By Counterforce Health Team in Amvuttra (vutrisiran) —

Do You Qualify for Amvuttra (vutrisiran) Coverage by UnitedHealthcare in Texas? Decision Tree & Next Steps

Answer Box: Fastest Path to Amvuttra Coverage in Texas

You likely qualify if you have confirmed hATTR amyloidosis (genetic testing or biopsy), polyneuropathy stage PND ≤ IIIb or ATTR cardiomyopathy, and a specialist prescription. UnitedHealthcare requires prior authorization through OptumRx specialty pharmacy. Start today: Call member services (number on your insurance card) to verify formulary status, then have your neurologist/cardiologist gather TTR genetic results and stage documentation. Submit via the UnitedHealthcare Provider Portal or fax for fastest processing (typically 15-30 days). If denied, Texas law provides strong appeal rights including peer-to-peer review and independent external review.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Document Checklist
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet": Alternatives to Discuss
  6. If Denied: Texas Appeal Path
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Fixes
  9. FAQ: Texas-Specific Questions
  10. Sources & Further Reading

How to Use This Decision Tree

This guide helps you determine if you qualify for Amvuttra (vutrisiran) coverage through UnitedHealthcare in Texas and provides your next steps based on your situation. Amvuttra is a quarterly injection for hereditary transthyretin amyloidosis (hATTR) affecting the nerves (polyneuropathy) or heart (cardiomyopathy).

Start here: Answer the eligibility questions below, then follow the path that matches your situation. Each section includes specific documents to gather, forms to complete, and deadlines to track.

Note: This covers commercial UnitedHealthcare plans and Medicare Advantage. ERISA self-funded employer plans may have different rules.

Eligibility Triage: Do You Qualify?

Work through these questions with your healthcare team:

Primary Requirements Checklist

✓ Diagnosis Confirmed?

  • TTR genetic testing showing pathogenic variant (hereditary hATTR)
  • OR cardiac biopsy with TTR amyloid confirmed by immunohistochemistry
  • OR Tc-99m-PYP/DPD scintigraphy Grade 2-3 uptake with normal monoclonal proteins

✓ Disease Stage Appropriate?

  • Polyneuropathy: PND score ≤ IIIb or FAP Stage 1-2
  • Cardiomyopathy: Confirmed ATTR-CM with heart failure symptoms

✓ Prescriber Qualified?

  • Neurologist (for polyneuropathy) or cardiologist (for cardiomyopathy)
  • Specialist has documented rationale for Amvuttra vs. alternatives

✓ No Exclusions?

  • Age 18 or older
  • No prior liver transplant
  • Not currently on other hATTR therapies (Onpattro, Tegsedi, Wainua)

Your Path Forward

If you checked all boxes → "Likely Eligible" - Proceed to document gathering If you missed 1-2 boxes → "Possibly Eligible" - Additional testing may be needed If you missed 3+ boxes → "Not Yet" - Consider alternatives or exception requests

If "Likely Eligible": Document Checklist

You meet the basic criteria. Here's what to gather for your prior authorization:

Required Documentation

Document Type What You Need Where to Get It
Genetic Testing TTR gene sequencing report showing pathogenic variant Lab report from genetics testing
Specialist Evaluation Letter from neurologist/cardiologist with diagnosis, staging, treatment rationale Your specialist's office
Disease Staging PND score, mNIS+7 baseline, or cardiac function tests Neurologic exam results or echocardiogram
Prior Treatments Documentation of previous therapies tried/failed/contraindicated Medical records
Insurance Info Member ID, group number, prescriber NPI/DEA Insurance card, provider info

Submission Process

  1. Verify Coverage: Call UnitedHealthcare member services (number on your card) to confirm:
    • Amvuttra is on your formulary (typically Tier 5 specialty)
    • Prior authorization requirements for your specific plan
    • Preferred specialty pharmacy (usually OptumRx)
  2. Complete PA Form: Your provider can access forms via:
  3. Submit Complete Package: Include all documents above plus medical necessity letter citing:
    • FDA labeling for your indication
    • Clinical guidelines (AHA/ACC for cardiomyopathy, peripheral neuropathy guidelines)
    • Patient-specific rationale

Timeline: 15-30 business days for standard review; 72 hours if urgent/expedited

If "Possibly Eligible": Tests to Request

You may qualify but need additional documentation. Here's what to discuss with your doctor:

Missing Genetic Confirmation?

  • Request TTR gene sequencing through programs like:
    • NavigATTR (Prevention Genetics) - for patients with family history or symptoms
    • Alnylam Act® - free testing and genetic counseling
  • Timeline: 2-3 weeks for results
  • Next step: Reapply for PA once genetic results confirm hATTR

Unclear Disease Stage?

  • Polyneuropathy: Request formal PND scoring and mNIS+7 assessment
  • Cardiomyopathy: May need cardiac MRI, NT-proBNP, or advanced imaging
  • Track symptoms: Document progression over 3-6 months if borderline staging

Specialist Referral Needed?

  • For polyneuropathy: Neurologist familiar with amyloidosis
  • For cardiomyopathy: Cardiologist with amyloid experience
  • Many academic medical centers have specialized amyloidosis clinics

If "Not Yet": Alternatives to Discuss

If you don't meet current criteria, consider these options:

Other hATTR Therapies

  • Onpattro (patisiran): IV infusion every 3 weeks, similar efficacy
  • Tegsedi (inotersen): Weekly self-injection, requires monitoring
  • Wainua (eplontersen): Monthly self-injection, newer option

ATTR Cardiomyopathy Alternatives

  • Vyndaqel/Vyndamax (tafamidis): TTR stabilizer, oral daily
  • Attruby (acoramidis): Newer oral stabilizer option

Exception Request Strategy

If you don't meet standard criteria but have compelling clinical need:

  1. Document why alternatives are inappropriate
  2. Include peer-reviewed literature supporting off-label use
  3. Emphasize progression risk without treatment
  4. Consider compassionate use programs

If Denied: Texas Appeal Path

Texas provides strong patient appeal rights. Here's your step-by-step process:

Level 1: Internal Appeal

  • Deadline: 180 days from denial letter
  • Timeline: 30 days for pre-service decisions
  • How to file:
    • UnitedHealthcare Provider Portal (preferred)
    • Written appeal to address in denial letter
    • Include all original documents plus additional evidence

Level 2: Peer-to-Peer Review

  • When: Request within 21 days of denial
  • Process: Your doctor discusses case directly with UHC medical director
  • Success rate: High with strong clinical justification
  • Tip: Can file simultaneously with Level 1 appeal

External Review (Texas IRO)

After exhausting internal appeals:

  • Deadline: 4 months from final denial
  • Process: Independent Review Organization reviews case
  • Cost: Free to patient (UHC pays)
  • Timeline: 20 days standard, 5 days expedited
  • Overturn rate: ~50% for specialty drugs with comprehensive documentation
  • Contact: Texas Department of Insurance at 1-800-252-3439
From our advocates: "We've seen the strongest appeals combine clinical progression data with peer-reviewed literature. One case involved a patient whose neuropathy worsened significantly over 6 months - including objective measures like 10-meter walk time and mNIS+7 scores. The appeal included recent studies on Amvuttra's quarterly convenience advantage and the patient's specific contraindications to infusion therapies. The external reviewer overturned the denial within 15 days."

Coverage Requirements at a Glance

Requirement UnitedHealthcare Standard How to Document Source
Prior Authorization Required for all plans Submit via provider portal or OptumRx UHC Provider Portal
Diagnosis hATTR with genetic confirmation or biopsy TTR gene report or pathology UHC RNA Therapy Policy
Staging PND ≤ IIIb or confirmed ATTR-CM Neurologic exam or cardiac imaging Clinical documentation
Prescriber Neurologist or cardiologist Include NPI/DEA on PA form PA form requirements
Age 18+ years Birth date on member info Standard eligibility
Exclusions No liver transplant, no concurrent hATTR drugs Medical history documentation Policy exclusions
Pharmacy OptumRx specialty network Coordinate through provider Specialty drug requirements

Common Denial Reasons & Fixes

Denial Reason How to Overturn Documents Needed
"Genetic testing not provided" Submit TTR gene sequencing report Lab report with pathogenic variant
"Disease stage not documented" Include formal neurologic or cardiac assessment PND score, mNIS+7, or echo results
"Not prescribed by specialist" Transfer prescription to neurologist/cardiologist New prescription from qualified provider
"Step therapy required" Document failures/contraindications to alternatives Prior therapy records, adverse event notes
"Experimental/investigational" Cite FDA approval and clinical guidelines FDA label, AHA/ACC guidelines
"Not medically necessary" Strengthen clinical rationale with outcomes data Progression documentation, quality of life measures

FAQ: Texas-Specific Questions

How long does UnitedHealthcare PA take in Texas? Standard review is 15-30 business days. Expedited review (when delay would jeopardize health) is decided within 72 hours. Texas doesn't set specific PA timelines for private insurers, but federal rules apply to most plans.

What if Amvuttra isn't on my formulary? Request a formulary exception with your PA. Include medical necessity letter explaining why formulary alternatives (like Onpattro or Tegsedi) aren't appropriate. Non-formulary appeals have lower success rates but are still worth pursuing with strong clinical justification.

Can I request expedited appeals in Texas? Yes, if delay would seriously jeopardize your health. You can request expedited internal appeals (72-hour decision) and expedited external review (5-day decision) simultaneously if criteria are met.

Does UnitedHealthcare require step therapy for Amvuttra? Current policies don't explicitly require trying other hATTR drugs first, but some plans may prefer alternatives. Document any contraindications or failures with other therapies (Onpattro, Tegsedi, Wainua) to strengthen your case.

What if I have Medicare Advantage through UnitedHealthcare? Medicare Advantage follows similar PA requirements but has different appeal timelines (60 days for initial internal appeal). External review goes through Medicare's system, not Texas IRO.

How much does Amvuttra cost without insurance? List price is approximately $119,351 per quarterly injection (~$476,000/year). Alnylam Assist offers patient support programs that may help with copays or provide free drug for eligible uninsured patients.

Coverage assistance is available through specialized platforms that help patients navigate the complex prior authorization and appeals process. Counterforce Health analyzes denial letters and insurance policies to create targeted, evidence-backed appeals that address specific payer requirements. Their platform helps ensure appeals include the right clinical documentation, peer-reviewed citations, and procedural elements that Texas payers expect - potentially saving months in the approval process.

For patients facing denials, having expert support can make the difference between a successful appeal and prolonged delays in accessing critical medications like Amvuttra. The platform's Texas-specific knowledge includes understanding UnitedHealthcare's utilization management patterns and the state's Independent Review Organization process.

Sources & Further Reading

This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on your specific insurance plan and clinical situation. Always verify current requirements with your insurer and consult your healthcare provider for medical guidance. For assistance with Texas insurance appeals, contact the Texas Department of Insurance at 1-800-252-3439.

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