By Counterforce Health Team in Onpattro (patisiran) —

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

Answer Box: Getting Onpattro (Patisiran) Covered by Humana in Pennsylvania

Humana typically requires prior authorization for Onpattro (patisiran), a specialty medication for hereditary transthyretin amyloidosis polyneuropathy (hATTR-PN). Key requirements: genetic confirmation of TTR variant, neurologist evaluation, documented hATTR-PN diagnosis, and weight-based dosing justification. First step: Have your prescriber submit a prior authorization request through Humana's provider portal with genetic testing results and clinical documentation. If denied, you have 65 days to appeal under Medicare Advantage rules. Pennsylvania's state external review doesn't apply to Medicare plans, so follow federal Medicare appeal processes.

Table of Contents

  1. Humana's Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Dosing and Quantity Limits
  5. Required Diagnostic Documentation
  6. Site of Care and Specialty Pharmacy Requirements
  7. Supporting Evidence for Approval
  8. Appeals Process for Pennsylvania Residents
  9. Common Denial Reasons and Solutions
  10. Cost Assistance and Support Programs
  11. FAQ

Humana's Coverage Policy Overview

Humana covers Onpattro (patisiran) primarily through Medicare Advantage plans, which follow both Medicare guidelines and Humana's specific formulary policies. The medication requires prior authorization across all Humana Medicare plans due to its high cost—approximately $450,000-$500,000 annually depending on patient weight.

Plan Types and Coverage:

  • Medicare Advantage (Part C): Covers Onpattro as a specialty medication with prior authorization
  • Medicare Part D: May cover depending on formulary placement
  • Dual Special Needs Plans: Follow Medicare Advantage guidelines with additional Medicaid coordination

You can check your specific plan's formulary and prior authorization requirements using Humana's Prior Authorization Search Tool (verify with the source linked).

Medical Necessity Requirements

Humana's medical necessity criteria for Onpattro align with FDA labeling and clinical guidelines. Your prescriber must document:

Primary Requirements

  • FDA-approved indication: Polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults
  • Genetic confirmation: Pathogenic TTR gene variant identified through genetic testing
  • Specialist evaluation: Prescription by or consultation with neurologist, geneticist, or amyloidosis specialist
  • Clinical staging: Documentation of hATTR-PN with functional status assessment

Documentation Standards

According to Carelon Medical Benefits Management guidelines, genetic testing for TTR variants is considered medically necessary when transthyretin amyloidosis diagnosis has been confirmed and may only be performed once per lifetime for a given condition.

Clinician Corner: Your medical necessity letter should include: (1) specific TTR variant identified, (2) clinical presentation consistent with hATTR-PN, (3) functional assessment scores if available (mNIS+7, 6-minute walk test), (4) treatment goals and monitoring plan, and (5) weight-based dosing calculation.

Step Therapy and Exception Pathways

Humana may require step therapy depending on your specific plan's formulary design. Common requirements include:

Potential Step Therapy Requirements:

  • Trial of supportive care measures
  • Documentation of disease progression
  • Consideration of alternative therapies (Tegsedi, Amvuttra, Wainua)

Medical Exception Criteria:

  • Contraindications to required step therapy medications
  • Previous trial and failure of step therapy agents
  • Clinical urgency requiring immediate Onpattro initiation

If step therapy applies to your case, work with your prescriber to document any previous treatments tried and their outcomes, including dates of therapy, duration, and reasons for discontinuation.

Dosing and Quantity Limits

Onpattro dosing is strictly weight-based and administered every 3 weeks via IV infusion. According to FDA prescribing information:

Approved Dosing:

  • Patients < 100 kg: 0.3 mg/kg once every 3 weeks
  • Patients ≥ 100 kg: 30 mg once every 3 weeks

Quantity Limits:

  • Maximum dose: 30 mg per infusion
  • Frequency: Every 3 weeks (not more frequent)
  • Annual approval typically required for renewal

Insurance documentation must include patient weight and dosing calculation to justify the requested quantity. Each infusion requires approximately 80 minutes of administration time plus premedication.

Required Diagnostic Documentation

Your approval package should include comprehensive diagnostic documentation:

Genetic Testing Results

  • TTR gene sequencing report showing pathogenic variant
  • Laboratory performing the test and methodology used
  • Genetic counseling documentation (recommended)

Clinical Assessment

  • Neurological examination findings
  • Functional status assessment
  • Baseline neuropathy scores (mNIS+7 if available)
  • Six-minute walk test results (if performed)

Supporting Labs and Imaging

  • Tissue biopsy results (if performed)
  • Cardiac imaging to rule out cardiomyopathy
  • Vitamin A levels (baseline, as Onpattro can cause deficiency)

Site of Care and Specialty Pharmacy Requirements

Onpattro requires administration in a healthcare facility due to infusion-related reaction risks. Humana typically requires:

Infusion Site Requirements:

  • Outpatient infusion center or hospital
  • Trained healthcare professionals for IV administration
  • Emergency equipment available for allergic reactions
  • Premedication administration capability

Specialty Pharmacy Coordination: Many patients receive Onpattro through specialty pharmacies like Accredo that coordinate with infusion centers. The specialty pharmacy handles:

  • Prior authorization submission
  • Insurance benefit verification
  • Delivery to infusion site
  • Patient support services

Supporting Evidence for Approval

Strengthen your prior authorization with evidence-based documentation:

Clinical Guidelines:

  • FDA-approved prescribing information
  • Relevant neurological society recommendations
  • Published clinical trial data (APOLLO study)

Patient-Specific Evidence:

  • Disease progression documentation
  • Impact on quality of life measures
  • Treatment goals and expected outcomes

When citing evidence, focus on peer-reviewed sources and official guidelines rather than manufacturer-sponsored materials alone.

Appeals Process for Pennsylvania Residents

If Humana denies your Onpattro prior authorization, Pennsylvania residents with Medicare Advantage plans must follow federal Medicare appeal procedures, not Pennsylvania's state external review process.

Medicare Advantage Appeal Timeline

Level 1: Plan Reconsideration

  • Deadline: 65 days from denial date
  • Timeline: Decision within 30 days (standard) or 72 hours (expedited)
  • How to file: Online through Humana member portal, phone, or mail

Level 2: Independent Review

  • Automatic: If Level 1 upholds denial
  • Timeline: 30 days for decision
  • Reviewer: Independent contractor, not Humana

Level 3: Administrative Law Judge

  • Threshold: $180 minimum (2024)
  • Timeline: 90 days for decision
  • Process: Phone or video hearing
Note: Pennsylvania's Independent External Review Program, which has overturned about 50% of appealed denials since 2024, does not apply to Medicare Advantage plans. Medicare beneficiaries must use federal appeal processes.

Required Appeal Documents

  • Original denial letter
  • Medical records supporting necessity
  • Prescriber letter of support
  • Any additional clinical evidence

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
No genetic confirmation Submit TTR gene testing results Pathogenic variant report from certified lab
Lack of specialist evaluation Obtain neurologist consultation Specialist evaluation letter with hATTR-PN diagnosis
Off-label use request Clarify FDA-approved indication Documentation of polyneuropathy, not cardiomyopathy
Insufficient clinical documentation Provide comprehensive records Complete medical history, exam findings, staging
Dosing concerns Justify weight-based calculation Patient weight, dosing formula, frequency rationale

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements.

Cost Assistance and Support Programs

Manufacturer Support:

  • Alnylam Assist provides patient support services
  • Financial assistance programs for eligible patients
  • Insurance navigation and prior authorization support

Medicare Programs:

  • Extra Help (Low Income Subsidy) for Part D costs
  • Medicare Supplement Insurance for additional coverage

Foundation Support:

  • Patient advocate foundations may provide grants
  • Disease-specific organizations offer financial assistance

FAQ

How long does Humana prior authorization take for Onpattro in Pennsylvania? Standard prior authorization decisions are made within 72 hours for urgent requests or 14 days for standard requests under Medicare guidelines.

What if Onpattro isn't on Humana's formulary? You can request a formulary exception by demonstrating medical necessity and that preferred alternatives are inappropriate for your condition.

Can I get an expedited appeal if my condition is worsening? Yes, Medicare allows expedited appeals when delays could seriously jeopardize your health. Your doctor must support the expedited request.

Does Humana require step therapy for Onpattro? Step therapy requirements vary by specific plan. Check your formulary or contact Humana to confirm current requirements for your plan.

What happens if I move from Pennsylvania to another state? Your Humana Medicare Advantage coverage may change based on plan availability in your new state. Contact Humana before moving to understand your options.

Can I appeal to Pennsylvania state regulators? No, Medicare Advantage appeals follow federal processes. Contact Medicare (1-800-MEDICARE) for assistance with Medicare-related issues.

From our advocates: We've seen cases where patients initially faced denials due to incomplete genetic testing documentation, but succeeded on appeal when their neurologist provided a comprehensive letter explaining the specific TTR variant, disease progression, and why Onpattro was the most appropriate treatment option. The key was presenting a complete clinical picture rather than just meeting minimum requirements.

Getting Additional Help

If you need assistance navigating Humana's prior authorization process or appealing a denial, consider reaching out to:

  • Medicare's State Health Insurance Assistance Program (SHIP) in Pennsylvania
  • Counterforce Health for specialized appeal assistance
  • Your prescribing physician's patient advocacy team

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for guidance specific to your situation. Coverage policies and requirements may change, so verify current information with Humana and relevant authorities.

Sources & Further Reading

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