By Counterforce Health Team in Filspari (sparsentan) —

UnitedHealthcare's Coverage Criteria for Filspari (sparsentan) in Florida: What Counts as "Medically Necessary"?

Answer Box: UnitedHealthcare requires prior authorization for Filspari (sparsentan) with specific medical necessity criteria: biopsy-proven primary IgA nephropathy, nephrologist involvement, REMS enrollment, and documented proteinuria ≥0.5-1.0 g/day. Step therapy typically requires maximally tolerated ACE inhibitor/ARB first. Fastest approval path: (1) Complete REMS certification for prescriber and patient enrollment, (2) Submit PA with biopsy report, quarterly LFT plan, and RAS inhibitor history, (3) Use peer-to-peer review if denied. Start with your nephrologist requesting REMS enrollment forms today.

Table of Contents

  1. Policy Overview: How UHC Determines Coverage
  2. Indication Requirements: FDA Status and Medical Necessity
  3. Step Therapy & Exceptions: Required Trials
  4. Quantity Limits & Renewal Requirements
  5. Required Diagnostics & Documentation
  6. Site of Care & REMS-Certified Specialty Pharmacy
  7. Evidence to Support Medical Necessity
  8. Sample "Meets Criteria" Narrative Template
  9. Common Denial Reasons & Solutions
  10. Appeals Process for Florida Patients
  11. FAQ: UnitedHealthcare Filspari Coverage

Policy Overview: How UHC Determines Coverage

UnitedHealthcare's coverage for Filspari (sparsentan) varies by plan type but consistently requires prior authorization through OptumRx. The drug falls under specialty pharmacy benefits with REMS restrictions.

Plan Types and Coverage Patterns

  • Commercial/Employer Plans: Standard PA with 12-month initial authorization
  • Medicare Advantage: Enhanced scrutiny due to OptumRx management
  • Medicaid Community Plan: Electronic submission required as of June 2025
  • Individual/ACA Marketplace: Subject to Florida's enhanced appeal timelines under PTAHA

All plans require nephrologist involvement and REMS compliance before coverage consideration.

Indication Requirements: FDA Status and Medical Necessity

FDA-Approved Indication

Filspari is FDA-approved for adults with primary IgA nephropathy at risk for disease progression. UnitedHealthcare's medical necessity policy requires:

  • Primary IgA nephropathy diagnosis (not secondary causes)
  • Risk of disease progression documented through proteinuria and/or declining eGFR
  • Age ≥18 years (adult indication only)

Biopsy Requirements

IgA nephropathy can only be definitively diagnosed through kidney biopsy showing dominant mesangial IgA deposits. UHC typically requires:

  • Pathology report confirming IgA-dominant mesangial staining
  • Oxford MEST-C scoring when available
  • Exclusion of secondary causes (liver disease, autoimmune conditions)

Step Therapy & Exceptions: Required Trials

Standard Step Therapy Requirements

UnitedHealthcare's OptumRx formulary management typically requires:

  1. Maximally tolerated ACE inhibitor or ARB at ≥50% of maximum labeled dose
  2. Optimized blood pressure control with additional agents as needed
  3. Documentation of inadequate response after appropriate trial period (usually 90+ days)

Medical Exception Pathways

Step therapy can be bypassed when:

  • Contraindications exist to required alternatives
  • Previous intolerance is documented with specific adverse effects
  • Clinical urgency requires immediate Filspari initiation

Document exceptions with specific clinical rationale and supporting lab values showing disease progression despite optimal standard therapy.

Quantity Limits & Renewal Requirements

Initial Authorization Limits

  • Duration: 12 months for most UHC plans
  • Quantity: 30-day supply per fill (standard specialty pharmacy limit)
  • Strength-specific PA: Separate authorizations may be required for 200mg (initiation) and 400mg (maintenance) strengths

Reauthorization Criteria

UnitedHealthcare requires documented clinical response for renewal:

  • Reduction in proteinuria from baseline measurements
  • Stable or improved eGFR trends
  • Continued REMS compliance with quarterly liver function monitoring

Required Diagnostics & Documentation

Laboratory Requirements

Baseline (within 30 days of initiation):

  • Spot urine protein/creatinine ratio or 24-hour urine protein
  • Serum creatinine and calculated eGFR
  • Comprehensive liver function panel (ALT, AST, bilirubin, alkaline phosphatase)

Ongoing Monitoring:

Proteinuria Thresholds

Current nephrology guidelines support biopsy and treatment when proteinuria ≥0.5 g/day in suspected IgA nephropathy. UHC typically expects:

  • Quantified proteinuria (not just dipstick results)
  • Persistent elevation over ≥3 months
  • Documentation of progression risk through trending values

Site of Care & REMS-Certified Specialty Pharmacy

No Facility Administration Required

Unlike infusion therapies, Filspari is self-administered oral medication with no site-of-care restrictions. Coverage in provider-administered settings is typically not medically necessary.

REMS Distribution Requirements

Filspari is only available through REMS-certified specialty pharmacies. Key requirements:

  • Prescriber REMS certification must be completed before prescribing
  • Patient REMS enrollment required before first dispense
  • Pharmacy REMS certification required for dispensing
  • UHC network participation - verify specialty pharmacy is in-network
Tip: Use Travere TotalCare to coordinate REMS enrollment and identify in-network REMS-certified pharmacies for your UHC patients.

Evidence to Support Medical Necessity

Clinical Guidelines to Reference

  1. KDIGO 2024 IgA Nephropathy Guidelines: Support early biopsy for proteinuria ≥0.5 g/day
  2. FDA Prescribing Information: Establishes approved indication and monitoring requirements
  3. Nephrology Society Guidance: American Society of Nephrology position statements on IgA nephropathy management

Peer-Reviewed Evidence

Include citations demonstrating:

  • Progressive nature of IgA nephropathy with current proteinuria levels
  • Inadequacy of standard therapy alone for your patient's risk profile
  • Clinical trial data supporting Filspari's efficacy in similar patients

Sample "Meets Criteria" Narrative Template

"This 45-year-old patient has biopsy-proven primary IgA nephropathy (Oxford MEST-C: M1E0S1T0C0) with persistent proteinuria of 2.1 g/day despite maximally tolerated lisinopril 40mg daily for 6 months. eGFR has declined from 65 to 58 mL/min/1.73m² over 12 months, indicating disease progression. The prescribing nephrologist is REMS-certified, the patient is enrolled in Filspari REMS, and baseline liver function tests are normal. Quarterly LFT monitoring is scheduled per REMS requirements. This clinical presentation meets FDA labeling for primary IgA nephropathy at risk for progression and aligns with KDIGO guideline recommendations for targeted therapy."

Common Denial Reasons & Solutions

Denial Reason Documentation to Include Appeal Strategy
Missing REMS enrollment REMS enrollment confirmation forms Submit completed prescriber and patient REMS forms
Inadequate diagnosis Kidney biopsy pathology report Include IgA-dominant staining confirmation and Oxford scoring
Step therapy not met Prior medication trials and outcomes Document ACE/ARB optimization with specific doses, duration, and response
Quantity limits exceeded Current dosing rationale Provide FDA labeling support for prescribed strength/frequency
Not medically necessary Clinical progression data Submit trending proteinuria and eGFR values showing disease progression

Appeals Process for Florida Patients

Internal Appeal Timeline

Under Florida's Patient Timely Access to Healthcare Act:

  • Standard appeals: 30-day resolution maximum
  • Urgent appeals: 24-72 hours for conditions with severe pain or significant deterioration potential
  • Peer-to-peer review: Request within 21 days of denial

External Review Rights

After final internal denial:

  • Timeline: 4 months to request external review
  • Process: File through Florida Office of Insurance Regulation
  • Cost: No charge to consumer
  • Expedited option: Available for urgent medical situations
Note: Florida's enhanced appeal protections apply to fully-insured plans. Self-funded ERISA plans follow federal timelines.

When to File Regulatory Complaints

Contact Florida's consumer hotline (1-800-FL-HEALTH) if UHC exceeds statutory deadlines or fails to provide required denial documentation.

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements like those for Filspari. Our platform analyzes denial letters, identifies specific coverage criteria, and drafts evidence-backed appeals that address each payer's unique requirements. By automating the appeals process and providing targeted clinical documentation, Counterforce Health helps turn insurance denials into approvals more efficiently.

FAQ: UnitedHealthcare Filspari Coverage

How long does UnitedHealthcare prior authorization take for Filspari in Florida? Standard PA decisions are typically made within 30 days under Florida's new timeline requirements. Expedited review is available within 72 hours for urgent cases.

What if Filspari is non-formulary on my UHC plan? Non-formulary drugs can still be covered through medical exception processes. Submit clinical documentation showing medical necessity and inadequate alternatives.

Can I request an expedited appeal if my kidney function is declining? Yes. Progressive kidney disease with risk of irreversible damage qualifies for expedited appeal processing under Florida's expanded urgent care definitions.

Does step therapy apply if I failed ACE inhibitors outside Florida? Yes. Prior therapy trials from any location count toward step therapy requirements when properly documented with specific medications, doses, duration, and outcomes.

What happens if I miss REMS monitoring appointments? Missing required quarterly liver function tests can result in coverage suspension. Maintain consistent monitoring and notify your pharmacy of any delays.

How do I find a REMS-certified specialty pharmacy in my UHC network? Contact Travere TotalCare for assistance identifying pharmacies that are both UHC-contracted and REMS-certified for Filspari dispensing.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for specific coverage determinations. For additional assistance with insurance appeals in Florida, contact the Florida Department of Financial Services Consumer Helpline at 1-877-MY-FL-CFO.

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