By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (Patisiran) Covered by Humana in Texas: Complete Timeline & Appeals Guide

Answer Box: Getting Onpattro Covered by Humana in Texas

Humana requires prior authorization for Onpattro (patisiran) in Texas with a 7-day standard decision timeline (72 hours if expedited). Key requirements: genetic confirmation of TTR variant, neurologist evaluation for hATTR polyneuropathy, and baseline functional assessments (mNIS+7, 6MWT). Submit electronically via Humana's provider portal for fastest processing—95% of requests will be processed within one business day by 2026. If denied, you have 65 days to appeal with strong success rates when proper documentation is provided.

First step today: Contact your neurologist to gather genetic testing results, baseline assessments, and request a medical necessity letter while your clinic submits the prior authorization form electronically.

Table of Contents

  1. What Affects Onpattro Approval Timing
  2. Pre-Submission Preparation (0-2 Days)
  3. Submission to Initial Review (1-7 Days)
  4. Additional Information Requests (1-7 Days)
  5. Decision Window & Reading Results
  6. If Denied: Texas Appeal Process
  7. Renewal Cycles & Reauthorization
  8. Timeline Visual & Milestones
  9. Time-Saving Strategies
  10. Common Denial Reasons & Solutions
  11. Costs & Patient Assistance
  12. FAQ

What Affects Onpattro Approval Timing

Several factors influence how quickly Humana processes your Onpattro (patisiran) prior authorization in Texas:

Benefit Type & Complexity

  • Onpattro is a specialty tier medication requiring prior authorization under all Humana Medicare plans
  • As a rare disease treatment for hereditary transthyretin-mediated amyloidosis (hATTR-PN), it requires extensive clinical documentation
  • The high cost (~$450,000+ annually) triggers enhanced utilization management review

Documentation Completeness The most critical factor affecting timing is having complete documentation upfront. Humana's standard review timeline is 7 calendar days, but incomplete submissions can add weeks to the process.

Submission Method Electronic submissions via Humana's provider portal process significantly faster than paper/fax submissions, with 95% processed within one business day by 2026.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

Before submitting your prior authorization, gather these required documents:

Clinical Requirements:

  • Genetic testing confirming pathogenic TTR variant
  • Neurologist evaluation confirming hATTR polyneuropathy diagnosis
  • ICD-10 code documentation (typically E85.1 for hereditary amyloidosis)
  • Baseline functional assessments: mNIS+7 and 6-minute walk test (6MWT)
  • Medical necessity letter from prescribing neurologist

Administrative Items:

Tip: Start gathering documentation as soon as your neurologist recommends Onpattro. Genetic testing and specialist evaluations can take weeks to complete.

Clinician Corner: Medical Necessity Letter Essentials

Your neurologist's letter should include:

  • Confirmed hATTR-PN diagnosis with specific TTR mutation
  • Current functional status (mNIS+7 score, 6MWT results)
  • Rationale for selecting Onpattro over alternatives like Amvuttra or Tegsedi
  • Expected treatment goals and monitoring plan
  • Patient's current stage (typically I-II for approval)

Submission to Initial Review (1-7 Days)

How to Submit

Electronic Submission (Recommended):

  • Use Humana's provider portal for fastest processing
  • Upload all clinical documentation directly
  • Real-time status tracking available

Alternative Methods:

  • Fax: 877-486-2621 (verify current number)
  • Phone: Providers: 866-488-5995; Members: 866-773-5959

What Reviewers Check First

Humana's clinical team initially verifies:

  1. Diagnosis confirmation - Is hATTR-PN properly documented?
  2. Genetic evidence - Is there confirmed pathogenic TTR variant?
  3. Specialist involvement - Is a neurologist prescribing?
  4. Functional status - Are baseline assessments within approval parameters?
  5. Medical necessity - Is rationale clearly documented?

Humana must respond within 7 calendar days for standard requests and 72 hours for expedited reviews when delay could jeopardize health.

Additional Information Requests (1-7 Days)

If Humana requests additional information, you have 14 days to respond. The review timeline restarts upon receipt of requested documentation.

Common Information Requests:

  • Updated functional assessments if baseline scores are missing
  • Clarification on prior therapy trials or contraindications
  • Additional specialist consultation notes
  • Confirmation of infusion site and administration plan

How to Respond Quickly:

  • Submit electronically through the provider portal when possible
  • Include a cover letter referencing the original PA request number
  • Ensure all requested items are clearly labeled and complete

Decision Window & Reading Results

Approval Outcomes

Full Approval:

  • Typically granted for 6-12 months initially
  • Specifies quantity limits and refill restrictions
  • Includes authorized specialty pharmacy network

Partial Approval:

  • May approve reduced quantity or shorter duration
  • Often includes step therapy requirements
  • Requires additional documentation for full coverage

Denial:

  • Must include specific reason and appeal rights information
  • Common reasons: insufficient documentation, lack of genetic confirmation, or non-formulary status

Understanding Your Approval Letter

Your approval letter will specify:

  • Authorized quantity per fill and total authorized
  • Approved specialty pharmacies
  • Duration of authorization
  • Renewal requirements and timeline

If Denied: Texas Appeal Process

Internal Appeal (Redetermination)

Timeline: You have 65 days from denial notice to file an appeal

How to Appeal:

  1. Complete Humana's redetermination request form
  2. Include additional clinical documentation addressing denial reason
  3. Request expedited review if delay could harm your health
  4. Submit via provider portal, fax, or mail

Response Timeline:

  • Standard appeals: 7 calendar days
  • Expedited appeals: 72 hours

External Review (Independent Review Entity)

If Humana upholds the denial, you can request review by an Independent Review Entity (IRE):

  • Timeline: Same as internal appeals (7 days standard, 72 hours expedited)
  • Process: CMS-contracted independent reviewers evaluate your case
  • Binding: If IRE approves, Humana must provide coverage

Texas State Resources

While Medicare appeals follow federal rules, Texas residents can get help from:

From our advocates: We've seen cases where patients received approval on appeal by submitting updated mNIS+7 scores showing disease progression alongside a detailed letter from their neurologist explaining why Onpattro was the most appropriate choice given their specific TTR mutation and functional status. Complete documentation addressing the specific denial reason is key.

Renewal Cycles & Reauthorization

Renewal Requirements

Onpattro reauthorization through Humana typically requires annual renewal with updated clinical documentation:

Required Documentation for Renewal:

  • Updated mNIS+7 and 6MWT scores compared to baseline
  • Neurologist progress notes showing continued benefit or stabilization
  • Evidence of ongoing need and absence of unacceptable toxicity
  • Updated treatment plan and monitoring schedule

Timing: Submit renewal requests 30 days before current authorization expires to avoid treatment interruptions.

Timeline Visual & Milestones

Milestone Standard Timeline Expedited Timeline Key Actions
Pre-submission prep 0-2 days Same Gather documentation
Initial submission Day 1 Day 1 Submit via provider portal
Humana decision 1-7 days 24-72 hours Review approval/denial
Additional info request +1-7 days +24-72 hours Respond within 14 days
Internal appeal 65 days to file Same 7 days for decision
External review After internal denial Same 7 days for IRE decision
Renewal 30 days before expiration N/A Submit updated assessments

Time-Saving Strategies

Portal Usage

Bundled Evidence Strategy

Submit comprehensive documentation packages including:

  • All required clinical assessments in one submission
  • Detailed medical necessity letter addressing potential concerns
  • Evidence of prior therapy considerations or contraindications

Direct Specialty Routing

  • Ensure your neurologist is listed as the prescribing provider
  • Include specialist credentials and board certification
  • Reference specific hATTR treatment guidelines when available

Counterforce Health helps patients and providers streamline this complex process by analyzing denial patterns and crafting targeted appeals that address payer-specific requirements. Their platform can identify exactly what documentation Humana needs for Onpattro approval and help draft compelling medical necessity arguments. Learn more at www.counterforcehealth.org.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
No genetic confirmation Submit TTR gene testing results Pathogenic variant confirmation from certified lab
Missing specialist evaluation Obtain neurologist consultation Specialist letter confirming hATTR-PN diagnosis
Insufficient functional assessment Complete baseline testing mNIS+7 and 6MWT scores
Non-formulary status Request formulary exception Medical necessity letter explaining why alternatives won't work
Step therapy requirement Document prior failures Records showing contraindications or failures with other treatments

Costs & Patient Assistance

Manufacturer Support

  • Alnylam Assist program provides coverage support and patient assistance
  • Copay assistance may be available for eligible patients
  • Free drug programs for uninsured patients meeting income requirements

Foundation Grants

Research patient assistance foundations that support rare disease treatments, though specific programs vary by availability and eligibility.

FAQ

How long does Humana prior authorization take for Onpattro in Texas? Standard requests receive decisions within 7 calendar days. Expedited requests are processed within 72 hours when delay could jeopardize health.

What if Onpattro is non-formulary on my Humana plan? You can request a formulary exception by demonstrating medical necessity and why formulary alternatives are inappropriate for your specific case.

Can I request an expedited appeal in Texas? Yes, if your prescriber states that waiting for standard review could seriously harm your health, both internal appeals and external reviews can be expedited to 72-hour decisions.

Does step therapy apply if I've tried other treatments outside Texas? Yes, documentation of prior therapy trials from any location can satisfy step therapy requirements, provided proper medical records are submitted.

What happens if I move to Texas while on Onpattro? Humana has transition policies for new members. During the first 90 days after enrolling, prior authorization may not be required for ongoing treatments, but subsequent review will occur.

How often do I need to renew Onpattro authorization? Renewals are typically required annually with updated clinical assessments showing continued benefit.

Can my doctor request a peer-to-peer review? Yes, if your initial request is denied, your neurologist can request a peer-to-peer discussion with Humana's medical director to discuss your case directly.

What if Humana doesn't respond within the required timeframe? Contact Humana immediately at 800-867-6601 to check status. Failure to respond within required timeframes may constitute an automatic approval in some cases.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance plan for personalized guidance. For additional help with insurance appeals in Texas, contact the Texas Department of Insurance at 1-800-252-3439 or visit www.tdi.texas.gov.

When navigating complex prior authorization requirements, services like Counterforce Health can provide valuable support by analyzing your specific situation and helping craft targeted appeals that address payer requirements effectively.

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