By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by Blue Cross Blue Shield in New Jersey: Complete Prior Authorization and Appeal Guide

Quick Answer: Getting Tegsedi Covered by Blue Cross Blue Shield in New Jersey

Tegsedi (inotersen) requires prior authorization from Blue Cross Blue Shield plans in New Jersey, typically as a non-preferred specialty drug. To get coverage: (1) Your neurologist submits a PA request with hATTR polyneuropathy diagnosis, genetic testing, and clinical justification, (2) If denied, file internal appeals within 180 days, then (3) Request external review through New Jersey's IHCAP within 90-120 days of final denial. Start by calling the number on your insurance card to confirm your plan's specific PA requirements and obtain the correct forms.

Table of Contents

  1. Coverage Requirements Overview
  2. Prior Authorization Process
  3. Common Denial Reasons & Solutions
  4. Appeals Process in New Jersey
  5. Cost Assistance Programs
  6. Specialty Pharmacy Requirements
  7. Scripts for Key Conversations
  8. FAQ

Coverage Requirements Overview

Blue Cross Blue Shield plans in New Jersey treat Tegsedi as a specialty medication requiring prior authorization and specialty pharmacy dispensing. Here's what you need to know:

Coverage at a Glance

Requirement Details Where to Verify Source
Prior Authorization Required for all BCBS plans Member portal or PA form BCBS TX Performance List
Formulary Status Non-preferred (higher copay) Plan formulary document BCBS TX Balanced List
Quantity Limit 4 syringes per 28 days Drug list or PA approval BCBS IL Dispensing Limits
Specialty Pharmacy Required (no retail pickup) Plan pharmacy network Blue Shield CA Specialty List
Diagnosis Required hATTR polyneuropathy (ICD-10: E85.2) PA form clinical section BCBS TN Policy
Note: Requirements vary by specific BCBS plan. Horizon Blue Cross Blue Shield of New Jersey is the largest insurer in the state with approximately 39% market share.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

1. Confirm Your Plan's Requirements (Patient/Clinic)

  • Call the member services number on your insurance card
  • Ask specifically: "What are the prior authorization requirements for Tegsedi (inotersen)?"
  • Request the PA form and submission instructions
  • Timeline: Same day call

2. Gather Required Documentation (Clinic)

  • Genetic testing confirming pathogenic TTR mutation
  • Clinical notes documenting polyneuropathy progression
  • Prior treatment history and outcomes
  • Current functional assessment scores
  • Timeline: 1-2 days to compile

3. Complete PA Submission (Prescriber)

  • Use plan-specific PA form or FEP Blue template
  • Submit via plan portal, fax, or mail
  • Include detailed medical necessity letter
  • Timeline: Submit within 3-5 days of gathering docs

4. Follow Up on Decision (Patient/Clinic)

  • Standard review: 5-7 business days
  • Expedited review: 24-72 hours if urgent
  • Request peer-to-peer review if initially denied
  • Timeline: Decision within 7-14 days

Medical Necessity Requirements

Your neurologist's PA submission must include:

  • Confirmed Diagnosis: Hereditary transthyretin-mediated amyloidosis with polyneuropathy
  • Genetic Evidence: Pathogenic TTR gene mutation results
  • Disease Severity: Documented polyneuropathy with functional impairment
  • Treatment History: Prior therapies tried or contraindicated alternatives
  • Safety Monitoring Plan: Regular platelet and kidney function testing per FDA boxed warnings
Clinician Corner: Include specific neuropathy scores (NIS-LL, mBMI) when available, and reference FDA labeling for dosing and monitoring requirements. Address why other hATTR treatments (patisiran, tafamidis) are not appropriate for this patient.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing genetic testing Submit TTR mutation results Genetic lab report with pathogenic variant
Insufficient diagnosis documentation Provide detailed clinical notes Neurology consult with polyneuropathy findings
No prior therapy documentation Show treatment history Medication records, adverse event notes
Not enrolled in REMS program Complete enrollment REMS confirmation for patient and prescriber
Quantity limit exceeded Justify dosing Clinical rationale for weekly 284mg dose
Non-preferred status Request tier exception Medical necessity for Tegsedi vs. alternatives

When Administrative Fixes Aren't Enough

If your denial involves clinical disagreement rather than missing paperwork, prepare for the appeals process. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to draft point-by-point rebuttals aligned to the plan's own rules.

Appeals Process in New Jersey

New Jersey offers a comprehensive appeals system with binding external review through the Independent Health Care Appeals Program (IHCAP).

Internal Appeals Timeline

Level 1 Internal Appeal

  • File within: 180 days of denial (verify with your denial letter)
  • Standard decision: 10-30 calendar days
  • Expedited decision: 24-72 hours for urgent cases
  • Required: Updated medical necessity letter addressing denial reasons

Level 2 Internal Appeal (if available)

  • File within: 30 days of Level 1 denial
  • Standard decision: 15-30 calendar days
  • Expedited decision: 72 hours
  • Strategy: Include new clinical information or peer-reviewed evidence

External Review: IHCAP

If internal appeals fail, New Jersey's IHCAP provides binding independent review:

Filing Requirements:

  • Must complete all internal appeals first
  • File within 90-120 days of final internal denial
  • Submit through [Maximus IHCAP portal](verify with the source linked below)
  • Include all denial letters, medical records, and prescriber statement

Timeline:

  • Preliminary review: 5 business days
  • Standard decision: 45 calendar days
  • Expedited decision: 48 hours for urgent cases
  • Cost: Free to patients; insurers pay all fees

Success Factors:

  • Strong medical necessity evidence
  • Alignment with FDA labeling and clinical guidelines
  • Documentation of failed alternatives or contraindications
  • Clear functional impact without treatment
From our advocates: We've seen specialty drug appeals succeed when the medical necessity letter directly addresses each policy criterion and includes specific citations to FDA labeling or peer-reviewed guidelines. The key is showing why the patient's clinical situation requires this specific medication rather than plan-preferred alternatives.

Cost Assistance Programs

Manufacturer Support

Ionis Patient Support Foundation

  • Copay assistance for commercially insured patients
  • Not available for government insurance (Medicare, Medicaid)
  • Enrollment required during REMS program setup
  • Contact: [Ionis patient support line](verify with the source linked below)

Financial Assistance Options

  • Patient Advocate Foundation: Specialty drug copay assistance
  • HealthWell Foundation: hATTR-specific grants when available
  • State programs: New Jersey may offer additional assistance through DOBI

Specialty Pharmacy Requirements

Tegsedi must be dispensed through BCBS-contracted specialty pharmacies:

Common Network Pharmacies

  • Accredo Specialty Pharmacy (many BCBS plans)
  • Walgreens Specialty Pharmacy (select plans)
  • Plan-specific networks (verify with member services)

Dispensing Process

  1. Prescriber e-prescribes to designated specialty pharmacy
  2. Pharmacy coordinates PA and REMS enrollment
  3. Medication shipped to patient or clinic
  4. No retail pharmacy pickup available

Scripts for Key Conversations

Calling Blue Cross Blue Shield Member Services

"Hi, I'm calling about prior authorization requirements for Tegsedi, also called inotersen, for my hereditary amyloidosis. Can you tell me: (1) Is this drug on my plan's formulary? (2) What's the prior authorization process? (3) Which specialty pharmacy should I use? (4) Can you email me the PA form?"

Requesting Expedited Review

"My patient has progressive hATTR polyneuropathy and delaying treatment could result in irreversible nerve damage. I'm requesting an expedited prior authorization review. The clinical urgency is documented in my attached letter."

Peer-to-Peer Request Script

"I'd like to request a peer-to-peer review for my Tegsedi prior authorization denial. I'm a neurologist specializing in amyloidosis, and I can explain why this patient specifically needs inotersen rather than your preferred alternatives."

FAQ

How long does Blue Cross Blue Shield PA take in New Jersey? Standard prior authorization decisions are typically made within 5-7 business days. Expedited reviews for urgent cases are completed within 24-72 hours.

What if Tegsedi is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. If denied, appeal through internal processes and then New Jersey's IHCAP external review.

Can I request an expedited appeal in New Jersey? Yes, if your physician certifies that waiting for standard review could seriously jeopardize your health or ability to regain function. Both internal appeals and IHCAP offer expedited timelines.

Does step therapy apply to Tegsedi? Some plans require trying preferred hATTR treatments first. Document medical reasons why alternatives are inappropriate (contraindications, prior failures, or clinical factors).

What's the difference between medical and pharmacy benefit coverage? Tegsedi is typically covered under pharmacy benefits as a specialty drug. Verify with your plan, as this affects which forms to use and where to submit appeals.

How much does Tegsedi cost with insurance? As a non-preferred specialty drug, expect high coinsurance (often 25-50% of drug cost). Manufacturer copay assistance can significantly reduce out-of-pocket costs for commercially insured patients.

Can my doctor appeal on my behalf? Yes, prescribers can file appeals with patient consent. Many specialty practices handle appeals as part of patient care coordination.

What happens if IHCAP overturns my denial? The decision is binding on your insurance company. They must cover the treatment as directed by the independent review organization.

Disclaimer: This information is for educational purposes only and is not medical advice. Always consult with your healthcare provider about treatment decisions. For official appeals guidance, contact the New Jersey Department of Banking and Insurance or your insurance plan directly.

Need help with your appeal? Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted appeals by analyzing denial letters and plan policies to create evidence-backed rebuttals that align with payer requirements.

Sources & Further Reading

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