mhn SGLT2 Inhibitors Prior Auth Coverage | OpenPayer

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mhn SGLT2 Inhibitors Prior Auth Coverage | OpenPayer

Coverage Criteria and Medical Necessity

Initial Approval — Type 2 Diabetes Mellitus

Covered when ALL of the following are met

Type 2 Diabetes Mellitus initial

Age: a. For Farxiga, Invokana, Invokamet, Invokamet XR, Jardiance, Synjardy, or Xigduo XR: ≥ 10 years; b. All other SGLT2 inhibitors: ≥ 18 years

Initial Approval — Heart Failure

Covered when ALL of the following are met

Heart Failure initial: 1. Diagnosis of heart failure; 2. Request is for Farxiga, Inpefa, or Jardiance; 3. Prescribed by or in consultation with a cardiologist; 4. Age ≥ 18 years; 5. One of: (a) for brand Farxiga requests: member must use generic dapagliflozin unless contraindicated or adverse effects; (b) for all other requests: failure of generic dapagliflozin unless contraindicated or adverse effects; 6. If request is for Farxiga or Jardiance, HF is NYHA Class II, III, or IV; 7. If request is for Inpefa, both: (a) member has type 2 diabetes mellitus; and (b) member was recently (within 30 days) hospitalized or had an urgent HF visit for intravascular volume overload; 8. Member does not have a diagnosis of type 1 diabetes mellitus; 9. Dose limits: Farxiga or Jardiance — 10 mg per day and 1 tablet per day; Inpefa — 400 mg per day and 1 tablet per day.

Initial Approval — Chronic Kidney Disease

Covered when ALL of the following are met

Chronic Kidney Disease initial: 1. Diagnosis of chronic kidney disease (CKD); 2. Request is for Farxiga or Jardiance; 3. Age ≥ 18 years; 4. BOTH: (a) eGFR ≥ 20 mL/min/1.73 m2; and (b) UACR ≥ 200 mg/g; 5. One of: (a) for brand Farxiga requests: member must use generic dapagliflozin unless contraindicated or adverse effects; (b) for all other requests: failure of generic dapagliflozin unless contraindicated or adverse effects; 6. Member does not have type 1 diabetes mellitus or polycystic kidney disease; 7. Member has not received immunosuppressive therapy for kidney disease in the past 6 months; 8. Member is currently receiving an ACE inhibitor or ARB at maximally tolerated doses for ≥ 4 weeks unless contraindicated; 9. Dose limits: 10 mg per day and 1 tablet per day.

Initial Approval — Inpefa (non-HF)

Covered when ALL of the following are met

Inpefa non-HF initial: 1. Diagnosis of both: (a) type 2 diabetes mellitus; and (b) CKD with eGFR between 25 and 60 mL/min/1.73 m2; 2. Request is for Inpefa; 3. Age ≥ 18 years; 4. One of: (a) if age 18–54 years: member has at least one major cardiovascular risk factor; (b) if age ≥ 55 years: member has at least two minor cardiovascular risk factors; 5. Failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; 6. Dose limits: 400 mg per day and 1 tablet per day.

Continued Therapy

Covered when ALL of the following are met

Continued therapy general: A. Member meets one of: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; B. Request is for an SGLT2 inhibitor other than Inpefa; C. One of: (a) for brand Farxiga or Xigduo XR requests: member must use generic dapagliflozin or dapagliflozin/metformin unless contraindicated or adverse effects; (b) for all other requests: failure of generic dapagliflozin unless contraindicated or adverse effects; D. Member is responding positively to therapy; E. If dose increase requested, new dose does not exceed the FDA‑approved maximum recommended dose (see Section V). Approval duration: 12 months.

Continued Therapy — Heart Failure

Covered when ALL of the following are met

Continued therapy HF: 1. Currently receiving medication via Centene benefit, or documentation that member is currently receiving Farxiga, Inpefa, or Jardiance for HF and has received medication for at least 30 days; 2. Request is for Farxiga, Inpefa, or Jardiance; 3. One of: (a) for brand Farxiga requests: member must use generic dapagliflozin unless contraindicated or adverse effects; (b) for all other requests: failure of generic dapagliflozin unless contraindicated or adverse effects; 4. Member is responding positively to therapy; 5. If dose increase requested, new dose does not exceed agent-specific limits: Farxiga or Jardiance — 10 mg per day and 1 tablet per day; Inpefa — 400 mg per day and 1 tablet per day. Approval duration: 12 months.

Continued Therapy — Chronic Kidney Disease

Covered when ALL of the following are met

Continued therapy CKD: 1. Member meets one of: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Request is for Farxiga or Jardiance; 3. One of: (a) for brand Farxiga requests: member must use generic dapagliflozin unless contraindicated or adverse effects; (b) for all other requests: failure of generic dapagliflozin unless contraindicated or adverse effects; 4. Member is responding positively to therapy; 5. If dose increase requested, new dose does not exceed: 10 mg per day and 1 tablet per day. Approval duration: 12 months.

Continued Therapy — Inpefa (non-HF)

Covered when ALL of the following are met

Continued therapy Inpefa non-HF: 1. Member meets one of: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Request is for Inpefa; 3. Failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; 4. Member is responding positively to therapy; 5. If dose increase requested, new dose does not exceed 400 mg per day and 1 tablet per day. Approval duration: 12 months.

Continuation/Specific-agent (Inpefa) criteria

Coverage authorized when ALL of the following are met for the specified request type

General requirements for renewal/continuation (other agents): 1) Failure of generic dapagliflozin unless contraindicated or clinically significant adverse effects; 2) Member is responding positively to therapy; 3) For dose increases, new dose does not exceed agent-specific maximum (e.g., 10 mg/day or 1 tablet/day).see dose limits

Approval duration: 12 months

Inpefa for non-heart failure diagnoses: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Request is for Inpefa; 3) Failure of generic dapagliflozin unless contraindicated; 4) Member is responding positively to therapy; 5) For dose increases, new dose does not exceed 400 mg/day or 1 tablet/day.Inpefa max 400 mg/day

Approval duration: 12 months

Other/Off-label requests

Other uses pathway: 1) If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, refer to: (a) CP.PMN.255 for drugs on formulary/PDL (Medicaid); or (b) CP.PMN.16 for drugs not on formulary/PDL (Medicaid); OR 2) If requested use is not listed under section III and criterion 1 does not apply, refer to off‑label use policy CP.PMN.53.

Notable updated coverage criteria

Policy criteria have been periodically updated to reflect new FDA indications and guideline changes; notable criteria updates include:

CKD coverage eGFR: For chronic kidney disease indications, eGFR requirement updated to at least 20 mL/min/1.73 m2 per 2024 KDIGO guidance.>= 20 mL/min/1.73 m2

see chunk 43 for revision details

Pediatric diabetes: Certain agents (e.g., Jardiance, Synjardy, Invokana/combination products, Farxiga/Xigduo XR) have pediatric extensions for use in patients aged >= 10 years per product labeling.age >= 10 years

see chunks 42-43 for multiple agent updates

Heart failure (HF): HF criteria updated to reflect indications for HF regardless of ejection fraction per FDA and guideline updates (e.g., Jardiance, Farxiga).

SGLT2 inhibitors (except Inpefa) are not to be used for patients with type 1 diabetes or for treatment of diabetic ketoacidosis (DKA); these agents may increase the risk of DKA. Additional agent-specific limitations of use apply (for example, reduced effectiveness at low eGFR and restrictions related to recent immunosuppressive therapy or polycystic kidney disease) and should be reviewed in the product prescribing information prior to approval.

Requests for indications that are not FDA-approved and are not specifically addressed in this policy are excluded unless supported by the applicable off-label use policy (CP.PMN.53) or other evidence of coverage documentation. Specifically, Inpefa (sotagliflozin) is not authorized for use in patients with type 1 diabetes and such requests will be denied.

The product Qternmet XR was removed from the market and has been removed from this policy. Product-specific contraindications and limitations of use have been revised in several updates (for example, updated Jardiance prescribing information and other agent PIs); providers should consult the current product labeling for agent-specific contraindications and limitations.

Use of SGLT2 inhibitors is limited in populations where agents are not expected to be effective or are contraindicated (for example, low eGFR thresholds vary by agent and some agents are not recommended in settings such as polycystic kidney disease or recent immunosuppressive therapy). Additionally, metformin-containing combination products carry the usual metformin considerations (including lactic acidosis risk). Boxed warnings and major safety concerns described in product labeling should be followed per prescribing information.

Policy revisions over time have included therapeutic redirection to preferred generic dapagliflozin formulations, updates to pediatric age approvals, and removal of certain metformin bypass provisions. Notable recent changes include removal of the dapagliflozin bypass for some canagliflozin-containing product requests (1Q2026) and periodic updates to redirection and prior authorization requirements; review the revision history for specific effective dates and details.

Agent List, Dosing, and Clinical Thresholds

SGLT2 agents requiring prior authorizationNDC | mixed

	bexagliflozin (Brenzavvy)
	canagliflozin (Invokana)
	canagliflozin/metformin (Invokamet, Invokamet XR)
	dapagliflozin (Farxiga)
	dapagliflozin/metformin (Xigduo XR)
	dapagliflozin/saxagliptin (Qtern)
	ertugliflozin (Steglatro)
	ertugliflozin/metformin (Segluromet)
	empagliflozin (Jardiance)
	empagliflozin/linagliptin (Glyxambi)

1–10 of 14

1/2

inv-18: eGFR — CKD coverage threshold

CKD eGFR minimumeGFR ≥ 20 mL/min/1.73 m2

Applicable agents for CKD coverageFarxiga or Jardiance (requests for Synjardy/Synjardy XR or Xigduo XR refer to diabetes criteria)

Age requirementAge ≥ 18 years

Additional CKD requirementsMember must be on ACE inhibitor or ARB at maximally tolerated dose ≥4 weeks unless contraindicated

inv-19: UACR — albuminuria threshold for CKD coverage

UACR thresholdUACR ≥ 200 mg/g

Context

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required — Prior authorization and dose limits

Prior authorization is required for SGLT2 inhibitors listed in this policy. Dose limits in the criteria must be followed; requests exceeding the FDA‑approved maximum dose will be denied. Approval durations are generally 12 months.

Affected products include branded and combination SGLT2 inhibitors (e.g., Farxiga, Invokana, Jardiance, Synjardy, Xigduo XR, Steglatro, Segluromet, Inpefa) and their generic equivalents.
Dose limits: Farxiga/Jardiance — 10 mg/day (1 tablet/day); Inpefa — 400 mg/day (1 tablet/day); dapagliflozin maximum = 10 mg/day (see Appendix B).

Documentation Required

Documentation Required — Provider must submit clinical information

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant lab results (e.g., HbA1c, eGFR, UACR), hospitalization records when applicable, and medication history showing prior therapies and responses.

Background and Rationale

SGLT2 inhibitors are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes; several agents also have FDA-labeled indications for reducing heart failure hospitalizations, cardiovascular death, and slowing progression of chronic kidney disease. These agents are typically used in combination with other glucose-lowering therapies or as part of comprehensive cardiovascular/renal risk management depending on the agent-specific indications.

Definitions and Clinical Terms

inv-37: SGLT2 inhibitor indications — Agent-specific FDA-approved indications summary

Glycemic control indicationAdjunct to diet and exercise to improve glycemic control in adults (all SGLT2 inhibitors)

Pediatric diabetes indicationSelected agents (Farxiga, Invokana, Invokamet/Invokamet XR, Jardiance, Synjardy, Xigduo XR) indicated for patients ≥10 years

Heart failure indicationsFarxiga, Jardiance, and Inpefa indicated to reduce risk of CV death, HHF, and urgent HF visit in adults with HF

Chronic kidney disease indicationDapagliflozin and empagliflozin products indicated to reduce risk of sustained eGFR decline, ESKD, CV death, and HHF in adults with CKD at risk of progression

inv-38: ASCVD — definition used in policy

ASCVD definition

Policy Revision History

2021-09-16annual_review

1Q2022 annual review: removed Qternmet XR from policy and updated references; template changes applied to continued therapy and FDA indication text.

2022-03-11rt4_update

RT4 updated FDA Approved Indication(s) and HF criteria per Jardiance's revised indication for HF regardless of ejection fraction and updated Xigduo XR limitation of use.

2022-06-01clinical_guideline_alignment