CurrentCignaPolicy N/A

STEP THERAPY POLICY Diabetes -Dipeptidyl Peptidase-4 Inhibitors Step Therapy Policy

Policy Summary

PayerCigna

PolicySTEP THERAPY POLICY Diabetes -Dipeptidyl Peptidase-4 Inhibitors Step Therapy Policy

Policy CodePolicy N/A

Change TypeSelected and Annual Revisions (2023-2025)

Effective Date

Next Review Date

Key ActionDocument that the patient meets one of the Step 1/Step 2 criteria (trial of an approved metformin product or Step 1 product, prior Step 2 trial, initiation of single-entity DPP-4 plus metformin, or prescriber-declared contraindication to metformin) to obtain coverage; approvals are for 1 year.

SourceLink

POLICY UPDATE CHANGES

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

Added sitagliptin/metformin extended-release (authorized generic to Zituvimet XR) to Step 2 products.

Removed Fortamet ER from metformin-containing products (obsolete) but noted it still counts toward a trial of a Step 1 product.

Added dapagliflozin/metformin extended-release (authorized generic to Xigduo XR) to metformin-containing products.

Added saxagliptin and saxagliptin/metformin extended-release (generic to Onglyza and Kombiglyze XR) to Step 2 products and to single-entity approval list for combination initiation.

Multiple metformin-containing product names were clarified to their ER forms; several obsolete products were removed from automation but still count toward trials.

1 yearApproval Duration

Coverage Summary

Defines step therapy requirements for DPP-4 inhibitor products and certain combination products for adults with type 2 diabetes across Cigna-administered health benefit plans. DPP-4 inhibitors and combination products are indicated to improve glycemic control in adults with type 2 diabetes as adjuncts to diet and exercise. SGLT-2/DPP-4 combination products are not addressed in this policy. Coverage for Step 2 DPP-4 products requires documentation that the patient has met one of the Step 1/Step 2 criteria described; approvals are provided for 1 year. Exceptions not meeting criteria are considered not medically necessary.

Key Facts

Approval Duration1 year

Required TrialsStep 1 + Step 2

Covered DPP-4 ProductsMultiple

Coverage Criteria and Step Therapy Rules

Specific Scenarios

Covered when ONE of the following is met:

ANY of the following

Patient has tried one Step 1 Product
Trial of one Step 1 product satisfies requirement; approvals provided for 1 year
Patient has tried one of the specified metformin-containing products (listed below)
A trial of one of these metformin-containing products also satisfies the Step 1 requirement
Patient has tried one Step 2 Product
If patient has tried one Step 2 product, approve the requested Step 2 product

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Step 1 Product: generic metformin or generic metformin extended-release (generic to Glucophage XR only) and listed metformin-containing products. Step 2 Product: listed DPP-4 inhibitors and DPP-4 combination products enumerated in the policy (examples include Brynovin, Januvia, Tradjenta, Nesina, Onglyza, and multiple sitagliptin and combination products).

Drug/Product Lists (for step mapping)

Step 1 Products (generic metformin)mixedCovered

No codes listed

Step 2 Products (DPP-4 inhibitors and combination products)mixedCovered

	Brynovin (sitagliptin oral solution - Azurity)
	Januvia (sitagliptin tablets - Merck)
	Janumet (sitagliptin/metformin tablets - Merck)
	Janumet XR (sitagliptin/metformin extended-release tablets - Merck)
	Kombiglyze XR (saxagliptin/metformin extended-release tablets - AstraZeneca, generic)
	Onglyza (saxagliptin tablets - AstraZeneca, generic)
	Tradjenta (linagliptin tablets - Boehringer Ingelheim)
	Jentadueto (linagliptin/metformin tablets - Boehringer Ingelheim)
	Jentadueto XR (linagliptin/metformin extended-release tablets - Boehringer Ingelheim)
	Nesina (alogliptin tablets - Takeda, authorized generic)

1–10 of 20

1/2

Metformin-containing products that satisfy Step 1 trialmixedCovered

	Glumetza ER
	Riomet
	metformin oral solution
	metformin extended-release (generics to Fortamet ER and Glumetza ER)
	glyburide/metformin
	glipizide/metformin
	Actoplus Met
	pioglitazone/metformin
	Invokamet
	Invokamet XR

1–10 of 21

1/3

Prior Authorization & Documentation Requirements

Prior Authorization

Step therapy requirement

Coverage for Step 2 DPP-4 products requires documentation that the patient has met one of the Step 1/Step 2 criteria described (trial of one Step 1 product or specified metformin-containing product, prior trial of one Step 2 product, initiation of single-entity DPP-4 plus metformin, or contraindication to metformin). Approvals are provided for 1 year.

Trial documentation showing use of a Step 1 product (generic metformin or generic metformin extended‑release) or one of the listed metformin-containing products
Name of prior Step 2 product trialed (if applicable)
Prescriber statement documenting initiation of single-entity DPP-4 plus metformin or a contraindication to metformin

Documentation Required

Metformin contraindication documentation

Background and Evidence

Dipeptidyl peptidase-4 (DPP-4) inhibitors and specified combination products are indicated to improve glycemic control in adults with type 2 diabetes mellitus when used as adjuncts to diet and exercise. Various combination products combine DPP-4 inhibitors with metformin, SGLT-2 inhibitors, and/or thiazolidinediones; SGLT-2/DPP-4 combination products are not addressed by this policy. The American Diabetes Association Standards of Care (2025) are cited in the guideline section and note that DPP-4 inhibitors are options as add-on therapy after metformin, with metformin contraindications (for example, severe renal impairment or acute/chronic metabolic acidosis, including diabetic ketoacidosis) requiring documentation if metformin cannot be used.

Policy Revision History

10/22/2025material_changeLatest

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

08/06/2025material_change

Added sitagliptin/metformin extended-release (authorized generic to Zituvimet XR) to Step 2 products.

05/14/2025non_material_change

Removed Fortamet ER from metformin-containing products (obsolete) but noted it still counts toward a trial of a Step 1 product.