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ph-91202

Filspari (sparsentan) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91202

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	10-01-2023

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Filspari® (sparsentan) Tablet	Slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression		1

Agent(s)

FDA Indication(s)

Notes

Ref#

Filspari®

(sparsentan)

Tablet

Slow kidney function decline 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).(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) Recent literature also supports the use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) as a component of maximal supportive care.(4,5) Furthermore, recent guidelines recommend simultaneous commencement of disease-modifying therapy and therapies to manage the consequences of IgAN-induced nephron loss.(4)

Guidelines define a patient with IgAN is at risk of progressive loss of kidney function if they have a proteinuria greater than or equal to 0.5 g/d (or equivalent).(4) Proteinuria of 0.5 g/d is approximately equivalent to a urine protein to creatinine ratio (UPCR) of 0.44 g/g.(3) 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.(4) 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.(4,5) 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:(4)

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).(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)

Elevations in aminotransferases (ALT or AST) of at least 3 times the upper limit of normal (ULN) were observed in up to 2.5% of Filspari treated patients in clinical studies. Transaminases and bilirubin should be measured before initiating treatment, monthly for the first 12 months, and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3x ULN. Filspari should be avoided in patients with elevated aminotransferases greater than 3 times ULN at baseline because monitoring for hepatoxicity may be more difficult and these patients may be at increased risk for serious hepatotoxicity.
Because Filspari can cause major birth defects if used by pregnant patients, pregnancy testing is required before initiation of treatment, during treatment, and one month after discontinuation of treatment with Filspari. Patients who can become pregnant must use effective contraception before the initiation of treatment, during treatment, and for one month after the discontinuation of treatment with Filspari.

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. September 2024.
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	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
4	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
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

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 ; SourceRx-Performance

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 ; SourceRx-Performance
Filspari	sparsentan tab	400 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
	Initial Evaluation 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 slow kidney function decline 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 The patient will NOT use the requested agent in combination with an ACEi, ARB, endothelin receptor antagonist (ERA, e.g., bosentan), or aliskiren 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: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met: The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND The patient has had clinical benefit with the requested agent AND The patient will NOT use the requested agent in combination with an angiotensin-converting-enzyme inhibitor (ACEi, e.g., benazepril, lisinopril), angiotensin II blocker (ARB, e.g., losartan), endothelin receptor antagonist (ERA, e.g., bosentan), or aliskiren 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: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Module

Clinical Criteria for Approval

Initial Evaluation

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 slow kidney function decline 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
The patient will NOT use the requested agent in combination with an ACEi, ARB, endothelin receptor antagonist (ERA, e.g., bosentan), or aliskiren 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: 12 months

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

Renewal Evaluation

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

The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
The patient has had clinical benefit with the requested agent AND
The patient will NOT use the requested agent in combination with an angiotensin-converting-enzyme inhibitor (ACEi, e.g., benazepril, lisinopril), angiotensin II blocker (ARB, e.g., losartan), endothelin receptor antagonist (ERA, e.g., bosentan), or aliskiren 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: 12 months

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

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

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: 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 12 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 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.