By Counterforce Health Team in Zokinvy (lonafarnib) —

How to Get Zokinvy (lonafarnib) Covered by UnitedHealthcare in New York: Complete Appeal Guide

Quick Answer: Getting Zokinvy Covered by UnitedHealthcare in New York

UnitedHealthcare requires prior authorization for Zokinvy (lonafarnib) with specific genetic testing requirements. For HGPS patients, you need confirmed diagnosis only. For progeroid laminopathies, you must document heterozygous LMNA mutation with progerin-like protein accumulation OR homozygous/compound heterozygous ZMPSTE24 mutations. Submit via the UnitedHealthcare Provider Portal or call 866-889-8054. If denied, New York's external appeal system through the Department of Financial Services gives you strong patient rights with up to 180 days to file and binding decisions on insurers.

First step today: Gather your genetic testing results, clinical notes confirming diagnosis, and patient's height/weight for BSA calculation (must be ≥0.39 m²).

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process in New York
  5. Clinician Corner: Medical Necessity Letter
  6. Cost Savings and Patient Support
  7. When to Escalate
  8. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Zokinvy prescriptions UnitedHealthcare Provider Portal UHC PA Requirements
Age/BSA Limits Patient ≥12 months, BSA ≥0.39 m² Calculate using height/weight FDA Label
HGPS Diagnosis Confirmed Hutchinson-Gilford Progeria Syndrome Clinical notes + genetic testing UHC PA Policy
Progeroid Laminopathies Must document specific LMNA or ZMPSTE24 mutations Genetic testing report UHC PA Policy
Quantity Limits 4 capsules per day maximum Formulary guidelines OptumRx Select Formulary
No Step Therapy No required trial of other medications UHC policy review UHC PA Policy

Step-by-Step: Fastest Path to Approval

1. Confirm Eligibility Requirements

Who does it: Patient's healthcare team
Documents needed: Recent height/weight measurements, genetic testing results
Timeline: Same day

Calculate body surface area using the Mosteller formula. Patient must be ≥12 months old with BSA ≥0.39 m². Verify genetic confirmation of HGPS or qualifying progeroid laminopathy.

2. Gather Required Documentation

Who does it: Clinic staff
Documents needed:

  • Genetic testing report showing LMNA mutation (for HGPS) or specified mutations (for progeroid laminopathies)
  • Clinical notes documenting diagnosis
  • Height, weight, and BSA calculation
  • Prescriber information and NPI

Timeline: 1-2 business days

3. Submit Prior Authorization Request

Who does it: Prescribing physician or authorized staff
How to submit: UnitedHealthcare Provider Portal or call 866-889-8054
Timeline: Submit immediately once documentation is complete

Upload all required documents through the secure portal. For urgent cases, call the PA line directly and request expedited review.

4. Track Your Request

Who does it: Patient or clinic staff
How to check: Provider portal or member services
Timeline: Check status within 2-3 business days

UnitedHealthcare typically responds to standard PA requests within 5-7 business days. Expedited requests receive responses within 24-72 hours.

5. Receive Determination

Timeline: 5-7 business days (standard), 24-72 hours (expedited)

If approved, the authorization will specify covered quantity and duration (typically 12 months for Zokinvy). If denied, you'll receive a detailed explanation of the denial reason.

6. If Denied: Request Peer-to-Peer Review

Who does it: Prescribing physician
How to request: UnitedHealthcare Provider Portal P2P scheduling form
Timeline: Must request within 24 hours of denial notification

The peer-to-peer review allows your physician to speak directly with a UnitedHealthcare medical director to discuss the clinical rationale and provide additional information.

7. File Appeal if Necessary

Who does it: Patient, physician, or authorized representative
Timeline: Up to 180 days in New York
How to file: Internal appeal first, then external review through NY Department of Financial Services if needed

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents to Submit
Missing genetic confirmation Submit complete LMNA testing results Genetic testing report from CLIA-approved lab showing pathogenic LMNA variant
BSA below threshold Recalculate with current measurements Updated height/weight with BSA calculation showing ≥0.39 m²
Insufficient clinical documentation Provide comprehensive medical summary Detailed clinical notes documenting HGPS features and treatment rationale
Dosing outside FDA guidelines Adjust prescription to label recommendations Updated prescription following FDA dosing tables based on BSA
Non-specialist prescriber Obtain specialist consultation Letter from genetics specialist, pediatric cardiologist, or HGPS-experienced physician

Appeals Process in New York

New York offers some of the strongest patient appeal rights in the country. Here's your roadmap:

Internal Appeal (Required First Step)

  • Timeline: File within 180 days of denial
  • How to file: UnitedHealthcare member portal, phone, or mail
  • Response time: 30 days (standard), 72 hours (urgent)
  • Required documents: Original denial letter, medical records, physician letter

External Review Through NY Department of Financial Services

  • When to use: After internal appeal denial or if UnitedHealthcare doesn't respond within required timeframes
  • Timeline: 4 months from final internal denial to request external review
  • Cost: Maximum $25 fee (waived for financial hardship or Medicaid)
  • How to file: NY DFS External Appeals Portal
Note: New York's 2025 Healthcare Appeals Reform Act extended appeal deadlines from 60-120 days to 180 days, giving patients more time to gather documentation and file appeals.

Expedited Appeals for Urgent Cases

If delay in treatment could jeopardize the patient's health:

  • Timeline: 72 hours for standard urgent appeals, 24 hours for urgent drug denials
  • Requirements: Physician attestation that delay poses health risk
  • Reviewer: Independent medical expert in relevant specialty (rare disease experience for Zokinvy cases)

Free Help Available: Contact Community Health Advocates at 888-614-5400 for free assistance with appeals in New York.

Clinician Corner: Medical Necessity Letter

When submitting a PA request or appeal for Zokinvy, your medical necessity letter should include these key elements:

Essential Components Checklist

  • Patient identification: Age, BSA calculation with height/weight
  • Confirmed diagnosis: HGPS or specified progeroid laminopathy with genetic testing results
  • Clinical rationale: Why Zokinvy is medically necessary for this specific patient
  • FDA indication alignment: Reference that patient meets FDA-approved criteria
  • Dosing justification: Explain prescribed dose based on BSA and FDA tables
  • Monitoring plan: How you'll track efficacy and safety
  • Prognosis without treatment: Expected disease progression without intervention

Key Guidelines to Reference

  • FDA Prescribing Information: Zokinvy (lonafarnib) Label
  • Progeria Research Foundation Guidelines: Clinical management recommendations
  • GeneReviews HGPS Chapter: Diagnostic and management standards

Sample Language for Medical Necessity

"This [age]-year-old patient with genetically confirmed HGPS (LMNA mutation: [specify]) has a BSA of [X] m², meeting FDA criteria for Zokinvy treatment. Given the progressive nature of HGPS and documented mortality benefit of lonafarnib in clinical trials, treatment is medically necessary to reduce mortality risk as indicated in the FDA-approved labeling."

Cost Savings and Patient Support

Manufacturer Support Programs

  • Eiger BioPharmaceuticals Patient Support: Contact through prescriber for potential copay assistance and prior authorization support
  • Verify eligibility: Programs typically available for commercially insured patients with coverage determination

Additional Resources

  • Progeria Research Foundation: May provide guidance on accessing care and connecting with experienced centers
  • State Programs: New York residents may qualify for additional support through state rare disease initiatives
Important: Always verify current program availability and eligibility requirements directly with the manufacturer or program administrator.

When to Escalate

Contact New York state regulators if:

  • UnitedHealthcare fails to respond within required timeframes
  • You believe the denial violates state insurance laws
  • You need help navigating the external appeal process

New York Department of Financial Services
Consumer Helpline: 1-800-342-3736
File a complaint online

Community Health Advocates (Free Help)
Phone: 888-614-5400
Provides free assistance with insurance appeals for New York residents

FAQ

How long does UnitedHealthcare PA take in New York?
Standard prior authorization requests typically receive responses within 5-7 business days. Expedited requests for urgent cases are processed within 24-72 hours.

What if Zokinvy is non-formulary on my plan?
Zokinvy appears on OptumRx formularies with prior authorization requirements. If your specific plan excludes it, you can request a formulary exception as part of the appeal process.

Can I request an expedited appeal?
Yes, if your physician attests that delay in treatment could jeopardize your health. Expedited appeals in New York must be decided within 72 hours (24 hours for urgent drug denials).

Does step therapy apply to Zokinvy?
No, UnitedHealthcare's current policy for Zokinvy does not include step therapy requirements. Approval is based on diagnosis confirmation and meeting FDA criteria.

What happens if my internal appeal is denied?
You can request an external review through the New York Department of Financial Services within 4 months of the final internal denial. The external reviewer's decision is binding on UnitedHealthcare.

How much does Zokinvy cost without insurance?
Cash prices can approach $90,000 per month for typical dosing. This makes insurance coverage critical for most families.

Can I get help with the appeals process?
Yes, Community Health Advocates provides free assistance to New York residents at 888-614-5400. Counterforce Health also helps patients, clinicians, and pharmacies turn insurance denials into successful, evidence-backed appeals.

What if I'm on Medicare Advantage with UnitedHealthcare?
The same PA requirements apply, but appeal timelines follow Medicare regulations. You have additional rights under Medicare, including the ability to request an Independent Review Entity (IRE) review.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations can change. Always verify current requirements with your insurer and consult with healthcare professionals for medical decisions.

When insurance denials feel overwhelming, remember that Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies get prescription drugs approved by turning denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each plan's specific requirements, making the appeals process more manageable for families facing rare disease coverage challenges.

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