By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by Blue Cross Blue Shield in Pennsylvania: Complete Appeal Guide with Forms and Timelines

Quick Answer: Getting Tegsedi Covered by BCBS in Pennsylvania

Blue Cross Blue Shield prior authorization for Tegsedi (inotersen) requires: genetic confirmation of hATTR polyneuropathy, documented step therapy failures, REMS enrollment, and a comprehensive lab monitoring plan. If denied, you have 180 days for internal appeals, then 4 months for Pennsylvania's Independent External Review. Start today: Call BCBS member services (number on your card) to request the specific PA form for your plan—Highmark or Independence Blue Cross have different submission portals.

Table of Contents

  1. Understanding Your BCBS Coverage
  2. Prior Authorization Requirements
  3. Step-by-Step: Fastest Path to Approval
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Playbook for Pennsylvania
  6. Medical Necessity Letter Checklist
  7. Pennsylvania's External Review Process
  8. Cost-Saving Options
  9. FAQ

Understanding Your BCBS Coverage

Pennsylvania has two major Blue Cross Blue Shield plans: Highmark Blue Shield (western PA) and Independence Blue Cross (Philadelphia region). Both require prior authorization for Tegsedi, but their submission processes differ slightly.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all plans Member portal or PA form request
Formulary Tier Specialty tier (high cost-share) Plan formulary document
Step Therapy Must try Onpattro or Amvuttra first Medical policy section
REMS Enrollment FDA safety program mandatory Tegsedi REMS website
Lab Monitoring Weekly platelets, monthly renal Provider must document plan
Appeals Deadline 180 days internal, then 4 months external Pennsylvania Insurance Department

Prior Authorization Requirements

BCBS plans in Pennsylvania follow consistent criteria for Tegsedi coverage, based on FDA labeling and clinical evidence:

Essential Documentation:

  • Genetic confirmation of hATTR with polyneuropathy (ICD-10: E85.1)
  • Clinical notes detailing sensorimotor neuropathy symptoms
  • Step therapy compliance: documented failure, intolerance, or contraindication to patisiran (Onpattro) or vutrisiran (Amvuttra)
  • REMS enrollment verification for both patient and prescriber
  • Lab monitoring plan with baseline values:
    • Platelet count ≥100 x 10⁹/L
    • Normal renal function (creatinine, urine protein)
    • Liver function tests
Note: Tegsedi carries FDA warnings for thrombocytopenia and glomerulonephritis, making the REMS program and monitoring plan non-negotiable requirements.

Step-by-Step: Fastest Path to Approval

1. Identify Your Specific BCBS Plan

  • Check your insurance card for "Highmark" or "Independence"
  • Call member services to confirm PA requirements
  • Timeline: Same day

2. Complete REMS Enrollment

  • Visit the Tegsedi REMS website
  • Both patient and prescriber must enroll before submission
  • Timeline: 1-2 business days

3. Gather Required Documentation

  • Genetic test results confirming TTR mutation
  • Clinical notes showing neuropathy progression
  • Records of prior therapy failures (Onpattro/Amvuttra)
  • Baseline lab results meeting safety criteria
  • Timeline: 3-5 days (depending on records availability)

4. Submit Prior Authorization

  • Highmark: Use CoverMyMeds portal or fax to 1-888-447-4369
  • Independence Blue Cross: Fax to 1-888-671-5285 or online portal
  • Include all supporting documents
  • Timeline: Same day submission

5. Follow Up

  • Standard decision: 15 business days
  • Expedited (if urgent): 72 hours
  • Track status through member portal
  • Timeline: 2-3 weeks for standard review

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing genetic confirmation Submit TTR gene test results Lab report with specific mutation
Incomplete step therapy Document Onpattro/Amvuttra trial Treatment notes, adverse effects, failure reasons
No REMS enrollment Complete safety program REMS confirmation numbers
Insufficient lab monitoring plan Provide detailed protocol Baseline labs, monitoring schedule, responsible provider
"Not medically necessary" Clinical appeal with evidence Functional assessments, disease progression notes

Appeals Playbook for Pennsylvania

Pennsylvania's appeal process has multiple levels, with specific timelines and requirements:

Level 1: Internal Appeal

  • Deadline: 180 days from denial date
  • How to file: Written request to BCBS appeals department
  • Required: Original denial letter, additional medical evidence, provider statement
  • Timeline: 30 days for standard, 72 hours for expedited
  • Success rate: Varies by plan and documentation quality

Level 2: Pennsylvania External Review

  • Eligibility: Must complete internal appeal first
  • Deadline: 4 months after final internal denial
  • How to file: Pennsylvania Insurance Department portal
  • Timeline: 45 days for standard, 72 hours for expedited
  • Success rate: Approximately 50% of appeals overturned in 2024
From Our Advocates: We've seen strong success when families combine clinical progression notes with quality-of-life impact statements. One case involved documenting how delayed treatment affected a patient's ability to work and care for family—the external reviewer emphasized functional decline in their approval decision.

Medical Necessity Letter Checklist

Essential Elements for Your Physician:

Clinical Problem

  • Confirmed hATTR diagnosis with genetic testing
  • Document specific TTR mutation and inheritance pattern
  • Describe current neuropathy symptoms and functional limitations

Prior Treatment History

  • List all previous therapies attempted
  • Detail reasons for discontinuation (ineffective, adverse effects, contraindications)
  • Include duration and dosing of prior treatments

Medical Rationale

  • Explain why Tegsedi is clinically appropriate
  • Reference FDA approval for hATTR polyneuropathy
  • Cite relevant clinical guidelines or studies

Safety Considerations

  • Acknowledge thrombocytopenia and renal risks
  • Detail monitoring plan and safety protocols
  • Confirm REMS program compliance

Counterforce Health helps clinicians draft evidence-backed appeal letters that address payer-specific criteria while incorporating the latest clinical evidence and FDA guidance.

Pennsylvania's External Review Process

Pennsylvania launched its Independent External Review Program in January 2024, giving consumers a powerful tool to overturn insurance denials:

Key Benefits:

  • State-supervised process (not federal default)
  • 50% success rate in first year
  • Binding decisions on insurers
  • Free to consumers

How It Works:

  1. Complete BCBS internal appeals first
  2. Receive "Final Adverse Benefit Determination"
  3. File external review within 4 months at pa.gov/reviewmyclaim
  4. Independent medical reviewers evaluate case
  5. Decision within 45 days (72 hours if expedited)

What to Include:

  • All denial letters and internal appeal decisions
  • Complete medical records
  • Physician statements supporting medical necessity
  • Any additional clinical evidence
Tip: Pennsylvania's consumer assistance program offers free help with complex appeals. Contact the [Pennsylvania Health Law Project](verify with the source linked below) for guidance.

Cost-Saving Options

While pursuing coverage, explore these financial assistance options:

Manufacturer Support

  • Ionis patient assistance programs
  • Copay cards for eligible commercial patients
  • Free drug programs for qualifying uninsured patients

Foundation Grants

  • Patient Advocate Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State Programs

  • Pennsylvania Pharmaceutical Assistance Contract for the Elderly (PACE)
  • Medicaid coverage for eligible individuals

FAQ

How long does BCBS prior authorization take in Pennsylvania? Standard reviews take 15 business days. Expedited reviews (for urgent cases) are completed within 72 hours.

What if Tegsedi is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and that formulary alternatives are inappropriate.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. Your physician must provide documentation supporting the urgent need.

Does step therapy apply if I tried alternatives outside Pennsylvania? Yes, documented trials from any location count toward step therapy requirements, provided you have proper medical records.

What happens if my external review is denied? External review decisions are final and binding. However, you may be able to file a new request if your medical condition changes significantly.

How much does Tegsedi cost without insurance? Tegsedi is a high-cost specialty medication. Contact the manufacturer for current pricing and patient assistance program eligibility.

When Coverage is Approved

Once Tegsedi is approved, work with your healthcare team to:

  • Coordinate with an in-network specialty pharmacy
  • Schedule baseline monitoring labs
  • Plan your injection training and ongoing care
  • Set up regular safety monitoring appointments

Counterforce Health's platform helps patients and providers navigate the complex prior authorization process by turning denials into targeted, evidence-backed appeals that address each payer's specific requirements.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance plan's member services for the most current coverage requirements and procedures.

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