CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Jardiance (empagliflozin) — Coverage Criteria

Defines authorization, continuation, and quantity limit rules for Jardiance (empagliflozin) for Neighborhood Health Plan of Rhode Island members (Medicaid scope). Applies to prescribers and pharmacy benefit managers processing requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJardiance (empagliflozin) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months and document at least one paid 30‑day Jardiance claim in the prior 365 days for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 momaximum approval period

30 dayspaid claim required

1/dayquantity limit

Medicaidscope

Coverage and Authorization Criteria

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Indication options: 1) Treatment of heart failure (NYHA class II-IV). OR 2) Adjunct to diet and exercise to improve glycemic control in patients ≥10 years with type 2 diabetes mellitus AND patient has not achieved adequate glucose control using an adequate/maximized dose and appropriate duration of metformin (2 grams/day) AND dapagliflozin. OR 3) Chronic kidney disease at risk of progression AND patient has experienced an inadequate outcome, intolerance, or contraindication with dapagliflozin.

Authorization period: 12 months

inv-11: Initial therapy

Initial authorization may be granted for 12 months when one of the following is met.

Initial therapy options: 1) Heart failure (NYHA class II-IV). 2) Adjunct therapy in type 2 diabetes patients ≥10 years who have inadequate glucose control despite adequate/maximized metformin (2 g/day) and dapagliflozin. 3) Chronic kidney disease at risk of progression with inadequate outcome, intolerance, or contraindication to dapagliflozin.

Authorization length: 12 months

inv-02: Continuation of therapy

Criteria for continued coverage after initial approval:

Continuation requirement: At least one paid claim of at least a 30-day supply of Jardiance within the last 365 days>=1 paid 30-day claim in prior 365 days

If present, therapy may continue

inv-12: Continuation

Conditions under which continuation of Jardiance is approved:

Paid-claim evidence: At least one paid claim of at least a 30-day supply within the last 365 days is required for continuation of coverage>=1 paid 30-day claim in prior 365 days

Evidence must be on record for continuation

Use of Jardiance (empagliflozin) outside of the listed indications or without documentation of required prior therapy may be denied. Specifically, requests for indications other than: (1) treatment of heart failure (NYHA class II-IV); (2) adjunct to diet and exercise for glycemic control in patients ≥10 years with type 2 diabetes mellitus who have not achieved adequate control despite adequate/maximized metformin (2 grams/day) and dapagliflozin; or (3) chronic kidney disease at risk of progression with inadequate outcome, intolerance, or contraindication to dapagliflozin — are not covered. For type 2 diabetes adjunct approvals, the record must document prior trial of metformin 2 grams/day and dapagliflozin as specified.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Criteria

Prior authorization may be granted for up to 12 months when the patient meets one of the listed indications: heart failure (NYHA II-IV); adjunct to diet and exercise for type 2 diabetes in patients age ≥10 who have not achieved adequate glucose control despite adequate/maximized metformin (2 g/day) and a trial of dapagliflozin; or chronic kidney disease at risk of progression with inadequate outcome, intolerance, or contraindication to dapagliflozin.

Authorization duration: up to 12 months when criteria met
Covered indications include: heart failure (NYHA II-IV); adjunctive therapy for T2DM (age ≥10) after adequate/maximized metformin (2 g/day) and trial of dapagliflozin; CKD at risk of progression after inadequate response/intolerance/contraindication to dapagliflozin

Step Therapy

Step Therapy Requirement for Type 2 Diabetes

For members with type 2 diabetes, a step-therapy requirement applies: prior adequate/maximized dosing and duration of metformin (2 g/day) and a trial of dapagliflozin are required where clinically appropriate before approval.

Metformin must have been used at an adequate/maximized dose (2 g/day) for an appropriate duration
Trial of dapagliflozin is required unless contraindicated or not tolerated

Documentation Required

Required Documentation

Required documentation must be submitted with initial and continuation requests. Initial requests should include relevant clinical documentation supporting the indication. For continuation/renewal, there must be documentation of at least one paid claim for a ≥30-day supply within the last 365 days.

Initial requests: clinical records supporting the requested indication and prior therapies tried
Continuation requests: at least one paid claim for a ≥30-day supply within the past 365 days

Denial Risk

Failure to Meet Indication or Documentation Criteria

Requests that do not meet at least one of the listed indication criteria or lack required documentation should be denied or returned for additional information.

Denial risk if none of the listed indications are met (heart failure NYHA II-IV; adjunct to diet/exercise in T2DM age ≥10 after metformin and dapagliflozin; CKD at risk of progression after dapagliflozin failure/intolerance/contraindication)
Denial risk if required documentation (including paid claim for continuation) is missing

Step	Requirement
1
Prior trial of metformin at an adequate/maximized dose (2 g/day) and trial of dapagliflozin documenting inadequate glucose control despite therapy

Background and Indications

Empagliflozin (Jardiance) is approved for several cardiometabolic and renal indications relevant to clinical management. Covered uses include treatment of heart failure (NYHA class II-IV), use as an adjunct to diet and exercise to improve glycemic control in patients aged ≥10 years with type 2 diabetes mellitus (when patients have not achieved adequate glucose control despite adequate/maximized metformin at 2 grams/day and dapagliflozin), and treatment of chronic kidney disease at risk of progression for patients who have had an inadequate outcome, intolerance, or contraindication to dapagliflozin. When approved, initial authorizations are for 12 months.

Definitions and Populations

Definition — NYHA class II-IV

Definition termHeart failure (NYHA class II-IV)

DescriptionNew York Heart Association functional classification II-IV as referenced in the indication for treatment of heart failure

Policy contextOne of the covered indications permitting a 12-month authorization when met

Definition — CKD at risk of progression

Definition termChronic kidney disease at risk of progression

DescriptionCKD population described in the indication as at risk of progression where empagliflozin reduces risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization

Policy contextPresence of this diagnosis is one of the covered indications for a 12-month authorization