How to Get Onpattro (patisiran) Covered by UnitedHealthcare in Washington: Complete Appeals Guide with Templates
Quick Answer: Getting Onpattro Covered by UnitedHealthcare in Washington
Fastest path to approval: 1) Ensure genetic testing confirms pathogenic TTR variant, 2) Submit prior authorization through UnitedHealthcare Provider Portal with neurologist evaluation, baseline mNIS+7 and 6MWT scores, 3) If denied, request peer-to-peer review within 24 hours, then file internal appeal within 180 days. Washington residents have strong external review rights through Independent Review Organizations (IROs) with binding decisions. Start today: Call UnitedHealthcare at the number on your insurance card to confirm your plan's specific prior authorization requirements.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Read the Denial: Decode Reason Codes
- Fixable Causes Before You Appeal
- First-Level Appeal Strategy
- Peer-to-Peer Review Process
- Washington External Review Rights
- Medical Necessity Letter Template
- Common Denial Reasons & Solutions
- Cost Assistance Options
- When to Contact Washington Regulators
- Frequently Asked Questions
Coverage Requirements at a Glance
Requirement | What It Means | Where to Find It | Timeline |
---|---|---|---|
Prior Authorization | Required for all Onpattro prescriptions | UnitedHealthcare Provider Portal | 15 business days standard |
Genetic Testing | Pathogenic TTR variant confirmation | Lab report with specific mutation | Must be current |
Neurologist Evaluation | Specialist diagnosis of hATTR-PN | Neurology consultation note | Within 6 months |
Baseline Measurements | mNIS+7 and 6-minute walk test | Clinical assessment documentation | Required for approval |
Step Therapy | May require trying alternatives first | UnitedHealthcare formulary policy | Exceptions possible |
Step-by-Step: Fastest Path to Approval
1. Confirm Your Plan Requirements
Who does it: Patient or clinic staff
Document needed: Insurance card, member ID
How to submit: Call UnitedHealthcare member services
Timeline: Same day
Source: UnitedHealthcare Member Portal
2. Gather Required Documentation
Who does it: Healthcare team
Documents needed:
- Genetic test results showing pathogenic TTR variant
- Neurologist evaluation confirming hATTR-PN diagnosis
- Baseline mNIS+7 score and 6-minute walk test results
- Prior therapy documentation (if applicable) Timeline: 1-2 weeks to collect
3. Submit Prior Authorization
Who does it: Prescribing physician
How to submit: UnitedHealthcare Provider Portal or designated API
Timeline: Submit 2-3 weeks before intended treatment start
Expected decision: 15 business days (24 hours for urgent requests)
4. If Denied: Request Peer-to-Peer Review
Who does it: Prescribing physician
How to request: Call UnitedHealthcare Provider Services
Timeline: Within 24 hours of denial
Expected outcome: Decision within 24 business hours
5. File Internal Appeal
Who does it: Patient, physician, or authorized representative
How to submit: UnitedHealthcare appeals portal or mail
Timeline: Within 180 days of denial
Decision timeframe: 30 days standard, 72 hours expedited
6. Request Washington External Review
Who does it: Patient or representative
How to request: Through Washington Office of the Insurance Commissioner
Timeline: Within 60 days of final internal denial
Decision: Binding on UnitedHealthcare within 20 days
Read the Denial: Decode Reason Codes
When UnitedHealthcare denies Onpattro coverage, the denial letter will include specific reason codes. Common codes include:
- PA required: Prior authorization not submitted or incomplete
- Non-formulary: Drug not on preferred list (exceptions possible)
- Step therapy: Must try preferred alternatives first
- Medical necessity: Clinical criteria not met
- Quantity limit: Dosing exceeds plan limits
Each denial letter must include your appeal rights and deadlines. In Washington, you have 180 days from the denial date to file an internal appeal.
Fixable Causes Before You Appeal
Before filing an appeal, check if these common issues can be quickly resolved:
Missing Documentation
- Genetic test results not submitted
- Neurologist evaluation missing or outdated
- Baseline functional assessments incomplete
Coding Issues
- Wrong ICD-10 code (should be E85.1 for hATTR amyloidosis)
- Incorrect drug name or NDC number
- Missing prior therapy documentation
Benefit vs. Medical Policy
- Request submitted to wrong benefit (pharmacy vs. medical)
- Site of care restrictions not addressed
- Prescriber not recognized as specialist
Tip: Call UnitedHealthcare's provider line to clarify missing requirements before appealing. This can save weeks of back-and-forth.
First-Level Appeal Strategy
Your internal appeal should address the specific denial reason with targeted evidence:
Structure Your Appeal:
- Header: Patient information, claim number, denial date
- Request: Clear statement requesting coverage approval
- Clinical Summary: Diagnosis, symptoms, functional impact
- Evidence: Address each denial reason with supporting documentation
- Conclusion: Restate medical necessity and request approval
Key Evidence to Include:
- Complete genetic testing report
- Neurologist's detailed evaluation
- Baseline mNIS+7 and 6MWT scores
- FDA approval documentation for hATTR-PN
- Published clinical guidelines supporting treatment
Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific policies.
Peer-to-Peer Review Process
UnitedHealthcare offers peer-to-peer consultations where your physician can discuss the case directly with a medical director.
How to Request:
- Call UnitedHealthcare Provider Services immediately after denial
- Request must be made within 24 hours (varies by plan)
- Consultation scheduled within 24 business hours
Preparation Checklist:
- Review complete patient file
- Prepare concise clinical summary
- Have specific denial reasons ready to address
- Reference relevant clinical guidelines
- Document any contraindications to alternatives
During the Call:
- Present case clearly and concisely
- Address specific denial criteria
- Emphasize unique patient circumstances
- Reference FDA approval and clinical evidence
Washington External Review Rights
Washington State provides strong consumer protections through Independent Review Organizations (IROs).
Eligibility: After completing internal appeals or in urgent situations where delay could harm your health.
How to Request:
- Contact the Washington Office of the Insurance Commissioner at 1-800-562-6900
- Submit request within 60 days of final internal denial
- Complete external review request form
- Provide supporting medical documentation
Process:
- OIC assigns certified IRO within 3 business days
- You have 5 business days to submit additional information
- IRO panel includes appropriate medical specialists
- Decision within 20 days (72 hours for expedited)
Outcome: IRO decisions are binding on UnitedHealthcare. If approved, the insurer must provide coverage.
Medical Necessity Letter Template
Essential Components
Patient Information
- Name, DOB, member ID
- Diagnosis: hATTR amyloidosis with polyneuropathy (ICD-10: E85.1)
- Pathogenic TTR variant: [specify mutation]
Clinical Justification
[Patient Name] has genetically confirmed hereditary transthyretin amyloidosis
with progressive polyneuropathy. Genetic testing revealed [specific TTR variant].
Current symptoms include [list specific symptoms and progression].
Baseline functional assessments:
- mNIS+7 score: [X] indicating [severity level]
- 6-minute walk test: [Y] meters
- Functional impact: [describe ADL limitations]
Onpattro (patisiran) is FDA-approved for this indication and represents
standard of care to slow disease progression. [Address any step therapy
requirements or contraindications to alternatives.]
Supporting Evidence
- Reference APOLLO clinical trial results
- Cite relevant treatment guidelines
- Include specialist recommendations
- Document prior therapy failures if applicable
Common Denial Reasons & Solutions
Denial Reason | Solution | Required Documentation |
---|---|---|
No genetic confirmation | Submit genetic test results | Lab report with pathogenic TTR variant |
Missing specialist evaluation | Obtain neurologist consultation | Detailed neurology note with staging |
Insufficient functional assessment | Complete baseline measurements | mNIS+7 and 6MWT scores |
Step therapy not met | Document contraindications or failures | Prior therapy records and rationale |
Non-formulary status | Request medical exception | Clinical justification letter |
Quantity limits exceeded | Justify weight-based dosing | Dosing calculations and FDA guidance |
Cost Assistance Options
Alnylam Assist Program
- Copay assistance for eligible patients
- Financial hardship support
- Prior authorization assistance
- Contact: alnylamassist.com
Foundation Support
- Patient Access Network Foundation
- HealthWell Foundation
- National Organization for Rare Disorders (NORD)
State Programs
- Washington Apple Health (Medicaid expansion)
- Premium assistance through Washington Healthplanfinder
When to Contact Washington Regulators
Contact the Washington Office of the Insurance Commissioner if:
- UnitedHealthcare doesn't respond within required timeframes
- You believe the denial violates state insurance laws
- You need help navigating the external review process
- You want to file a complaint about claim handling
Contact Information:
- Phone: 1-800-562-6900
- Website: insurance.wa.gov
- Consumer Advocacy team available for guidance
The OIC provides template appeal letters and can walk you through the external review process at no cost.
Frequently Asked Questions
How long does UnitedHealthcare prior authorization take in Washington? Standard prior authorization decisions are required within 15 business days. Urgent requests must be decided within 24 hours. UnitedHealthcare's automated PreCheck system can approve qualifying requests in under 30 seconds.
What if Onpattro is non-formulary on my plan? Non-formulary drugs can still be covered through medical exceptions. Submit a detailed clinical justification demonstrating medical necessity and why formulary alternatives are inappropriate.
Can I request an expedited appeal? Yes, expedited appeals are available when standard timelines could seriously jeopardize your health. Internal expedited appeals must be decided within 24 hours.
Does step therapy apply if I failed treatments outside Washington? Prior therapy from any location counts toward step therapy requirements, provided medical records clearly document the drugs attempted, duration, and reasons for discontinuation.
What happens if my external review is denied? IRO decisions are final for the coverage dispute, but you can contact the Washington OIC for guidance on any procedural issues or consider legal consultation.
How much does Onpattro cost without insurance? The wholesale acquisition cost is approximately $9,785 per vial, with annual costs typically ranging from $450,000-$500,000+ depending on patient weight and dosing requirements.
Can my doctor request a peer-to-peer review after I'm denied? Yes, physicians can request peer-to-peer consultations with UnitedHealthcare medical directors, typically within 24 hours of a denial. This allows direct discussion of the clinical rationale.
What documentation do I need for an appeal? Essential documents include the denial letter, complete medical records, genetic testing results, specialist evaluations, functional assessments (mNIS+7, 6MWT), and any prior therapy documentation.
From our advocates: We've seen many Onpattro appeals succeed when families gathered comprehensive baseline measurements before the initial submission. Patients who worked closely with their neurologists to document functional decline and treatment urgency had stronger cases, though outcomes depend on individual circumstances and plan policies.
Sources & Further Reading
- UnitedHealthcare Provider Portal - Prior authorization submissions and status
- Washington Office of the Insurance Commissioner Appeals Guide - External review process
- Alnylam Assist Program - Patient support and resources
- FDA Onpattro Prescribing Information - Official labeling
- Washington State External Review Law RCW 48.43.535 - Legal requirements
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For personalized assistance with complex appeals, services like Counterforce Health can help analyze denial letters and develop targeted appeal strategies based on your plan's specific policies.
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