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Tarpeyo Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1177
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
05-19-2022 |
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Tarpeyo® Delayed release capsule |
Reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression |
|
1 |
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 may years. Eventually, IgAN can lead to end-stage renal disease (ESRD).(3)
The goal of treatment for these patients that remain at high risk for progressive disease is a reduction of proteinuria to less than 1 g/d.(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 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 16mg 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 patients with hypersensitivity to budesonide or any of the ingredients of Tarpeyo. Serious hypersensitivity reactions, including anaphylaxis have occurred with other budesonide formulations.(1) |
REFERENCES
Number |
Reference |
1 |
Tarpeyo prescribing information. Calliditas Therapeutics AB. December 2023. |
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 |
Rovin BH, Adler SG, Barratt J, et al. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney International. 2021;100(4):S1-S276. doi:10.1016/j.kint.2021.05.021 |
4 |
Reference no longer used. |
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 |
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 |
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:
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:
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.
ALBP _ Commercial _ CSReg _ Tarpeyo__PAQL _ProgSum_ 10-01-2024 _
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