CurrentUnitedHealthcarePolicy N/A

Tarpeyo (budesonide delayed-release) — Prior Authorization and Medical Necessity Criteria

Policy governing prior authorization and medical necessity criteria for Tarpeyo (budesonide delayed-release capsules) for adults with primary IgA nephropathy (IgAN) at risk of progression, affecting UnitedHealthcare members and prescribing providers.

Policy Summary

PayerUnitedHealthcare

PolicyTarpeyo (budesonide delayed-release) — Prior Authorization and Medical Necessity Criteria

Policy CodePolicy N/A

Change TypeClarified indications and updated references (non‑material)

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization with documentation of renal biopsy-confirmed primary IgAN, current eGFR ≥35 mL/min/1.73 m2, prior 30-day glucocorticoid trial (or intolerance), and nephrologist involvement.

SourceLink

POLICY UPDATE CHANGES

Updated indication language and references during the 02/2024 and 02/2025 reviews.

9 monthsauthorization duration

≥35eGFR threshold

renal biopsydiagnosis confirmation

requirednephrologist requirement

30 days

Policy Summary

PayerUnitedHealthcare

PolicyTarpeyo (budesonide delayed-release) — Prior Authorization and Medical Necessity Criteria

Policy CodePolicy N/A

Change TypeClarified indications and updated references (non‑material)

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Tarpeyo (budesonide delayed-release)

Initial Therapy

Covered when ALL of the following are met:

Initial Authorization for Tarpeyo

Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by renal biopsy.
Risk and intent: Patient is at risk for disease progression and intended use is to reduce loss of kidney function.
Renal function: Estimated glomerular filtration rate (eGFR) ≥ 35 mL/min/1.73 m2.>= 35 mL/min/1.73 m2
Concomitant RAAS therapy or intolerance
- Option 1: Patient is on a stabilized dose and receiving concomitant therapy with a maximally tolerated angiotensin‑converting enzyme (ACE) inhibitor (e.g., captopril, enalapril) or a maximally tolerated angiotensin II receptor blocker (ARB) (e.g., candesartan, valsartan).
- Option 2: Patient has an allergy, contraindication, or intolerance to ACE inhibitors and ARBs.
Prior glucocorticoid trial: History of failure, contraindication, or intolerance to a 30‑day trial of a glucocorticoid (e.g., methylprednisolone, prednisone).
Prescriber requirement: Prescribed by or in consultation with a nephrologist.

Operational note: Prior authorization approvals are issued for 9 months and require meeting all specified clinical criteria.

Coverage is limited to adults with primary immunoglobulin A nephropathy (IgAN) that is confirmed by renal biopsy. Patients are not eligible if the diagnosis is not primary IgAN confirmed by renal biopsy or if renal function is below the required threshold of eGFR < 35 mL/min/1.73 m2 (see eligibility threshold).

Prior to approval, documentation must show the patient has been trialed on a maximally tolerated ACE inhibitor or ARB (unless there is documented allergy, contraindication, or intolerance). Use of Tarpeyo is considered not medically necessary if required prior therapies are not attempted or if there is no documentation of contraindication/intolerance. Additionally, there must be a history of failure, contraindication, or intolerance to a 30-day glucocorticoid trial (for example, methylprednisolone or prednisone) unless glucocorticoids are contraindicated.

Key Clinical Thresholds & Coding-Adjacent Data

eGFR — clinical threshold required for eligibility

eGFR thresholdEstimated glomerular filtration rate (eGFR) ≥ 35 mL/min/1.73 m2

Measurement basiseGFR reported in mL/min/1.73 m2 as documented in clinical records

Eligibility ruleMember must have current eGFR ≥ 35 mL/min/1.73 m2 at time of prior authorization

Exclusion triggereGFR below 35 mL/min/1.73 m2 results in ineligibility per policy

Provider Requirements, Documentation & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — approvals are issued for 9 months and are contingent on meeting all specified clinical criteria. State mandates and member-specific benefit plan coverage may affect authorization.

Note

Treatment Stabilization Requirement

Patient must be on a stabilized dose and receiving concomitant therapy with a maximally tolerated ACE inhibitor or ARB unless there is a documented allergy, contraindication, or intolerance. Provider must document current medications and stabilization status.

Examples: ACE inhibitors (e.g., captopril, enalapril)
Examples: ARBs (e.g., candesartan, valsartan)
If ACEi/ARB intolerance documented, note specific allergy/contraindication

Clinical Background

Tarpeyo (budesonide delayed‑release) is indicated to reduce the loss of kidney function in adults with primary IgA nephropathy (IgAN) who are at risk for disease progression. The medication is intended as adjunctive therapy for patients meeting clinical criteria, including biopsy confirmation of primary IgAN, adequate renal function (minimum eGFR ≥ 35 mL/min/1.73 m2), use with a stabilized, maximally tolerated ACE inhibitor or ARB when possible, and prior trial or documented intolerance to a 30‑day course of glucocorticoids. Prior authorization is required and approvals are issued for 9 months when all criteria are met.

Definitions

Definition of primary immunoglobulin A nephropathy (IgAN)

DefinitionPrimary immunoglobulin A nephropathy (IgAN) is a primary glomerular disease characterized by IgA deposition in the glomerulus leading to progressive loss of kidney function; for this policy diagnosis must be confirmed by renal biopsy.

Diagnosis confirmationRequires renal biopsy documenting primary IgA nephropathy to meet authorization criteria.

Clinical relevanceIgAN patients considered for Tarpeyo are those at risk for disease progression and to reduce loss of kidney function.

Prescriber involvementTreatment with Tarpeyo must be prescribed by or in consultation with a nephrologist as part of authorization requirements.