Inpefa (sotagliflozin) drug coverage
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Defines Cigna's coverage and prior authorization requirements for Inpefa (sotagliflozin) for adults to reduce risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits; applies to health benefit plans administered by Cigna Companies unless a client-specific plan document controls.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Heart Failure — Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Approvals provided for 1 year if preferred product criteria is met.
inv-02: Type 2 Diabetes + CKD + CV risk — Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Approvals provided for 1 year if preferred product criteria is met.
Applies to Employer and Individual/Family plan product tables.
Use of Inpefa (sotagliflozin) for Type 1 Diabetes and for any other uses not described in the FDA‑approved indications is considered not medically necessary. The policy notes that Inpefa is indicated to reduce risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or in adults with type 2 diabetes mellitus plus chronic kidney disease and cardiovascular risk factors; uses outside those indications—including Type 1 Diabetes—are excluded from coverage.
Patients with heart failure who are being considered for Inpefa should be reviewed under the Heart Failure criteria in this policy rather than as an exception to the exclusion list.
Inpefa (sotagliflozin) for Type 1 Diabetes is specifically listed as a condition not covered and is considered not medically necessary under this policy. The document states that Inpefa’s FDA‑approved indications are limited to adults with heart failure or adults with type 2 diabetes plus chronic kidney disease and cardiovascular risk factors, and explicitly excludes Type 1 Diabetes from coverage.
Initial Coverage Criteria
inv-13: Initial Coverage Criteria — Initial approval criteria and step requirements
Initial approval criteria and step requirements
Applies to Employer and Individual/Family plans as specified in product tables.
Provider Actions and Authorization
Prior authorization required — 1 year approvals
Prior Authorization (PA) is required for benefit coverage of Inpefa. When criteria are met, approvals are provided for a duration of 1 year.
Step/failure vs other SGLT2s required for many plans
For Employer and Individual/Family plans, the prescriber must document a trial and either inadequate efficacy or significant intolerance to both dapagliflozin (Farxiga, generics) and empagliflozin (Jardiance) before Inpefa is eligible under the preferred product criteria.
- Applies to Employer and Individual/Family plan product tables
Must fail BOTH dapagliflozin and empagliflozin
Patient must have tried, and according to the prescriber experienced inadequate efficacy or significant intolerance with BOTH dapagliflozin (Farxiga, generics) and empagliflozin (Jardiance) prior to coverage of Inpefa for Employer and Individual/Family plans.
- Failure criteria defined as inadequate efficacy OR significant intolerance
Submit requests with appropriate codes and documentation
Submit authorization requests with the appropriate covered diagnosis and procedure codes; review of requests will consider the applicable benefit plan document and relevant clinical information provided by the prescriber.
Claims without covered codes will be denied
Claims for services not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered.
Step Therapy Requirements
| Plan Type | Step Therapy Requirement |
|---|---|
| Employer Plans | Patient has tried, and according to the prescriber, experienced inadequate efficacy OR significant intolerance with BOTH dapagliflozin (Farxiga, generics) and empagliflozin (Jardiance). |
| Individual and Family Plans | Patient has tried, and according to the prescriber, experienced inadequate efficacy OR significant intolerance with BOTH dapagliflozin (Farxiga, generics) and empagliflozin (Jardiance). |
Definitions
Background
Inpefa (sotagliflozin) is described in this policy as a dual SGLT1/SGLT2 inhibitor indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure, or in adults with type 2 diabetes mellitus plus chronic kidney disease and other cardiovascular risk factors. The policy emphasizes that these are the FDA‑approved indication groups and that uses outside those indications are not covered.
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