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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 |
1/1/2024 |
5/19/2022 |
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Tarpeyo® Delayed release capsule |
Reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/g |
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
IgAN |
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)
|
Efficacy |
The effect of Tarpeyo on proteinuria was assessed in a randomized, double-blind, multicenter study (NEFIGAN, NCT: 03643965) in patients with biopsy-proven IgAN, estimated glomular filtration rate (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 nine months followed by a 2-week taper of either Tarpeyo 8 mg once daily or placebo. Of the 199 patients who completed the Month 9 visit, 68% were male, 86% were Caucasian, 12% were Asian, and 16% were from the US. The median age was 44 years (range 23 to 73 years). At baseline, the mean eGFR was approximately 58 mL/min/1.73 m^2, with 62% of patients having an eGFR 3.5 g/24 hours. Approximately 73% of patients had a history of hypertension and 5% had a history of type 2 diabetes mellitus. At baseline, 98% were treated with an ACEI or ARB and less than 1% of patients were on a sodium-glucose cotransporter-2 (SGLT2) inhibitor.(1,2)
|
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 2021. |
2 |
Fellström, B. C., Barratt, J., Cook, H., Coppo, R., Feehally, J., de Fijter, J. W., Floege, J., Hetzel, G., Jardine, A. G., Locatelli, F., Maes, B. D., Mercer, A., Ortiz, F., Praga, M., Sørensen, S. S., Tesar, V., & Del Vecchio, L. (2017). Targeted-release Budesonide versus placebo in patients with IGA nephropathy (NEFIGAN): A double-blind, randomised, placebo-controlled phase 2B trial. The Lancet, 389(10084), 2117–2127. https://doi.org/10.1016/s0140-6736(17)30550-0 |
3 |
Rovin, B. H., Adler, S. G., Barratt, J., Bridoux, F., Burdge, K. A., Chan, T. M., Cook, H. T., Fervenza, F. C., Gibson, K. L., Glassock, R. J., Jayne, D. R. W., Jha, V., Liew, A., Liu, Z.-H., Mejía-Vilet, J. M., Nester, C. M., Radhakrishnan, J., Rave, E. M., Reich, H. N., … Floege, J. (2021). KDIGO 2021 Clinical Practice guideline for the management of Glomerular Diseases. Kidney International, 100(4), S1–S276. https://doi.org/10.1016/j.kint.2021.05.021 |
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 with PA |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: 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.
BCBSAL _ Commercial _ CSReg _ Tarpeyo _PAQL _ProgSum_ 1/1/2024