CurrentCignaPolicy IP0413

Nephrology - Tarpeyo

Defines Cigna prior authorization, coverage criteria, and billing-related requirements for Tarpeyo (budesonide delayed-release capsules) for adults with primary immunoglobulin A nephropathy (IgAN). Includes initial and continuation approval criteria, documentation requirements, product-preference language for employer/individual plans, and exclusions.

Policy Summary

PayerCigna

PolicyNephrology - Tarpeyo

Policy CodePolicy IP0413

Change TypeRevisions to criteria & documentation

Effective DateMar 1, 2026

Next Review Date

Key ActionPrior Authorization is required for Tarpeyo; approvals provided for the durations specified (not to exceed 10 consecutive months).

SourceLink

POLICY UPDATE CHANGES

High risk criterion revised multiple times: proteinuria/UPCR thresholds adjusted (notably to UPCR ≥ 0.8 g/g OR proteinuria ≥ 0.5 g/day as of 12/15/2024 and subsequent edits).

Documentation requirements were added (07/01/2025).

Conditions Not Covered note: removed prior criterion about use beyond 10 months (06/01/2024).

Updated policy template (11/01/2025 and 03/01/2026).

10Maximum consecutive approval duration

≥18Age requirement (years)

≥0.5/≥0.8Proteinuria / UPCR thresholds

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≥30eGFR threshold (mL/min/1.73 m²)

Coverage Summary

Coverage stance: Covered with criteria for Tarpeyo (budesonide delayed-release) for the FDA-approved indication of primary immunoglobulin A nephropathy (IgAN). Policy number: IP0413. Effective date: 2026-03-01. Approval duration limit: 10 months (approvals in months use a 30-day month and total approvals must not exceed 10 consecutive months).

Threshold summary

Age requirement≥ 18 years

Proteinuria threshold≥ 0.5 g/day

UPCR threshold≥ 0.8 g/g

Prior RAS inhibitor therapy≥ 90 days at maximum or maximally tolerated dose

eGFR threshold≥ 30 mL/min/1.73 m²

Maximum approval duration10 months (1 month = 30 days)

Initial Therapy Criteria

A) Initial Therapy (Approve for 10 months)

Patient is ≥ 18 years of age≥ 18 years
The diagnosis has been confirmed by biopsy
[documentation required]
Patient is at high risk of disease progression (both a and b required)
- a) Proteinuria requirement (ONE of the following)
  - Proteinuria ≥ 0.5 g/day≥ 0.5 g/day
    [documentation required]

Continuation Therapy Criteria

B) Patient is Currently Receiving Tarpeyo (Approve for up to 10 months total)

Patient is ≥ 18 years of age≥ 18 years
The diagnosis has been confirmed by biopsy
[documentation required]
Prior RAS inhibitor therapy (ONE of the following for ≥ 90 days)
- Angiotensin converting enzyme inhibitor for ≥ 90 days≥ 90 days

Employer / Individual & Family Plans — Preferred Product Requirement

Employer Plans / Individual & Family Plans - Preferred Product Requirement

Patient has tried and cannot take ONE systemic corticosteroid (other than Tarpeyo) for the diagnosis
Document attempted therapy/intolerance/contraindication as required

Conditions Not Covered

Use of Tarpeyo for indications other than primary IgA nephropathy
Tarpeyo for any other use is considered not medically necessary.

Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of Tarpeyo; approvals provided for the durations specified (not to exceed 10 consecutive months).

Documentation Required

Documentation required for diagnosis and protein metrics

Documentation required for biopsy confirmation of IgAN and for proteinuria or UPCR values; documentation may include chart notes, laboratory tests, claims records, and must include patient-specific identifying information.

Prior Authorization

Specialist prescribing requirement

Tarpeyo must be prescribed by or in consultation with a nephrologist.

Applicable Codes

Policy identifiersmixed

IP0413

Coverage Policy Number

Clinical Evidence

≥3 monthsOptimized supportive care requirement in trial: max tolerated/allowed ACEi or ARB ≥3 months

Background/evidence: Tarpeyo is indicated to reduce loss of kidney function in adults with primary IgAN at risk of rapid progression. The pivotal randomized trial comprised a 9-month randomized treatment period with a subsequent 15-month observational follow-up, and demonstrated statistically greater reduction in UPCR and less eGFR decline versus placebo. The recommended dosing from the prescribing information is 16 mg orally once daily for 9 months, with a taper to 8 mg once daily for the last 2 weeks. Safety and efficacy of subsequent courses of Tarpeyo have not been established.

Background & Definitions

Tarpeyo (budesonide delayed-release) is indicated to reduce the loss of kidney function in adults with primary IgA nephropathy at risk of rapid progression. The recommended regimen is 16 mg orally once daily for 9 months, with dose reduction to 8 mg once daily for the last 2 weeks when discontinuing therapy. The pivotal efficacy evaluation was a randomized, 9-month trial with patients subsequently followed for an additional 15 months in an observational period; during the randomized phase and the observational follow-up Tarpeyo showed greater reductions in proteinuria (UPCR) and less decline in eGFR compared with placebo. The safety and efficacy of repeating treatment with subsequent courses of Tarpeyo have not been established.

Definition — Optimized supportive care: Includes maximal tolerated RAS inhibitor therapy, blood pressure control, lifestyle modification, and cardiovascular risk modification; prescriber attestation of ≥ 90 days is required in the policy.

Revision History

03/01/2026annual_revisionLatest

Annual revision updated preferred product table language to require that the patient has tried and cannot take ONE systemic corticosteroid (other than Tarpeyo). Marked as a material change to preferred product criteria.

11/01/2025template_update

Updated policy template; Employer and Individual & Family Plans preferred product table language changed from 'Failure, contraindication or intolerance to ONE systemic corticosteroid' to 'Patient has tried and cannot take ONE systemic corticosteroid (other than Tarpeyo) for the diagnosis' with examples added.

Policy Summary

PayerCigna

PolicyNephrology - Tarpeyo

Policy CodePolicy IP0413

Change TypeRevisions to criteria & documentation

Effective DateMar 1, 2026

Next Review Date

Key ActionPrior Authorization is required for Tarpeyo; approvals provided for the durations specified (not to exceed 10 consecutive months).

SourceLink

On This Page

Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 g/g≥ 0.8 g/g

[documentation required]

b) Prior RAS inhibitor therapy (ONE of the following for ≥ 90 days)

Receiving the maximum or maximally tolerated dose of an angiotensin converting enzyme inhibitor for ≥ 90 days≥ 90 days
Receiving the maximum or maximally tolerated dose of an angiotensin receptor blocker for ≥ 90 days≥ 90 days

According to the prescriber, the patient has received ≥ 90 days of optimized supportive care (including blood pressure management, lifestyle modification, and cardiovascular risk modification)≥ 90 days

Prescriber attestation required

Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m²≥ 30 mL/min/1.73 m²

Patient has not previously been treated with Tarpeyo

For currently receiving Tarpeyo, use continuation criteria

The medication is prescribed by or in consultation with a nephrologist

Preferred product criteria is met for the products listed in the preferred product table

Angiotensin receptor blocker for ≥ 90 days

Prescriber attestation required

Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m²≥ 30 mL/min/1.73 m²

The medication is prescribed by or in consultation with a nephrologist

If patient already received months of therapy, approve remaining months to complete 10 consecutive monthsMaximum total approval = 10 months (1 month = 30 days)

Approval is not to exceed 10 consecutive months (1 month = 30 days).

Billing Rule

Approval duration arithmetic

When approval is authorized in months, 1 month = 30 days; total approvals must not exceed 10 consecutive months.

Step Therapy

Prior therapy requirement (RAS inhibitors)

Patient must have been receiving the maximum or maximally tolerated dose of an ACE inhibitor or ARB for ≥ 90 days prior to approval.

Documentation Required

Employer/Individual plan additional requirement

For Employer and Individual & Family plans, patient must have tried and cannot take ONE systemic corticosteroid (other than Tarpeyo); document attempted therapy, intolerance, or contraindication. Examples of systemic corticosteroids include methylprednisolone and prednisone.

Documentation requirements were added (examples of acceptable documentation listed).

04/15/2025no_substantive_change

No criteria changes.

12/15/2024threshold_revision

High risk criterion revised: urine-to-protein-creatinine ratio ≥ 0.8 g/g OR proteinuria threshold revised to ≥ 0.5 g/day.

06/01/2024clarification

Annual revision revised high risk criterion wording (previously UPCR ≥ 1.5 g/g OR proteinuria ≥ 0.75 g/day to UPCR ≥ 0.8 g/g OR proteinuria ≥ 0.75 g/day); Conditions Not Covered note removed prior criterion regarding use beyond 10 months.