By Counterforce Health Team in Tegsedi (inotersen) —

Work With Your Doctor to Get Tegsedi (inotersen) Approved by UnitedHealthcare in Virginia: Complete Prior Authorization Guide

Quick Answer: Getting Tegsedi (inotersen) covered by UnitedHealthcare in Virginia requires genetic confirmation of hATTR polyneuropathy, REMS program enrollment, and documented failure of Onpattro (step therapy). Start by scheduling a visit with your neurologist to review diagnostic requirements and gather clinical documentation. If denied, Virginia's Bureau of Insurance offers external review within 120 days of your final denial letter.

Table of Contents

Set Your Goal: What Approval Requires

Your partnership with your doctor is crucial for getting Tegsedi (inotersen) approved by UnitedHealthcare. This rare disease medication requires extensive documentation, and your physician needs your active participation to build a compelling case.

Coverage Requirements at a Glance

Requirement What It Means Your Role
Genetic confirmation TTR gene mutation documented Provide family history, consent to testing
REMS enrollment Safety program participation Complete patient enrollment forms
Step therapy Trial of Onpattro first Document previous treatments and outcomes
Specialist prescription Neurologist involvement required Maintain regular neurology appointments
Lab monitoring plan Ongoing safety assessments Commit to weekly/monthly blood draws

Source: UnitedHealthcare Prior Authorization Requirements

Partnership Goals

  • Immediate: Gather complete diagnostic evidence
  • Short-term: Submit thorough prior authorization
  • Long-term: Maintain coverage through monitoring compliance

Visit Preparation: Building Your Case

Before your appointment, create a comprehensive symptom and treatment timeline. Your doctor needs this information to craft a compelling medical necessity letter.

Symptom Documentation Checklist

  • Neurological symptoms: Numbness, tingling, pain, weakness (rate severity 1-10)
  • Functional impact: Walking difficulties, balance issues, hand coordination problems
  • Progression timeline: When symptoms started, how they've worsened
  • Daily life effects: Work limitations, self-care challenges, mobility aids needed

Treatment History Summary

Document every therapy you've tried:

  • Medication names and doses
  • Duration of treatment
  • Reasons for discontinuation (ineffective, side effects, contraindications)
  • Current medications and supplements
Tip: Bring a written summary to your appointment. This ensures nothing important gets missed and helps your doctor write a more detailed letter.

Family History Notes

hATTR polyneuropathy is hereditary, so family information matters:

  • Relatives with similar symptoms
  • Known genetic testing results in family members
  • Age of symptom onset in affected relatives

Evidence Kit: Essential Documentation

Work with your healthcare team to compile this evidence before submitting your prior authorization.

Required Clinical Documentation

Genetic Testing Results

  • TTR gene sequencing confirming pathogenic mutation
  • Laboratory report with specific mutation identified (e.g., V30M)
  • Source: Clinical genetic testing from certified labs like Invitae or Mayo Clinic

Neurological Assessment

  • Nerve conduction studies showing axonal polyneuropathy
  • Clinical scales: mNIS+7 or Polyneuropathy Disability (PND) score
  • Functional assessment documenting progressive decline

Laboratory Results

  • Baseline platelet count ≥100 × 10⁹/L
  • Kidney function (eGFR ≥45 mL/min/1.73 m²)
  • Urinalysis with protein-to-creatinine ratio

Step Therapy Documentation

UnitedHealthcare typically requires Onpattro (patisiran) trial before approving Tegsedi. Document:

  • Previous Onpattro use: Dates, doses, duration
  • Reason for discontinuation: Infusion reactions, transportation barriers, lack of efficacy
  • Clinical notes supporting the switch to subcutaneous therapy

Medical Necessity Letter Structure

Your doctor's letter of medical necessity is the cornerstone of your prior authorization. Here's what it should include:

Essential Components

1. Diagnosis Statement "Patient has genetically confirmed hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy (ICD-10: E85.1), supported by [specific TTR mutation] identified through genetic testing."

2. Clinical Rationale

  • Progressive sensorimotor polyneuropathy symptoms
  • Functional decline documented by standardized assessments
  • Impact on activities of daily living and quality of life

3. Treatment Justification

  • FDA approval for hATTR polyneuropathy
  • Clinical trial evidence supporting efficacy
  • Rationale for choosing Tegsedi over alternatives

4. Safety Monitoring Plan

  • REMS program enrollment completed
  • Weekly platelet monitoring protocol
  • Monthly kidney function assessments

5. Risks of Delay

  • Progressive nature of hATTR polyneuropathy
  • Irreversible neurological damage without treatment
  • Declining functional status affecting independence
Clinician Corner: Include specific citations from FDA labeling and clinical guidelines. Reference the Tegsedi prescribing information and published efficacy studies to strengthen your case.

Peer-to-Peer Support

If your initial prior authorization is denied, UnitedHealthcare may offer a peer-to-peer (P2P) review. This is your doctor's opportunity to speak directly with a medical director.

How to Support Your Doctor

Provide Availability Windows

  • Offer to coordinate your schedule with your doctor's
  • Be flexible with timing to accommodate the P2P call
  • Understand this conversation happens between physicians

Prepare a Case Summary Help your doctor prepare by organizing:

  • One-page clinical summary with key facts
  • Timeline of treatments tried and failed
  • Specific functional limitations affecting your daily life

P2P Success Strategies

Your doctor should emphasize:

  • Medical necessity based on diagnosis and progression
  • Step therapy compliance or valid exceptions
  • Safety monitoring capabilities and commitment
  • Patient-specific factors making Tegsedi most appropriate

After Your Visit: Next Steps

Document everything and maintain organized records for potential appeals.

What to Save

  • Copy of prior authorization submission
  • All supporting clinical documents
  • Correspondence with UnitedHealthcare
  • Denial letters with specific reasons cited

Portal Communication

Use UnitedHealthcare's member portal to:

  • Track prior authorization status
  • Upload additional documents if requested
  • Communicate with your care team
  • Download determination letters
Note: Response times for specialty drug prior authorizations typically range from 3-14 business days, but complex cases may take longer.

Respectful Persistence: Follow-Up Strategy

Maintain professional, persistent communication throughout the process.

Follow-Up Timeline

  • Week 1: Confirm submission received
  • Week 2: Check status if no response
  • Week 3: Contact member services for update
  • Week 4: Consider expedited review if clinically appropriate

Escalation Steps

  1. Member services: 1-877-842-3210 (verify current number)
  2. Pharmacy benefits: OptumRx customer service
  3. Case management: Request assignment for complex cases
  4. State resources: Virginia Bureau of Insurance if needed

Appeals Process in Virginia

Virginia provides robust consumer protections for insurance denials through the State Corporation Commission's Bureau of Insurance.

Internal Appeals with UnitedHealthcare

  • Timeline: 180 days from denial date
  • Levels: Two internal review levels typically available
  • Expedited option: Available for urgent medical needs

External Review Process

If internal appeals fail, Virginia offers independent external review:

Eligibility Requirements

  • Completed UnitedHealthcare's internal appeals process
  • Denial based on medical necessity or experimental treatment determination
  • Virginia-issued plan or opted-in self-funded plan

Timeline and Process

  • Deadline: 120 days from final internal denial
  • Standard review: Decision within 45 days
  • Expedited review: Decision within 72 hours for urgent cases

Required Forms

  • Form 216-A: External Review Request
  • Form 216-B: Authorized Representative (if applicable)
  • Form 216-C: Physician Certification (for expedited review)

Submission Options

  • Fax: 804-371-9915
  • Email: [email protected]
  • Mail: State Corporation Commission, Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218

Source: Virginia Bureau of Insurance External Review Process

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
Missing REMS enrollment Complete Tegsedi REMS program at tegsedirems.com
No step therapy trial Document Onpattro failure, intolerance, or contraindication
Insufficient genetic evidence Provide complete TTR gene sequencing report with mutation details
Inadequate monitoring plan Submit detailed lab monitoring protocol with frequency
Wrong specialist Ensure prescription from or consultation with neurologist
Lab values outside range Repeat labs if values have improved; provide current results

FAQ

How long does UnitedHealthcare prior authorization take in Virginia? Standard prior authorizations typically take 3-14 business days. Expedited reviews for urgent cases can be completed within 72 hours.

What if Tegsedi is non-formulary on my plan? Non-formulary medications can still be covered through the prior authorization process with strong medical necessity documentation and step therapy compliance.

Can I request an expedited appeal in Virginia? Yes, if your physician certifies that waiting for standard review could seriously jeopardize your health. Use Form 216-C for expedited external review.

Does step therapy apply if I failed Onpattro outside Virginia? Yes, treatment failures from other states count toward step therapy requirements. Provide complete documentation of the previous trial.

What costs should I expect while waiting for approval? Tegsedi offers patient assistance programs. Contact Counterforce Health for help navigating manufacturer support options and temporary coverage solutions.

How do I know if my plan is eligible for Virginia external review? Virginia-issued commercial plans and many self-funded employer plans that opt-in are eligible. Contact the Bureau of Insurance at 1-877-310-6560 to verify eligibility.

About Counterforce Health Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address the specific reasons for coverage denials. We understand the complex prior authorization requirements for specialty medications like Tegsedi and can help you navigate UnitedHealthcare's approval process more effectively.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about your specific condition and treatment options. Insurance coverage policies change frequently; verify current requirements with your insurer and healthcare team.

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