CurrentHealth NetPolicy CP CPA.347

Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Policy governs medical necessity and prior authorization for sodium-glucose co-transporter 2 (SGLT2) inhibitor agents for commercial lines of business. Applies to requests for listed SGLT2 products and indications (type 2 diabetes, heart failure, CKD) processed through Health Net/Centene-affiliated health plans.

Policy Summary

PayerHealth Net

PolicySodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Policy CodePolicy CP CPA.347

Change TypeNo material changes

Effective DateNov 1, 2020

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information demonstrating the member meets all stated approval criteria and prior-therapy requirements when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12Typical approval duration

>=3Required trial duration before approval (when applicable)

400Maximum sotagliflozin (Inpefa) dose allowed

Age ≥10/≥18Pediatric age exception for some products

Medical Necessity Criteria — SGLT2 Inhibitors

Initial Approval — Type 2 Diabetes Mellitus (non-Inpefa)

Covered when ALL of the following are met:

ALL of the following

Agent, age and prior therapy requirements
- Diagnosis of type 2 diabetes mellitus
- Age requirement by product
  - Request is for an SGLT2 inhibitor other than Inpefa
  - Invokana, Invokamet, or Invokamet XR: age ≥ 10 years
  - All other SGLT2 inhibitors: age ≥ 18 years
- Prior metformin requirement or exception
  - Failure of ≥ 3 consecutive months of metformin (unless contraindicated or clinically significant adverse effects experienced)
  - For antidiabetic medication–naive members: concurrent use with metformin acceptable if HbA1c ≥ 8.5% (test within past 3 months)
- CV-indication bypass conditions
  - If request is for an agent with proven CV benefit (dapagliflozin-, canagliflozin-, empagliflozin-containing products), member has established ASCVD, indicators of high ASCVD risk, heart failure, or chronic kidney disease
Product-specific cross-failures and sequencing (examples)
- If request is for Qtern or Steglujan: failure of ≥ 3 consecutive months of Glyxambi or Trijardy XR unless adverse effects/contraindicated
- If request is for Glyxambi or Trijardy XR: failure of ≥ 3 consecutive months of an empagliflozin-, dapagliflozin-, or sitagliptin-containing product unless adverse effects/contraindicated
- Failure of ≥ 3 consecutive months each of an empagliflozin- and dapagliflozin-containing product is required in some sequencing pathways unless adverse effects/contraindicated
Bexagliflozin / canagliflozin / ertugliflozin family additional rules
- If request is for bexagliflozin-, canagliflozin- or ertugliflozin-containing product, one of the following must be met:
- ANY of the following
  - If canagliflozin product requested: member has established CV disease and failure of ≥ 3 months of an empagliflozin-containing product (unless contraindicated or adverse effects)
  - Or member has multiple CV risk factors and failure of ≥ 3 months of a dapagliflozin-containing product (unless contraindicated or adverse effects)
  - Or member has diabetic nephropathy and failure of ≥ 3 months each of empagliflozin- and dapagliflozin-containing products (unless contraindicated or adverse effects)
Requested dose does not exceed FDA-approved maximum recommended dose

Requested dose does not exceed FDA-approved maximum recommended dose

Initial Approval — Heart Failure (Inpefa / sotagliflozin)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of heart failure
Request is for Inpefa (sotagliflozin)
Prescribed by or in consultation with a cardiologist
Age > 18 years
Member does not have a diagnosis of type 1 diabetes mellitus
Member was recently (within the last 30 days) hospitalized or had an urgent HF visit to an ED, HF unit, or infusion center due to intravascular volume overload (examples: dyspnea, JVD, pitting edema ≥1+, rales, radiographic pulmonary congestion)

Initial Approval — Inpefa for CKD / Other non-HF indications

Covered when ALL of the following are met:

ALL of the following

Request is for Inpefa
Diagnosis of type 2 diabetes mellitus
CKD with eGFR between 25 and 60 mL/min/1.73 m2 (when applicable)
Age-dependent CV risk requirements
- If age 18 to 54 years: member has at least one major CV risk factor (see Appendix E)
- If age ≥ 55 years: member has at least two minor CV risk factors (see Appendix E)

Continued Therapy — Type 2 Diabetes Mellitus (non-Inpefa)

Covered when ONE of the following is met:

ANY of the following

ANY of the following
- Member is currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (state addenda apply)
ALL of the following
- Request is for an SGLT2 inhibitor other than Inpefa
- Member is responding positively to therapy

Continued Therapy — Heart Failure (Inpefa)

Covered when ALL of the following are met:

ALL of the following

Member is currently receiving Inpefa via Centene benefit and documentation shows at least 30 days of prior Inpefa therapy for HF
Member is responding positively to therapy
ALL of the following
- If request is for a dose increase, new dose does not exceed 400 mg per day≤ 400 mg/day
- If request is for a dose increase, new dose does not exceed 1 tablet per day≤ 1 tablet/day

Not authorized / Exclusions

Coverage is NOT authorized for the following:

ANY of the following

Inpefa for type 1 diabetes
Non–FDA approved indications not addressed in this policy unless sufficient documentation per off-label policy (CP CPA.09) or evidence of coverage

Products and Coding

SGLT2 products listed (by brand / generic)mixedCovered

bexagliflozin	Brenzavvy (tablet 20 mg) — listed product requiring authorization
canagliflozin	Invokana (100 mg, 300 mg) — listed product; pediatric extension for some formulations
canagliflozin/metformin	Invokamet, Invokamet XR — listed; pediatric extension to ≥10 years
dapagliflozin	Farxiga — listed; CV/renal benefit indications referenced
dapagliflozin/saxagliptin	Qtern — listed
empagliflozin/linagliptin	Glyxambi — listed
empagliflozin/linagliptin/metformin	Trijardy XR — listed
empagliflozin	Jardiance — listed
empagliflozin/metformin	Synjardy / Synjardy XR — listed
ertugliflozin	Steglatro — listed

1–10 of 14

1/2

Provider Requirements and Authorization Rules

Prior Authorization

Prior authorization required

Requests for the listed SGLT2 inhibitors require prior authorization and must meet the applicable initial or continuation criteria. Inpefa (sotagliflozin) uses separate criteria sets for heart failure (HF) and for CKD/other non-HF indications—refer to the HF-specific criteria set and the non-HF criteria set when requesting Inpefa.

Documentation Required

Submit supporting documentation

Provider must submit documentation supporting that the member has met all approval criteria.

Office chart notes
Laboratory results
Other clinical information (e.g., imaging, hospitalization records)

Step Therapy

Demonstrate prior therapy failures or contraindications

For many product requests the provider must document failure of specified prior SGLT2 or other antihyperglycemic agents for at least 3 consecutive months unless contraindicated or clinically significant adverse effects occurred.

Failure of ≥ 3 consecutive months of metformin when required (unless contraindicated or adverse effects)
Product-specific sequencing failures (e.g., failure of Farxiga and Jardiance for Inpefa HF; failures of empagliflozin- and dapagliflozin-containing products in some pathways)
Document any contraindications or clinically significant adverse effects that excuse a trial

Documentation Required

Prescriber specialty requirement for Inpefa (HF)

Inpefa requests for heart failure must be prescribed by or in consultation with a cardiologist as a condition of approval.

Documentation Required

Dose limit checks

If the request is for a dose increase or initiation, the requested dose must not exceed product-specific FDA maximums; for Inpefa the policy limits dosing to a maximum of 400 mg per day (one tablet per day).

Inpefa (sotagliflozin): maximum 400 mg/day and 1 tablet/day
Ensure requested dose does not exceed FDA‑approved maximum recommended dose for the specific SGLT2 product

Thresholds and Defined Terms

Key thresholds

HbA1c threshold (antidiabetic‑naive patients)≥ 8.5% (test within past 3 months)

Inpefa maximum dose400 mg/day (1 tablet/day)

eGFR range for Inpefa CKD indication25–60 mL/min/1.73 m2

Required metformin trial duration≥ 3 consecutive months (unless contraindicated or clinically significant adverse effects)

Definitions

ASCVDAtherosclerotic cardiovascular disease (includes coronary heart disease, cerebrovascular disease, peripheral arterial disease presumed atherosclerotic)

HFHeart failure

eGFREstimated glomerular filtration rate (mL/min/1.73 m2)

UACRUrine albumin-to-creatinine ratio

Clinical and Administrative Background

Sodium‑glucose co‑transporter 2 (SGLT2) inhibitors are oral antihyperglycemic agents indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; selected products (Invokana, Invokamet, Invokamet XR) have pediatric labeling to age ≥ 10 years [[3]]. Several SGLT2 agents — notably dapagliflozin (Farxiga), canagliflozin (Invokana), and empagliflozin (Jardiance) — have demonstrated cardiovascular and renal benefits in clinical trials, including reductions in hospitalization for heart failure (HHF), some measures of major adverse cardiovascular events, and slowing of kidney disease progression [[3],[25],[26],[27]].

Products in this class have specific renal and age limitations in their prescribing information; some agents are ineffective or not recommended below certain eGFR thresholds, and the policy includes product‑specific renal exceptions (for example, Brenzavvy, Inpefa, Invokana, and Steglatro are noted as exceptions in the renal‑impairment contraindication list) [[4],[37]].

Inpefa (sotagliflozin) is included in the policy with distinct criteria for heart failure and for chronic kidney disease/other indications. For heart failure, Inpefa coverage requires a diagnosis of HF, prescription by or in consultation with a cardiologist, adult age > 18 years, recent HF hospitalization or urgent HF visit for volume overload, a diagnosis of type 2 diabetes, and prior failure of Farxiga and Jardiance unless contraindicated; Inpefa dosing is limited to a maximum of 400 mg/day (1 tablet/day) [[10]]. For non‑HF indications involving CKD, Inpefa coverage requires type 2 diabetes with CKD and an eGFR between 25 and 60 mL/min/1.73 m2, age‑dependent cardiovascular risk factor requirements, prior failure of Farxiga (unless contraindicated), and the same 400 mg/day (1 tablet/day) dose limit [[11],[29],[31]].

Policy Dates

2020-11-01Effective date

Policy became effective.

2025-02-25Last reviewLatest

Most recent annual review and updates (references reviewed and updated; RT4 pediatric age update for Invokana family reflected).

Policy Summary

PayerHealth Net

PolicySodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Policy CodePolicy CP CPA.347

Change TypeNo material changes

Effective DateNov 1, 2020

Next Review Date

SourceLink

On This Page

Member has a diagnosis of type 2 diabetes mellitus

Failure of Farxiga (dapagliflozin) and Jardiance (empagliflozin), unless clinically significant adverse effects are experienced or both are contraindicated

Dose limits for Inpefa

Dose does not exceed 400 mg per day≤ 400 mg/day
Dose does not exceed 1 tablet per day≤ 1 tablet/day

Approval duration: 12 months

Failure of Farxiga (dapagliflozin), unless clinically significant adverse effects or contraindicated

Dose limits for Inpefa

Dose does not exceed 400 mg per day≤ 400 mg/day
Dose does not exceed 1 tablet per day≤ 1 tablet/day

Approval duration: 12 months

If request is for a dose increase, new dose does not exceed FDA-approved maximum recommended dosedoes not exceed product maximum

title": "Continued Therapy — Type 2 Diabetes Mellitus (non-Inpefa)

ref": "b0_3" } ] } ] }

title': 'Continued Therapy — Heart Failure (Inpefa)

Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors

Medical Necessity Criteria — SGLT2 Inhibitors

Products and Coding

Provider Requirements and Authorization Rules

Thresholds and Defined Terms

Clinical and Administrative Background

Cross‑Reference Policies to Read

Policy Dates