By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (patisiran) Covered by Blue Cross Blue Shield in Florida: Complete Guide with Forms and Appeal Templates

Answer Box: Getting Onpattro Covered in Florida

Eligibility: Blue Cross Blue Shield Florida covers Onpattro (patisiran) for hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults 18+ with confirmed TTR gene mutation and specialist evaluation. Fastest path: Gather genetic testing, neurologist consultation, and baseline scores (mNIS+7, 6MWT) before submitting prior authorization. Start today: Contact your neurologist to order TTR gene sequencing from a CLIA-certified lab if not already done. Submit PA through Florida Blue's provider portal with complete documentation package.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before coverage Florida Blue PA portal
Age Limit 18 years or older Florida Blue medical policy
Genetic Testing Pathogenic TTR mutation confirmed CLIA-certified lab report
Specialist Evaluation Neurologist, geneticist, or amyloidosis specialist Medical records/consultation notes
Diagnosis Documentation hATTR polyneuropathy with PND score ≤ IIIb Clinical assessment
Baseline Scores mNIS+7 and 6-minute walk test Neurological evaluation
Exclusions No liver transplant; no combination therapy Medical history review

Step-by-Step: Fastest Path to Approval

1. Confirm Genetic Diagnosis

Who does it: Your neurologist or ordering physician
Document needed: TTR gene sequencing results from CLIA-certified laboratory
Timeline: 2-4 weeks for results
Key point: Direct-to-consumer genetic tests (like 23andMe) won't be accepted—you need clinical-grade testing.

2. Specialist Evaluation

Who does it: Neurologist, geneticist, or amyloidosis specialist
Document needed: Consultation report confirming hATTR polyneuropathy
Timeline: Varies by specialist availability
Key point: The specialist must document progressive polyneuropathy and rule out other causes.

3. Baseline Assessments

Who does it: Treating neurologist
Documents needed:

  • mNIS+7 score (modified Neuropathy Impairment Score)
  • 6-minute walk test results
  • Polyneuropathy Disability (PND) score ≤ IIIb Timeline: Can be done during specialist visit

4. Prior Authorization Submission

Who does it: Prescribing physician's office
How to submit: Florida Blue provider portal or fax
Required documents:

  • Completed PA form
  • Genetic test results
  • Specialist consultation notes
  • Baseline assessment scores
  • Insurance verification Timeline: 15 business days for standard review

5. Follow Up and Track

Who does it: Patient and clinic staff
What to do: Monitor PA status through provider portal
Timeline: Contact Florida Blue if no response within 15 days

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Missing genetic confirmation Submit CLIA-certified TTR gene sequencing results showing pathogenic variant
Lack of specialist evaluation Provide neurologist consultation confirming hATTR polyneuropathy diagnosis
Insufficient baseline documentation Submit complete mNIS+7 scores, 6MWT results, and PND assessment
Request for cardiac indication Clarify that approval is requested only for FDA-approved polyneuropathy indication
Missing prior therapy documentation Document contraindications or failures of alternative treatments when applicable

Appeals Process for Florida Blue Cross Blue Shield

If your initial prior authorization is denied, Florida law provides clear appeal rights:

Internal Appeal (Level 1)

  • Deadline: 180 days from denial notice
  • How to file: Submit written appeal to Florida Blue Member Appeals Department
  • Timeline: 30 days for pre-service; 60 days for post-service
  • Required: Original denial letter, medical records, physician letter

External Review (Level 2)

  • Deadline: 4 months after final internal denial
  • How to file: External Review Request form to Florida Blue
  • Address: PO Box 44197, Jacksonville, FL 32231-4197
  • Expedited option: Available for urgent cases (fax to 1-904-565-6637)
  • Cost: Free to consumer
From our advocates: We've seen Onpattro appeals succeed when the neurologist's letter clearly documents progressive polyneuropathy symptoms and includes specific mNIS+7 scores showing functional decline. One key factor: explicitly stating that the request is for the FDA-approved polyneuropathy indication, not cardiac involvement, even when both are present.

Medical Necessity Letter Template

Key Components for Your Neurologist

Patient Information

  • Demographics and insurance details
  • Confirmed hATTR diagnosis with genetic variant

Clinical Justification

  • Progressive polyneuropathy symptoms and examination findings
  • Baseline mNIS+7 score and functional impact
  • PND score documentation (must be ≤ IIIb)

Treatment Rationale

  • Reference to FDA approval for hATTR polyneuropathy
  • Citation of clinical trial data (APOLLO study)
  • Explanation of why Onpattro is medically necessary

Supporting Evidence

  • Prior treatments tried (if applicable) and reasons for discontinuation
  • Contraindications to alternatives
  • Expected clinical benefits

Sample Letter Excerpt

"I am requesting approval for Onpattro (patisiran) for [Patient Name], who has genetically confirmed hATTR amyloidosis with progressive polyneuropathy. Genetic testing revealed [specific TTR variant]. The patient's current mNIS+7 score is [X], indicating [severity level]. Onpattro is FDA-approved specifically for this indication and represents the appropriate standard of care to slow disease progression and preserve neurological function."

Costs and Financial Assistance

List Price: Approximately $450,000-$500,000 annually depending on patient weight

Financial Support Options:

  • Alnylam Assist: Manufacturer's patient support program
  • Commercial insurance copay assistance available
  • Foundation grants for eligible patients
  • Clinical trial enrollment opportunities

Medicare Coverage: Part B may cover Onpattro when administered in qualified healthcare settings

Appeals and External Review Support

When prior authorization fails, Florida residents have robust appeal rights. The state's external review process is overseen by the Department of Financial Services and provides independent medical review at no cost to patients.

For additional help navigating insurance challenges, Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical documentation to create targeted, evidence-backed appeals that align with each payer's specific requirements.

State Resources for Help:

Frequently Asked Questions

Q: How long does Florida Blue's prior authorization process take? A: Standard review takes up to 15 business days. Expedited review for urgent cases takes 72 hours.

Q: What if Onpattro isn't on my formulary? A: You can request a formulary exception through the prior authorization process with medical necessity documentation.

Q: Can I appeal if I'm denied for having cardiac symptoms? A: Yes. Clarify in your appeal that you're requesting coverage only for the FDA-approved polyneuropathy indication, even if cardiac involvement exists.

Q: Do I need to try other treatments first? A: Step therapy requirements vary by plan. If contraindications exist to alternatives, document these clearly in your PA request.

Q: What happens if my external review is denied? A: External review decisions are binding under federal law. However, you may have additional options through state regulatory complaints or legal consultation.

Q: How often do I need reauthorization? A: Typically every 6-12 months, with documentation of continued medical necessity and clinical benefit (stable or improved mNIS+7 scores).

When to Escalate

Contact Florida's insurance regulators if:

  • Florida Blue fails to respond within required timeframes
  • Appeal procedures aren't followed properly
  • You believe the denial violates state or federal law

Florida Department of Financial Services

Important Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures can change. Always verify current requirements with Florida Blue and consult with your healthcare providers for medical decisions. For personalized assistance with complex cases, consider consulting with specialists like Counterforce Health who can provide targeted support for insurance appeals and prior authorization challenges.

Sources & Further Reading

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