By Counterforce Health Team in Onpattro (patisiran) —

Renewing Onpattro (Patisiran) Coverage with Humana in Washington: Complete Timeline & Documentation Guide

Answer Box: Renewing Onpattro (Patisiran) with Humana in Washington

Start your renewal process 4-6 weeks before your current authorization expires. Humana typically requires updated mNIS+7 scores, 6-minute walk test results, and neurologist documentation showing stabilization or improvement versus baseline. Submit via Humana's provider portal with complete clinical evidence. Standard decisions take up to 7 days; expedited reviews within 72 hours if medically urgent. If denied, you have 65 days to appeal and can request external review through Washington's Office of the Insurance Commissioner.

Table of Contents

  1. Renewal Triggers: When to Start the Process
  2. Evidence Update: What Clinical Data You Need
  3. Renewal Packet: Required Documents Checklist
  4. Timeline: Submission Windows & Decision Timeframes
  5. If Coverage Lapses: Bridge Options & Emergency Steps
  6. Annual Changes: What to Verify Each Year
  7. Appeals Process: Washington-Specific Rights
  8. Cost-Saving Programs & Support
  9. FAQ: Common Renewal Questions

Renewal Triggers: When to Start the Process

Standard Renewal Timeline

Most Humana Medicare Advantage plans approve Onpattro (patisiran) for 12-month periods, requiring reauthorization before expiration. Check your original approval letter or Humana member portal for your exact expiration date.

Start gathering documentation 4-6 weeks early because:

  • Updated neurologic assessments take time to schedule
  • Labs and functional tests need recent dates (typically within 30-60 days)
  • Appeals can add 30-60 additional days if initial renewal is denied

Early Warning Signs to Act Immediately

Contact your neurologist's office right away if you notice:

  • Formulary changes: Onpattro moved to a higher tier or removed entirely
  • Plan changes: You've switched Humana products or Medicare plans
  • Billing issues: Claims being rejected or requiring additional authorization
  • Provider network changes: Your infusion center is no longer in-network
Tip: Set a calendar reminder 60 days before your PA expires. Many patients miss renewal deadlines because they don't track authorization periods.

Evidence Update: What Clinical Data You Need

Core Response Measures

Humana's renewal decisions focus on objective evidence of benefit compared to your pre-treatment baseline. Based on current payer policies, you'll need:

Neurologic Assessment:

  • mNIS+7 score or equivalent neuropathy impairment measure
  • 6-minute walk test (6MWT) distance in meters
  • Muscle strength testing (MRC sum score if available)
  • PND/FAP stage documentation

Functional Status:

  • Gait speed or timed walk assessments
  • Activities of daily living capacity
  • Nutritional status (weight, modified BMI)
  • Quality of life measures

Documentation of Stability or Improvement

Your neurologist's note should clearly state whether your condition has:

  • Improved from baseline (best case scenario)
  • Stabilized with no significant progression
  • Progressed slower than expected without treatment

Even modest decline may support continuation if it's less than the natural history of untreated hATTR-PN.

Safety and Tolerability

Document any:

  • Infusion-related reactions and how they're managed
  • Vitamin A deficiency monitoring and supplementation
  • Adherence to the every-3-week schedule
  • Concurrent medications or therapies

Renewal Packet: Required Documents Checklist

Primary Documents

  • Completed prior authorization form (Humana Medicare Part D Coverage Determination)
  • Updated neurologist consultation with current exam findings
  • Comparative clinical data (baseline vs. current scores)
  • Genetic testing results (if not previously submitted)
  • Treatment adherence records (infusion logs, pharmacy fills)

Supporting Clinical Evidence

  • Laboratory results (recent CBC, CMP, vitamin A levels)
  • Imaging studies if cardiac involvement suspected
  • Prior therapy documentation (what was tried before Onpattro)
  • Specialist consultation notes from other providers if applicable

Medical Necessity Letter Structure

Your neurologist should address:

  1. Current diagnosis with ICD-10 codes (typically E85.1 for hereditary amyloidosis)
  2. Treatment response with specific metrics vs. baseline
  3. Why continuation is medically necessary
  4. Risk of discontinuation (disease progression, functional decline)
  5. Alternative therapy considerations and why Onpattro remains optimal

Timeline: Submission Windows & Decision Timeframes

Humana Decision Timeframes

According to Humana's Medicare policies:

  • Standard review: Up to 7 calendar days from complete submission
  • Expedited review: Within 72 hours if delay would jeopardize health
  • Additional information requests: 14 days to respond without resetting the clock

Optimal Submission Schedule

8 weeks before expiration:

  • Schedule updated neurologic assessment
  • Order current labs and functional tests
  • Verify current Humana formulary status

4-6 weeks before expiration:

  • Complete all clinical assessments
  • Gather comparative baseline data
  • Draft medical necessity letter

2-3 weeks before expiration:

  • Submit complete renewal packet
  • Follow up within 48 hours to confirm receipt
  • Prepare appeal documentation if needed

If Coverage Lapses: Bridge Options & Emergency Steps

Immediate Actions

If your authorization expires before renewal is approved:

  1. Contact Alnylam Assist at the number on their official support page for potential bridge programs
  2. Request expedited review if any delay poses health risks
  3. File an urgent appeal with your neurologist's support
  4. Explore temporary alternatives with your specialist (not self-directed)

Treatment Interruption Management

According to the FDA label, if a dose is missed:

  • Within 3 days: Continue original schedule
  • More than 3 days late: Restart every 3 weeks from new dose date

Never stop Onpattro without specialist guidance - hATTR-PN progression can resume quickly.

Alternative Therapy Considerations

If Onpattro coverage cannot be restored, discuss with your neurologist:

  • Vutrisiran (Amvuttra) - quarterly subcutaneous injections
  • Inotersen (Tegsedi) - weekly subcutaneous injections
  • Tafamidis - for mixed cardiac/neurologic presentations
Note: Most plans prohibit concurrent therapy with multiple hATTR agents, so switching requires new prior authorization.

Annual Changes: What to Verify Each Year

Formulary Updates

Each January, check your plan's updated formulary for:

  • Tier placement changes (higher copays/coinsurance)
  • Prior authorization requirements (new restrictions)
  • Step therapy mandates (try other drugs first)
  • Quantity limits or dosing restrictions

Network Changes

Verify that your:

  • Neurologist remains in-network
  • Infusion center is still covered
  • Specialty pharmacy (if applicable) is contracted

Humana operates CenterWell Specialty Pharmacy for home infusion options, which may offer cost advantages over hospital outpatient settings.

Plan Design Changes

Review your Annual Notice of Change for:

  • Copay/coinsurance modifications
  • Deductible changes
  • Out-of-pocket maximums (especially important for high-cost drugs)

Appeals Process: Washington-Specific Rights

Internal Appeals (First Step)

If Humana denies your renewal:

  1. File within 65 days of the denial notice
  2. Submit via Humana member portal or written request
  3. Include all supporting clinical documentation
  4. Request expedited review if medically urgent (72-hour decision)

External Review (Washington State)

Washington provides strong consumer protections through external review. After exhausting internal appeals:

  1. Request external review within 180 days of final internal denial
  2. File with Washington's Office of the Insurance Commissioner
  3. Independent specialists will review your case
  4. Decision is binding on Humana if overturned

Contact the OIC Consumer Advocacy line at 1-800-562-6900 for assistance with appeals.

Counterforce Health Support

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Onpattro. Their platform analyzes denial letters, identifies the specific coverage criteria, and drafts evidence-backed rebuttals that align with each payer's requirements. For patients facing Humana denials in Washington, this targeted approach can significantly improve appeal success rates by ensuring all clinical evidence and procedural requirements are properly addressed.

Cost-Saving Programs & Support

Manufacturer Support

Alnylam Assist offers multiple programs:

  • Benefits verification and PA support
  • Copay assistance for commercially insured patients
  • Bridge programs for coverage gaps
  • Free drug programs for qualifying uninsured patients

Medicare-Specific Savings

Part D Out-of-Pocket Cap: Under Medicare's redesigned Part D structure, extremely high-cost drugs like Onpattro will hit the annual out-of-pocket maximum, after which coverage becomes more comprehensive.

Low-Income Subsidies (LIS): If you qualify for Medicare's Extra Help program, specialty drug copays are significantly reduced.

State Resources

Washington's Apple Health (Medicaid) may provide additional coverage options for dual-eligible beneficiaries.

FAQ: Common Renewal Questions

How long does Humana take to decide on Onpattro renewals in Washington? Standard reviews take up to 7 days from complete submission. Expedited reviews are decided within 72 hours when delay would jeopardize health or function.

What if my mNIS+7 score has worsened slightly since starting Onpattro? Slight worsening may still support continuation if it's less progression than expected without treatment. Your neurologist should document this in the context of natural disease history.

Can I request an expedited renewal if my current PA is about to expire? Yes, if any delay in treatment would pose serious health risks. Your neurologist must document the medical urgency in the request.

Does step therapy apply to Onpattro renewals? Generally no for renewals if you're already stable on therapy. Step therapy typically applies to initial authorizations requiring trial of less expensive alternatives first.

What if Onpattro is removed from my Humana plan's formulary? You can request a formulary exception with strong clinical justification, or consider switching to a different Humana plan during open enrollment that covers Onpattro.

How do I find in-network infusion centers in Washington? Use Humana's provider finder or call member services. Option Care Health operates 12 infusion suites across Washington that may provide Onpattro infusions.

Can I appeal to Washington state if Humana denies my renewal? Yes. Washington's external review process allows independent medical experts to overturn insurer denials. Contact the Office of the Insurance Commissioner at 1-800-562-6900.

What happens if I miss a renewal deadline? Contact your neurologist immediately to request expedited processing. You may need to restart the prior authorization process, but don't stop treatment without medical supervision.

This guide is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider before making treatment decisions. For additional support with Washington insurance issues, contact the Office of the Insurance Commissioner at 1-800-562-6900.

Sources & Further Reading:

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