CurrentCignaPolicy N/A

Diabetes - Sodium Glucose Co-Transporter-2 (SGLT-2) Inhibitors Step Therapy Policy

Defines Cigna's step therapy requirements for sodium-glucose co-transporter-2 (SGLT-2) inhibitor products for treatment of type 2 diabetes and related indications; applies to Cigna-administered health benefit plans and providers submitting coverage requests.

Policy Summary

PayerCigna

PolicyDiabetes - SGLT-2 Inhibitors Step Therapy

Policy CodePolicy N/A

Change TypeStep placement updates and additions

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization: document a 130-day look-back demonstrating a trial of a Step 1 product (metformin) or record an applicable exception to obtain approval for Step 2/3 products.

SourceLink

POLICY UPDATE CHANGES

Steglatro and Segluromet were moved from Step 2 to Step 3 effective 01/01/2025.

Bexagliflozin (Brenzavvy) and bexagliflozin tablets-GSMS were added to Step 3.

A new criterion was added to approve Farxiga or Jardiance without a Step 1 trial for patients with type 2 diabetes and peripheral arterial disease.

List of metformin-containing products counting as Step 1 trials was updated (additions and obsolete designations noted).

Dapagliflozin pediatric/hf/CKD indications and updated clinical guideline references were included in the overview.

3therapy steps (Step 1–3)

130-daylook-back period

1 yearapproval duration

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Coverage Criteria

Step 2 Products

Covered when ANY of the following are met

Step 2 coverage: 1) Patient has tried one Step 1 Product within the 130-day look-back period; OR 2) Patient has tried one Step 2 Product; OR 3) Patient has tried one Step 3 Product; OR 4) Initiating dual therapy with metformin AND Farxiga or Jardiance; OR 5) Patient has a contraindication to metformin per prescriber (examples include acute or chronic metabolic acidosis, including diabetic ketoacidosis); OR 6) Patient has heart failure; OR 7) Patient has chronic kidney disease; OR 8) Patient has atherosclerotic cardiovascular disease or, per prescriber, the patient has ≥2 cardiovascular risk factors; OR 9) Patient has type 2 diabetes AND peripheral arterial disease (PAD).

Approvals provided for 1 year.

Step 3 Products

Covered when ALL of the following are met

Step 3 coverage: 1) Patient has tried one Step 2 Product. Note: A trial of a Step 1 Product is required prior to a Step 2 Product unless exception criteria are met.

Approvals provided for 1 year.

Any request that does not meet the stated step therapy criteria in this policy is considered not medically necessary.

Requests that fail to meet the step therapy criteria in this policy, or that are submitted with diagnosis or procedure codes that are not covered under this coverage policy, will be denied as not covered/not medically necessary. Providers must bill using the most appropriate codes as of the submission date; claims without covered codes under the applicable coverage policy will be denied.

Drug Listing & Coding

SGLT-2 products by trade/generic name and Step placementmixed

Brenzavvy	bexagliflozin tablets (TheracosBio)
bexagliflozin tablets -GSMS	bexagliflozin tablets -GSMS
Farxiga	dapagliflozin tablets
Invokana	canagliflozin tablets
Invokamet	canagliflozin and metformin HCl tablets
Invokamet XR	canagliflozin and metformin HCl extended-release tablets
Jardiance	empagliflozin tablets
Segluromet	ertugliflozin and metformin tablets
Steglatro	ertugliflozin tablets
Synjardy	empagliflozin/metformin HCl tablets

1–10 of 13

1/2

Metformin-containing products that satisfy Step 1 trialmixedCovered

Glumetza ER	metformin-containing product
Riomet	metformin oral solution
metformin extended-release (generics to Fortamet ER and Glumetza ER)	metformin ER generics
glyburide/metformin	combination product
glipizide/metformin	combination product
Actoplus Met	pioglitazone/metformin
Kombiglyze XR	saxagliptin/metformin extended-release
Janumet	sitagliptin/metformin
Zituvimet	sitagliptin/metformin authorized generic

inv-07: Look-back period

Look-back period130-day

Applies toPatient history used to determine Step 2 or Step 3 exclusion from step therapy

What counts in periodDocumentation of a trial of one Step 1, Step 2, or Step 3 product within the 130-day window (per policy rules)

Consequence of no historyIf required trial(s) are not documented within 130 days, step therapy criteria must be met or request may be denied

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization: Step therapy prior authorization is required. This program requires use of lower-step products before higher-step products; approvals are issued for 1 year.

Program encourages Step 1 before Step 2 and Step 2 before Step 3.
All approvals are provided for 1 year in duration.

Step Therapy

Step Therapy Operational Steps

Step therapy operational steps: Providers must document patient medication history within a 130-day look-back and show prior trials or applicable exceptions to meet step requirements.

Requests for a Step 2 Product — patient with history of any one of the following within the 130-day look-back is excluded from Step Therapy: one Step 1 Product; one of listed metformin-containing products; one Step 2 Product; or one Step 3 Product.
Requests for a Step 3 Product — patient with history of one Step 2 Product within the 130-day look-back is excluded from Step Therapy.

Background

Sodium-glucose co-transporter-2 (SGLT-2) inhibitors are an oral class of antihyperglycemic agents used as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. Specific agents in the class (for example, dapagliflozin, empagliflozin, canagliflozin, ertugliflozin, and bexagliflozin) have additional indications or evidence supporting use in patients with heart failure and chronic kidney disease, and selected agents have pediatric approvals for patients ≥10 years. Clinical guidelines recommend considering SGLT-2 inhibitors when comorbid cardiovascular or renal disease is present, reflecting their cardiovascular and renal benefit profile.

Definitions

inv-13: SGLT-2 inhibitors — class definition and example agents

Class definitionSGLT-2 inhibitors: a class of oral antihyperglycemics used as adjuncts to diet and exercise to improve glycemic control in type 2 diabetes; selected agents also have cardiovascular, heart failure, and chronic kidney disease indications.

Example agents (policy listing)Brenzavvy (bexagliflozin), bexagliflozin tablets -GSMS, Farxiga (dapagliflozin), Invokana (canagliflozin), Invokamet (canagliflozin/metformin), Invokamet XR, Jardiance (empagliflozin), Segluromet (ertugliflozin/metformin), Steglatro (ertugliflozin), Synjardy, Synjardy XR, Xigduo XR (dapagliflozin/metformin), authorized generics as listed in policy.

Clinical roleRecommended when comorbidities such as ASCVD, CKD, or heart failure are present; certain agents are recommended regardless of metformin use per ADA/AACE guidance.

Additional indications notedJardiance and dapagliflozin have heart failure and CKD indications; Jardiance reduces risk of CV death in established CV disease; Invokana has CV and renal outcome indications.