CurrentCignaPolicy N/A

Diabetes - Dipeptidyl Peptidase-4 Inhibitors Step Therapy Policy

Defines step therapy requirements for coverage of dipeptidyl peptidase-4 (DPP-4) inhibitors and specified combination products for adults with type 2 diabetes across Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyDiabetes - Dipeptidyl Peptidase-4 Inhibitors Step Therapy Policy

Policy CodePolicy N/A

Change TypeMaterial additions and product list updates

Effective DateN/A

Next Review DateN/A

Key ActionRequire a trial of a Step 1 product (generic metformin or specified metformin-containing products) before coverage of most Step 2 DPP-4 products.

SourceLink

POLICY UPDATE CHANGES

Brynovin was added to the list of Step 2 products and to the list of single-entity DPP-4 inhibitors approved when initiating dual therapy with metformin.

Sitagliptin/metformin extended-release (authorized generic to Zituvimet XR) was added to Step 2 products.

Zituvimet and Zituvimet XR were added to the list of Step 2 products.

Automation changes removed several obsolete metformin-containing products (e.g., Riomet ER, Fortamet ER previously flagged obsolete) and clarified Glumetza/Fortamet to ER where applicable.

~30named DPP-4 and combination products listed

1 yearauthorization duration for approvals

Step 1 → Step 2required sequence for most approvals

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Coverage Criteria

Initial and general step therapy criteria

Covered when ONE of the following step therapy paths is met:

Step 1 trial: Patient has tried one Step 1 Product (generic metformin or specified metformin-containing products)1 trial

A trial of specified metformin-containing products listed in the policy (including Glumetza ER, Riomet, metformin oral solution, metformin ER generics, and several metformin combination products) satisfies this requirement.

Prior Step 2 trial: Patient has tried one Step 2 Product1 trial

If the patient has tried one Step 2 product, approve the requested Step 2 product.

Initiating dual therapy with DPP-4 + metformin: If initiating dual (combination) therapy with a single-entity DPP-4 inhibitor AND metformin, approve a single-entity DPP-4 inhibitorN/A

Single-entity DPP-4 inhibitors that qualify include Brynovin, Januvia, Onglyza, saxagliptin, Tradjenta, Nesina, alogliptin, Zituvio, and sitagliptin (authorized generic to Zituvio).

Metformin contraindication: If the patient has a contraindication to metformin per the prescriber, approve a single-entity DPP-4 inhibitorN/A

Examples of contraindications include acute or chronic metabolic acidosis, including diabetic ketoacidosis.

SGLT-2/DPP-4 combination products are not addressed in this policy. For coverage rules related to agents that combine an SGLT-2 inhibitor with a DPP-4 inhibitor, refer to the separate Diabetes - SGLT-2 and DPP-4 Step Therapy Policy.

Any use that does not meet the step therapy criteria described in this policy is considered not medically necessary. Coverage for Step 2 products will only be determined per the Step Therapy criteria at the point of service, and approvals are provided for 1 year when criteria are met.

Provider Actions and Billing

Step Therapy

Step therapy prior authorization

Step therapy prior authorization applies at the point of service. If the Step Therapy rule is not met for a Step 2 product at the time of dispensing, coverage will be determined by the Step Therapy criteria in this policy. All approvals are provided for a 1 year duration.

Step Therapy

Required sequence for Step 1 and Step 2 products

A trial of a Step 1 product is required before coverage of a Step 2 DPP-4 product is approved, unless one of the metformin-containing products listed in the policy has been tried (these satisfy the Step 1 requirement). If the patient has already tried one Step 2 product, the requested Step 2 product can be approved. Initiation of dual therapy with a single-entity DPP-4 inhibitor plus metformin or a prescriber-documented contraindication to metformin also meet criteria for approval as described in the policy.

Background

Dipeptidyl peptidase-4 (DPP-4) inhibitors are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. This policy defines step therapy expectations for DPP-4 agents and specified combination products, encouraging initial use of a Step 1 product (generic metformin or specified metformin-containing products) before most Step 2 DPP-4 products. The policy lists covered Step 2 DPP-4 agents and metformin-containing products and specifies exceptions where a single-entity DPP-4 inhibitor may be approved (for example, when initiating dual therapy with metformin or when metformin is contraindicated).

Definitions and Contraindications

inv-09: DPP-4 inhibitors indicated to improve glycemic control in adults with type 2 diabetes

IndicationDipeptidyl peptidase-4 (DPP-4) inhibitors are indicated to improve glycemic control in adults with type 2 diabetes mellitus as monotherapy or in combination when used as adjuncts to diet and exercise.

Use casesCan be used as monotherapy or as add-on (combination) therapy to achieve glycemic targets.

Combination productsAvailable as combinations with metformin, SGLT-2 inhibitors, and/or thiazolidinediones; note SGLT-2/DPP-4 combinations are addressed in a separate policy.

Relative efficacyDPP-4 inhibitors have lower glycemic efficacy compared with some other antihyperglycemic classes and generally lack cardiorenal indications.

Policy scopeThis policy defines step therapy requirements for DPP-4 inhibitors and specified combination products for adults with type 2 diabetes across Cigna-administered plans.

Initial Therapy Criteria

Initial therapy rules

Step definitions and allowed initial uses

Step 1 products: Generic metformin or generic metformin extended-release (generic to Glucophage XR) or specified metformin-containing products listed in policy1 trial

Step 1 is defined as generic metformin or generic metformin extended-release (generic to Glucophage XR). A trial of listed metformin-containing products (see policy list) also satisfies Step 1.

Step 2 products: Listed Step 2 DPP-4 products and combination productsN/A

Step 2 includes Brynovin, Januvia, Janumet, Janumet XR, Kombiglyze XR, saxagliptin/metformin ER, Onglyza, saxagliptin, Tradjenta, Jentadueto, Jentadueto XR, Nesina, alogliptin, Kazano, alogliptin/metformin, Oseni, alogliptin/pioglitazone, Zituvio, sitagliptin (authorized generic to Zituvio), Zituvimet, sitagliptin/metformin (authorized generic to Zituvimet), Zituvimet XR, and sitagliptin/metformin ER (authorized generic to Zituvimet XR).

Continuation and Renewal Criteria

Continuation/renewal

Approvals and renewals

Duration: Approvals are provided for 1 year in duration.1 year

All approvals under this Step Therapy program are for a 1-year duration.

Step Therapy Details

Criteria	Requirement
Step 1 trial	Patient has tried one Step 1 Product (generic metformin or generic metformin extended‑release [generic to Glucophage XR] or a listed metformin-containing product). A trial of any of the metformin-containing products listed in the policy (e.g., Glumetza ER, Riomet, metformin oral solution, metformin extended‑release generics, glyburide/metformin, glipizide/metformin, Actoplus Met, pioglitazone/metformin, Invokamet, Invokamet XR, Synjardy, Synjardy XR, Xigduo XR, dapagliflozin/metformin ER, Segluromet) satisfies this requirement; approvals provided for 1 year.
Prior Step 2 trial	Patient has tried one Step 2 Product; if so, approve the requested Step 2 Product. (Step 2 products include: Brynovin; Januvia; Janumet; Janumet XR; Kombiglyze XR; saxagliptin/metformin ER; Onglyza; saxagliptin; Tradjenta; Jentadueto; Jentadueto XR; Nesina; alogliptin; Kazano; alogliptin/metformin; Oseni; alogliptin/pioglitazone; Zituvio; sitagliptin [authorized generic to Zituvio]; Zituvimet; sitagliptin/metformin [authorized generic to Zituvimet]; Zituvimet XR; sitagliptin/metformin ER [authorized generic to Zituvimet XR]).
Initiating dual therapy with metformin	If initiating dual (combination) therapy with a single‑entity DPP‑4 inhibitor AND metformin, approve a single‑entity DPP‑4 inhibitor. Single‑entity DPP‑4 examples listed: Brynovin, Januvia, Onglyza, saxagliptin, Tradjenta, Nesina, alogliptin, Zituvio, sitagliptin (authorized generic to Zituvio).
Metformin contraindication	If the patient has a contraindication to metformin per the prescriber (e.g., severe/acute or chronic metabolic acidosis including diabetic ketoacidosis), approve a single‑entity DPP‑4 inhibitor.