By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (inotersen) Covered by Cigna in Pennsylvania: Decision Tree, Forms & Appeals

Answer Box: Quick Eligibility Check

To get Tegsedi (inotersen) covered by Cigna in Pennsylvania: You need confirmed hATTR polyneuropathy with genetic testing, specialist prescription, REMS enrollment, and often proof you've tried Onpattro (patisiran) first. Submit prior authorization through Express Scripts specialty pharmacy with complete documentation. If denied, use Pennsylvania's new external review process—about 50% of appeals are successful. First step today: Contact your neurologist to confirm TTR gene testing results and gather prior therapy records.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Document Checklist & Submission
  4. If "Possibly Eligible": Tests to Complete
  5. If "Not Yet": Alternative Options
  6. If Denied: Pennsylvania Appeals Process
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Solutions
  9. FAQ: Cigna & Pennsylvania Specifics
  10. Sources & Further Reading

How to Use This Guide

This decision tree helps Pennsylvania residents navigate Cigna's requirements for Tegsedi (inotersen), a specialty drug for hereditary transthyretin-mediated (hATTR) polyneuropathy. Work through each section based on where you are in the process.

Important note: Tegsedi's manufacturer announced US commercial discontinuation as of September 2024. Verify current availability with your specialty pharmacy before proceeding.

Tip: Bookmark this page and work through it with your neurologist or amyloidosis specialist. They'll need to handle most submissions.

Eligibility Triage: Do You Qualify?

Answer these questions to determine your approval likelihood:

Likely Eligible ✅

  • Confirmed hATTR diagnosis with TTR gene mutation testing
  • Symptomatic polyneuropathy documented by neurologist
  • Age 18 or older
  • Prescribed by neurologist, geneticist, or amyloidosis specialist
  • Tried and failed Onpattro (patisiran) OR have documented contraindication
  • Willing to enroll in REMS program with weekly/biweekly lab monitoring

Possibly Eligible ⚠️

  • Suspected hATTR but genetic testing pending
  • Family history of transthyretin amyloidosis but no symptoms yet
  • Haven't tried Onpattro but have compelling medical reasons to skip it
  • Cardiac hATTR but also have polyneuropathy symptoms

Not Yet Eligible ❌

  • No genetic confirmation of TTR mutation
  • Asymptomatic (no polyneuropathy symptoms)
  • Under age 18
  • Haven't tried required first-line therapy without valid medical reason
  • Unable to comply with REMS monitoring requirements

If "Likely Eligible": Document Checklist & Submission

Required Documents for Prior Authorization

Medical Records:

  • TTR genetic test results showing pathogenic variant
  • Neurological assessment confirming polyneuropathy
  • Documentation of Onpattro trial/failure OR contraindication letter
  • Baseline lab results (platelets, kidney function, liver enzymes)
  • Specialist prescription with ICD-10 codes

Insurance Documentation:

  • Current Cigna member ID card
  • Specialty pharmacy benefit verification
  • Prior authorization form (obtain from Express Scripts)

REMS Requirements:

  • Provider REMS enrollment confirmation
  • Patient REMS enrollment (complete online)
  • Lab monitoring plan signed by prescriber

Submission Process

  1. Contact Express Scripts Specialty Pharmacy at the number on your Cigna card
  2. Complete prior authorization form with your prescriber
  3. Submit via provider portal or fax (verify current number)
  4. Timeline: Standard review within 72 hours; expedited within 24 hours for urgent cases
  5. Follow up if no response within timeframe
Clinician Corner: Include FDA labeling language in your medical necessity letter: "Tegsedi is indicated for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults." Reference specific TTR mutation and functional decline measurements.

If "Possibly Eligible": Tests to Complete

Genetic Testing Priority

  • Order TTR gene sequencing through major lab (LabCorp, Quest, Mayo)
  • Expected timeline: 2-3 weeks for results
  • Insurance coverage: Usually covered when medically indicated
  • Cost if self-pay: Typically $500-1,500

Additional Documentation Needed

  • Nerve conduction studies to confirm polyneuropathy
  • Family history documentation if available
  • Previous medication trials and outcomes
  • Functional assessment scores (if used by your clinic)

Timeline to Reapply

Plan for 4-6 weeks to gather complete documentation before submitting prior authorization.

If "Not Yet": Alternative Options

First-Line Treatments to Discuss

  • Onpattro (patisiran): IV infusion every 3 weeks, often required first
  • Amvuttra (vutrisiran): Subcutaneous injection every 3 months
  • Wainua (eplontersen): Monthly subcutaneous injection

Exception Request Strategy

If you have compelling reasons to skip step therapy:

  • Severe infusion reactions to IV therapies
  • Venous access issues preventing infusions
  • Geographic barriers to infusion centers
  • Documented allergy to alternative formulations

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex cases like these, helping patients navigate step therapy requirements and formulary exceptions.

If Denied: Pennsylvania Appeals Process

Pennsylvania offers one of the strongest consumer appeal systems in the US, with about 50% of external reviews overturning insurer denials.

Internal Appeals (Required First)

  1. File with Cigna within 180 days of denial
  2. Submit additional evidence if available
  3. Request peer-to-peer review for complex cases
  4. Timeline: 30 days for standard, 72 hours for expedited
  5. Get Final Adverse Benefit Determination letter

Pennsylvania External Review

After exhausting internal appeals:

Eligibility:

  • ACA marketplace plans, individual/small group plans
  • Large employer plans (if not self-funded)
  • Must have Final Adverse Benefit Determination

Process:

  1. Submit within 4 months of final denial
  2. File online at pa.gov external review portal or by mail
  3. Independent medical experts review your case
  4. 45 days for standard cases, 72 hours for urgent
  5. No cost to consumer

Success Rate: 50-53% of appeals are overturned in favor of patients

From Our Advocates: We've seen several hATTR cases succeed in external review when the initial submission included peer-reviewed evidence showing Onpattro failures and detailed functional decline documentation. The key is demonstrating medical necessity with objective measures, not just symptom descriptions.

When to Escalate Further

Contact Pennsylvania Insurance Department consumer services if:

  • Cigna doesn't follow required timelines
  • You suspect bad faith denial practices
  • External review decision isn't honored

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all cases Express Scripts specialty Cigna PA Policy
Specialty Tier High copay/coinsurance Member portal formulary Cigna formulary documents
Step Therapy Try Onpattro first PA criteria documents Payer policy guides
REMS Enrollment Mandatory safety program Tegsedi REMS website FDA requirements
Age Restriction 18+ years only FDA labeling Product prescribing info
Specialist Prescription Neurologist/geneticist PA form requirements Coverage policies

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Step therapy not completed" Prove Onpattro trial/failure Chart notes, pharmacy records, adverse event reports
"Not medically necessary" Strengthen clinical justification Functional assessments, genetic testing, specialist letter
"REMS not enrolled" Complete enrollment REMS confirmation numbers for patient and provider
"Experimental/investigational" Cite FDA approval FDA labeling, published guidelines
"Quantity limits exceeded" Justify dosing frequency Clinical rationale for weekly dosing

FAQ: Cigna & Pennsylvania Specifics

How long does Cigna prior authorization take in Pennsylvania? Standard review: 72 hours. Expedited review: 24 hours for life-threatening situations. Pennsylvania law doesn't change these federal timelines.

What if Tegsedi is non-formulary on my plan? Request formulary exception through Cigna's process. You'll need medical necessity documentation and often peer-to-peer review. Counterforce Health can help prepare evidence-backed exception requests.

Can I request expedited appeal in Pennsylvania? Yes, if your health condition poses immediate serious jeopardy. Both Cigna internal appeals and Pennsylvania external review offer expedited timelines.

Does Pennsylvania's external review apply to employer plans? Only if your employer plan is subject to state regulation. Large self-funded ERISA plans use federal external review instead.

What happens if I paid out-of-pocket during appeals? If you win your appeal, Cigna must reimburse covered expenses retroactively. Keep all receipts and documentation.

How do I know if my TTR genetic test is sufficient? The test must identify a pathogenic TTR variant. "Variants of uncertain significance" may not qualify. Ask your geneticist to clarify the clinical interpretation.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage decisions depend on individual plan terms and medical circumstances.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform identifies denial reasons and drafts point-by-point rebuttals aligned to each plan's specific requirements, pulling the right clinical evidence and citations to support medical necessity arguments.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.