By Counterforce Health Team in Tegsedi (inotersen) —

If Tegsedi (Inotersen) Isn't Approved by Aetna CVS Health in Virginia: Formulary Alternatives & Exception Paths

Answer Box: Your Path Forward When Tegsedi Is Denied

If Aetna CVS Health denies Tegsedi (inotersen) in Virginia, you have clear alternatives and appeal options. Onpattro (patisiran) is typically the required first-line treatment under Aetna's step therapy policy. After documented failure or intolerance to Onpattro, you can request a formulary exception for Tegsedi with comprehensive clinical documentation. Start today by: (1) requesting your complete medical records from prior hATTR treatments, (2) confirming your neurologist can provide a medical necessity letter, and (3) contacting Aetna member services at 1-800-872-3862 to understand your specific formulary tier and PA requirements.

Table of Contents

When Alternatives Make Sense

Aetna CVS Health follows a step therapy approach for hATTR polyneuropathy treatments, requiring patients to try preferred alternatives before approving Tegsedi. This isn't necessarily a roadblock—many patients achieve excellent outcomes with first-line options.

Key considerations for alternatives:

  • Clinical effectiveness: All FDA-approved hATTR treatments show significant neuropathy progression slowing in clinical trials
  • Administration differences: Onpattro requires IV infusion every 3 weeks; Tegsedi is weekly self-injection
  • Monitoring requirements: Each medication has specific lab monitoring protocols
  • Access timeline: Preferred alternatives often have faster approval times (5-10 business days vs. 30-45 days for exceptions)

According to Aetna's clinical policy bulletin, alternatives are considered medically necessary when patients have contraindications, intolerance, or ineffective response to other agents in the class.

Typical Alternatives for hATTR Polyneuropathy

Primary Alternative: Onpattro (Patisiran)

Coverage Status: Preferred agent on most Aetna formularies
Administration: IV infusion every 21 days at certified infusion centers
Key Advantages:

  • Established efficacy data from APOLLO trial
  • Generally faster prior authorization approval
  • Comprehensive infusion center support

Monitoring Requirements:

  • Baseline and periodic vitamin A levels
  • Liver function tests
  • Infusion reactions monitoring

Secondary Options: Amvuttra and Wainua

Amvuttra (vutrisiran): Quarterly subcutaneous injection, newer alternative with similar mechanism to patisiran
Wainua (eplontersen): Monthly subcutaneous injection, most recently approved option

Both typically require documented failure or contraindication to Onpattro under current Aetna policies.

From our advocates: We've seen success when patients document specific reasons why IV infusion isn't feasible—such as difficult venous access, distance from infusion centers, or work schedule conflicts. These practical considerations, combined with clinical factors, strengthen exception requests.

Coverage Comparison: Your Options

Treatment Formulary Status Prior Auth Step Therapy Administration Typical Approval Time
Onpattro (patisiran) Preferred Required None IV infusion 5-10 business days
Amvuttra (vutrisiran) Non-preferred Required After Onpattro SC injection 15-30 business days
Tegsedi (inotersen) Non-formulary* Exception needed After alternatives SC injection 30-45 business days
Wainua (eplontersen) Non-preferred Required After Onpattro SC injection 15-30 business days

*Note: Tegsedi was discontinued by the manufacturer in late 2024, but existing stock and appeals remain valid through specialty pharmacies.

Exception Strategy: When to Request Tegsedi

Strong Clinical Scenarios for Tegsedi Exception

Medical contraindications to alternatives:

  • Severe infusion reactions to Onpattro despite premedication
  • Inability to maintain IV access for regular infusions
  • Geographic barriers to infusion center access (documented travel >2 hours)

Clinical intolerance patterns:

  • Documented adverse effects from alternative agents with dates, doses, and outcomes
  • Allergic reactions or hypersensitivity to components in preferred agents
  • Significant quality of life impacts from alternative administration methods

Required Documentation Package

Essential Clinical Records:

  1. Genetic confirmation: TTR gene mutation test results from CLIA-certified lab
  2. Specialist evaluation: Neurologist assessment with mNIS+7 or PND scores
  3. Prior therapy documentation: Complete records of Onpattro trial including start/stop dates, doses, clinical response, and reasons for discontinuation
  4. Baseline laboratories: Platelet count ≥100,000/μL, urinary protein-to-creatinine ratio <1000 mg/g
  5. REMS enrollment: Confirmation of both patient and prescriber enrollment in Tegsedi REMS program

Medical Necessity Letter Components:

  • Confirmed hATTR polyneuropathy diagnosis with genetic evidence
  • Detailed prior treatment history and outcomes
  • Clinical rationale for Tegsedi over alternatives
  • Monitoring plan addressing thrombocytopenia and nephrotoxicity risks
  • Reference to FDA labeling and clinical trial data (NEURO-TTR study)

Counterforce Health Platform Integration

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Tegsedi. Their platform ingests denial letters, plan policies, and clinical notes to identify the specific denial basis—whether PA criteria, step therapy, non-formulary status, or "not medically necessary"—then drafts point-by-point rebuttals aligned to Aetna's own rules.

For Tegsedi appeals, Counterforce Health pulls the right citations—FDA labeling, NEURO-TTR study data, specialty guidelines, and recognized drug compendia—and weaves them into appeals with required clinical facts like diagnosis codes, prior trial failures, contraindications, and treatment goals.

Switching Logistics with CVS Specialty

Coordinating Your Transfer

Step 1: Verify Current Availability
Call CVS Specialty at 1-800-237-2767 to confirm Tegsedi stock availability given the manufacturer discontinuation notice.

Step 2: REMS Program Setup
Both you and your prescriber must enroll at tegsedirems.com before any prescription can be filled.

Step 3: Prior Authorization Transfer
If switching from another specialty pharmacy:

  • Request complete PA documentation transfer
  • Ensure continuous coverage during transition
  • Coordinate lab monitoring schedules

Step 4: Delivery and Monitoring Coordination
CVS Specialty will:

  • Schedule initial delivery and injection training
  • Set up automated refill reminders
  • Coordinate required lab monitoring (weekly platelets, biweekly renal function)

Documentation for Switching

When transferring from alternative therapy, provide CVS Specialty with:

  • Complete treatment timeline from previous agent
  • Documentation of therapeutic outcomes or adverse effects
  • Current lab values and monitoring history
  • Updated medical necessity letter specific to Tegsedi need

Re-trying for Tegsedi Later

What to Document During Alternative Therapy Trial

Clinical Response Tracking:

  • Baseline and follow-up neuropathy scores (mNIS+7, PND)
  • Quality of life assessments
  • Functional status changes
  • Any progression despite treatment

Tolerance Documentation:

  • All adverse effects with dates and severity ratings
  • Impact on daily activities or work capacity
  • Any dose modifications or treatment interruptions
  • Premedication requirements or special handling needs

Practical Barriers:

  • Travel time and costs for infusion appointments
  • Work or family schedule conflicts
  • Insurance coverage changes affecting access to infusion centers

Timing Your Re-request

Most insurers require at least 90 days of alternative therapy trial before considering exceptions. However, document any significant issues immediately—you can request expedited review for safety concerns or rapid disease progression.

Virginia Appeals Process

Internal Appeals with Aetna CVS Health

Timeline: 180 days from denial notice to file
Standard review: 30-45 business days
Expedited review: 72 hours for urgent medical situations

Required submission materials:

  • Completed Aetna appeal form
  • Copy of denial letter
  • Medical necessity letter from prescriber
  • All supporting clinical documentation
  • Patient impact statement (optional but helpful)

Virginia External Review

After exhausting internal appeals, Virginia's Bureau of Insurance External Review provides independent assessment.

Key Virginia advantages:

  • 120 days to file after final internal denial
  • Free process with no patient costs
  • 45-day standard review (72 hours for urgent cases)
  • Binding decision on the insurer

Contact Virginia Bureau of Insurance:

The Bureau randomly assigns cases to Independent Review Organizations with relevant clinical expertise, ensuring conflict-free evaluation by board-certified physicians.

FAQ

How long does Aetna CVS Health prior authorization take for Tegsedi in Virginia?
Standard PA review takes 30-45 business days for exception requests. Expedited review (72 hours) is available when your doctor certifies that delays could jeopardize your health.

What if Tegsedi is completely non-formulary on my plan?
You can request a formulary exception with comprehensive clinical documentation. Success rates improve significantly with documented failure or contraindication to preferred alternatives.

Can I request expedited appeal if I'm already on Tegsedi?
Yes, if continuation is medically urgent. Your prescriber must certify that interruption could seriously jeopardize your health or ability to regain function.

Does step therapy apply if I failed alternatives outside Virginia?
Yes, documented failures from other states are generally accepted. Ensure you have complete medical records showing dates, doses, and specific reasons for discontinuation.

What happens if CVS Specialty can't fill Tegsedi due to discontinuation?
CVS Specialty may have remaining stock or can coordinate with other REMS-certified pharmacies. If unavailable, you can appeal for coverage of alternative agents without additional step therapy requirements.

How much does external review cost in Virginia?
Virginia external review is completely free for consumers. The state covers all administrative and review costs.

Can I get help with the appeals process in Virginia?
Yes, the Virginia Bureau of Insurance Consumer Services (1-877-310-6560) provides free guidance. Counterforce Health also specializes in evidence-backed appeals for specialty medications.

What if my employer plan is self-funded?
Many Virginia-headquartered self-funded plans opt into the state external review process. If not, you may have federal external review options through HHS.

This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions. For official Virginia insurance regulations and appeal forms, visit the State Corporation Commission Bureau of Insurance.

Sources & Further Reading

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