By Counterforce Health Team in Onpattro (patisiran) —

Get Onpattro (Patisiran) Covered by Cigna in Florida: Prior Authorization, Appeals, and Cost Savings Guide

Answer Box: Getting Onpattro Covered by Cigna in Florida

Onpattro (patisiran) requires prior authorization from Cigna in Florida for all plans. To get approved, you need genetic confirmation of hATTR amyloidosis with polyneuropathy, specialist evaluation, and complete clinical documentation. If denied, Florida law guarantees internal appeals (180 days) and external review (4 months after final denial). First step today: Have your neurologist submit the prior authorization request through Cigna's provider portal with genetic test results and polyneuropathy documentation.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Understanding Your Cigna Coverage
  4. Cost Reduction Strategies
  5. Formulary Exceptions and Step Therapy
  6. Appeals Process in Florida
  7. Common Denial Reasons and Solutions
  8. Scripts for Key Conversations
  9. FAQ
  10. Sources and Further Reading

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Always required Cigna provider portal or 866.494.2111 Cigna PA Policy
Age Requirement 18 years or older FDA prescribing information FDA Access Data
Diagnosis Genetic confirmation of hATTR-PN Genetic test report Cigna Coverage Policy
Specialist Involvement Neurologist or amyloidosis expert Specialist consultation notes Cigna Coverage Policy
Concomitant Therapy Cannot use with Tegsedi or tafamidis Medication history review Cigna Coverage Policy
Appeals Deadline 180 days from denial Denial letter instructions Florida Insurance Law

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Clinic)

  • Genetic test confirming pathogenic TTR variant
  • Neurologist consultation confirming hATTR polyneuropathy
  • Functional assessment scores (mNIS+7, 6-minute walk test)
  • Prior therapy history and outcomes
  • Timeline: 1-2 weeks to collect

2. Submit Prior Authorization (Clinic)

  • Use Cigna provider portal or call 866.494.2111
  • Include all clinical documentation and specialist notes
  • Request expedited review if clinically urgent
  • Timeline: Same day submission possible

3. Cigna Review Process

  • Standard review: 72 hours for non-urgent requests
  • Expedited review: 24 hours for urgent cases
  • Cigna may request peer-to-peer review with prescriber
  • Timeline: 1-3 business days

4. If Approved

  • Prescription routed to Cigna specialty pharmacy (typically Accredo)
  • Coordinate infusion scheduling at approved facility
  • Timeline: 3-5 business days for first infusion

5. If Denied

  • Review denial letter for specific reasons
  • Gather additional documentation to address concerns
  • Submit internal appeal within 180 days
  • Timeline: Begin appeal process immediately

6. Internal Appeal Process

  • Submit written appeal with supporting evidence
  • Include updated clinical notes or additional specialist opinions
  • Request expedited appeal if medically urgent
  • Timeline: 30 days for standard, 72 hours for expedited

7. External Review (If Needed)

  • File with Florida Department of Financial Services
  • Independent medical review of denial
  • No cost to patient
  • Timeline: 4 months to request, decision within 45 days

Understanding Your Cigna Coverage

Benefit Design Basics

Onpattro is typically covered under your medical benefit rather than prescription drug benefit because it's administered as an IV infusion. This means it's subject to your medical deductible and coinsurance rather than prescription copays.

Key Coverage Points:

  • Usually classified as a specialty medical benefit
  • Requires administration at an approved infusion center
  • Subject to medical deductible and coinsurance (typically 10-20%)
  • Annual out-of-pocket costs can range from $10,000-$50,000+ depending on your plan

What to Ask Your Benefits Department

When investigating your coverage, ask these specific questions:

  1. "Is Onpattro covered under medical or pharmacy benefits?"
  2. "What is my specialty drug coinsurance percentage?"
  3. "Which infusion centers are in-network for specialty biologics?"
  4. "What is my annual out-of-pocket maximum?"
  5. "Are there any quantity limits or site-of-care restrictions?"

Cost Reduction Strategies

Manufacturer Assistance: Alnylam Assist

Copay Program (Commercial Insurance Only):

  • Can reduce out-of-pocket costs to $0-$25 per infusion
  • Eligibility: Must have commercial insurance covering Onpattro
  • Exclusions: Medicare, Medicaid, TRICARE, uninsured patients
  • How to Apply: Call 833-256-2748 or visit Alnylam Assist

Patient Assistance Program (Uninsured/Underinsured):

  • Free drug for qualifying patients
  • Income requirements vary (typically up to 500% of Federal Poverty Level)
  • Requires detailed financial documentation

Foundation Support

HealthWell Foundation:

  • Provides up to $2,800 annually for amyloidosis treatments
  • Eligibility: U.S. residents with insurance, income up to 500% FPL
  • Application requires Social Security Number
  • Apply at: HealthWell Foundation Amyloidosis Fund

Case Management Services

Counterforce Health specializes in turning insurance denials into successful appeals for complex treatments like Onpattro. Their platform analyzes denial letters, identifies the specific coverage criteria, and drafts evidence-backed appeals that address each payer's requirements. For patients facing repeated denials or complex coverage issues, professional advocacy can significantly improve approval odds while reducing the administrative burden on both patients and clinicians.

Formulary Exceptions and Step Therapy

When Step Therapy May Apply

While Cigna typically doesn't require step therapy for Onpattro in confirmed hATTR cases, some situations may trigger additional requirements:

  • Medicare Advantage plans may have stricter step therapy protocols
  • Previous therapy documentation may be required to show medical necessity
  • Off-label use requests will face additional scrutiny

Requesting Formulary Exceptions

Documentation Needed:

  • Clinical rationale for why standard treatments are inappropriate
  • Evidence of prior therapy failures or contraindications
  • Specialist recommendation supporting Onpattro as medically necessary

Submission Process:

  • Complete Cigna formulary exception form
  • Submit through provider portal or fax to specialty pharmacy
  • Include comprehensive clinical documentation
  • Timeline: 72 hours for standard review, 24 hours for expedited

Appeals Process in Florida

Internal Appeals

First Level Internal Appeal:

  • Deadline: 180 days from denial notice
  • Submission: Written request to Cigna with supporting documentation
  • Timeline: 30 days for decision (72 hours if expedited)
  • Cost: No charge to member

Second Level Internal Appeal:

  • Available if first level is denied
  • Timeline: 30 days for decision
  • Independent reviewer not involved in original decision

External Review

Florida contracts with independent review organizations for external appeals:

Eligibility:

  • Must exhaust internal appeals first
  • Denial must involve medical necessity or experimental treatment determination
  • Deadline: 4 months after final internal denial

Process:

  • File request with Florida Department of Financial Services
  • Contact: 1-877-MY-FL-CFO (877-693-5236)
  • Independent medical expert reviews case
  • Timeline: Decision within 45 days
  • Cost: Free to patient

Required Documentation:

  • Copy of denial letter
  • All medical records supporting the request
  • Completed external review application
  • Any additional evidence not previously submitted

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
No genetic confirmation Submit genetic test results Pathogenic TTR variant report
Insufficient specialist evaluation Get neurologist consultation Detailed specialist notes confirming hATTR-PN
Missing functional assessments Complete outcome measures mNIS+7, 6-minute walk test, quality of life scores
Request for non-FDA use Clarify indication Documentation confirming polyneuropathy, not cardiomyopathy
Lack of prior therapy documentation Provide treatment history Records of previous treatments, outcomes, intolerances
Site of care restrictions Justify infusion center choice Medical necessity for specific facility
From Our Advocates: We've seen cases where genetic testing was done years ago and the results weren't immediately accessible. One patient's appeal was successful after their genetic counselor provided a detailed letter explaining the specific TTR mutation and its clinical significance. The key was connecting the genetic finding directly to the patient's current symptoms and progression.

Scripts for Key Conversations

Calling Cigna Member Services

"Hello, I'm calling about prior authorization for Onpattro, also called patisiran, for my hereditary transthyretin amyloidosis. My member ID is [number]. Can you tell me the current status of my prior authorization request submitted on [date]? If it was denied, I'd like to understand the specific reasons and start the appeal process."

Provider Peer-to-Peer Request

"I'm requesting a peer-to-peer review for my patient's Onpattro prior authorization. The patient has genetically confirmed hATTR amyloidosis with progressive polyneuropathy. I have documentation of their TTR mutation, neurological progression, and functional decline. When can we schedule this clinical discussion?"

Pharmacy Coordination

"I'm calling to coordinate my Onpattro infusion. My prior authorization was approved on [date] with reference number [number]. I need to schedule my first infusion and understand the premedication protocol. Can you also confirm this is being billed under my medical benefit?"

FAQ

How long does Cigna prior authorization take for Onpattro in Florida? Standard review takes 72 hours, expedited review takes 24 hours. Complex cases requiring peer-to-peer review may take 5-7 business days.

What if Onpattro is not on my Cigna formulary? You can request a formulary exception with clinical documentation. Non-formulary drugs require additional justification but can be covered if medically necessary.

Can I request an expedited appeal in Florida? Yes, if delay could seriously jeopardize your health or ability to regain maximum function. Expedited appeals are decided within 72 hours.

Does step therapy apply if I've tried other treatments outside Florida? Treatment history from other states counts toward step therapy requirements. Provide documentation of all previous therapies and outcomes.

What happens if my external review is denied? External review decisions are binding on the insurance company. If approved, Cigna must cover the treatment. If denied, you may have limited additional options.

How much will Onpattro cost with Cigna coverage? Costs vary by plan but typically range from $10,000-$50,000 annually after deductible and coinsurance. Manufacturer copay assistance can reduce this to $0-$300 annually for commercial plans.

Can I switch infusion centers if approved? Yes, but the new center must be in Cigna's network and approved for specialty infusions. Notify Cigna specialty pharmacy of any changes.

What if I lose my job and Cigna coverage? Contact Counterforce Health immediately to explore COBRA continuation, marketplace plans, or manufacturer assistance programs. Don't let coverage gaps interrupt treatment.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with Cigna directly and consult with your healthcare provider about treatment decisions. For assistance with complex coverage issues, consider consulting with a healthcare advocacy service.

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