By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by UnitedHealthcare in Washington: Complete Prior Authorization Guide

Answer Box: Fast Track to Tegsedi Coverage

To get Tegsedi (inotersen) covered by UnitedHealthcare in Washington: 1) Ensure both patient and prescriber are enrolled in the FDA REMS program before submitting prior authorization, 2) Submit complete PA documentation through the UnitedHealthcare Provider Portal including genetic testing, clinical notes, and lab monitoring plan, 3) If denied, file internal appeals within 180 days, then request external review through Washington's Office of the Insurance Commissioner. Most approvals require confirmed hATTR polyneuropathy diagnosis, baseline labs showing adequate kidney/platelet function, and specialist prescription.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Tegsedi prescriptions UnitedHealthcare Provider Portal
REMS Enrollment Both patient and prescriber must be certified FDA REMS Program
Specialist Prescription Neurologist or cardiologist required UnitedHealthcare PA forms
Genetic Testing Confirmed pathogenic TTR mutation Clinical documentation
Lab Monitoring Weekly platelets, monthly kidney function FDA labeling requirements
Age Requirement 18 years or older Standard PA criteria
Appeal Deadline 180 days from denial Washington state law

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis and Eligibility

Who does it: Prescribing physician
Documents needed: Genetic testing results, clinical notes
Timeline: Before PA submission

Verify confirmed hATTR polyneuropathy with genetic testing showing pathogenic TTR mutation. Document clinical symptoms including progressive sensorimotor neuropathy, autonomic dysfunction, or cardiac involvement.

2. Complete REMS Enrollment

Who does it: Both patient and prescriber
Documents needed: REMS certification
Timeline: Must be completed before PA submission

Both patient and prescriber must enroll in the Tegsedi REMS program. This is mandatory due to risks of thrombocytopenia and kidney injury.

3. Obtain Baseline Laboratory Values

Who does it: Healthcare team
Documents needed: Lab results within 30 days
Timeline: Before treatment initiation

Required labs include:

  • Platelet count ≥100 × 10⁹/L
  • eGFR ≥45 mL/min/1.73 m²
  • Complete metabolic panel
  • Liver function tests

4. Submit Prior Authorization

Who does it: Prescriber or staff
How to submit: UnitedHealthcare Provider Portal
Timeline: 5-7 business days for standard review

Submit complete PA packet including medical necessity letter, clinical documentation, lab results, and REMS certification.

5. Arrange Specialty Pharmacy

Who does it: Healthcare team
Documents needed: Approved PA
Timeline: After approval

Tegsedi is only available through REMS-certified specialty pharmacies. The pharmacy will coordinate delivery and ongoing monitoring compliance.

6. Monitor for Ongoing Coverage

Who does it: Healthcare team
Documents needed: Lab results, clinical assessments
Timeline: Ongoing

Maintain weekly platelet monitoring and monthly kidney function tests. Document clinical response for reauthorization requests.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Missing REMS enrollment Submit proof of both patient and prescriber REMS certification
Inadequate diagnosis documentation Provide genetic testing results and detailed clinical notes
Step therapy not completed Document contraindications or failures of alternatives like patisiran
Insufficient lab monitoring plan Submit detailed monitoring protocol with lab scheduling
Non-specialist prescriber Transfer prescription to neurologist or cardiologist
Off-label use Confirm on-label use for hATTR polyneuropathy only
From Our Advocates: We've seen many Tegsedi approvals succeed after initial denials when the prescriber adds a detailed explanation of why alternative treatments like patisiran aren't suitable—whether due to infusion center access issues, patient preference for self-administration, or previous treatment failures. The key is being specific about why Tegsedi is the most appropriate choice.

Appeals Playbook for UnitedHealthcare in Washington

Internal Appeals Process

Level 1 Appeal

  • Deadline: 180 days from denial date
  • How to submit: UnitedHealthcare Provider Portal or mail
  • Timeline: 30 days for standard, 72 hours for urgent
  • Required documents: Denial letter, additional clinical evidence, medical necessity letter

Level 2 Appeal (if available)

  • Deadline: 60 days from Level 1 denial
  • Process: Same as Level 1
  • Timeline: 30 days for decision

External Review in Washington

After completing UnitedHealthcare's internal appeals, Washington residents can request an independent external review through the Office of the Insurance Commissioner.

Key Details:

  • Deadline: 180 days from final internal denial
  • Process: Submit request through UnitedHealthcare, who forwards to OIC
  • Timeline: 20-45 days for standard review, 72 hours for urgent
  • Cost: No charge to patient
  • Decision: Final and binding on UnitedHealthcare

Contact Information: Washington State Office of the Insurance Commissioner
Consumer Advocacy: 1-800-562-6900
Fax: (360) 586-2018

Medical Necessity Letter Essentials

Your medical necessity letter should include:

Clinical Documentation

  • Diagnosis: Confirmed hATTR polyneuropathy with genetic testing
  • Symptoms: Progressive sensorimotor neuropathy, autonomic dysfunction
  • Functional impact: Activities of daily living limitations
  • Disease staging: PND score, FAP stage, or NIS assessment

Treatment History

  • Prior therapies: Document trials of or contraindications to alternatives
  • Treatment failures: Specific reasons why other options aren't suitable
  • Clinical rationale: Why Tegsedi is most appropriate

Safety Considerations

  • Monitoring plan: Weekly platelet counts, monthly kidney function
  • Risk mitigation: REMS enrollment confirmation
  • Contraindication screening: Ruled out severe kidney disease, thrombocytopenia

Supporting Evidence

Reference FDA labeling and clinical guidelines supporting Tegsedi use in hATTR polyneuropathy.

Costs & Patient Assistance Options

Manufacturer Support

Ionis/Akcea may offer patient assistance programs for eligible patients. Contact the manufacturer directly for current programs and eligibility criteria.

Copay Assistance

Many patients with commercial insurance may qualify for copay reduction programs. Check with your specialty pharmacy about available options.

Foundation Grants

Organizations like the HealthWell Foundation and Patient Access Network Foundation sometimes provide grants for rare disease medications.

When to Escalate: Washington State Resources

If you're facing persistent denials or procedural issues with UnitedHealthcare, Washington offers strong consumer protections:

Office of the Insurance Commissioner

  • Consumer Hotline: 1-800-562-6900
  • Online complaints: Available on the OIC website
  • Services: Help with appeals, complaint investigation, external review coordination

External Review Process

Washington's independent review process provides a final avenue when internal appeals fail. The state assigns certified Independent Review Organizations (IROs) with relevant medical expertise.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes for medications like Tegsedi.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Tegsedi? Standard prior authorization decisions typically come within 5-7 business days. Urgent requests may be processed within 24-72 hours if medical urgency is documented.

What if Tegsedi isn't on my UnitedHealthcare formulary? Non-formulary medications can still be covered through the prior authorization process. You may need to demonstrate medical necessity and why formulary alternatives aren't appropriate.

Can I request an expedited appeal in Washington? Yes, if your health could be seriously jeopardized by delays, you can request an expedited appeal. Decisions must come within 72 hours for urgent cases.

Do I need to try other treatments first? UnitedHealthcare often requires step therapy, meaning you may need to try alternatives like patisiran first unless contraindicated or previously failed.

What happens if my appeal is denied? After completing UnitedHealthcare's internal appeals, you can request an external review through Washington's Office of the Insurance Commissioner. This provides an independent medical review that's binding on the insurer.

How much does Tegsedi cost without insurance? Tegsedi is a high-cost specialty medication. Exact pricing varies, but manufacturer assistance programs may be available for eligible patients.

Can my primary care doctor prescribe Tegsedi? Most insurers, including UnitedHealthcare, require prescription by or consultation with a neurologist or cardiologist familiar with hATTR treatment.

What if I move from Washington to another state? External review processes vary by state. Contact your new state's insurance department for local appeal procedures and timelines.

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 personalized guidance. Coverage policies and procedures may change; verify current requirements with UnitedHealthcare and Washington state regulators.

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