By Counterforce Health Team in Amvuttra (vutrisiran) —

How to Get Amvuttra (Vutrisiran) Covered by UnitedHealthcare in Washington: Complete Guide to Prior Authorization, Appeals, and External Review

Answer Box: Getting Amvuttra Covered by UnitedHealthcare in Washington

UnitedHealthcare requires prior authorization for Amvuttra (vutrisiran) in Washington. Submit documentation including TTR genetic testing, specialist evaluation, and baseline outcomes via OptumRx PreCheck Prior Authorization or call 1-800-711-4555. If denied, appeal within 65 days internally, then request external review through Washington's Independent Review Organization (IRO). Contact the Washington Office of the Insurance Commissioner at 1-800-562-6900 for free appeal assistance.

First step today: Call UnitedHealthcare member services to confirm your plan's formulary status and obtain prior authorization forms.

Table of Contents

  1. Coverage Requirements Overview
  2. Prior Authorization Process
  3. Required Documentation
  4. Common Denial Reasons & Solutions
  5. Appeals Process in Washington
  6. External Review Through Washington's IRO
  7. Cost Savings and Patient Support
  8. When to Contact Washington's Insurance Commissioner
  9. FAQ

Coverage Requirements Overview

Amvuttra (vutrisiran) is a next-generation siRNA therapy for transthyretin amyloidosis (ATTR), administered as a subcutaneous injection every three months. UnitedHealthcare classifies it as a Tier 5 specialty medication requiring prior authorization through OptumRx.

The drug is FDA-approved for two indications:

  • hATTR polyneuropathy in adults (approved 2022)
  • ATTR cardiomyopathy (wild-type or hereditary) to reduce cardiovascular death and hospitalizations (approved March 2025)

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all plans OptumRx PA Guidelines
Formulary Tier Tier 5 specialty Verify with member services
Step Therapy May require trial of alternatives Plan-specific
Quantity Limits 1 syringe per 90 days Standard dosing
Site of Care Healthcare provider administration FDA labeling
Appeals Deadline 65 days (internal) Medicare Advantage standard

Prior Authorization Process

Step 1: Verify Coverage

Call UnitedHealthcare member services with your member ID to confirm:

  • Formulary status for your specific plan
  • Prior authorization requirements
  • Preferred specialty pharmacy network

Step 2: Submit Prior Authorization

Option A: OptumRx PreCheck Prior Authorization

  • Automated system for qualifying submissions
  • Approvals in under 30 seconds if criteria are met
  • Integrates with electronic medical records via Surescripts

Option B: Traditional Submission

  • Call 1-800-711-4555 for drug-specific guidelines
  • Submit via UnitedHealthcare Provider Portal
  • Fax completed forms (verify current fax number with provider services)

Step 3: Timeline Expectations

  • Standard review: 30 days for pre-service requests
  • Expedited review: 72 hours if delay jeopardizes health
  • Part B drug coverage: 7 days standard timeline

Required Documentation

Core Requirements for All Patients

TTR Genetic Testing

  • Confirmed TTR gene mutation for hereditary ATTR
  • Wild-type confirmation for non-hereditary ATTR-CM
  • Include complete laboratory report

Specialist Evaluation

  • Prescribing physician must be a neurologist (for polyneuropathy) or cardiologist (for cardiomyopathy)
  • Letter detailing clinical rationale aligned with FDA labeling
  • Documentation of patient's current functional status

Baseline Outcome Measures For polyneuropathy patients:

  • Polyneuropathy Disability (PND) score ≤ IIIb
  • Modified Neuropathy Impairment Score (mNIS+7)
  • Familial Amyloidotic Polyneuropathy (FAP) stage 1-2

For cardiomyopathy patients:

  • Echocardiogram or cardiac MRI results
  • NYHA functional class
  • NT-proBNP levels
  • 6-minute walk test results (if applicable)

Prior Therapy Documentation

Document trials and outcomes of alternative treatments:

  • For polyneuropathy: Wainua, Onpattro, Tegsedi
  • For cardiomyopathy: Tafamidis (Vyndaqel/Vyndamax), acoramidis (Attruby)

Include dates of treatment, duration, reasons for discontinuation (lack of efficacy, intolerance, contraindications).

Clinician Corner: Medical Necessity Letter ChecklistPatient diagnosis with ICD-10 codeTTR genetic testing resultsDisease progression documentationPrior therapy trials with specific dates and outcomesClinical rationale citing FDA labelingBaseline functional assessmentsTreatment goals and monitoring planReference to relevant clinical guidelines

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
Missing genetic confirmation Submit TTR gene testing Laboratory report with mutation analysis
Insufficient specialist evaluation Obtain detailed specialist letter Neurologist/cardiologist assessment with treatment rationale
Inadequate prior therapy trials Document alternative treatments Pharmacy records, physician notes showing trial/failure
Missing baseline assessments Complete functional evaluations PND score, mNIS+7, echocardiogram, NT-proBNP
"Not medically necessary" Submit peer-reviewed evidence FDA labeling, clinical guidelines, specialist society recommendations

Appeals Process in Washington

Internal Appeals (Required First Step)

For Medicare Advantage Plans:

  1. Level 1: Plan Reconsideration
    • File within 65 days of denial notice
    • Submit via UnitedHealthcare Provider Portal or mail
    • Include all supporting documentation
    • Timeline: 30 days standard, 72 hours expedited
  2. Level 2: Independent Review Entity (IRE)
    • Automatically forwarded if Level 1 upheld
    • Conducted by MAXIMUS (federal contractor)
    • Same timelines as Level 1

For Commercial Plans: Follow UnitedHealthcare's two-step process:

  1. Reconsideration via Provider Portal
  2. Formal Appeal if reconsideration denied

Peer-to-Peer Review Option

Request within 24 hours of denial (outpatient: 21 calendar days):

  • Schedule via UnitedHealthcare Provider Portal
  • Present additional clinical evidence to medical director
  • Often resolves issues before formal appeal

At Counterforce Health, we help patients and clinicians turn insurance denials into targeted, evidence-backed appeals. Our platform identifies the specific denial basis and drafts point-by-point rebuttals aligned with each payer's own rules, pulling the right clinical evidence and weaving it into appeals that meet procedural requirements.

External Review Through Washington's IRO

If internal appeals are unsuccessful, Washington residents can request external review through an Independent Review Organization (IRO).

How to Request External Review

  1. Timeline: 180 days from final internal denial
  2. Process: Submit request to UnitedHealthcare or directly to Washington's Office of the Insurance Commissioner
  3. Cost: Free to patients
  4. Decision: Binding on the insurer if overturned

Required Information

  • Final internal denial letter
  • All medical records and supporting documentation
  • Completed external review request form
  • Statement explaining why you disagree with the denial

Timeline for External Review

  • Standard: 30 days from complete submission
  • Expedited: 72 hours if health is in serious jeopardy
  • IRO Assignment: Washington OIC assigns from certified registry
Note: External review decisions are binding on UnitedHealthcare. If the IRO overturns the denial, the insurer must provide coverage.

Cost Savings and Patient Support

Alnylam Assist Program

  • Patient support services for Amvuttra
  • Prior authorization assistance
  • Financial support for eligible patients
  • Contact: alnylamassist.com

Estimated Costs

  • List price: ~$476,000 annually (quarterly injections at $119,351 per dose)
  • Patient responsibility varies by plan design
  • Specialty pharmacy dispensing required

Additional Resources

  • Manufacturer support: Alnylam provides HCP resources and PA checklists
  • Foundation assistance: Research patient assistance foundations for rare diseases
  • State programs: Washington may have additional support through Apple Health (Medicaid)

When to Contact Washington's Insurance Commissioner

The Washington Office of the Insurance Commissioner provides free consumer advocacy for insurance disputes.

Contact Information

  • Phone: 1-800-562-6900 (Consumer Advocacy)
  • Website: insurance.wa.gov
  • Services: Appeal assistance, template letters, complaint filing

When to Call

  • Need help understanding denial reasons
  • Require assistance with appeal documentation
  • Want to file a complaint about insurer practices
  • Need guidance on external review process

The OIC maintains template appeal letters specifically for medication denials and can provide personalized guidance for rare disease cases.

From Our Advocates: We've seen patients successfully overturn Amvuttra denials by focusing on three key elements: comprehensive genetic testing documentation, detailed specialist letters explaining medical necessity, and clear evidence of prior therapy failures. The combination of strong clinical documentation and Washington's robust external review process creates multiple pathways to coverage approval.

FAQ

How long does UnitedHealthcare prior authorization take for Amvuttra in Washington? Standard review is 30 days for pre-service requests. Expedited review (72 hours) is available if delay would jeopardize your health.

What if Amvuttra is non-formulary on my plan? Non-formulary medications can still be covered through the exception process. Submit prior authorization with strong medical necessity documentation and evidence that formulary alternatives are inappropriate.

Can I request an expedited appeal in Washington? Yes, expedited appeals are available for pre-service requests when standard timing would jeopardize life, health, or ability to regain maximum function. Your physician must certify the urgency.

Does step therapy apply if I've tried alternatives outside Washington? Yes, prior therapy trials from any location count toward step therapy requirements. Provide documentation of previous treatments and outcomes.

What happens if my appeal is denied at all levels? After exhausting UnitedHealthcare's internal appeals and Washington's external review, you may have options for federal court review (for amounts over $1,840) or additional advocacy through the OIC.

Can my doctor initiate appeals on my behalf? Yes, physicians can initiate pre-service appeals but must notify you. For post-service appeals, you may need to provide written authorization for your doctor to act as your representative.

How do I track my appeal status? Use the UnitedHealthcare Provider Portal, call member services, or track through 1-800-MEDICARE for Medicare Advantage plans.

What if I need Amvuttra urgently while appealing? Discuss with your physician about requesting expedited review. In some cases, you may need to pay out-of-pocket and seek reimbursement if the appeal succeeds.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations may change. Always verify current requirements with UnitedHealthcare and consult with your healthcare provider about treatment decisions.

For additional support with complex appeals, Counterforce Health specializes in turning insurance denials into successful approvals through evidence-based appeal strategies tailored to each payer's specific requirements.

Sources & Further Reading

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