed agents to avoid denial

Indication and Definitions

inv-09: Indication — Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (per product labeling).

Indication (per product labeling)Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Products covered by this indicationSitagliptin (Januvia, Zituvio) and sitagliptin/metformin combinations (Janumet, Janumet XR, Zituvimet, Zituvimet XR).

PopulationAdults with type 2 diabetes mellitus for whom sitagliptin and/or metformin therapy is appropriate.

Therapeutic roleAdjunct therapy to diet and exercise to improve glycemic control.

Labeling sourceProduct labeling statements for sitagliptin and sitagliptin/metformin products as cited in policy background.

Background

Sitagliptin and sitagliptin/metformin combinations are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The sitagliptin single-agent products (Januvia, Zituvio) are appropriate when sitagliptin monotherapy is clinically indicated; combination products (Janumet, Janumet XR, Zituvimet, Zituvimet XR) are indicated when treatment with both sitagliptin and metformin or metformin extended-release is appropriate.

This policy references product labeling and established clinical standards to define medical necessity for these DPP-4 inhibitor agents. Where applicable, authorization durations are set to 12 months, and state-specific exceptions (for example, a 30-day required trial in Connecticut) are noted within the criteria.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyDPP-4 inhibitor prior authorization for sitagliptin and sitagliptin/metformin products

Policy CodePolicy P 2245-13

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateJul 1, 2025

SourceLink

On This Page

OpenPayer

DPP-4 inhibitor prior authorization for sitagliptin and sitagliptin/metformin products

Coverage Criteria and Covered Products

Initial Therapy Rules

Step Therapy Requirements

Prior Authorization and Documentation Requirements

Referenced Clinical References and Codes

Re-authorization / Continuation Criteria

Indication and Definitions

Background