CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tarpeyo (targeted‑release budesonide) — Coverage Criteria for Primary IgA Nephropathy

Policy governing coverage and authorization criteria for Tarpeyo for treatment of primary immunoglobulin A nephropathy (IgAN) in adults; applies to Neighborhood Health Plan of Rhode Island members subject to medical necessity review.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTarpeyo (targeted‑release budesonide) — Coverage Criteria for Primary IgA Nephropathy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of biopsy‑confirmed primary IgAN, proteinuria ≥1 g/day or UPCR ≥0.8 g/g, and evidence of stable maximally tolerated RAS inhibitor therapy (or intolerance).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10 monthsmaximum initial authorization period

≥1 g/dayproteinuria threshold for eligibility

4/dayTarpeyo 4 mg quantity limit

Adultsindicated population

Coverage Criteria for Tarpeyo (budesonide)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTarpeyo (targeted‑release budesonide) — Coverage Criteria for Primary IgA Nephropathy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

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Initial authorization criteria

Covered when ALL of the following are met:

Indication: Member is an adult with biopsy-confirmed primary immunoglobulin A nephropathy (IgAN).

Proteinuria: Documentation with laboratory report and/or chart note(s) showing proteinuria >= 1 g/day OR baseline urine protein-to-creatinine ratio (UPCR) >= 0.8 g/g based on a 24-hour urine collection.>= 1 g/day or UPCR >= 0.8 g/g

RAS inhibitor therapy: Member is receiving a stable dose of a maximally tolerated renin-angiotensin system (RAS) inhibitor (ACEI or ARB) for at least 3 months prior to initiation, OR has documented intolerance or contraindication to RAS inhibitors.3 months

Concomitant therapy exclusion: Member is not receiving Tarpeyo in combination with Fabhalta or Filspari.

Glucocorticoid intolerance: Member has experienced an intolerance to oral glucocorticoids (e.g., prednisone) when applicable and as documented.

Coding and Key Eligibility Measures

Proteinuria (24-hour) or UPCR

24‑hour urine protein threshold>= 1 g/day

UPCR threshold>= 0.8 g/g (baseline urine protein‑to‑creatinine ratio)

Specimen basisBased on 24‑hour urine collection

Tarpeyo — targeted-release budesonide

Generic nameTargeted‑release budesonide (Tarpeyo)

Indication summaryIndicated to reduce loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression

PopulationAdults with biopsy‑confirmed primary IgA nephropathy

Coverage stance for other usesAll other indications considered experimental/investigational and not medically necessary

Proteinuria eligibility threshold

Proteinuria eligibility — absolute>= 1 g/day based on 24‑hour urine collection

Proteinuria eligibility — ratio>= 0.8 g/g baseline urine protein‑to‑creatinine ratio (UPCR)

Required documentationLaboratory report and/or chart note(s) demonstrating the 24‑hour urine or UPCR result

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals may be granted for up to 10 months when all clinical criteria are met.

Prior authorization required
Maximum approval duration: up to 10 months

Documentation Required

RAS inhibitor trial

Member must be on a stable dose of a maximally tolerated renin-angiotensin system (RAS) inhibitor (ACE inhibitor or ARB) for at least 3 months prior to initiation of Tarpeyo, unless there is documented intolerance or contraindication to RAS inhibitor therapy.

Acceptable agents: ACEIs or ARBs
Document duration: ≥3 months at stable dose

Documentation Required

Required Clinical Documentation

Required clinical documentation must include a kidney biopsy confirming primary IgA nephropathy and laboratory reports or chart notes showing proteinuria ≥1 g/day OR urine protein-to-creatinine ratio (UPCR) ≥0.8 g/g.

Kidney biopsy report confirming primary IgAN
Laboratory report or chart note documenting proteinuria ≥1 g/day OR UPCR ≥0.8 g/g

Documentation Required

RAS inhibitor therapy documentation

Document the member’s RAS inhibitor therapy: medication name, dose, start date, and evidence the dose has been stable and maximized (or documentation of intolerance/contraindication) for ≥3 months prior to Tarpeyo initiation.

Medication name and dose (ACEI or ARB)
Start date and notes showing stability at maximally tolerated dose for ≥3 months
If not on RAS inhibitor, provide documentation of intolerance or contraindication

Denial Risk

Indication restriction

Requests for Tarpeyo for any indication other than primary IgA nephropathy are considered experimental/investigational and not medically necessary.

Indication restricted to primary IgA nephropathy

OpenPayer

Tarpeyo (targeted‑release budesonide) — Coverage Criteria for Primary IgA Nephropathy

Coverage Criteria for Tarpeyo (budesonide)

Coding and Key Eligibility Measures

Provider Requirements and Prior Authorization

Background