By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (Patisiran) Covered by Humana in Virginia: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Onpattro (Patisiran) Covered by Humana in Virginia

Humana requires prior authorization for Onpattro (patisiran) with specific genetic and clinical documentation. Your fastest path to approval: (1) Have your neurologist submit genetic testing confirming a pathogenic TTR variant, (2) Include baseline mNIS+7 scores and functional assessment, (3) Submit via Humana's provider portal for 24-72 hour review. If denied, you have 65 days to appeal internally, then can request Virginia's external review through the State Corporation Commission within 120 days. Start today: Contact your prescriber to gather genetic testing results and request prior authorization submission.

Table of Contents

  1. Humana's Coverage Policy for Onpattro
  2. Medical Necessity Requirements
  3. Step Therapy and Exceptions
  4. Quantity and Frequency Limits
  5. Required Diagnostics and Documentation
  6. Site of Care Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Letter
  9. Appeals Process for Humana Denials
  10. Virginia External Review Process
  11. Cost and Financial Assistance
  12. Common Denial Reasons and Solutions

Humana's Coverage Policy for Onpattro

Humana covers Onpattro (patisiran) as a Tier 5 specialty medication under Medicare Part B for physician-administered infusions. The medication requires prior authorization across all Humana Medicare Advantage plans, with coverage limited to FDA-approved indications.

Plan Types and Coverage

  • Medicare Advantage: Covers under Part B medical benefit when administered in physician office or infusion center
  • Part D: Does not cover Onpattro as it's not self-administered
  • Commercial plans: Follow similar PA requirements with potential formulary variations

Humana's prior authorization list specifically includes Onpattro for all members, regardless of plan tier.

Medical Necessity Requirements

FDA-Approved Indication

Onpattro is approved exclusively for polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. Requests for cardiac amyloidosis (ATTR-CM) will be denied as this is not an FDA-approved indication.

Core Documentation Requirements

Requirement Documentation Needed Where to Find
Genetic Confirmation Pathogenic TTR gene variant test results Genetic testing lab report
Specialist Evaluation Neurologist, geneticist, or amyloidosis specialist consultation Specialist consultation notes
Clinical Staging mNIS+7 baseline scores, functional status assessment Neurological evaluation
Age Verification Patient ≥18 years old Medical records
Diagnosis Confirmation ICD-10 codes for hATTR-PN Provider documentation
Note: Humana requires genetic testing to confirm a pathogenic TTR variant before considering coverage. Wild-type (non-hereditary) transthyretin amyloidosis is not covered.

Step Therapy and Exceptions

Humana does not require step therapy for Onpattro when prescribed for FDA-approved hATTR-PN, recognizing it as a first-line treatment option alongside other siRNA therapies.

Alternative Treatments Considered

  • Amvuttra (vutrisiran): Subcutaneous siRNA, every 3 months
  • Wainua (eplontersen): Subcutaneous antisense, every 4 weeks
  • Tegsedi (inotersen): Subcutaneous antisense, weekly
  • Supportive care: Symptom management only

Medical necessity letters should explain why Onpattro is preferred over alternatives, particularly for patients who cannot self-inject or have contraindications to subcutaneous therapies.

Quantity and Frequency Limits

Dosing Parameters

  • Weight-based dosing: 0.3 mg/kg for patients <100 kg; fixed 30 mg for patients ≥100 kg
  • Frequency: Every 3 weeks (21 days ± 3 days acceptable)
  • HCPCS billing: J0222 (0.1 mg units), maximum 300 units per dose

Renewal Requirements

Humana typically approves initial authorizations for 6-12 months, requiring renewal documentation:

  • Updated mNIS+7 scores showing stability or improvement
  • Continued functional assessment
  • Absence of significant adverse effects
  • Ongoing medical necessity per specialist evaluation

Required Diagnostics and Documentation

Genetic Testing Requirements

TTR gene sequencing must demonstrate a pathogenic variant among the approximately 130 known amyloidogenic mutations. The genetic testing report should include:

  • Specific variant identified (e.g., Val30Met, Thr60Ala)
  • Classification as pathogenic or likely pathogenic
  • Testing laboratory certification

Neurological Assessment

Comprehensive evaluation must document:

  • Nerve conduction studies confirming large-fiber polyneuropathy
  • Clinical staging using validated tools (mNIS+7, PND score)
  • Functional capacity assessment (6-minute walk test when appropriate)
  • Cardiac screening to rule out significant cardiac involvement
Tip: Submit baseline vitamin A levels, as Onpattro can cause deficiency requiring supplementation.

Site of Care Requirements

Onpattro must be administered in qualified healthcare settings with appropriate monitoring capabilities:

Approved Administration Sites

  • Physician offices with infusion capabilities
  • Hospital outpatient infusion centers
  • Specialty pharmacy infusion suites
  • Ambulatory surgery centers with appropriate staffing

Infusion Requirements

  • Duration: Approximately 80 minutes (including premedication)
  • Monitoring: Vital signs, infusion reaction assessment
  • Equipment: IV access, emergency medications, trained staff
  • Premedication: Antihistamine, corticosteroid, acetaminophen

Evidence to Support Medical Necessity

Clinical Guidelines and Evidence

When preparing medical necessity documentation, reference these authoritative sources:

FDA Prescribing Information: Establishes safety and efficacy for hATTR-PN based on the APOLLO trial showing significant improvement in neuropathy progression.

Neuromuscular Society Guidelines: Recommend gene-silencing therapies as first-line treatment for hATTR-PN when diagnosis is confirmed.

Peer-Reviewed Literature: The landmark APOLLO study demonstrated 34% relative reduction in mNIS+7 progression compared to placebo.

Documentation Best Practices

  • Cite specific guideline recommendations supporting Onpattro use
  • Include baseline functional assessments with objective measures
  • Document previous treatments if applicable (though not required)
  • Emphasize urgency of treatment to prevent irreversible nerve damage

Sample Medical Necessity Letter

Key Elements for Prescriber Letters:

"Patient [Name] is an [age]-year-old adult with genetically confirmed hereditary transthyretin amyloidosis polyneuropathy (hATTR-PN) caused by [specific TTR variant]. Genetic testing performed by [lab] on [date] confirmed a pathogenic variant.

Neurological evaluation demonstrates progressive sensorimotor polyneuropathy with baseline mNIS+7 score of [X], consistent with Stage [I/II] disease. Nerve conduction studies confirm large-fiber neuropathy characteristic of hATTR-PN.

Onpattro (patisiran) is FDA-approved and guideline-recommended as first-line therapy for this indication. The patient meets all coverage criteria and requires immediate treatment to prevent irreversible neurological progression. Alternative therapies are not appropriate due to [specific clinical rationale if applicable].

I request approval for Onpattro 0.3 mg/kg IV every 3 weeks, administered in our certified infusion center with appropriate monitoring and premedication protocols."

Appeals Process for Humana Denials

Internal Appeals Timeline

If Humana denies your Onpattro request, you have 65 days from the denial notice to file an internal appeal.

Standard Appeal Process:

  1. Submit within 65 days via Humana member portal, phone, or mail
  2. Include required documents: Original denial letter, updated medical necessity letter, additional clinical evidence
  3. Decision timeline: 30 days for standard review, 72 hours for expedited appeals
  4. Expedited criteria: When delay could jeopardize life, health, or function

Required Appeal Documentation

  • Complete denial notice with reason codes
  • Prescriber letter addressing specific denial reasons
  • Updated clinical documentation supporting medical necessity
  • Any new evidence (lab results, imaging, specialist opinions)
Tip: Request expedited review if you're experiencing rapid neurological progression, as hATTR-PN can cause irreversible damage.

Virginia External Review Process

If Humana upholds their denial after internal appeals, Virginia residents can request external review through the State Corporation Commission (SCC) Bureau of Insurance.

External Review Timeline and Process

Step Timeline Action Required
File Request Within 120 days of final denial Submit written request to SCC
Eligibility Review 5 business days SCC confirms eligibility
IRO Assignment Day 7 Independent Review Organization assigned
Additional Info 5 business days after assignment Submit extra documentation to IRO
Final Decision Within 45 days IRO issues binding determination

How to File External Review

Contact the Virginia SCC Bureau of Insurance:

  • Website: scc.virginia.gov
  • Phone: 1-877-310-6560
  • Submit written request including denial notices, medical records, and appeal history

Expedited External Review available when delay could seriously jeopardize health - decided within 72 hours for urgent cases.

Important: Virginia's external review is free to consumers, and the IRO's decision is binding on Humana.

Cost and Financial Assistance

Medicare Coverage Structure

With Humana Medicare Advantage, Onpattro falls under Part B medical coverage:

  • 2025 Part D out-of-pocket maximum: $2,100 annually
  • After maximum: Medicare covers 100% of costs
  • Typical annual cost: $450,000-$500,000 depending on patient weight

Financial Assistance Programs

Alnylam Assist: Manufacturer's patient support program offering:

  • Copay assistance for eligible patients
  • Prior authorization support
  • Financial counseling services
  • Free drug program for qualifying uninsured patients

Medicare Extra Help: Low-income subsidy program reducing Part D costs for eligible beneficiaries.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
No genetic confirmation Submit TTR gene testing results Pathogenic variant report from certified lab
Missing specialist evaluation Obtain neurologist consultation Specialist notes confirming hATTR-PN diagnosis
Insufficient clinical staging Complete functional assessments mNIS+7 scores, nerve conduction studies
Off-label use request Clarify FDA-approved indication Emphasize polyneuropathy (not cardiac) indication
Missing baseline measures Gather comprehensive evaluation Vitamin A levels, cardiac screening, functional tests

When Coverage Appeals Fail

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform identifies specific denial reasons and drafts point-by-point responses aligned to each plan's requirements, significantly improving approval rates for complex specialty medications like Onpattro.

For patients facing repeated denials, Counterforce Health provides the expertise needed to navigate payer-specific workflows and produce letters that meet procedural requirements while tracking deadlines and required documentation.

FAQ: Onpattro Coverage by Humana in Virginia

Q: How long does Humana prior authorization take for Onpattro? A: Standard review takes up to 30 days; expedited review 24-72 hours when health is at risk.

Q: What if Onpattro is non-formulary on my plan? A: Request a formulary exception with medical necessity documentation explaining why formulary alternatives are inappropriate.

Q: Can I get expedited appeals in Virginia? A: Yes, both Humana internal appeals and Virginia external reviews offer expedited processes for urgent medical situations.

Q: Does step therapy apply if I haven't tried other treatments? A: No, Humana recognizes Onpattro as first-line therapy for hATTR-PN without requiring prior medication trials.

Q: What happens if Virginia external review denies coverage? A: The IRO decision is final and binding, though you retain rights to pursue legal action separately.

Q: Are there alternatives if I can't get Onpattro covered? A: Other FDA-approved options include Amvuttra (vutrisiran), Wainua (eplontersen), and Tegsedi (inotersen).

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always verify current requirements with Humana directly and consult your healthcare provider for medical decisions. For personalized assistance with appeals, contact the Virginia SCC Bureau of Insurance at 1-877-310-6560.

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