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ph-91177

Tarpeyo Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91177

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, SourceRx-Performance, and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
10-01-2025	05-19-2022

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Tarpeyo® (budesonide) Delayed release capsule	To reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression		1

Agent(s)

FDA Indication(s)

Notes

Ref#

Tarpeyo®

(budesonide)

Delayed release capsule

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

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Immunoglobulin A Nephropathy

Immunoglobulin A nephropathy (IgAN), also known as Berger’s disease, is a kidney disease that occurs when IgA deposits build up in the kidneys, causing inflammation that damages the glomeruli, in turn causing the kidneys to leak blood and protein into the urine. The damage may lead to scarring of the nephrons that progresses slowly over many years. Eventually, IgAN can lead to end-stage renal disease (ESRD).(3)

Kidney biopsy is required to confirm the diagnosis of IgAN as there are no validated diagnostic serum or urine biomarkers for IgAN. Biopsy is indicated when a patient has signs of a severe or progressive disease. After a diagnosis has been established, guidelines recommend that all patients with IgAN be assessed for secondary causes (e.g., liver cirrhosis, HIV, hepatitis, inflammatory bowel disease).(3)

The primary focus of IgAN management should be optimized supportive care (e.g., blood pressure management, maximally tolerated angiotensin-converting-enzyme inhibitor [ACEi] or angiotensin II blocker [ARB], lifestyle modification, address cardiovascular risk). Guidelines recommend that all patients with proteinuria greater than 0.5 g/d be treated with an ACEi or ARB irrespective of whether they have hypertension.(3) Recent literature also supports the use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) as a component of maximal supportive care.(3,5) Furthermore, recent guidelines recommend simultaneous commencement of disease-modifying therapy and therapies to manage the consequences of IgAN-induced nephron loss.(3)

Guidelines define a patient with IgAN at risk of progressive loss of kidney function if they have a proteinuria greater than or equal to 0.5 g/d (or equivalent).(3) Proteinuria of 0.5 g/d is approximately equivalent to a urine protein to creatinine ratio (UPCR) of 0.44 g/g.(4) Systemic glucocorticoids have no proven impact on levels of pathogenic forms of IgA or IgA immune complexes and are used to manage glomerular inflammation. However, Tarpeyo (Nefecon) is recommended in the 2024 KDIGO guidelines as efficacy data supports a reduction in pathogenic IgA and IgA immune complexes.(3) The American Journal of Kidney Disease (AJKD) recommends corticosteroids (targeted release budesonide, Nefecon, or reduced dose corticosteroids) for high-risk patients with inflammatory lesions seen on kidney biopsy.(5) Most literature supports some use of corticosteroids as part of a treatment regimen however, the dose and duration is questionable.(3,5) Furthermore, long-term outcomes-based comparative studies for corticosteroids in the IgAN setting is lacking and future studies are needed to determine any clinical significance. It is further noted that the following patient characteristics are likely to increase the risks of systemic glucocorticoid toxicity:(3)

eGFR less than 30 mL/min/1.73 m^2
Diabetes and prediabetes
Obesity
Latent infections (e.g., viral hepatitis, tuberculosis)
Active peptic ulceration
Uncontrolled psychiatric illness
Osteoporosis
Cataracts

The goal of treatment in patients with IgAN at risk of progressive loss of kidney function is to reduce the rate of loss of kidney function to less than 1 mL/min per year for the rest of the patient's life. An additional treatment goal is the reduction of proteinuria to less than 0.5 g/d (or equivalent).(3)

Efficacy

The effect of Tarpeyo on proteinuria and kidney function was assessed in a randomized, double-blind, phase 3, 2-part, multicenter study (NefIgArd, NCT: 03643965) in adult patients (n=364) with biopsy-proven IgAN, eGFR greater than or equal to 35 mL/min/1.73 m^2 , and proteinuria (defined as either greater than or equal to 1 g/day or urine protein to creatinine ratio (UPCR) greater than or equal to 0.8 g/g) who were on a stable (12-week) dose of maximally-tolerated renin-angiotensin-system (RAS) inhibitor therapy. Patients with other glomerulopathies, nephrotic syndrome, or those who had been treated with systemic immunosuppressive medications were excluded. Patients were randomized 1:1 to either Tarpeyo 16 mg once daily or placebo and treated for 9 months followed by a 2-week taper of either Tarpeyo 8 mg once daily or placebo. Patients were then observed for 15 months, during which no study drug was administered. At baseline, the mean eGFR was approximately 58 mL/min/1.73 m^2 and the mean UPCR was 1.5 g/g. The median age was 43 years (range from 20-73 years). At baseline, 98% of patients were treated with an ACEi or ARB.(1,2)

The primary outcome for Part A of the study was the ratio (reduction) of UPCR (based on 24-hour urine collections) at 9 months compared to baseline. An interim analysis was based on the first 199 randomized patients who completed the Month 9 visit. A 31% reduction in UPCR was seen in patients treated with Tarpeyo 16 mg daily compared to a 5% reduction in the placebo group (95% CI: 16% to 42% reduction; p=0.0001). The final analysis of all 364 patients was consistent with the results of the interim analysis.(1,2)

The primary outcome for Part B of the study was a time-weighted average of the log ratio of eGFR at each time point over 2 years relative to baseline to assess the effect of Tarpeyo on long-term kidney function. After 2 years there was a 5.9 mL/min/1.73 m^2 difference in mean change from baseline in eGFR (95% CI: 3.3 to 8.5 mL/min/1.73 m^2; p less than 0.0001). This treatment effect at 2 years was consistent across key subgroups, including baseline disease characteristics (e.g., baseline proteinuria).(1)

Safety

Tarpeyo is contraindicated in the following:(1)

Hypersensitivity to budesonide or any of the ingredients of Tarpeyo

REFERENCES

Number	Reference
1	Tarpeyo prescribing information. Calliditas Therapeutics AB. June 2024.
2	Barratt J, Lafayette RA, Kristensen JK, et al. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney International. 2023;103(2):391-402. doi:10.1016/j.kint.2022.09.017.
3	KDIGO 2024 CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF IMMUNOGLOBULIN A NEPHROPATHY (IgAN) AND IMMUNOGLOBULIN A VASCULITIS (IgAV); 2024. https://kdigo.org/wp-content/uploads/2024/08/KDIGO-2024-IgAN-IgAV-Guideline-Public-Review-Draft.pdf.
4	Pitcher D, Braddon F, Hendry B, et al. Long-Term outcomes in IGA nephropathy. Clinical Journal of the American Society of Nephrology. 2023;18(6):727-738. doi:10.2215/cjn.0000000000000135.
5	Caster DJ, Lafayette RA. The treatment of primary IGA nephropathy: Change, change, change. American Journal of Kidney Diseases. 2023;83(2):229-240. doi:10.1053/j.ajkd.2023.08.007.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

Tarpeyo	budesonide delayed release cap	4 MG	M ; N ; O ; Y	N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

Tarpeyo	Budesonide Delayed Release Cap	4 MG	120	Capsules	30	DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Tarpeyo	budesonide delayed release cap	4 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Tarpeyo	Budesonide Delayed Release Cap	4 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
PA	Target Agent(s) will be approved when ALL of the following are met: The patient has a diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy AND The requested agent will be used to reduce the loss of kidney function in a patient at risk for disease progression AND ONE of the following: The patient has a urine protein-to-creatinine ratio (UPCR) greater than or equal to 0.44 g/g OR The patient has proteinuria greater than or equal to 0.5 g/day AND The patient’s eGFR is greater than or equal to 30 mL/min/1.73 m^2 AND If the patient has an FDA labeled indication, then ONE of the following: The patient’s age is within FDA labeling for the requested indication for the requested agent OR There is support for using the requested agent for the patient’s age for the requested indication AND The patient has ONE of the following: Tried and had an inadequate response after at least a 3-month duration of therapy with a maximally tolerated angiotensin-converting-enzyme inhibitor (ACEi, e.g., benazepril, lisinopril) or angiotensin II blocker (ARB, e.g., losartan), or a combination medication containing an ACEi or ARB OR An intolerance or hypersensitivity to an ACEi or ARB, or a combination medication containing an ACEi or ARB OR An FDA labeled contraindication to ALL ACEi and ARB AND ONE of the following: The patient has an intolerance or hypersensitivity to oral generic budesonide that is not expected to occur with the requested agent OR The patient has an FDA labeled contraindication to oral generic budesonide that is not expected to occur with the requested agent AND ONE of the following: The patient has not previously been treated with a course of therapy (9 months) with the requested agent OR The patient has previously been treated with a course of therapy with the requested agent, AND there is support for an additional course of therapy with the requested agent AND The prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 10 months NOTE: If Quantity Limit applies, please refer to Quantity Limit criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Module

Clinical Criteria for Approval

Target Agent(s) will be approved when ALL of the following are met:

The patient has a diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy AND
The requested agent will be used to reduce the loss of kidney function in a patient at risk for disease progression AND
ONE of the following:
1. The patient has a urine protein-to-creatinine ratio (UPCR) greater than or equal to 0.44 g/g OR
2. The patient has proteinuria greater than or equal to 0.5 g/day AND
The patient’s eGFR is greater than or equal to 30 mL/min/1.73 m^2 AND
If the patient has an FDA labeled indication, then ONE of the following:
1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
2. There is support for using the requested agent for the patient’s age for the requested indication AND
The patient has ONE of the following:
1. Tried and had an inadequate response after at least a 3-month duration of therapy with a maximally tolerated angiotensin-converting-enzyme inhibitor (ACEi, e.g., benazepril, lisinopril) or angiotensin II blocker (ARB, e.g., losartan), or a combination medication containing an ACEi or ARB OR
2. An intolerance or hypersensitivity to an ACEi or ARB, or a combination medication containing an ACEi or ARB OR
3. An FDA labeled contraindication to ALL ACEi and ARB AND
ONE of the following:
1. The patient has an intolerance or hypersensitivity to oral generic budesonide that is not expected to occur with the requested agent OR
2. The patient has an FDA labeled contraindication to oral generic budesonide that is not expected to occur with the requested agent AND
ONE of the following:
1. The patient has not previously been treated with a course of therapy (9 months) with the requested agent OR
2. The patient has previously been treated with a course of therapy with the requested agent, AND there is support for an additional course of therapy with the requested agent AND
The prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 10 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit criteria.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
QL	Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication Length of Approval: up to 10 months

Module

Clinical Criteria for Approval

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication OR
2. BOTH of the following:
  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
  2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
3. BOTH of the following:
  1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 10 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.