By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (patisiran) Covered by Humana in New Jersey: Complete Prior Authorization and Appeals Guide

Answer Box: Quick Path to Onpattro Coverage

To get Onpattro (patisiran) covered by Humana in New Jersey: Your prescriber must submit prior authorization with genetic testing confirming TTR variant, neurologist evaluation documenting hATTR-PN, and baseline mNIS+7 scores. Humana requires 65 days for appeals under Medicare rules. If denied, New Jersey's Independent Health Care Appeals Program (IHCAP) provides external review within 180 days of final denial. First step today: Contact your prescriber to initiate genetic testing and gather clinical documentation for the PA submission.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation
  5. Step-by-Step: Fastest Path to Approval
  6. Common Denial Reasons & Fixes
  7. Appeals Playbook for New Jersey
  8. Specialty Pharmacy Network
  9. Costs & Financial Assistance
  10. FAQ
  11. Sources & Further Reading

Who Should Use This Guide

This guide helps patients with hereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR-PN) and their healthcare teams navigate Humana's prior authorization process for Onpattro (patisiran) in New Jersey. You'll need this if:

  • You have confirmed hATTR-PN with a pathogenic TTR gene variant
  • Your neurologist recommends Onpattro for polyneuropathy symptoms
  • You have Humana Medicare Advantage or commercial coverage
  • You've received a denial and need to appeal

Expected outcome: With proper documentation, most denials can be overturned. Medicare Advantage appeals have an ~82% success rate when properly submitted with complete clinical evidence.

Member & Plan Basics

Coverage Requirements

  • Active Humana coverage (Medicare Advantage Part B or commercial medical benefit)
  • Prior authorization required for all Onpattro prescriptions due to ~$450,000-$500,000 annual cost
  • No step therapy required for FDA-approved hATTR-PN indication
  • Site of care: Qualified infusion centers, physician offices, or hospital outpatient departments
Note: Onpattro is covered under medical benefits (Part B), not pharmacy benefits (Part D), because it requires IV infusion every 3 weeks.

Clinical Criteria Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
Genetic confirmation Pathogenic TTR variant via blood/saliva testing Invitae, Ambry Genetics, or similar lab Genetic testing labs
Specialist evaluation Neurologist, geneticist, or amyloidosis specialist prescription Provider credentials and consultation notes Humana PA requirements
FDA indication hATTR-PN polyneuropathy (not cardiomyopathy) ICD-10: E85.2, G62.9 FDA label
Baseline assessments mNIS+7 scores, functional status (PND ≤IIIb) Neurological exam documentation Clinical assessment tools
Weight-based dosing 0.3 mg/kg (max 30mg) IV every 3 weeks Patient weight documentation Dosing guidelines

Required Documentation

Your prescriber must submit:

  • Genetic test results showing pathogenic TTR variant
  • Neurologist evaluation confirming hATTR-PN diagnosis
  • Baseline mNIS+7 scores (modified Neuropathy Impairment Score +7)
  • Functional assessment including polyneuropathy disability stage
  • Weight documentation for proper dosing calculation
  • Treatment history if any prior therapies attempted

Coding & Documentation

ICD-10 Codes

  • Primary: E85.2 (Amyloidosis due to transthyretin mutation)
  • Secondary: G62.9 (Polyneuropathy, unspecified)
  • Additional: May include specific neuropathy codes (G60-G65 series)

HCPCS/Billing

  • J-Code: J3490 or C9030 (verify with current CMS updates)
  • Maximum units: 300 billable units every 3 weeks
  • Administration: Bill separately using appropriate HCPCS G-codes for infusion

Step-by-Step: Fastest Path to Approval

1. Confirm Genetic Testing (Patient + Provider)

Who: Patient schedules, provider orders
Document: TTR gene sequencing results showing pathogenic variant
Timeline: 2-3 weeks for results
Resource: Alnylam Act genetic testing program

2. Specialist Evaluation (Provider)

Who: Neurologist, geneticist, or amyloidosis specialist
Document: Consultation note confirming hATTR-PN diagnosis
Timeline: Schedule within 2-4 weeks
Submit: Include mNIS+7 baseline scores and functional assessment

3. Gather Clinical Documentation (Provider)

Who: Healthcare team
Documents: Weight, baseline assessments, treatment history
Timeline: 1-2 business days to compile
Format: Comprehensive clinical summary with all required elements

4. Submit Prior Authorization (Provider)

Who: Prescriber or designated staff
How: Humana provider portal or fax to 502-508-9300
Timeline: Submit within 1 week of gathering documentation
Confirmation: Record PA reference number for tracking

5. Enroll with Specialty Pharmacy (Patient + Provider)

Who: Complete Alnylam Assist enrollment together
Timeline: Within 24-48 hours of PA approval
Options: Accredo, CVS Specialty, Orsini, or other preferred network pharmacy
Resource: Alnylam Assist enrollment

6. Coordinate Infusion Site (Patient + Provider)

Who: Patient with specialty pharmacy support
Options: Physician office, outpatient infusion center, qualified facility
Timeline: Schedule first infusion within 1-2 weeks of drug shipment
Duration: Plan for 80-minute infusions including premedication

7. Track and Monitor (Ongoing)

Who: Healthcare team with patient participation
Schedule: Every 3 weeks for infusions, quarterly assessments
Documentation: Update mNIS+7 scores for renewal authorizations
Renewal: Annual PA renewal required with stability/improvement data

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
No genetic confirmation Submit TTR sequencing results Pathogenic variant report from certified lab
Missing specialist evaluation Provide neurologist consultation Board-certified neurologist note confirming hATTR-PN
Off-label use request Clarify FDA-approved indication Emphasize polyneuropathy (not cardiomyopathy) indication
Insufficient baseline data Submit complete assessments mNIS+7 scores, functional status, weight documentation
Site of care issues Confirm qualified facility Verify infusion center meets Humana network requirements
From our advocates: We've seen denials overturned quickly when providers include a comprehensive letter addressing each PA criterion point-by-point, with genetic test results attached as the first supporting document. The key is demonstrating clear medical necessity within FDA labeling.

Appeals Playbook for New Jersey

Humana Internal Appeals

  • Level 1 Reconsideration: 65 days from denial date
  • Timeline: 30 days standard, 72 hours expedited
  • How to file: Humana member portal, phone (1-800-457-4708), or mail
  • Required: Denial letter, additional clinical documentation, provider letter

New Jersey External Review (IHCAP)

If Humana upholds the denial, New Jersey's Independent Health Care Appeals Program provides independent medical review:

  • Deadline: 180 days from final internal denial
  • Process: Submit directly to Maximus Federal Services (contracted IURO)
  • Cost: Free to patients (insurer pays all fees)
  • Timeline: 5 business days for acceptance, 45 days for decision
  • Success rate: Approximately 50% of external appeals favor consumers nationwide

Contact Information:

  • IHCAP Hotline: 1-888-393-1062
  • NJ DOBI Consumer Hotline: 1-800-446-7467
  • Expedited appeals: Available when delay would cause serious harm
Tip: New Jersey allows providers to file external appeals on behalf of patients with consent, which can streamline the process for complex cases like Onpattro.

Specialty Pharmacy Network

Onpattro requires distribution through certified specialty pharmacies. Humana-preferred options include:

  • Accredo Health Group: 1-866-581-5248
  • CVS Specialty: Supports home infusion coordination
  • Orsini Specialty Pharmacy: 24/7 support, in-home nursing available
  • US Bioservices: AmerisourceBergen network

Enrollment Process:

  1. Complete Alnylam Assist Start Form
  2. Case manager contacts within 1-2 business days
  3. Benefit verification and shipment coordination
  4. Infusion site scheduling and support

Costs & Financial Assistance

Medicare Coverage (2025)

  • Part B deductible: $257 annually
  • Coinsurance: 20% after deductible (typically $90,000-$100,000 annually)
  • Out-of-pocket maximum: No cap under Part B (consider Medigap)

Financial Assistance Programs

  • Alnylam Assist: Patient support program with financial assistance eligibility
  • Medicare Extra Help: Not applicable (Part B coverage)
  • State programs: New Jersey pharmaceutical assistance programs for qualifying residents
  • Foundation grants: National Organization for Rare Disorders (NORD), HealthWell Foundation
Note: Commercial insurance patients may have different cost-sharing structures and copay assistance options.

FAQ

How long does Humana prior authorization take in New Jersey? Standard PA decisions take up to 30 days. Expedited requests (when health is at risk) are processed within 72 hours. Submit complete documentation to avoid delays.

What if Onpattro is non-formulary on my plan? Humana typically covers Onpattro under medical benefits (Part B) rather than pharmacy benefits, so formulary status is less relevant. PA focuses on medical necessity criteria.

Can I request an expedited appeal if denied? Yes, if delays would seriously jeopardize your health. Both Humana and New Jersey's IHCAP process expedited appeals with shortened timelines.

Does step therapy apply if I've tried treatments outside New Jersey? Humana doesn't require step therapy for Onpattro when prescribed for FDA-approved hATTR-PN. Prior treatment history from any state should be documented but isn't required for approval.

What happens if I move from New Jersey during treatment? Your Humana coverage typically continues, but appeals processes may change based on your new state's regulations. Notify both Humana and your specialty pharmacy of address changes.

How often do I need prior authorization renewal? Initial authorizations typically last 6-12 months. Renewals require updated mNIS+7 scores showing stability or improvement, along with continued medical necessity documentation.

Sources & Further Reading

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals that address specific payer requirements. For complex cases like Onpattro coverage, we identify the exact denial basis and draft point-by-point rebuttals aligned with each plan's own rules.

This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. For personalized guidance, consult with your healthcare provider and contact Humana directly. New Jersey residents can access free assistance through the state's consumer protection programs listed above.

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