WHA

FILSPARI (sparsentan)

Self-Administration – oral tablets

 

Diagnosis considered for coverage:

 

Primary immunoglobulin A nephropathy (IgAN): Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.

This indication is approved under accelerated approval based on a reduction of proteinuria. It has not been established whether Filspari slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

 

Coverage Criteria:

 

For diagnosis of primary immunoglobulin A nephropathy (IgAN):

  • Diagnosis of primary immunoglobulin A nephropathy (IgAN) is confirmed by a kidney biopsy; AND
  • Patient is at risk of rapid disease progression (as shown by a urine protein-to-creatinine ratio [UPCR] greater than or equal to 1.5 g/g, or by other criteria such as clinical risk scoring using the International IgAN Prediction Tool).
  • Used to reduce proteinuria; AND
  • Patient has an estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m2; AND
  • Patient has been on a minimum 90-day trial of a maximally tolerated dose of one of the following:
    • An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril)
    • An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan); AND
  • Medication will not be used in combination with any of the following:
    • Angiotensin receptor blockers (ARBs)
    • Endothelin receptor antagonists (ERAs) (e.g., ambrisentan, bosentan, Opsumit)
    • Aliskiren; AND
  • Prescribed by or in consultation with a nephrologist.

 

Reauthorization Criteria:

 

For diagnosis of IgAN:

  • Patient demonstrates a positive clinical response to therapy as demonstrated by a decrease in urine protein-to-creatinine ratio (UPCR) from baseline; AND
  • Medication is not taken in combination with any of the following:
    • Angiotensin receptor blockers
    • Endothelin receptor antagonists (ERAs) (e.g., ambrisentan, bosentan, Opsumit)
    • Aliskiren

 

Dosing:

 

  • Initial: 200 mg orally once daily for 14 days.
  • Maintenance: increase to 400 mg once daily, as tolerated.

 

Coverage Duration:

 

  • 1 year

 

Authorization is not covered for the following:
  • The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information:
  • Immunoglobulin A nephropathy (IgAN) is characterized by the formation of IgA immune complexes that deposit within the glomeruli of the kidney. Over time, these complexes lead to progressive deterioration in renal function. Signs and symptoms include proteinuria, hematuria, and hypertension.
  • According to the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for the management of glomerular diseases (2021), optimized supportive care is the primary focus of IgAN treatment. It includes blood pressure management, maximally tolerated ACE inhibitor/ARB therapy, lifestyle modification (e.g., dietary sodium restriction, smoking cessation, weight control, and exercise), and addressing cardiovascular risk.
  • Filspari (sparsentan) became the second drug and first non-immunosuppressive therapy to be approved for IgAN.
    • Filspari (sparsentan) is approved under accelerated approval based on reduction of proteinuria. It has not been established whether sparsentan slows kidney function decline in patients with IgAN. Sparsentan was also granted orphan drug designation and priority review.
  • The International IgAN Prediction Tool helps determine the risk of a 50% decline in eGFR or progression to kidney failure up to 6.7 years from the time of kidney biopsy.
    • https://kdigo.org/wp-content/uploads/2017/02/KDIGO-GD-Guideline-Key-Takeaways-for-Clinicians-IgAN.pdf
    • https://qxmd.com/calculate/calculator_499/international-igan-prediction-tool-at-biopsy-adults
    • Oxford classification MEST criteria scores as follows: mesangial hypercellularity (M0/M1), endocapillary hypercellularity (E0/E1), segmental glomerulo- sclerosis (S0/S1), tubular atrophy/interstitial fibrosis (T0/T1/T2).

 

Policy Updates:
  • 09/01/2023 – New program for Filspari approved by P&T (P&T 08/15/2023).

 

References:
  1. Filspari Package Insert. Travere Therapeutics, Inc. San Diego, CA. February 2023.
  2. Rovin BH, Adler SG, Barratt J, Bridoux F, Burdge KA, Chan TM, Cook HT, Fervenza FC, Gibson KL, Glassock RJ, Jayne DR. KDIGO 2021 clinical practice guideline for the management of glomerular diseases. Kidney international. 2021 Oct 1;100(4):S1-276.
  3. Heerspink HJ, Radhakrishnan J, Alpers CE, Barratt J, Bieler S, Diva U, Inrig J, Komers R, Mercer A, Noronha IL, Rheault MN. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. The Lancet. 2023 May 13;401(10388):1584-94.

 

Last review date: September 1, 2023