By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (patisiran) Covered by Blue Cross Blue Shield in Pennsylvania: Complete Appeals Guide with Forms and Timelines

Answer Box: Getting Onpattro Covered in Pennsylvania

Blue Cross Blue Shield in Pennsylvania requires prior authorization for Onpattro (patisiran) with strict medical necessity criteria. You need genetic confirmation of hATTR polyneuropathy, neurologist evaluation, and documented functional assessments. If denied, Pennsylvania's new external review program has overturned 50% of appealed denials in 2024. First step today: Gather your genetic test results, baseline mNIS+7 scores, and specialist consultation notes—these are the three most common missing pieces in denials.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all BCBS plans Member portal or provider forms BCBS PA Criteria
Age Restriction 18 years or older Medical records FDA labeling
Genetic Testing Pathogenic TTR variant confirmed Lab results with specific mutation Clinical guidelines
Specialist Evaluation Neurologist or amyloidosis specialist Consultation notes BCBS medical policy
Functional Assessment mNIS+7 score, 6-minute walk test Baseline testing documentation FDA Access Data
Appeals Deadline 180 days for commercial plans Denial letter Pennsylvania Insurance Dept

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis Documentation

Who: You and your neurologist
What: Genetic test showing pathogenic TTR variant (e.g., V30M, A97S, T60A)
Timeline: 10-21 days if testing needed
Submit: Include with initial PA request

2. Complete Baseline Functional Assessments

Who: Neurologist or amyloidosis specialist
What: mNIS+7 score, 6-minute walk test, polyneuropathy disability score
Timeline: Same visit as specialist consultation
Why: BCBS requires objective measures of neuropathy severity

3. Submit Prior Authorization

Who: Prescribing physician's office
What: Complete PA form with all supporting documentation
How: Fax to BCBS at number on member ID card or submit via provider portal
Timeline: 5-15 business days for determination

4. If Denied, Request Peer-to-Peer Review

Who: Prescribing physician
What: Direct discussion with BCBS medical director
Timeline: Must request within 30 days of denial
Prep: Have patient chart, genetic results, and functional scores ready

5. File Internal Appeal if Still Denied

Who: Patient or physician
What: Formal written appeal with additional evidence
Timeline: 60 days from denial notice
Include: Updated clinical notes, peer-reviewed literature, guideline citations

6. Request External Review (Pennsylvania)

Who: Patient
What: Independent review through Pennsylvania Insurance Department
Timeline: Within 4 months of final internal denial
Success rate: 50% of appeals overturned in 2024

Tip: Most successful approvals happen at the peer-to-peer stage when the prescribing specialist can directly address medical director concerns about genetic confirmation and functional impairment documentation.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"No genetic confirmation" Submit pathogenic TTR variant test results Lab report with specific mutation identified
"Lack of specialist evaluation" Provide neurologist or amyloidosis specialist consultation Detailed consultation note with diagnosis confirmation
"Missing functional assessment" Complete baseline mNIS+7 and 6-minute walk test Objective scoring documentation
"Not medically necessary" Demonstrate progressive neuropathy and functional decline Serial assessments showing deterioration
"Experimental/investigational" Cite FDA approval for hATTR polyneuropathy FDA labeling and orphan designation
"Step therapy required" Document contraindications or failures of alternatives Prior medication trials and outcomes

Appeals Playbook for Pennsylvania

Internal Appeals Process

Level 1 - Standard Internal Appeal

  • Deadline: 180 days from denial (commercial plans)
  • Timeline: 30 days for non-urgent, 72 hours for urgent
  • Submit: Written appeal with supporting documentation
  • Contact: Member services number on insurance card

Level 2 - Expedited Appeal

  • When: Life-threatening situation or urgent medical need
  • Timeline: 72 hours for determination
  • Required: Physician statement of urgency
  • Process: Call member services to request expedited review

Pennsylvania External Review Process

Pennsylvania launched its Independent External Review Program in January 2024, giving consumers a powerful tool to overturn insurance denials. Here's how it works:

Eligibility Requirements:

  • Must complete internal appeals process first
  • Receive Final Adverse Benefit Determination letter
  • Submit within 4 months of final denial

How to Request:

Timeline:

  • Standard Review: 45 days from IRO assignment
  • Expedited Review: 72 hours for urgent cases
  • Additional Info: 15 days to submit supporting documents

Success Rate: In 2024, Pennsylvania reported that 259 out of 517 external appeals (50%) were decided in favor of patients, forcing insurers to provide coverage.

From our advocates: We've seen cases where patients initially denied for Onpattro received approval through Pennsylvania's external review after submitting updated functional assessments showing continued disease progression. The key was demonstrating that the patient met all clinical criteria despite the initial denial. This is a composite example and outcomes vary by individual case.

Medical Necessity Letter Essentials

When your physician writes a medical necessity letter for Onpattro, it should address these key points:

Clinical Documentation Checklist

Patient Background:

  • Confirmed diagnosis of hATTR amyloidosis with polyneuropathy
  • Genetic testing results showing pathogenic TTR variant
  • Age 18 or older
  • Current functional status (FAP stage 1 or 2)

Disease Progression:

  • Baseline mNIS+7 score demonstrating neuropathy severity
  • 6-minute walk test results
  • Documentation of progressive symptoms
  • Impact on daily activities and quality of life

Treatment Rationale:

  • Why Onpattro is appropriate for this patient
  • Contraindications to alternative therapies
  • Expected benefits based on clinical trial data
  • Monitoring plan for treatment response

Supporting Evidence:

  • FDA approval for hATTR polyneuropathy
  • Clinical trial data from APOLLO study
  • Professional society guidelines
  • Peer-reviewed literature supporting use

Counterforce Health helps patients and clinicians create targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each payer's specific requirements. Their platform pulls the right clinical citations and weaves them into appeals with the required documentation for buy-and-bill therapies like Onpattro.

Pennsylvania's External Review Process

Pennsylvania's new external review program represents a significant win for patients. Since launching in 2024, the program has demonstrated real results:

Key Statistics:

  • 517 external appeals filed in first year
  • 259 cases (50%) ruled in favor of patients
  • Average review time: 45 days for standard cases
  • 72 hours for expedited urgent cases

What Makes Pennsylvania's Process Effective:

  • Independent Review Organizations (IROs) with clinical expertise
  • Strict timelines that insurers must follow
  • Binding decisions that insurers cannot overturn
  • No cost to consumers

Getting Help:

  • Pennsylvania Insurance Department Consumer Services: 1-877-881-6388
  • Online portal for submissions
  • Pennsylvania Health Law Project for low-income assistance

Cost Assistance Programs

Onpattro's annual cost can exceed $450,000, making financial assistance crucial:

Manufacturer Support:

  • Alnylam Assist: Patient support program
  • Copay assistance for eligible commercially insured patients
  • Free drug program for uninsured patients meeting criteria

Foundation Grants:

  • Patient Access Network Foundation
  • Good Days (formerly Chronic Disease Fund)
  • HealthWell Foundation

State Resources:

  • Pennsylvania pharmaceutical assistance programs
  • Medicaid coverage for eligible patients

FAQ: Your Most Common Questions

Q: How long does BCBS prior authorization take in Pennsylvania? A: Standard PA decisions take 5-15 business days. Expedited requests for urgent cases are decided within 72 hours. If you don't hear back within the standard timeframe, call member services.

Q: What if Onpattro isn't on my formulary? A: You can request a formulary exception. Your physician needs to demonstrate medical necessity and why formulary alternatives aren't appropriate for your condition.

Q: Can I get an expedited appeal if my condition is worsening? A: Yes. If your physician documents that delay in treatment poses a serious threat to your health, you can request expedited review with 72-hour decision timelines.

Q: What happens if I lose my external review? A: The IRO's decision is final for that specific request. However, you may be able to file a new request if your clinical situation changes or additional evidence becomes available.

Q: Do I need to use a specific infusion center? A: BCBS typically requires in-network providers. Check with your plan for approved infusion centers and ensure your chosen site meets their requirements for specialty drug administration.

Q: How often do I need to renew authorization? A: Most BCBS plans require annual reauthorization with documentation of continued clinical benefit, typically measured by stability or improvement in functional assessments like mNIS+7 scores.

When to Escalate

If you've exhausted internal appeals and external review options, consider these steps:

File a Complaint with Pennsylvania Insurance Department:

  • Consumer complaint process separate from external review
  • Can address patterns of inappropriate denials
  • May trigger regulatory investigation of insurer practices

Contact Your State Representatives:

  • Pennsylvania legislators have oversight of insurance practices
  • Can be helpful for systemic issues affecting multiple patients

Legal Consultation:

  • Consider if you believe the insurer violated state or federal law
  • ERISA plans have different rules than state-regulated insurance

Tracking Your Appeal

Keep detailed records throughout the process:

Document Everything:

  • Date and time of all phone calls
  • Names of representatives you speak with
  • Reference numbers for appeals and reviews
  • Copies of all submitted documents

Key Dates to Track:

  • Initial denial date
  • Appeal submission deadlines
  • Expected decision dates
  • External review eligibility periods

The appeals process can feel overwhelming, but Pennsylvania patients now have more tools than ever to challenge inappropriate denials. With proper documentation and persistence, many patients successfully obtain coverage for this life-changing treatment.

Counterforce Health's platform can help streamline this process by automatically identifying denial reasons and generating targeted appeals with the specific evidence and documentation that payers require for Onpattro approvals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by specific BCBS plan and can change. Always verify current requirements with your insurer and consult with your healthcare provider about treatment decisions. For personalized assistance with insurance appeals, contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388.

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