By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (patisiran) Covered by UnitedHealthcare in Pennsylvania: Complete PA Guide with Appeal Scripts

Answer Box: Getting Onpattro Covered by UnitedHealthcare in Pennsylvania

UnitedHealthcare requires prior authorization for Onpattro (patisiran) but does NOT require step therapy with other hATTR treatments first. Key requirements: genetic confirmation of pathogenic TTR mutation, neurologist evaluation, disease staging (mNIS+7 or equivalent), and no concurrent RNA interference agents. If denied, Pennsylvania's new external review program overturns ~53% of specialty drug appeals. Start today: Gather TTR genetic testing results and request neurologist consultation for staging documentation.

Table of Contents

  1. UnitedHealthcare Plan Types & Coverage Implications
  2. Onpattro Formulary Status & Tier Placement
  3. Prior Authorization & Utilization Controls
  4. Specialty Pharmacy Requirements
  5. Cost-Share Dynamics
  6. Submission Process & Forms
  7. Common Approval Patterns
  8. Appeals Process for Pennsylvania
  9. FAQ: UnitedHealthcare Onpattro Coverage

UnitedHealthcare Plan Types & Coverage Implications

UnitedHealthcare offers several plan types in Pennsylvania, each with different implications for Onpattro coverage:

Commercial Plans (Employer-Sponsored)

  • HMO plans may require referrals to neurologists
  • PPO plans typically allow direct specialist access
  • All plans route specialty drug PA through OptumRx

Medicare Advantage

  • Subject to federal Medicare Part B coverage rules
  • May have additional utilization management requirements
  • New step therapy protections for existing users starting January 2026

Medicaid Plans

  • Follow Pennsylvania Medicaid guidelines
  • May have additional state-specific requirements
  • Often require enhanced documentation
Note: Onpattro is always covered under the medical benefit (not pharmacy benefit) regardless of plan type, using HCPCS code J0222.

Onpattro Formulary Status & Tier Placement

Coverage Requirements at a Glance

Requirement Details Verification Source
Prior Authorization Required for all plans UnitedHealthcare RNA Policy
Formulary Tier Specialty tier (Tier 3 or dedicated specialty) OptumRx Formulary
Step Therapy NOT required UnitedHealthcare RNA Policy
Specialty Pharmacy Required (Accredo/OptumRx) Provider Resources
Site of Care Hospital outpatient or licensed infusion center UnitedHealthcare RNA Policy

Alternative Treatments Covered:

  • Amvuttra (vutrisiran) - subcutaneous every 3 months
  • Wainua (eplontersen) - subcutaneous every 4 weeks
  • Tegsedi (inotersen) - subcutaneous weekly
  • Supportive care measures

Prior Authorization & Utilization Controls

Required Documentation Checklist

Essential Clinical Evidence:

  • ✅ Genetic testing confirming pathogenic TTR mutation
  • ✅ Neurologist evaluation with staging assessment
  • ✅ ICD-10 code E85.1 (hereditary transthyretin amyloidosis)
  • ✅ Disease severity documentation (one of the following):
    • mNIS+7 score
    • PND score ≤ IIIb
    • FAP Stage 1 or 2
    • 6-minute walk test results
    • Karnofsky Performance Status ≥ 60%

Exclusion Criteria (Must Document Absence):

  • No prior liver transplant
  • No concurrent use of other TTR-targeted therapies
  • Weight-appropriate dosing (0.3 mg/kg, max 30mg every 3 weeks)

Clinician Corner: Medical Necessity Letter

Your medical necessity letter should include:

  1. Patient-specific diagnosis with genetic variant details
  2. Functional assessment using validated scales (mNIS+7 preferred)
  3. Treatment rationale citing FDA labeling
  4. Monitoring plan for infusion reactions and vitamin A deficiency
  5. Site of care justification for infusion center administration
Tip: Include specific TTR mutation details (e.g., V30M, T60A) as UnitedHealthcare's policy requires genetic confirmation, not just clinical suspicion.

Specialty Pharmacy Requirements

Onpattro must be sourced through UnitedHealthcare's designated specialty pharmacy network:

Primary Options:

  • Accredo Health Group - Most common for UnitedHealthcare members
  • OptumRx Specialty Pharmacy - Integrated with UnitedHealthcare systems

Patient Enrollment Process:

  1. Provider submits approved PA to specialty pharmacy
  2. Pharmacy conducts benefits verification
  3. Patient enrollment call for delivery coordination
  4. Drug shipped to infusion site (not patient's home)
  5. Infusion scheduled with approved facility

Billing Structure:

  • Specialty pharmacy bills UnitedHealthcare for drug cost (J0222)
  • Infusion site bills for administration (CPT 96365/96366)
  • Patient responsible for applicable cost-sharing
Important: Onpattro cannot be obtained through retail or mail-order pharmacy. Attempts to fill through standard pharmacy channels will be denied.

Cost-Share Dynamics

Typical Cost Structure (Educational Only)

Specialty Tier Placement:

  • Deductible typically applies before coverage begins
  • Coinsurance often 20-40% of drug cost after deductible
  • Annual out-of-pocket maximums provide cost protection

Financial Assistance Options:

  • Alnylam Assist - Manufacturer support program
  • Patient Advocate Foundation - Copay assistance for qualifying patients
  • State pharmaceutical assistance programs in Pennsylvania
Note: This is educational information only. Consult your specific plan documents for exact cost-sharing details.

Submission Process & Forms

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Caregiver)

  • Insurance cards and policy information
  • Complete genetic testing results showing TTR mutation
  • All neurologist consultation notes
  • Previous treatment history and outcomes

2. Neurologist Evaluation (Healthcare Provider)

  • Complete functional assessment using mNIS+7 or equivalent
  • Document disease stage and progression
  • Confirm no contraindicated concurrent therapies

3. Submit Prior Authorization (Healthcare Provider)

  • Use UnitedHealthcare provider portal for fastest processing
  • Include all required clinical documentation
  • Request expedited review if medically urgent (72-hour timeline)

4. Track Submission Status

  • Monitor through provider portal or TrackIt system
  • Standard review: 30 days for pre-service requests
  • Follow up if no response within expected timeframe

5. If Approved: Coordinate Specialty Pharmacy

  • PA approval triggers specialty pharmacy enrollment
  • Confirm infusion site and delivery logistics
  • Schedule first infusion appointment

6. If Denied: Initiate Appeal Process

  • Request peer-to-peer review with UnitedHealthcare medical director
  • Gather additional supporting documentation
  • Consider Pennsylvania external review if internal appeals fail

Common Approval Patterns

What Strong Submissions Include

Successful PA Submissions Typically Feature:

  • Detailed genetic report with specific mutation identified
  • Comprehensive neurologist assessment with validated scoring
  • Clear documentation of hATTR-PN diagnosis (not cardiac amyloidosis)
  • Evidence of disease progression affecting quality of life
  • Appropriate weight-based dosing calculations

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
Insufficient genetic evidence Submit complete genetic panel results Pathogenic TTR variant confirmation
Missing specialist evaluation Obtain neurologist consultation Detailed assessment with staging
Inadequate disease staging Provide validated functional measures mNIS+7, 6MWT, or equivalent scores
Concurrent therapy concerns Document medication reconciliation Current medication list with rationale
Dosing discrepancies Verify weight-based calculations Patient weight and dosing justification

Appeals Process for Pennsylvania

Pennsylvania offers one of the strongest patient protection systems in the country for insurance appeals, especially since launching its Independent External Review Program in 2024.

Internal Appeals Timeline

UnitedHealthcare Internal Process:

  • Filing deadline: 180 days from denial date in Pennsylvania
  • Standard appeals: 30 days for pre-service, 60 days for post-service
  • Expedited appeals: 72 hours if delay would jeopardize health
  • Peer-to-peer option: Request medical director review (often improves success rates)

Pennsylvania External Review Program

New State-Supervised Process (2024+):

  • Eligibility: Must complete UnitedHealthcare internal appeals first
  • Filing window: 4 months from final adverse determination
  • Success rate: 53% of specialty drug appeals overturned in first year
  • Timeline: 45 days standard, 72 hours expedited

How to File External Review:

  1. Obtain final denial letter from UnitedHealthcare
  2. Submit request through Pennsylvania Insurance Department portal
  3. Include all medical records and supporting documentation
  4. Submit additional evidence within 15 days of assignment to IRO
  5. Await binding decision from independent medical reviewers
Pennsylvania Advantage: The state's external review program has shown particularly strong success rates for rare disease treatments, with independent reviewers often finding medical necessity where insurers initially denied coverage.

Patient Support Resources

Pennsylvania Insurance Department

  • Consumer Services: 1-877-881-6388
  • External Review Portal: Available at pa.gov
  • Filing Guide (PDF)

Additional Support:

  • Pennsylvania Health Law Project - Free legal assistance for complex appeals
  • Pennie Consumer Hotline - For marketplace plan issues

Counterforce Health: Expert Appeals Assistance

When facing complex prior authorization denials or appeals, many patients and providers turn to specialized services for support. Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to the plan's own rules, pulling the right medical evidence and weaving it into appeals that meet procedural requirements while tracking deadlines.

For Onpattro cases specifically, having expert assistance can be valuable given the complex genetic and neurological documentation requirements, especially when navigating Pennsylvania's multi-level appeals process.

FAQ: UnitedHealthcare Onpattro Coverage

Q: How long does UnitedHealthcare prior authorization take for Onpattro in Pennsylvania? A: Standard PA reviews take up to 30 days for pre-service requests. Expedited reviews are completed within 72 hours if delay would jeopardize health. Track status through the UnitedHealthcare provider portal.

Q: Does UnitedHealthcare require trying other hATTR treatments before Onpattro? A: No, UnitedHealthcare does not require step therapy for Onpattro. However, they prohibit concurrent use with other RNA interference agents or TTR stabilizers like Tegsedi or tafamidis.

Q: What if Onpattro is denied as "not medically necessary"? A: Request a peer-to-peer review with a UnitedHealthcare medical director. Ensure your submission includes genetic confirmation, neurologist evaluation, and validated disease staging measures. Consider Counterforce Health assistance for complex appeals.

Q: Can I get Onpattro through home infusion with UnitedHealthcare? A: Potentially, but this requires specific approval. Most UnitedHealthcare policies require administration in hospital outpatient departments or licensed infusion centers. Work with your specialty pharmacy to explore options.

Q: What's the success rate for Onpattro appeals in Pennsylvania? A: Pennsylvania's external review program overturned 53% of specialty drug denials in 2024. Internal appeal success rates aren't published, but peer-to-peer reviews often improve outcomes significantly.

Q: How much will Onpattro cost with UnitedHealthcare coverage? A: Costs vary by specific plan. Onpattro is typically on specialty tiers with coinsurance (often 20-40%) after deductible. Annual out-of-pocket maximums provide cost protection. Check with Alnylam Assist for potential copay assistance.

Q: What happens if I miss the Pennsylvania external review deadline? A: The 4-month deadline is generally firm, but contact the Pennsylvania Insurance Department at 1-877-881-6388 to discuss your specific situation. They may provide guidance on exceptional circumstances.

Q: Can my primary care doctor prescribe Onpattro? A: UnitedHealthcare requires prescription by or in consultation with a neurologist. Primary care physicians typically cannot meet this requirement independently.

This guide provides educational information about insurance coverage and is not medical advice. For clinical questions about Onpattro, consult your healthcare provider. For specific coverage details, contact UnitedHealthcare member services or review your plan documents.

Sources & Further Reading

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