By Counterforce Health Team in Tegsedi (inotersen) —

Tegsedi (Inotersen) Approval with UnitedHealthcare in Georgia: Answers to the Most Common Questions

Answer Box: Getting Tegsedi Covered by UnitedHealthcare in Georgia

Yes, UnitedHealthcare covers Tegsedi (inotersen) for hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy in adults, but requires prior authorization. The fastest path to approval: (1) Enroll in the Tegsedi REMS program immediately, (2) Document genetic TTR mutation and prior Onpattro trial/failure, (3) Submit comprehensive prior authorization via UnitedHealthcare Provider Portal with lab monitoring plan. If denied, you have 180 days for internal appeal, then 60 days for Georgia external review through the Department of Insurance.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Deadlines
  4. Medical Necessity Criteria
  5. Costs and Coverage
  6. Denials and Appeals in Georgia
  7. Renewals and Reauthorization
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Glossary

Coverage Basics

Is Tegsedi covered by UnitedHealthcare?

UnitedHealthcare covers Tegsedi (inotersen) through OptumRx for the FDA-approved indication: hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy in adults. Coverage requires prior authorization in all UnitedHealthcare plans, including commercial, Medicare Advantage, and individual marketplace plans.

Which UnitedHealthcare plans cover Tegsedi?

All UnitedHealthcare plans that include prescription drug coverage can cover Tegsedi, but it's typically placed on the specialty tier requiring prior authorization. This includes:

  • Commercial employer plans
  • Individual marketplace plans (ACA)
  • Medicare Advantage plans with Part D
  • Medicare Part D standalone plans
Note: Self-funded employer plans may have different criteria, so verify with your specific plan documents.

Prior Authorization Process

Who submits the prior authorization?

Your prescribing physician (typically a neurologist) must submit the prior authorization through the UnitedHealthcare Provider Portal or OptumRx system. Patients cannot submit PAs directly, but you can help gather required documentation.

How to check prior authorization status?

  • Patients: Call UnitedHealthcare Member Services (number on your insurance card)
  • Providers: Check the UnitedHealthcare Provider Portal or call provider services
  • Reference number: Keep your PA confirmation number for faster status checks

Timing and Deadlines

How long does prior authorization take?

  • Standard review: Up to 15 business days from complete submission
  • Urgent/expedited: 72 hours if medical urgency is documented
  • Incomplete submissions: Clock resets when additional information is requested
Tip: Start the process 3-4 weeks before your planned start date to account for REMS enrollment and potential appeals.

What if I need Tegsedi urgently?

For urgent medical situations, your doctor can request expedited review by documenting that a delay could seriously jeopardize your health. UnitedHealthcare must respond within 72 hours for expedited requests.

Medical Necessity Criteria

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Diagnosis hATTR polyneuropathy with genetic confirmation TTR gene test results
Step Therapy Trial/failure of Onpattro (patisiran) Medical records, prior authorizations
REMS Enrollment Safety program for prescriber and patient Tegsedi REMS website
Lab Monitoring Baseline and biweekly monitoring plan Lab results, monitoring protocol
Prescriber Neurologist or specialist consultation Provider credentials

What counts as step therapy?

UnitedHealthcare typically requires documented trial and failure (or contraindication/intolerance) of Onpattro (patisiran) before approving Tegsedi. Acceptable documentation includes:

  • Inadequate clinical response after appropriate trial period
  • Serious adverse reactions or intolerance
  • Medical contraindications to Onpattro
  • Clear clinical rationale why Tegsedi is preferred

Which labs are required?

Baseline requirements:

  • Complete blood count with platelet count
  • Comprehensive metabolic panel
  • Urinalysis with protein quantification
  • Estimated glomerular filtration rate (eGFR)

Ongoing monitoring: Every 2 weeks throughout treatment for thrombocytopenia and glomerulonephritis surveillance.

Costs and Coverage

Copay vs. coinsurance for Tegsedi?

For Medicare plans (2025): UnitedHealthcare Medicare members benefit from the $2,000 annual out-of-pocket cap on prescription drugs, including specialty medications like Tegsedi.

For commercial plans: Costs vary by plan design. Tegsedi is typically on the specialty tier with:

  • Higher copays ($100-500+ per month) or
  • Coinsurance (25-33% of drug cost) up to plan maximums
Money-saving tip: Check for manufacturer copay assistance programs and patient foundation grants that can help reduce out-of-pocket costs.

Denials and Appeals in Georgia

Why was my Tegsedi prior authorization denied?

Most common denial reasons:

Denial Reason How to Fix It
Off-label use Confirm hATTR polyneuropathy diagnosis with genetic testing
Missing step therapy Document Onpattro trial/failure or contraindication
No REMS enrollment Complete prescriber and patient REMS registration
Insufficient documentation Submit complete medical records, lab results, and monitoring plan
Quantity limits exceeded Provide clinical justification for dosing requirements

How to appeal a UnitedHealthcare denial in Georgia

Step 1: Internal Appeal (180 days from denial)

  • Submit detailed clinical documentation
  • Include medical necessity letter from prescriber
  • Request peer-to-peer review if needed
  • File through UnitedHealthcare Provider Portal or member services

Step 2: External Review (60 days from internal appeal denial)

  • File with Georgia Department of Insurance
  • Complete external review application
  • Submit all denial letters and supporting documentation
  • Review is free and binding on UnitedHealthcare
Critical deadline: You have only 60 days from receiving your internal appeal denial to request external review in Georgia.

Appeals Playbook for Georgia Residents

Internal Appeal Process:

  • Deadline: 180 days from initial denial
  • How to file: UnitedHealthcare Provider Portal or call member services
  • Required documents: Denial letter, medical records, prescriber letter
  • Timeline: Up to 30 days for standard, 72 hours for urgent

External Review Process:

  • Deadline: 60 days from internal appeal denial
  • How to file: Georgia DOI Consumer Complaint Form
  • Cost: Free to consumers
  • Timeline: 30 business days standard, 72 hours urgent
  • Decision: Binding on UnitedHealthcare

For assistance with appeals, contact:

  • Georgia DOI Consumer Services: 1-800-656-2298
  • Georgians for a Healthy Future: Consumer assistance organization

Renewals and Reauthorization

When do I need to reauthorize Tegsedi?

UnitedHealthcare typically approves Tegsedi for up to 12 months per authorization. You'll need reauthorization:

  • Before your current approval expires
  • If there are significant changes to your treatment
  • If you switch UnitedHealthcare plans
  • If formulary changes affect coverage

What's required for renewal?

  • Continued REMS program participation
  • Documentation of clinical benefit
  • Updated lab monitoring results
  • Confirmation that combination therapies are not being used
  • Prescriber attestation of ongoing medical necessity

Specialty Pharmacy Requirements

Why was my prescription transferred to OptumRx?

Tegsedi is a specialty medication that UnitedHealthcare requires to be dispensed through OptumRx Specialty Pharmacy. This ensures:

  • Proper handling and storage of the medication
  • Patient education and support services
  • Coordination with REMS program requirements
  • Insurance billing and prior authorization integration

What to expect from specialty pharmacy

  • Patient support coordinators to help with insurance and logistics
  • Clinical pharmacists for medication counseling
  • Home delivery with temperature-controlled shipping
  • Refill reminders and adherence support
  • Financial assistance program coordination

Troubleshooting Common Issues

Provider portal is down or not working

  • Try the UnitedHealthcare Provider mobile app
  • Call provider services directly: 1-888-842-4571
  • Submit via fax (verify current fax number with UnitedHealthcare)
  • Use backup submission methods outlined in your provider manual

Missing required forms

Key UnitedHealthcare forms for Tegsedi:

  • Prior Authorization Request Form
  • Medical Necessity Attestation
  • REMS Enrollment Verification
Important: Always verify you're using the most current form versions from the UnitedHealthcare Provider Portal.

Peer-to-peer review not scheduled

If your request for peer-to-peer review isn't being scheduled:

  1. Document your request in writing
  2. Follow up within 48 hours
  3. Escalate to UnitedHealthcare supervisor if needed
  4. Consider filing a complaint with Georgia DOI if delays are unreasonable

From Our Advocates

We've seen many Georgia patients successfully obtain Tegsedi coverage after initial denials by ensuring their REMS enrollment was complete and providing detailed documentation of why Onpattro wasn't suitable for their specific situation. The key is thorough preparation and understanding that the external review process in Georgia has strong patient protections—don't give up after the first denial.

Glossary

Prior Authorization (PA): Insurance approval required before coverage begins
Quantity Limits (QL): Restrictions on amount of medication covered per time period
Step Therapy (ST): Requirement to try preferred medications before covering alternatives
Peer-to-Peer (P2P): Direct conversation between prescribing and reviewing physicians
Medical Necessity (MN): Clinical justification that treatment is appropriate and needed
REMS: Risk Evaluation and Mitigation Strategy - FDA safety program
External Review: Independent review of insurance denials by state-appointed reviewers
Formulary: List of medications covered by insurance plan
EOB: Explanation of Benefits - document showing coverage decisions
OptumRx: UnitedHealthcare's pharmacy benefit manager

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals with the right clinical evidence and procedural requirements for each payer's specific workflows.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for specific coverage determinations. For personalized assistance with insurance appeals in Georgia, consider consulting with Counterforce Health or contacting the Georgia Department of Insurance Consumer Services Division.

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