By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (inotersen) Covered by Aetna (CVS Health) in Washington: Complete Prior Authorization Guide

Answer Box: Getting Tegsedi (inotersen) Covered by Aetna (CVS Health) in Washington

Aetna (CVS Health) requires prior authorization for Tegsedi (inotersen) with specific documentation: TTR gene mutation testing, specialist prescription, and FDA REMS enrollment. Submit via Availity portal or fax (866-752-7021) at least 2 weeks before treatment. If denied, Washington offers strong appeal rights including external review through Independent Review Organizations (IRO) with binding decisions. Start by confirming your specialist has genetic testing results and can document hereditary transthyretin-mediated amyloidosis (hATTR) diagnosis.

Table of Contents

Verify Your Plan and Find the Right Forms

Before starting your Tegsedi prior authorization, confirm you have an Aetna plan that covers specialty medications. Check your member ID card for "CVS Health" or "CVS Caremark" branding, which indicates your specialty drug benefits are managed through CVS systems.

Key Documents You'll Need:

Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Timeline
TTR Gene Testing Confirmed mutation in transthyretin gene Genetic testing lab report Before PA submission
Specialist Prescription Neurologist, geneticist, or amyloidosis specialist Medical records Required for approval
REMS Enrollment FDA safety program enrollment Tegsedi REMS website Before dispensing
Clinical Documentation hATTR symptoms and progression Medical charts, imaging Submit with PA
No Combination Therapy Not used with other hATTR treatments Prescriber attestation Ongoing requirement

Initial Authorization Criteria (12-month approval)

According to Aetna's 2024 Tegsedi policy, all of these must be met:

  1. Genetic confirmation: TTR gene mutation documented through genetic testing
  2. Clinical manifestations: Progressive peripheral sensory-motor polyneuropathy, amyloid deposition in biopsy, or TTR protein variants in serum
  3. Qualified prescriber: Neurologist, geneticist, or physician specializing in amyloidosis (or in consultation with one)
  4. No combination therapy: Will not be used with Amvuttra (vutrisiran), Onpattro (patisiran), Vyndamax, Vyndaqel, or Wainua (eplontersen)

Continuation Authorization Requirements

For renewal, you'll need to demonstrate clinical benefit compared to baseline using metrics such as:

  • Modified Neuropathy Impairment Scale+7 (mNIS+7) score improvement
  • Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) stabilization
  • Polyneuropathy Disability (PND) score changes
  • FAP stage progression assessment
  • Grip strength measurements

Submission Portals and Methods

Primary Submission: Availity Portal

Fastest option: Submit through Availity.com provider portal

  • Register for Novologix specialty drug module
  • Upload all supporting documents in one submission
  • Track approval status in real-time
  • Submit at least 2 weeks before intended start date

Alternative Submission Methods

Method Contact Best For Timeline
Fax 866-752-7021 or 888-267-3277 Complete documentation packages 3-5 business days
Phone 866-814-5506 (specialty medications) Urgent questions or status checks During business hours
Mail CVS Caremark, 1300 East Campbell Road, Richardson, TX 75081 Complex cases requiring hard copies 7-10 business days
Tip: Include a cover sheet with member ID, prescriber NPI, and "URGENT - Tegsedi Prior Authorization" if treatment start is time-sensitive.

Specialty Pharmacy Setup

Once approved, Tegsedi requires specialty pharmacy dispensing due to its REMS requirements and cold-chain storage needs.

CVS Specialty Pharmacy Setup:

  1. Your prescriber will receive approval notification
  2. CVS Specialty will contact you directly to coordinate delivery
  3. Complete REMS patient enrollment if not already done
  4. Schedule lab monitoring appointments per REMS protocol
  5. Arrange for proper medication storage (refrigeration required)

Required Lab Monitoring:

  • Platelet count: Baseline, weekly initially, then monthly
  • Renal function: Serum creatinine and eGFR monitoring
  • Urinalysis: Regular monitoring for proteinuria

Support Lines and Contacts

For Members

Need Phone Number Hours Notes
General Member Services 1-800-872-3862 24/7 Use for PA status, appeals
Specialty Pharmacy 1-800-237-2767 Mon-Fri 8AM-8PM ET CVS Specialty direct line
Prior Authorization Status 1-866-814-5506 Business hours Specialty medication PA team

For Providers

Aetna Provider Services: Access through Availity portal for fastest response Precertification Team: 1-866-752-7021 (fax same number for urgent requests) Peer-to-Peer Reviews: Request through provider portal when denial occurs

Washington State Appeals Process

Washington offers robust consumer protections for insurance denials through a two-level appeal system with external review rights.

Step-by-Step Appeals Process

Level 1: Internal Appeal

  1. Deadline: 60 days from denial notice
  2. Timeline: 14 days standard, 72 hours expedited
  3. How to file: Aetna member portal, call 1-800-872-3862, or written appeal
  4. Required: New clinical evidence and prescriber support letter

Level 2: External Independent Review

  1. Deadline: 120 days from final internal denial
  2. Timeline: 15 days standard, 72 hours expedited
  3. Process: Washington Office of Insurance Commissioner assigns Independent Review Organization
  4. Decision: Binding and enforceable on Aetna
Washington Advantage: IRO decisions are final and must be implemented by insurers. This gives you strong leverage in appeals.

Washington Consumer Advocacy

Office of Insurance Commissioner Consumer Help

The OIC can help you navigate appeals and has template letters available for common denial scenarios.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Submit specialist letter with clinical guidelines FDA label, neurology society guidelines, disease progression notes
"Experimental/investigational" Emphasize FDA approval for hATTR FDA approval letter, prescribing information
REMS not enrolled Complete enrollment before resubmission REMS confirmation, lab monitoring plan
Insufficient genetic testing Provide complete genetic analysis Full genetic testing report with TTR mutation details
Non-formulary status Request formulary exception Medical necessity letter, contraindications to alternatives

Clinician Corner: Medical Necessity Letter Checklist

When writing appeals, include these elements:

  • Patient's specific TTR mutation and clinical presentation
  • Prior treatments attempted and reasons for failure/intolerance
  • Clinical rationale for Tegsedi based on FDA labeling
  • Monitoring plan per REMS requirements
  • Expected outcomes and how you'll measure success

Key Citations to Include:

  • FDA prescribing information for Tegsedi
  • Neurology society guidelines on hATTR treatment
  • Peer-reviewed studies on inotersen efficacy

Cost Assistance Options

Manufacturer Support:

  • Ionis Patient Assistance Program: Financial assistance for eligible patients
  • Tegsedi Copay Program: May reduce out-of-pocket costs for commercially insured patients
  • Contact: Tegsedi patient support (verify current programs)

State and Foundation Resources:

  • Washington State Prescription Drug Program: Limited eligibility
  • HealthWell Foundation: Grants for rare disease medications
  • Patient Access Network Foundation: Copay assistance programs
Note: Manufacturer assistance programs typically cannot be combined with government insurance (Medicare, Medicaid).

FAQ

Q: How long does Aetna prior authorization take for Tegsedi in Washington? A: Standard PA decisions take 3-5 business days via electronic submission, up to 14 days for fax/mail. Expedited reviews (for urgent medical situations) are completed within 72 hours.

Q: What if Tegsedi is non-formulary on my Aetna plan? A: Request a formulary exception by documenting medical necessity and contraindications to covered alternatives. Include a specialist letter explaining why Tegsedi is clinically superior for your specific case.

Q: Can I request an expedited appeal in Washington? A: Yes, if delays could jeopardize your health. Call Aetna at 1-800-872-3862 and provide documentation that standard timelines would be harmful. Expedited appeals get 72-hour decisions.

Q: Does step therapy apply if I've tried other hATTR treatments outside Washington? A: Medical records from any state showing prior treatment failures should satisfy step therapy requirements. Ensure your new Washington provider has complete documentation of previous therapies.

Q: What's the difference between internal and external review? A: Internal appeals are reviewed by Aetna's own medical staff. External review uses independent specialists assigned by Washington state - their decisions are binding on Aetna and often more favorable to patients.

Q: How do I know if my plan is subject to Washington state appeals laws? A: Fully-insured plans (most individual and small group plans) follow Washington state rules. Self-funded employer plans may follow federal rules only. Check with your HR department or call Aetna to confirm.

When to Escalate to Washington Regulators

Contact the Washington Office of Insurance Commissioner if:

  • Aetna fails to respond within required timelines
  • You need help understanding your appeal rights
  • You believe your denial was inappropriate
  • You want to file a complaint about the appeals process

Contact Information:

  • Phone: 1-800-562-6900
  • Email: [email protected]
  • Online complaint form: Available at insurance.wa.gov

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 specific payer requirements. For complex cases like Tegsedi approvals, we help identify the exact documentation needed and draft point-by-point rebuttals aligned with each plan's criteria.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider about treatment options and contact your insurance company directly for current policy information. Washington state laws and Aetna policies may change; verify current requirements through official sources.

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