CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors — dapagliflozin, dapagliflozin/metformin, Steglatro

Covers authorization, quantity limits, and clinical requirements for dapagliflozin, dapagliflozin/metformin, and Steglatro for diabetes and specific non-diabetes indications (heart failure, CKD) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySGLT2 inhibitors — dapagliflozin, dapagliflozin/metformin, Steglatro

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date12/2017

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing indication, patient age, and prior adequate/maximized metformin trial when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthscoverage duration

1/daystd qty limit (dapagliflozin, dapagliflozin/metformin 10-1000mg, Steglatro)

2/dayqty limit (dapagliflozin/metformin 5-1000mg)

≥18 / ≥10minimum age

≥1 paid claimstep therapy

Coverage Criteria

Initial coverage criteria

Covered when ALL of the following are met:

Primary coverage logic: Request is for dapagliflozin, Steglatro, or dapagliflozin/metformin for treatment of diabetes; AND patient meets product-specific minimum age (Steglatro >= 18 years; dapagliflozin or dapagliflozin/metformin >= 10 years); AND for diabetes the patient has not achieved adequate glucose control on an adequate/maximized dose and appropriate duration of metformin (2 grams/day); OR request is for dapagliflozin for treatment of heart failure (NYHA class II-IV) or for patients with chronic kidney disease at risk of progression when used in conjunction with standard disease therapy.metformin 2 g/day

Logic includes an OR branch allowing non-diabetes indications for dapagliflozin (HF, CKD).

Requests for SGLT2 inhibitors that are for investigational uses will be excluded from coverage. Neighborhood defines investigational use as therapy administered at a dose or for a condition not recognized as a medically accepted indication in one of the standard reference compendia (AHFS-DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs) or lacking sufficient support in peer‑reviewed medical literature.

Drug Coding and Identifiers

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySGLT2 inhibitors — dapagliflozin, dapagliflozin/metformin, Steglatro

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date12/2017

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing indication, patient age, and prior adequate/maximized metformin trial when required.

SourceLink

On This Page

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Covered drug namesNDC | drug namesCovered

dapagliflozin	drug name listed in policy
dapagliflozin/metformin	drug combination listed in policy
Steglatro	ertugliflozin brand name listed in policy

Metformin prior therapy

Required prior metformin therapyPatient has not achieved adequate glucose control using an adequate/maximized dose and appropriate duration of metformin (2 grams/day).

Dose referencedMetformin maximized dose referenced in policy: 2 grams/day.

ApplicabilityApplies when request is for dapagliflozin, dapagliflozin/metformin, or Steglatro for treatment of diabetes (age and other criteria also apply).

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for dapagliflozin, dapagliflozin/metformin, or Steglatro.

Applies to: dapagliflozin, dapagliflozin/metformin, Steglatro
Coverage duration: up to 12 months
Quantity limits: dapagliflozin and Steglatro — 1 tablet per day; dapagliflozin/metformin 10‑1000 mg — 1 tablet per day; dapagliflozin/metformin 5‑1000 mg — 2 tablets per day

Documentation Required

Required Clinical Information

Documentation must demonstrate the clinical indication and patient-specific information to support medical necessity.

Indication: diabetes mellitus OR heart failure (NYHA class II–IV) OR chronic kidney disease (CKD) at risk of progression
Age: Steglatro — patient ≥18 years; dapagliflozin or dapagliflozin/metformin — patient ≥10 years
For diabetes indication: documentation that patient has not achieved adequate glucose control despite an adequate/maximized trial of metformin (≥2 g/day) for an appropriate duration
For heart failure or CKD indication (dapagliflozin): documentation that agent will be used in conjunction with standard disease-modifying therapy
Include prior and concomitant therapies, relevant labs, and any supporting clinical notes or specialty consults as applicable

Step Therapy

Step Therapy & Investigational Use

Step-therapy and investigational use rules that affect approval and denial risk.

Step therapy coding logic: formulary dapagliflozin, dapagliflozin/metformin, and Steglatro will be covered if there is at least one paid claim for a 30‑day supply of formulary metformin or an SGLT2 inhibitor within the last 365 days
Investigational use exclusion: requests for investigational uses — including doses or conditions not recognized as medically accepted indications in standard compendia (AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs) or supported by peer‑reviewed literature — will be denied

Background

Sodium‑Glucose Cotransporter 2 (SGLT2) inhibitors referenced in this policy include dapagliflozin, dapagliflozin/metformin, and Steglatro. These agents are oral antihyperglycemics used primarily for treatment of diabetes; dapagliflozin also has FDA‑recognized indications for heart failure (NYHA class II–IV) and for reducing the risk of chronic kidney disease progression when used with standard disease therapy. Age and prior‑therapy requirements in this policy reflect product labeling and clinical trial evidence: Steglatro ≥18 years; dapagliflozin or dapagliflozin/metformin ≥10 years, and for diabetes indications a trial of adequate/maximized metformin (2 g/day) is expected unless the request is for a non‑diabetes indication covered for dapagliflozin.

Definitions

Investigational — definition

DefinitionInvestigational use: use at a dose or for a condition not recognized as medically accepted indications per standard compendia (e.g., AHFS-DI, DrugDex, Clinical Pharmacology, Lexi-Drugs) or when insufficient peer-reviewed literature supports the use.

Coverage implicationRequests for investigational uses will not be covered under this policy.

Examples of non-accepted usesUses at unrecognized doses or for conditions not in standard compendia (specific examples not listed in policy).

Initial Therapy

Initial therapy

Initial therapy rules: Age requirements: Steglatro >= 18 years; dapagliflozin or dapagliflozin/metformin >= 10 years. For diabetes, failure to achieve adequate glucose control on an adequate/maximized metformin regimen (2 g/day) is required unless the request is for dapagliflozin used to treat heart failure (NYHA II-IV) or to slow progression in CKD when used with standard therapy.metformin 2 g/day

Step Therapy Requirements

Step	Requirement	Coverage
1
At least one paid claim of a 30-day supply of formulary metformin or a formulary SGLT2 within the last 365 days
Formulary payment allowed if requirement met

Quantity Limits

Quantity limit — dapagliflozin, dapagliflozin/metformin 10-1000mg, Steglatro

Drugs covereddapagliflozin; dapagliflozin/metformin 10-1000 mg; Steglatro.

Standard quantity limit1 tablet per day.

Coverage duration12 months (standard authorization period).

Quantity limit — dapagliflozin/metformin 5-1000mg

Drugdapagliflozin/metformin 5-1000 mg.

Quantity limit2 tablets per day.

ContextLimit specified within policy's quantity limits section for combination strength 5/1000 mg.