CurrentCignaPolicy N/A

Step Therapy Policy — SGLT-2 and DPP-4 Combination Products

Defines a Cigna step therapy program that requires use of specified Step 1 products (metformin, certain DPP-4 or SGLT-2 agents, or listed combination/metformin-containing products) before coverage of specified SGLT-2/DPP-4 combination products for adults with type 2 diabetes; approvals are for one year.

Policy Summary

PayerCigna

PolicyStep Therapy Policy — SGLT-2 and DPP-4 Combination Products

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument trial of one Step 1 product (generic metformin or listed alternatives) or a metformin contraindication to approve a Step 2 combination product for one year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4named combination products

1 yrapproval duration

Step 1required prior tier

NCapplicable state

Coverage Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Step therapy (Initial coverage for Step 2 products)

Covered when ALL of the following are met

Step therapy requirement: Member has previously tried and failed, had intolerance, or has a contraindication to one Step 1 Product OR one of the listed metformin-containing products OR one of the listed DPP-4 products OR one SGLT-2 inhibitor

Approvals are for 1 year.

Step 2 Product Coverage Criteria

Covered when ANY of the following are met:

Satisfy Step 1 trial: Patient has tried one Step 1 Product (generic metformin or generic metformin extended‑release) OR one of the listed metformin‑containing products (examples listed in policy)

See policy for full list of metformin‑containing products

Prior DPP-4 or SGLT-2 use: Patient has tried a DPP‑4 inhibitor, a DPP‑4 inhibitor‑containing product, OR an SGLT‑2 inhibitor, other than Glyxambi, Qtern, Steglujan, or Trijardy XR

Examples of agents are provided in policy (e.g., Januvia, Onglyza, Farxiga, Jardiance)

Metformin contraindication: Prescriber documents a contraindication to metformin; if documented, approve Glyxambi, Qtern, or Steglujan

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

Claims for services billed for conditions or diagnoses not covered under this coverage policy will be denied. Benefit plan documents and the specific terms in effect on the date of service govern coverage determinations; providers must submit claims using the most appropriate codes as of the effective date. Services billed without covered diagnosis or procedure codes under the applicable coverage policy will be denied as not covered.

Any exception to the stated step therapy criteria for the Step 2 products (Glyxambi, Qtern, Steglujan, Trijardy XR) that is not explicitly allowed by the policy is considered not medically necessary.

Requests for Glyxambi, Qtern, Steglujan, or Trijardy XR that do not meet the policy's Step Therapy requirements (including documentation of prior use of an acceptable Step 1 product or other allowable criteria) are considered not medically necessary and will not be approved.

Provider Actions and Documentation Requirements

Step Therapy

Step Therapy requirement for Step 2 products

This program requires a trial of a Step 1 product prior to coverage of Step 2 products. If the Step Therapy rule is not met at the point of service, coverage will be determined by the Step Therapy criteria and may be denied. All approvals are provided for 1 year.

Step 1 is generic metformin or generic metformin extended-release (generic to Glucophage XR).
A trial of one Step 1 product OR one of the listed metformin-containing products satisfies the Step 1 requirement. Listed metformin-containing products include (but are not limited to): Glumetza ER, Riomet, metformin oral solution, metformin extended-release (generics to Fortamet ER and Glumetza ER), glyburide/metformin, glipizide/metformin, Actoplus Met, pioglitazone/metformin, Janumet, Janumet XR, sitagliptin/metformin (authorized generic to Zituvimet), Zituvimet, sitagliptin/metformin extended-release (authorized generic to Zituvimet XR), Zituvimet XR, Kombiglyze XR, saxagliptin/metformin extended-release, Jentadueto, Jentadueto XR, Kazano, alogliptin/metformin, Synjardy, Synjardy XR, Xigduo XR, dapagliflozin/metformin extended-release, Invokamet, Invokamet XR, Segluromet.
If the patient has tried a DPP-4 inhibitor, a DPP-4 inhibitor–containing product, OR an SGLT-2 inhibitor (other than Glyxambi, Qtern, Steglujan, or Trijardy XR), approval of a Step 2 product is allowed.
If the prescriber documents a contraindication to metformin, Glyxambi, Qtern, or Steglujan may be approved. Examples of metformin contraindications include acute or chronic metabolic acidosis, including diabetic ketoacidosis.
Step 2 products covered under this rule include: Glyxambi, Qtern, Steglujan, Trijardy XR.
Any other exception outside these criteria is considered not medically necessary.

Billing Rule

Billing and coding requirement

When submitting claims, providers must use the most appropriate diagnosis and procedure codes as of the effective date of the submission. Claims for services not accompanied by covered codes under the applicable coverage policy will be denied as not covered.

Ensure coding reflects covered diagnosis/procedure codes for the requested service and matches the clinical documentation supporting Step Therapy criteria.
Billing submissions that do not include covered codes consistent with the policy will be denied.

Documentation Required

Documentation of trial or contraindication

Documentation of prior therapy is required to approve a Step 2 product. The prescriber must document a trial of one Step 1 product or one of the listed metformin-containing products, or document use of an allowed DPP-4 or SGLT-2 agent as specified.

Document the specific Step 1 product tried (generic metformin or generic metformin ER) or the metformin-containing product used, with dates and duration of therapy.
If approval is requested based on prior use of a DPP-4 inhibitor, DPP-4–containing product, or SGLT-2 inhibitor, document the specific agent(s) tried (examples: Brynovin, Januvia, Nesina, alogliptin, Onglyza, saxagliptin, Tradjenta, Zituvio for DPP-4; Brenzavvy, bexagliflozin, Farxiga, dapagliflozin, Invokana, Jardiance, Steglatro for SGLT-2).
If approval is requested due to contraindication to metformin, the prescriber must document the contraindication and clinical rationale (e.g., acute or chronic metabolic acidosis, including diabetic ketoacidosis).

Initial Therapy Criteria

Step 1 prior therapy requirement

Required prior therapies before Step 2 combination products

Acceptable Step 1 therapies: One Step 1 Product OR one of the listed metformin‑containing products OR one of the listed DPP‑4 products OR one SGLT‑2 inhibitor

Step 1 Product is defined as generic metformin or generic metformin extended‑release (generic to Glucophage XR). A trial of one listed metformin‑containing product also satisfies requirement.

Step Therapy Details and Tables

Step	Required prior therapy before approving a Step 2 product
Step 1
Use of one Step 1 Product: generic metformin or generic metformin extended‑release (generic to Glucophage XR).
Alternative Step 1 options that also satisfy the requirement (examples listed in policy): Glumetza ER, Riomet, metformin oral solution, metformin extended‑release (generics to Fortamet ER and Glumetza ER), glyburide/metformin, glipizide/metformin, Actoplus Met, pioglitazone/metformin, Janumet, Janumet XR, sitagliptin/metformin (authorized generic to Zituvimet), Zituvimet, sitagliptin/metformin extended‑release (authorized generic to Zituvimet XR), Zituvimet XR, Kombiglyze XR, saxagliptin/metformin extended‑release, Jentadueto, Jentadueto XR, Kazano, alogliptin/metformin, Synjardy, Synjardy XR, Xigduo XR, dapagliflozin/metformin extended‑release, Invokamet, Invokamet XR, Segluromet.

Condition documented	Policy action / coverage implication
Documentation of prior trial of one Step 1 Product (generic metformin or generic metformin ER) or one of the listed metformin‑containing products.
Approve a Step 2 product when the patient has tried one Step 1 Product or one of the listed metformin‑containing products (per policy list).
Documentation that the patient has tried a DPP‑4 inhibitor, a DPP‑4 inhibitor‑containing product, or an SGLT‑2 inhibitor (other than Glyxambi, Qtern, Steglujan, or Trijardy XR).
Approve a Step 2 product when prior use of an eligible DPP‑4 or SGLT‑2 agent (excluding Glyxambi, Qtern, Steglujan, Trijardy XR) is documented.
Prescriber documents a contraindication to metformin (examples: acute or chronic metabolic acidosis including diabetic ketoacidosis).
If metformin is contraindicated per prescriber, approve Glyxambi, Qtern, or Steglujan. All approvals are provided for 1 year in duration.

Definitions

SGLT-2 / DPP-4 abbreviations and component molecules

SGLT-2Sodium glucose co-transporter-2 inhibitor

DPP-4Dipeptidyl peptidase-4 inhibitor

EMPAEmpagliflozin (abbreviation used for component molecule)

DAPADapagliflozin (abbreviation used for component molecule)

ERTUErtugliflozin (abbreviation used for component molecule)

LINA / SAXA / SITA / CANA / ALOLinagliptin, saxagliptin, sitagliptin, canagliflozin, alogliptin (component molecule abbreviations defined in policy)

Metformin contraindications

Metformin contraindication: metabolic acidosisAcute or chronic metabolic acidosis, including diabetic ketoacidosis (with or without coma)

Metformin contraindication: renal impairmentSevere renal impairment defined as eGFR < 30 mL/min/1.73 m2

Clinical implicationPresence of these contraindications may allow approval of alternative combination products per policy

Background

Indications: SGLT‑2/DPP‑4 combination products (Glyxambi, Qtern, Steglujan, Trijardy XR) are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Trijardy XR also contains metformin XR as a component. While some SGLT‑2 agents have additional cardiorenal or heart‑failure indications, the efficacy of these fixed SGLT‑2/DPP‑4 combination products for those non-glycemic indications is not established in this policy. Approval of these agents under this policy is governed by the Step Therapy criteria and prior‑therapy requirements; authorizations are provided for 1 year when criteria are met.