By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by Blue Cross Blue Shield in Washington: Complete Guide with Forms and Appeals

Answer Box: Getting Tegsedi Covered by Blue Cross Blue Shield in Washington

Blue Cross Blue Shield (BCBS) in Washington requires prior authorization for Tegsedi (inotersen), typically requiring patients to first try preferred alternatives like Onpattro (patisiran) or Amvuttra (vutrisiran) unless contraindicated. To get Tegsedi approved:

  1. Document hATTR diagnosis with genetic testing showing pathogenic TTR mutation
  2. Try step therapy or document why preferred alternatives failed/aren't suitable
  3. Enroll in REMS program and establish lab monitoring plan

If denied, Washington's robust appeal process includes internal appeals (180 days) and external review through Independent Review Organizations (IROs) via the Office of the Insurance Commissioner.

Table of Contents

When Tegsedi Makes Sense vs. Alternatives

Tegsedi (inotersen) is a weekly subcutaneous injection for hereditary transthyretin-mediated amyloidosis (hATTR) polyneuropathy. However, most BCBS plans prefer other options first due to Tegsedi's significant safety monitoring requirements and the availability of equally effective alternatives.

Consider requesting Tegsedi when:

  • Patient cannot tolerate IV infusions (ruling out Onpattro)
  • Contraindications to preferred alternatives exist
  • Patient lives far from infusion centers
  • Previous treatment failure with first-line agents

Tegsedi requires intensive monitoring due to FDA black box warnings for thrombocytopenia and glomerulonephritis, including platelet counts every 2 weeks and kidney function every 3 months.

Typical BCBS Formulary Alternatives

Most Washington BCBS plans (Premera Blue Cross, Regence BlueShield) place these hATTR treatments in order of preference:

Drug Route Mechanism BCBS Status Key Considerations
Onpattro (patisiran) IV infusion every 3 weeks siRNA TTR silencer Preferred first-line Requires infusion center access
Amvuttra (vutrisiran) Subcutaneous every 3 months siRNA TTR silencer Preferred first-line Self-administered option
Tegsedi (inotersen) Subcutaneous weekly Antisense oligonucleotide Non-preferred; step therapy required Intensive safety monitoring
Wainua (eplontersen) Subcutaneous monthly Antisense oligonucleotide Newer alternative Limited coverage data

Educational Note: Vyndaqel (tafamidis) is primarily for cardiomyopathy, not polyneuropathy, and isn't a direct substitute for neuropathy-focused treatment.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Provider must request approval before dispensing BCBS provider portal or PA form
Genetic Confirmation Pathogenic TTR mutation documented Lab report with variant identification
Step Therapy Try preferred alternatives first Plan formulary and PA criteria
REMS Enrollment FDA safety program registration Tegsedi REMS website
Specialty Pharmacy Must use in-network specialty pharmacy BCBS pharmacy network directory
Lab Monitoring Plan Platelet/kidney function tracking schedule Provider documentation

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis and Genetics (Provider)

  • Document: Genetic testing showing pathogenic TTR mutation
  • Submit: Lab reports with variant classification
  • Timeline: Results typically available within 2-3 weeks

2. Attempt Step Therapy or Document Exceptions (Provider)

  • Try first: Onpattro or Amvuttra (unless contraindicated)
  • Document: Treatment failures, intolerances, or contraindications
  • Timeline: Minimum 3-month trial typically required

3. Enroll in REMS Program (Provider + Patient)

  • Complete: REMS enrollment at tegsedirems.com
  • Establish: Lab monitoring schedule (platelet count every 2 weeks)
  • Timeline: 1-2 business days for approval

4. Submit Prior Authorization (Provider)

  • Use: BCBS-specific PA form for your plan
  • Include: Medical necessity letter, genetic results, step therapy documentation
  • Submit via: Provider portal or fax (verify current submission method)
  • Timeline: 15 business days for standard review

5. Follow Up on Decision (Patient + Provider)

  • Check status: BCBS member portal or provider dashboard
  • If approved: Coordinate with specialty pharmacy
  • If denied: Begin appeal process immediately
Tip: Expedited reviews (48-72 hours) are available for urgent medical situations. Document why standard timeline would jeopardize patient health.

Exception Strategy for Non-Formulary Status

When Tegsedi isn't on your plan's formulary, request a formulary exception by demonstrating medical necessity:

Strong Exception Arguments:

  • Contraindications to preferred agents: Document specific medical reasons why Onpattro/Amvuttra cannot be used
  • Geographic barriers: Limited access to infusion centers for Onpattro
  • Treatment failures: Previous lack of efficacy with preferred alternatives
  • Unique patient factors: Comorbidities affecting treatment choice

Required Documentation:

  • Detailed medical necessity letter from neurologist
  • Genetic testing results confirming hATTR
  • Documentation of contraindications or failures
  • REMS enrollment confirmation
  • Baseline lab values and monitoring plan

Appeals Playbook for Washington

Washington state provides strong consumer protections for insurance appeals:

Internal Appeal (Level 1)

  • Deadline: 180 days from denial
  • Timeline: 30 days for decision (72 hours if expedited)
  • Submit to: BCBS appeals department (address on denial letter)
  • Include: Updated clinical documentation, peer-reviewed studies, FDA labeling

External Review (Level 2)

  • When: After internal appeal failure
  • Deadline: 180 days from final internal denial
  • Process: Request through Washington Office of the Insurance Commissioner
  • Cost: Free to patient
  • Timeline: 30 days for decision (72 hours if urgent)
  • Contact: Consumer Advocacy Helpline at 1-800-562-6900

The external review is conducted by independent medical experts and is binding on the insurer if they rule in your favor.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"Not medically necessary" Provide FDA labeling, clinical guidelines, and detailed symptom documentation
"Step therapy not completed" Document contraindications or previous failures with preferred agents
"Not enrolled in REMS" Complete REMS enrollment and provide confirmation
"Inadequate monitoring plan" Submit detailed lab schedule and provider oversight plan
"Experimental/investigational" Reference FDA approval and established clinical use

Clinician Corner: Medical Necessity Letter Checklist

Essential Elements for Strong PA Requests:

  • Confirmed genetic diagnosis with specific TTR variant
  • Clinical staging (PND score, FAP stage if applicable)
  • Documentation of polyneuropathy symptoms and functional impact
  • Previous treatment history and outcomes
  • Contraindications or failures with preferred alternatives
  • REMS enrollment status and monitoring plan
  • References to FDA labeling and clinical guidelines

Switching Between Treatments

Provider Coordination Requirements:

  • Document clinical rationale for switch (lack of efficacy, safety concerns, patient preference)
  • Minimum 9-month trial typically required before switching
  • Use standardized assessment tools (Neuropathy Impairment Score, Norfolk QoL-DN)
  • Coordinate with specialty pharmacy for seamless transition

Insurance Considerations:

  • New prior authorization required for different medication
  • Document why current therapy is no longer appropriate
  • May need to restart step therapy requirements

Re-trying for Tegsedi Later

Document During Alternative Therapy:

  • Objective disease progression measures
  • Functional decline or lack of improvement
  • Adverse events or intolerances
  • Patient-reported outcomes and quality of life impacts

Resubmission Strategy:

  • Wait minimum 6 months after initial denial
  • Gather additional clinical evidence
  • Document disease progression or treatment failures
  • Consider peer-to-peer review with medical director

Counterforce Health: Streamlining Your Appeal Process

Counterforce Health helps patients, clinicians, and specialty pharmacies transform insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify specific denial reasons—whether prior authorization criteria, step therapy, or "not medically necessary" determinations—then drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements.

For complex cases like Tegsedi appeals, having expert support can significantly improve approval odds by ensuring all documentation meets BCBS requirements and Washington state regulations.

FAQ

How long does BCBS prior authorization take in Washington? Standard review is 15 business days. Expedited review (for urgent cases) is 48-72 hours. External appeals through Washington's IRO process take up to 30 days.

What if Tegsedi is completely non-formulary on my plan? Request a formulary exception with documented medical necessity. If denied, use Washington's external review process, which has strong success rates for medically necessary treatments.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. Document the urgency and submit through expedited channels. Washington law requires 72-hour decisions for urgent appeals.

Does step therapy apply if I tried alternatives in another state? Generally yes, but document all previous treatments thoroughly. BCBS may accept out-of-state treatment records if properly documented.

What's the success rate for external appeals in Washington? Washington's external review process has favorable outcomes for patients when clinical evidence supports medical necessity. The independent medical experts can override insurer decisions.

Can I get help with the appeal process? Yes. Contact Washington's Office of the Insurance Commissioner at 1-800-562-6900 for free consumer advocacy support, or consider services like Counterforce Health for specialized appeal assistance.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For personalized assistance with Washington insurance appeals, contact the Office of the Insurance Commissioner's Consumer Advocacy line at 1-800-562-6900.

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