By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by UnitedHealthcare in Pennsylvania: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Tegsedi Covered by UnitedHealthcare in Pennsylvania

Fastest Path: Complete FDA REMS enrollment (both patient and prescriber) → Submit prior authorization through UHC Provider Portal with genetic testing, baseline labs, and neurologist consultation → If denied, file internal appeal within 180 days → Use Pennsylvania's External Review Program (50% overturn rate) within 4 months of final denial.

Start Today: Contact your neurologist to confirm REMS enrollment status and request genetic testing documentation. Pennsylvania residents benefit from the state's new Independent External Review Program, which overturned roughly half of insurance denials in 2024.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Understanding Your Costs and Savings Options
  4. Prior Authorization Process
  5. Common Denial Reasons and Solutions
  6. Appeals Process in Pennsylvania
  7. Scripts for Key Conversations
  8. When to Escalate
  9. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all UHC plans UHC Provider Portal UHC PA Requirements
REMS Enrollment Both patient and prescriber must be certified FDA REMS website FDA REMS Program
Genetic Testing Confirmed TTR mutation required Lab report with specific mutation UHC Medical Necessity
Specialist Prescription Neurologist required Consultation notes UHC Coverage Criteria
Baseline Labs Platelets ≥100, normal kidney function Recent lab results UHC Requirements
Specialty Pharmacy REMS-certified pharmacy only OptumRx or contracted network Specialty Network

Step-by-Step: Fastest Path to Approval

1. Confirm REMS Enrollment (Patient & Prescriber)

Who: Patient and prescriber together
Timeline: 1-2 weeks
Action: Both parties must complete FDA REMS certification before any PA submission. This is the #1 reason for denials.

2. Gather Required Documentation

Who: Patient with clinic support
Timeline: 1-2 weeks
Documents needed:

  • Genetic testing report showing specific TTR mutation
  • Baseline lab results (platelets ≥100 × 10⁹/L, normal kidney function)
  • Neurologist consultation notes
  • Clinical severity assessment (PND score ≤ IIIb or NIS 10-130)

3. Submit Prior Authorization

Who: Prescriber
How: UHC Provider Portal or call 866-889-8054
Timeline: 5-7 business days for standard review
Include: All documentation plus medical necessity letter explaining why alternatives aren't suitable

4. Track Status and Respond Quickly

Timeline: Check status daily after day 3
If additional info requested: Respond within 24-48 hours to avoid delays

Tip: Pennsylvania residents have stronger appeal rights than most states. If initially denied, you have multiple pathways to overturn the decision.

Understanding Your Costs and Savings Options

Formulary Tier and Cost-Sharing

Tegsedi is typically placed on UnitedHealthcare's highest specialty tier, which means significant out-of-pocket costs. Your exact copay or coinsurance depends on your specific plan design.

To find your costs:

  1. Log into your UHC member portal
  2. Use the "Find Care & Costs" tool
  3. Search for "Tegsedi" or "inotersen"
  4. Review your plan's specialty tier cost-sharing

Manufacturer Assistance Programs

Ionis offers patient support programs for Tegsedi, though specific copay assistance details vary by insurance type and eligibility criteria. Important limitation: Medicare and Medicaid beneficiaries cannot use manufacturer copay assistance due to federal regulations.

Next steps:

  • Contact your specialty pharmacy about available copay reduction programs
  • For manufacturer-specific programs, reach out to Ionis Connect directly
  • Confirm your insurance type (commercial vs. government) before applying

Alternative Financial Resources

If manufacturer assistance isn't available:

  • HealthWell Foundation
  • Patient Access Network Foundation
  • Pennsylvania-specific assistance programs (verify with state resources)
Note: Tegsedi was discontinued by the manufacturer in 2024, but existing patients can often continue therapy through 2026 under legacy coverage agreements. Contact your specialty pharmacy for current availability.

Prior Authorization Process

Medical Necessity Criteria

UnitedHealthcare requires documentation of:

Confirmed Diagnosis: Genetic testing showing pathogenic TTR mutation (such as V30M) establishing hereditary transthyretin-mediated (hATTR) polyneuropathy

Clinical Severity: At least one documented baseline measurement:

  • Polyneuropathy disability (PND) score ≤ IIIb
  • Familial amyloid polyneuropathy (FAP) Stage 1-2
  • Neuropathy Impairment Score (NIS) of 10-130

Safety Requirements: Baseline laboratory values showing:

  • Platelet count ≥ 100 × 10⁹/L
  • Normal kidney function (creatinine and urinalysis)
  • Acceptable liver function tests

Submission Process

Portal Access: Submit through the UnitedHealthcare Provider Portal at UHCprovider.com

  • Select "Prior Authorization and Notification"
  • Choose "Pharmacy Benefits" (not medical benefits)
  • Use diagnosis code E85.1 for hATTR polyneuropathy
  • Upload all supporting documentation as PDF files

Timeline: Standard review takes 5-7 business days; urgent cases may qualify for 24-72 hour review when medical urgency is documented.

Common Denial Reasons and Solutions

Denial Reason How to Fix It
Missing REMS enrollment Verify both patient and prescriber completed FDA REMS certification; resubmit with confirmation
Incomplete genetic testing Include complete genetic report showing specific TTR mutation (not just "amyloidosis")
Wrong diagnosis code Use E85.1 for hATTR polyneuropathy, not general amyloidosis codes
Insufficient clinical documentation Add baseline severity scores (PND, FAP stage, or NIS) and functional assessments
Step therapy not addressed Document why alternatives like patisiran aren't suitable (access, administration preference, contraindications)
Lab values don't meet thresholds Ensure platelets ≥100 and normal kidney function before resubmission
From our advocates: We've seen cases where initial denials were overturned simply by including a detailed explanation of why infusion-based alternatives weren't feasible due to patient mobility limitations or infusion center access issues. The key is addressing the specific denial reason with clinical documentation.

Appeals Process in Pennsylvania

Pennsylvania offers one of the strongest patient protection systems in the country for insurance appeals, with a 50% success rate in overturning denials through the state's Independent External Review Program.

Internal Appeals (Required First Step)

Timeline: File within 180 days of denial Process:

  1. Submit through UHC Provider Portal or mail
  2. Include denial letter, additional clinical evidence, and updated medical necessity letter
  3. Response time: 30 days standard (72 hours for urgent cases)

Pennsylvania Independent External Review

After exhausting internal appeals, Pennsylvania residents can request external review through the state's program, launched in January 2024.

Key Benefits:

  • Free to patients (insurer pays for review)
  • 50% overturn rate in first year of operation
  • Binding decisions that insurers must accept
  • State oversight rather than federal process

Timeline and Process:

  1. Deadline: Submit within 4 months of Final Adverse Benefit Determination letter
  2. Eligibility confirmation: Within 5 business days
  3. Review assignment: Within 1 business day if eligible
  4. Additional documentation: 15 business days to submit supporting materials
  5. Final decision: Within 45 days of assignment (72 hours for expedited cases)

How to File:

  • Online: pa.gov/reviewmyclaim
  • Phone: 1-877-881-6388
  • Contact: Pennsylvania Insurance Department, Consumer Services Bureau

Required Documentation for Appeals

When filing appeals, include:

  • Original denial letter with specific denial reasons
  • Medical records supporting medical necessity
  • Documentation from healthcare provider explaining prescription rationale
  • Any new clinical information not included in initial PA request
  • Peer-reviewed studies supporting off-label use (if applicable)

Scripts for Key Conversations

Calling UnitedHealthcare Member Services

"Hi, I'm calling about a prior authorization for Tegsedi, also called inotersen, for hereditary transthyretin amyloidosis polyneuropathy. My member ID is [ID number]. Can you tell me the current status of PA request [reference number] and what additional documentation might be needed?"

Follow-up questions:

  • "What specific clinical criteria weren't met?"
  • "Can you transfer me to the pharmacy benefits team?"
  • "Is there a peer-to-peer review option available?"

Requesting Peer-to-Peer Review

"This is Dr. [Name] requesting a peer-to-peer review for my patient's Tegsedi prior authorization denial. The patient has confirmed hATTR polyneuropathy with genetic testing, meets all baseline lab requirements, and has completed REMS enrollment. I'd like to discuss the clinical rationale with your medical director."

Specialty Pharmacy Coordination

"I'm calling about Tegsedi availability and coordination with my UnitedHealthcare coverage. My PA was approved on [date] with reference number [number]. Can you confirm REMS enrollment status and coordinate delivery with my treatment schedule?"

When to Escalate

State Regulator Contact

If you encounter issues with UnitedHealthcare's appeals process or believe your rights aren't being respected, contact:

Pennsylvania Insurance Department

  • Consumer Services: 1-877-881-6388
  • Website: pa.gov (insurance section)
  • File complaints for: delayed responses, improper denials, procedural violations

Counterforce Health Support

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, identifying specific coverage criteria, and drafting evidence-backed rebuttals. The platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes, particularly for specialty medications like Tegsedi where clinical documentation and payer-specific workflows are critical for approval.

For complex cases involving multiple denials or unclear coverage criteria, professional advocacy services can help identify the specific evidence needed to meet UnitedHealthcare's requirements and navigate Pennsylvania's appeal system effectively.

FAQ

How long does UnitedHealthcare prior authorization take for Tegsedi in Pennsylvania? Standard review takes 5-7 business days. Urgent cases with documented medical necessity may qualify for 24-72 hour review.

What if Tegsedi is non-formulary on my UHC plan? Non-formulary medications can still be covered through prior authorization when medical necessity is demonstrated and alternatives are inappropriate.

Can I request expedited appeal in Pennsylvania? Yes, if your health is at serious risk. Expedited external reviews are decided within 72 hours through Pennsylvania's program.

Does step therapy apply if I haven't tried alternatives? You may need to document why alternatives like patisiran aren't suitable (infusion access, administration preference, contraindications) rather than actually trying them first.

What happens if my appeal is denied? After internal appeals, you can request Pennsylvania's Independent External Review within 4 months. This program has overturned about 50% of denials in its first year.

Are there income limits for manufacturer assistance? Specific eligibility criteria vary. Contact your specialty pharmacy or Ionis directly for current program requirements. Medicare/Medicaid beneficiaries cannot use manufacturer copay assistance.

How do I find a REMS-certified specialty pharmacy? UnitedHealthcare typically directs prescriptions to OptumRx or contracted specialty pharmacies. Your prescriber can provide a list of certified pharmacies in your network.

What if I need to switch from another hATTR medication? Document the clinical rationale for switching, including any efficacy issues, tolerability problems, or access barriers with your current treatment.

Sources & Further Reading

Disclaimer: This article provides educational 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 directly for coverage determinations. Coverage policies and procedures may change; verify current requirements with official sources.

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