CurrentCignaPolicy IP0582

Inpefa

Cigna prior authorization and coverage criteria for Inpefa (sotagliflozin) for FDA‑approved indications (heart failure and type 2 diabetes to reduce CV death/HHF/urgent HF visit), plan-specific preferred product requirements, duration of approvals, and exclusions.

Policy Summary

PayerCigna

PolicyInpefa

Policy CodePolicy IP0582

Change TypeSelected Revision; Annual Revisions

Effective DateSep 15, 2025

Next Review Date

Key ActionPrior authorization is required for benefit coverage of Inpefa; approvals are provided for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated Individual and Family Plan preferred product requirements.

Updated coverage policy title from 'Sotagliflozin' to 'Inpefa' and clarified FDA‑approved indication language and addenda regarding heart failure review.

Annual Revision dated 9/15/2025 with no criteria changes noted.

2FDA‑Approved Indications Listed

1 yearApproval Duration

IP0582Policy Number

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Cigna prior authorization and coverage criteria for Inpefa (sotagliflozin) for FDA‑approved indications (heart failure and type 2 diabetes to reduce CV death, hospitalization for heart failure, and urgent heart failure visit), plan-specific preferred product requirements, duration of approvals, and exclusions. FDA‑approved indications listed: Heart failure and Type 2 diabetes with chronic kidney disease (CKD) plus cardiovascular risk factors. Approval duration: 1 year for approved indications. Plan-specific preferred product requirement note: for Employer and Individual/Family Plans, coverage requires documentation that the patient tried and, per the prescriber, experienced inadequate efficacy or significant intolerance to both Farxiga (dapagliflozin) and Jardiance (empagliflozin) prior to Inpefa authorization.

Initial Therapy — Type 2 Diabetes with CKD and CV Risk Factors (FDA‑Approved Indication)

Type 2 Diabetes (FDA‑Approved Indication)

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

A: Patient is ≥ 18 years of age
B: Patient has chronic kidney disease
C: Patient has one or more cardiovascular risk factor(s), according to the prescriber
Patients with heart failure should be reviewed under criteria for Heart Failure
D: Preferred product criteria are met for the product(s) as listed in the below table(s)
See Employer and Individual/Family Plans preferred product requirements.

Preferred Product Requirement (Plan‑Specific)

Employer and Individual/Family Plans Preferred Product Requirement

Coverage requires trial of alternative SGLT-2 inhibitors per plan type:

Patient has tried and, according to the prescriber, experienced inadequate efficacy OR significant intolerance with BOTH Farxiga (dapagliflozin) and Jardiance (empagliflozin)

This trial/documentation requirement applies to Employer and Individual/Family Plans; receipt of sample product does not satisfy criteria.

This policy is plan‑specific: the Employer and Individual/Family Plans require a trial and inadequate response or intolerance to alternative SGLT‑2 inhibitors before Inpefa is covered. See the definition for Preferred product criteria, which describes the plan‑specific requirement that patients must have tried and, according to the prescriber, experienced inadequate efficacy or significant intolerance with both Farxiga and Jardiance.

Unapproved Uses / Not Medically Necessary

Conditions Not Covered / Not Medically Necessary

Inpefa for any other use is considered not medically necessary, including but not limited to:

Type 1 Diabetes (Inpefa is not approved for glycemic control)

Patients with heart failure should be reviewed under criteria for Heart Failure

ref": "b4_0

title":

Inpefa for any other use is considered not medically necessary, including use for Type 1 diabetes. Inpefa is not indicated for glycemic control and is distinct from other SGLT‑2 inhibitors in that it does not have an indication for glucose lowering.

Provider Actions

Prior Authorization

Prior authorization is required

Prior authorization is required for benefit coverage of Inpefa; approvals are provided for 1 year when criteria are met.

Documentation Required

Trial documentation for alternatives

For Employer and Individual/Family Plans, documentation is required that the patient tried and had inadequate efficacy or significant intolerance to BOTH Farxiga and Jardiance as judged by the prescriber.

Billing Rule

Use appropriate codes

When billing, providers must use the most appropriate codes as of the effective date; claims without covered diagnosis codes under this policy will be denied.

Clinical Evidence

Key evidence referenced includes the pivotal trials SOLOIST‑WHF and SCORED (both noted as terminated early). Guideline summaries note SGLT‑2 inhibitors are recommended as core therapy for heart failure and for patients with type 2 diabetes and CKD with CV risk; the Inpefa trials are mentioned in guideline statements as supporting benefit for cardiovascular death, hospitalization for heart failure, and urgent heart failure visits.

Background & Definitions

Inpefa (sotagliflozin) is an SGLT‑1/2 inhibitor indicated to reduce the risk of cardiovascular death, hospitalization for heart failure (HHF), and urgent heart failure visits in adults with heart failure or in adults with type 2 diabetes plus chronic kidney disease and cardiovascular risk factors. Unlike other SGLT‑2 inhibitors, Inpefa is not indicated for glycemic control. Guideline support summarized in the policy notes SGLT‑2 inhibitors are recommended for heart failure and for patients with type 2 diabetes and CKD, and mentions the pivotal Inpefa trials in those guideline discussions.

Preferred product criteria: Plan‑specific requirement that may require a trial and inadequate response or intolerance to Farxiga (dapagliflozin) and Jardiance (empagliflozin) for Employer and Individual/Family Plans before Inpefa coverage is approved.

Revision History

2025-09-15annual_revision_effective_dateLatest

Annual Revision effective date 9/15/2025; no criteria changes noted.

2025-01-01material_revision

Selected Revision updated Individual and Family Plan preferred product requirements.

2024-11-01annual_revision

Annual Revision updated policy title from 'Sotagliflozin' to 'Inpefa' and added note that patients with heart failure should be reviewed under Heart Failure criteria for the Type 2 Diabetes indication and Conditions Not Covered.

OpenPayer