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Filspari (sparsentan) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1202
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 |
10-01-2023 |
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Filspari® Tablet |
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
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).(4) 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).(4) 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.(4) Guidelines define high risk of progression in IgAN as proteinuria greater than 0.75–1 g/d despite at least 90 days of optimized supportive care. It is suggested that patients who remain at high risk despite maximal supportive care be considered for a 6 month course of glucocorticoid therapy. They stress the importance of discussing treatment-emergent toxicity, particularly those who have an estimated glomerular filtration rate (eGFR) less than 50 mL/min/1.73 m^2. It is further noted that glucocorticoids should be given with extreme caution or avoided entirely in the following situations:(4)
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.(4) |
Efficacy |
Filspari (sparsentan) is an endothelin and angiotensin II receptor antagonist. The effect of Filspari on proteinuria was assessed in a randomized, double-blind, active-controlled, multicenter, global study (PROTECT, NCT03762850) in adults with biopsy-proven IgAN, eGFR greater than or equal to 30 mL/min/1.73 m^2, and total urine protein greater than or equal to 1.0 g/day on a maximized stable dose of renin-angiotensin- system (RAS) inhibitor treatment for at least 12 weeks that was at least 50% of maximum labeled dose.(1,2) Patients with other glomerulopathies or those who had been recently treated with systemic immunosuppressants were excluded. Patients were randomized (1:1) to either Filspari (400 mg once daily following 200 mg once daily for 14 days) or irbesartan (300 mg once daily following 150 mg once daily for 14 days). Rescue immunosuppressive treatment could be initiated per investigator discretion during the trial, but use of SGLT2 inhibitors was prohibited. The 281 patients who reached week 36 had a mean (SD) baseline eGFR of 56 (24) mL/min/1.73 m^2. Rescue immunosuppressive treatment was initiated in 1.4% and 5.7% of Filspari and irbesartan patients, respectively. The primary endpoint of the interim analysis was the relative change from baseline in urine protein to creatinine ratio (UPCR) at week 36. The adjusted geometric mean percent change (GMPC) from baseline was -45% in the Filspari arm and -15% in the irbesartan arm, a statistically significant reduction. The ratio of adjusted geometric mean (GM) relative to baseline at week 36 was 0.65 (0.55, 0.77; 95% CI; p less than 0.0001). The treatment effect on UPCR at Week 36 was consistent across subgroups including age, sex, race, and baseline eGFR and proteinuria levels.(1) |
Safety |
Filspari (sparsentan) has a boxed warning for hepatotoxicity and embryo-fetal toxicity and is available only through a risk evaluation and mitigation strategy (REMS) program (Filspari REMS):(1)
Filspari is contraindicated in patients who are pregnant. Filspari is contraindicated to be coadministered with ARBs, endothelin receptor antagonists (ERAs), or aliskiren.(1) Prior to initiating treatment with Filspari, discontinue use of renin-angiotensin-aldosterone system (RAAS) inhibitors, ERAs, and aliskiren.(1) |
REFERENCES
Number |
Reference |
1 |
Filspari prescribing information. Travere Therapeutics, Inc. February 2023 |
2 |
Heerspink HJL, Radhakrishnan J, Alpers CE, et al. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. The Lancet. 2023;401(10388):1584-1594. doi:10.1016/s0140-6736(23)00569-x |
3 |
Reference no longer used. |
4 |
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 |
5 |
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 |
|
||||||
Filspari |
sparsentan tab |
200 MG ; 400 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 |
|
|||||||||
Filspari |
sparsentan tab |
200 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Filspari |
sparsentan tab |
400 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Filspari |
sparsentan tab |
200 MG ; 400 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 |
Filspari |
sparsentan tab |
200 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Filspari |
sparsentan tab |
400 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 9 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.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
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: up to 12 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.
Commercial _ CSReg _ Filspari_PAQL _ProgSum_ 10-01-2024