By Counterforce Health Team in Firdapse (amifampridine) —

UnitedHealthcare's Coverage Criteria for Firdapse (amifampridine) in New Jersey: What Counts as "Medically Necessary"?

Answer Box: Getting Firdapse Approved by UnitedHealthcare in New Jersey

UnitedHealthcare requires prior authorization for Firdapse (amifampridine) through OptumRx with confirmed LEMS diagnosis by a neurologist, diagnostic testing (EMG and VGCC antibodies), and no seizure history. No step therapy is required. If denied, you have 60 days to appeal internally, then access to New Jersey's external review through Maximus Federal Services (for Medicare Advantage) or IHCAP (for commercial plans). First step today: Have your neurologist complete the OptumRx PA form with diagnostic documentation and submit via the provider portal.

Table of Contents

  1. Policy Overview: How UnitedHealthcare Covers Firdapse
  2. Indication Requirements: LEMS Diagnosis Standards
  3. Step Therapy & Exceptions: What You Must Try First
  4. Quantity & Frequency Limits: Dosing Maximums
  5. Required Diagnostics: Essential Tests and Documentation
  6. Site of Care & Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Narrative
  9. Appeals Process: New Jersey Rights and Timelines
  10. Common Denial Reasons & Solutions
  11. FAQ: Your Top Questions Answered

Policy Overview: How UnitedHealthcare Covers Firdapse

UnitedHealthcare covers Firdapse (amifampridine) as a specialty medication requiring prior authorization across all plan types in New Jersey. The drug appears on formularies as Tier 3 or 4 with quantity limits and must be dispensed through approved specialty pharmacies.

Plan Coverage by Type:

  • Commercial HMO/PPO: Prior authorization via OptumRx, 12-month approval periods
  • Medicare Advantage: Federal MA rules apply, external review through Maximus Federal Services
  • Medicaid MCO: State Medicaid criteria with OptumRx administration

Coverage is administered through OptumRx, UnitedHealthcare's pharmacy benefit manager, which maintains the prior authorization forms and approval criteria.

Indication Requirements: LEMS Diagnosis Standards

Firdapse is FDA-approved only for Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients ≥6 years. UnitedHealthcare follows this labeling strictly.

Required Diagnostic Elements:

  • Confirmed LEMS diagnosis with clinical triad: proximal limb weakness, autonomic symptoms, reduced reflexes
  • P/Q-type voltage-gated calcium channel (VGCC) antibodies with titers >30 pmol/L (present in 85-90% of cases)
  • Electromyography (EMG) with repetitive nerve stimulation showing >100% post-exercise CMAP increment
  • Neurologist confirmation of diagnosis and treatment plan
Note: About 10-15% of LEMS patients remain seronegative for VGCC antibodies. In these cases, diagnosis relies heavily on characteristic EMG findings and clinical presentation under specialist care.

Step Therapy & Exceptions: What You Must Try First

Good news: UnitedHealthcare does not require step therapy for Firdapse when treating confirmed LEMS. Unlike many specialty medications, you do not need to fail pyridostigmine or other symptomatic treatments first.

However, your medical necessity letter should document:

  • Any prior symptomatic treatments tried (pyridostigmine, IVIG, immunosuppression)
  • Response or intolerance to previous therapies
  • Rationale for why Firdapse is the appropriate first-line or subsequent treatment

This documentation strengthens your case even though step therapy isn't mandated.

Quantity & Frequency Limits: Dosing Maximums

UnitedHealthcare's quantity limits align with FDA labeling:

Patient Weight Maximum Daily Dose Maximum Single Dose Typical Monthly Quantity Limit
Adults & pediatric ≥45 kg 100 mg/day 20 mg 300 tablets (10 mg)
Pediatric <45 kg 50 mg/day 10 mg 150 tablets (10 mg)

Dosing Schedule: 3-5 divided doses daily, roughly every 3-4 hours while awake. The updated Firdapse prescribing information now supports 100 mg/day maximum for adults, increased from earlier 80 mg/day limits.

Renal/Hepatic Impairment: Start at lowest initial dose (15 mg/day if ≥45 kg, 5 mg/day if <45 kg) and titrate cautiously.

Required Diagnostics: Essential Tests and Documentation

Your prior authorization package must include specific diagnostic evidence:

Essential Lab Tests:

  • P/Q-type VGCC antibody results (Quest, Mayo, or equivalent CLIA lab)
  • Complete metabolic panel to assess renal function
  • Liver function tests if hepatic impairment suspected

Electrodiagnostic Studies:

  • EMG/NCS report showing characteristic LEMS findings
  • Repetitive nerve stimulation with documented post-exercise increment >100%
  • Must be performed by qualified neurologist or neuromuscular specialist

Clinical Documentation:

  • Neurology consultation notes confirming LEMS diagnosis
  • Medication history documenting no seizure disorder
  • Functional assessment showing disability from untreated LEMS
Tip: Blood draws for antibody testing should occur before starting immunosuppression to maximize sensitivity. VGCC antibodies may be undetectable for 6-12 months after symptom onset in some patients.

Site of Care & Specialty Pharmacy Requirements

Firdapse has restricted distribution and must be dispensed through approved specialty pharmacies:

Primary Options:

  • AnovoRx Group (Catalyst's exclusive specialty pharmacy)
  • Optum Specialty Pharmacy
  • Accredo Health Group

Submission Process:

  1. Verify in-network specialty pharmacy via UnitedHealthcare member services
  2. Send prescription directly to approved specialty pharmacy
  3. Specialty pharmacy initiates prior authorization process
  4. Patient enrollment in manufacturer support program typically required

Using an out-of-network pharmacy will result in denial or significantly higher cost-sharing.

Evidence to Support Medical Necessity

Your medical necessity letter should reference authoritative sources:

Primary Guidelines:

  • FDA Firdapse prescribing information - establishes on-label use for LEMS
  • American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) LEMS diagnostic criteria
  • Muscle Study Group consensus statements on LEMS treatment

Key Clinical Evidence Points:

  • Firdapse is the only FDA-approved amifampridine product for LEMS (Ruzurgi approval was withdrawn in 2022)
  • Clinical trials demonstrate significant improvement in muscle strength and functional capacity
  • LEMS without treatment leads to progressive weakness, falls, and loss of independence

Functional Impact Documentation: Include specific measures like:

  • Number of falls in past month
  • Distance able to walk without assistance
  • Ability to perform activities of daily living
  • Work or school attendance impacts

Sample Medical Necessity Narrative

[Patient Name] is a [age]-year-old with confirmed Lambert-Eaton myasthenic syndrome diagnosed by clinical presentation, positive P/Q-type VGCC antibodies (titer: [value] pmol/L), and characteristic EMG findings showing [specific increment percentage] post-exercise CMAP increment. The patient experiences significant proximal limb weakness, autonomic dysfunction including [specific symptoms], and functional impairment affecting [specific activities]. Prior treatments including [list medications/therapies tried] provided [outcome]. Firdapse (amifampridine) is the FDA-approved treatment for LEMS and is medically necessary to improve neuromuscular transmission, reduce fall risk, and restore functional capacity. Proposed dosing is [dose] mg divided [frequency] times daily, not exceeding FDA maximum limits. The patient has no seizure history or contraindications. Treatment goals include improved muscle strength, reduced falls, and enhanced quality of life with regular neurologic monitoring.

Appeals Process: New Jersey Rights and Timelines

If your Firdapse prior authorization is denied, New Jersey residents have strong appeal rights:

Internal Appeals (UnitedHealthcare)

Commercial Plans:

  • Level 1 Appeal: 60 days to file, 30 days for standard decision (72 hours expedited)
  • Level 2 Appeal: Available if required by plan
  • Submit via UnitedHealthcare provider portal, fax, or mail per denial letter instructions

Medicare Advantage Plans:

  • Reconsideration: 60 days to file, 30 days for decision (72 hours expedited)
  • Automatic forwarding to Independent Review Entity (Maximus Federal Services) if denied

External Review Options

Commercial Plans: New Jersey IHCAP

  • File within 180 days of final internal denial
  • Managed by Maximus Federal Services as Independent Utilization Review Organization
  • Free to patients, binding on insurers
  • Decision within 45 days (expedited available)

Medicare Advantage: Federal IRE process through Maximus Federal Services, not state IHCAP

From our advocates: We've seen cases where UnitedHealthcare initially denied Firdapse for "insufficient diagnostic evidence," but approval was granted on appeal when the neurologist provided a detailed letter explaining why seronegative LEMS was still the correct diagnosis based on EMG findings and clinical response to treatment. Thorough documentation of the diagnostic reasoning often resolves these denials.

Getting Help

Contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 or IHCAP-specific line at 1-888-393-1062 for guidance on the external review process.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
"Insufficient diagnostic evidence" Provide complete EMG report and VGCC antibody results EMG with RNS showing >100% increment, positive VGCC antibodies or explanation if seronegative
"Not prescribed by specialist" Ensure neurologist submits PA Neurology consultation notes confirming LEMS diagnosis
"Exceeds quantity limits" Verify dosing within FDA limits Prescription showing ≤100 mg/day (adults) or ≤50 mg/day (<45 kg)
"Seizure history contraindication" Document absence of seizure disorder Medication list and neurologic history confirming no seizures
"Missing medical necessity" Submit comprehensive letter Functional impact, treatment goals, monitoring plan

FAQ: Your Top Questions Answered

How long does UnitedHealthcare prior authorization take in New Jersey? Standard PA decisions are made within 3-5 business days. Expedited reviews (for urgent medical needs) are completed within 72 hours.

What if Firdapse is non-formulary on my plan? Firdapse appears on most UnitedHealthcare formularies as Tier 3 or 4. If truly non-formulary, request a formulary exception with medical necessity documentation.

Can I request an expedited appeal if denied? Yes, if delays would seriously jeopardize your health or ability to regain function. Your neurologist must certify the urgent medical need.

Does step therapy apply if I've tried treatments outside New Jersey? No step therapy is required for Firdapse in LEMS treatment, regardless of where prior therapies were tried.

What's the difference between commercial and Medicare Advantage appeals? Commercial plans use New Jersey's IHCAP for external review; Medicare Advantage uses federal IRE process through Maximus Federal Services.

How much does Firdapse cost without insurance? Retail cash prices can exceed $28,000 monthly. Catalyst's patient support program offers copay assistance and free drug programs for eligible patients.

Can my doctor submit the appeal for me? Yes, providers can file appeals on behalf of patients with written authorization. This is often more effective as they can provide detailed clinical rationale.

What happens if external review denies coverage? For commercial plans, you may have additional state-level complaint options. For Medicare Advantage, you can proceed to Administrative Law Judge hearing if the amount meets federal thresholds.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Firdapse. Our platform analyzes denial letters, identifies specific coverage gaps, and generates evidence-backed appeals that address each payer's unique criteria. We help patients, clinicians, and specialty pharmacies navigate the prior authorization process with targeted documentation that speaks directly to plan policies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions vary by plan and individual circumstances. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For assistance with appeals and prior authorizations, consider working with organizations like Counterforce Health that specialize in insurance navigation for specialty medications.

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