ModifiedBlue Cross Blue Shield - IowaPolicy 05.04.61

Tarpeyo (budesonide DR) for primary IgA nephropathy

Defines prior authorization, required documentation, clinical criteria for initial approval and limits for Tarpeyo (budesonide delayed release) to reduce loss of kidney function in adults with primary IgA nephropathy (IgAN). Applies to members for whom the benefit exists and requires nephrology prescriber involvement.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTarpeyo (budesonide DR) for primary IgA nephropathy

Policy CodePolicy 05.04.61

Change TypeRevised (June 2025)

Effective DateAug 15, 2025

Next Review Date

Key ActionSubmit prior authorization with lab report and/or chart notes documenting proteinuria >=1 g/day or UPCR >=0.8 g/g, kidney biopsy confirming primary IgAN, risk for progression (UPCR >=1.5 g/g), and evidence of stable maximally tolerated RAS inhibitor therapy for >=3 months or intolerance/contraindication.

POLICY UPDATE CHANGES

Policy revised June 2025; current effective date August 15, 2025.

38 weeksDuration limit (lifetime)

120 caps/30dQuantity limit

>=35eGFR threshold (mL/min/1.73 m2)

>=1.5 g/gUPCR for rapid progression risk

Coverage Summary

Coverage stance: covered_with_criteria. This policy (Policy # 05.04.61, effective August 15, 2025) covers Tarpeyo (budesonide delayed release) for adults with primary IgA nephropathy when specified criteria are met. Scope: defines prior authorization requirements, required documentation (including kidney biopsy confirmation and laboratory evidence of proteinuria/UPCR), clinical approval criteria (age ≥18, eGFR ≥ 35 mL/min/1.73 m2, requirement for stable maximally tolerated RAS inhibitor therapy or documented intolerance, nephrologist prescriber involvement), dosing and quantity/duration limits (e.g., quantity limit 120 capsules/30 days; lifetime duration limit 38 weeks), and exclusions (e.g., not to be used in combination with sparsentan or iptacopan). Indication summary: Tarpeyo is FDA-approved to reduce the loss of kidney function in adults with primary IgAN by delivering budesonide to the ileocecal region to target pathogenic mucosal IgA production.

Key thresholds and limits

Proteinuria (daily)>= 1 g/day

UPCR (baseline)>= 0.8 g/g

UPCR (rapid-progression risk)>= 1.5 g/g

eGFR cutoff>= 35 mL/min/1.73 m2

Maximum treatment duration (lifetime)38 weeks

Dosing limitsUp to 16 mg/day (4 capsules) for 9 months, then 8 mg/day (2 capsules) for 2 weeks

Quantity limit120 capsules per 30 days (4 capsules/day)

Initial Therapy Criteria

Criteria for Approval (Initial therapy)

Authorization of up to 10 months may be granted when ALL of the following criteria are met:

ALL of the following

Member has a diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy
Member is 18 years of age or older
Member is currently receiving a stable dose of maximally tolerated renin-angiotensin system (RAS) inhibitor therapy (e.g., ACE inhibitors or ARBs) for at least 3 months and will continue RAS inhibitor therapy OR member has an intolerance or contraindication to RAS inhibitors
stable dose for at least 3 months
Member has proteinuria greater than or equal to 1 g/day or baseline urine protein-to-creatinine ratio (UPCR) greater than or equal to 0.8 g/gproteinuria >= 1 g/day OR UPCR >= 0.8 g/g
Member is at risk for rapid disease progression defined by UPCR greater than or equal to 1.5 g/gUPCR >= 1.5 g/g
documented as required
Member's eGFR must be equal to or greater than 35 mL/min per 1.73 m2eGFR >= 35 mL/min/1.73 m2
Dosing limits
- Dose does not exceed 16 mg (4 capsules) per day for 9 months, followed by 8 mg (2 capsules) per day for two weeks<= 16 mg/day for 9 months then 8 mg/day for 2 weeks
  approval limited to this dosing schedule
The medication is prescribed by or in consultation with a nephrologist
Prescriber specialty requirement
The requested medication will not be used in combination with Filspari (sparsentan) or Fabhalta (iptacopan)
Member has not received more than 38 weeks of treatment with Tarpeyo (safety and efficacy of subsequent courses beyond 38 weeks not established)<= 38 weeks lifetime duration

Non-Formulary Exception Criteria

A non-formulary drug may be covered when the Criteria for Approval AND the following are met:

ALL of the following

The requested drug must be used for an FDA-approved indication or an indication supported in compendia of current literature (e.g., AHFS, Micromedex); diagnostic testing/lab results required when applicable
The prescribed dose/quantity must fall within FDA-approved labeling or dosing guidelines found in compendia of current literature
All covered formulary alternative drugs on any tier will be ineffective, have been ineffective, would not be as effective, or would have adverse effects; documentation required (chart notes indicating treatment failure, adverse event severity, dosage and duration of prior treatment), or contraindication to formulary alternatives
Documentation required

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization and required documentation

Submit prior authorization with laboratory report and/or chart notes documenting proteinuria >= 1 g/day or baseline UPCR >= 0.8 g/g, a kidney biopsy confirming primary IgAN, documentation that the member is at risk for progression (UPCR >= 1.5 g/g), and evidence of stable maximally tolerated RAS inhibitor therapy for at least 3 months or documentation of intolerance/contraindication.

Lab report or chart note: proteinuria >= 1 g/day OR UPCR >= 0.8 g/g
Kidney biopsy confirming primary IgAN
Lab report or chart note: UPCR >= 1.5 g/g (risk for progression)
Documentation of stable maximally tolerated RAS inhibitor therapy for >= 3 months or intolerance/contraindication

Documentation Required

Prescriber specialty requirement

Tarpeyo must be prescribed by or in consultation with a nephrologist. If prescribed following consultation, include the nephrology consultation note with the prior authorization request.

Billing Rule

Quantity and duration limits

Adhere to the quantity and duration limits: 120 capsules per 30 days (4 capsules/day) with a lifetime duration limit of 38 weeks. Authorization may be granted up to 10 months per request when the criteria for approval are met.

120 capsules per 30 days (4 capsules/day)
Duration limit: 38 weeks lifetime

Denial Risk

Combination therapy exclusion

Claims may be denied if Tarpeyo is used in combination with Filspari (sparsentan) or Fabhalta (iptacopan); the requested medication must not be used in combination with these agents per policy criteria.

Documentation Required

Non-formulary exception evidence

When requesting a non‑formulary exception, provide documentation that the requested drug is being used for an FDA‑approved indication or an indication supported in recognized compendia, that the prescribed dose/quantity falls within FDA labeling or compendia dosing guidelines, and evidence that all covered formulary alternatives were ineffective, not tolerated, or contraindicated (chart notes documenting treatment failure, adverse events, dose and duration, or contraindication).

FDA-approved indication or compendia support (e.g., AHFS, Micromedex)
Prescribed dose/quantity within FDA labeling or compendia guidelines
Documentation of formulary alternative failures, adverse events, or contraindications (chart notes, dose and duration)

Clinical Evidence

34%UPCR reduction at 9 months with Tarpeyo (vs 5% placebo; treatment difference 31%, 95% CI 16 to 42; p<0.0001)

5.9Mean eGFR difference at Year 2 favoring Tarpeyo (mL/min/1.73 m2; 95% CI 3.3 to 8.5)

~199Key trial: Nef-301 randomized double‑blind Phase III (~199 patients)

The key efficacy evidence derives from the randomized, double-blind Phase III trial Nef-301 (reported in the prescribing information), which met its prespecified endpoints. Trial results reported a 34% reduction in UPCR at 9 months with Tarpeyo versus 5% with placebo (treatment difference 31%; 95% CI 16 to 42; p<0.0001) and, in the Year 2 analysis, a mean eGFR treatment difference favoring Tarpeyo of 5.9 mL/min/1.73 m2 (95% CI 3.3 to 8.5).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTarpeyo (budesonide DR) for primary IgA nephropathy

Policy CodePolicy 05.04.61

Change TypeRevised (June 2025)

Effective DateAug 15, 2025

Next Review Date

On This Page

OpenPayer

Tarpeyo (budesonide DR) for primary IgA nephropathy

Coverage Summary

Initial Therapy Criteria

Not Medically Necessary

Non-Formulary Exception Criteria

Provider Actions & Authorization Requirements

Applicable Codes

Clinical Evidence

Background

Revision History