By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (patisiran) Covered by Humana in Ohio: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Onpattro Covered by Humana in Ohio

Onpattro (patisiran) requires prior authorization from Humana for hATTR polyneuropathy. The fastest path: (1) Gather genetic testing confirming pathogenic TTR variant, neurologist evaluation, and baseline mNIS+7/6MWT scores, (2) Submit complete prior authorization through Humana's provider portal with medical necessity letter, (3) If denied, file internal appeal within 65 days, then external review through Ohio Department of Insurance within 180 days. Start today by requesting your complete medical records and confirming your Humana plan's formulary status for Onpattro.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for Onpattro coverage Humana Prior Authorization Lists
Genetic Testing Pathogenic TTR variant confirmation Blood test via neurologist or genetics clinic
Specialist Evaluation Neurologist assessment confirming hATTR-PN Neurology clinic with EMG/nerve conduction studies
Baseline Measurements mNIS+7 score and 6-minute walk test Performed by certified assessor
Diagnosis Code ICD-10 E85.1 (hATTR amyloidosis) Medical records and billing
Age Requirement 18 years or older FDA labeling requirement

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis and Gather Documentation

Who does it: Patient with neurologist
Timeline: 2-4 weeks
Documents needed:

  • Genetic test results showing pathogenic TTR variant
  • Neurologist evaluation confirming hATTR polyneuropathy
  • Baseline mNIS+7 score (typically >20 for moderate severity)
  • 6-minute walk test results with distance in meters
  • Biopsy results if performed (Congo red staining)

2. Check Humana's Current Prior Authorization Requirements

Who does it: Patient or prescriber
Timeline: Same day
Use Humana's Prior Authorization Search Tool to verify current PA requirements for Onpattro.

3. Prepare Medical Necessity Letter

Who does it: Prescribing physician
Timeline: 1-2 weeks
Include all required elements (see Medical Necessity Letter Essentials section below). Alnylam provides a sample template.

4. Submit Prior Authorization Request

Who does it: Healthcare provider
Timeline: Submit immediately once complete
How to submit: Through Humana's provider portal, fax, or phone
Expected response time: 30 days for standard review, 72 hours for expedited

5. Monitor Status and Prepare for Appeals

Who does it: Patient and provider
Timeline: Check weekly
Track your request through Humana's member portal. If denied, you have 65 days to appeal.

From our advocates: We've seen the strongest approvals when families gather all genetic testing, neurologist notes, and functional assessments before submitting—rather than sending piecemeal documentation. Complete packets reduce back-and-forth delays and show payers you meet all criteria upfront.

Medical Necessity Letter Essentials

Your physician's medical necessity letter should include these critical components:

Patient Information:

  • Full name, date of birth, Humana member ID
  • Diagnosis: Polyneuropathy of hereditary transthyretin-mediated amyloidosis (ICD-10 E85.1)
  • Date of diagnosis

Clinical Documentation:

  • Pathogenic TTR variant identified (specify mutation)
  • Neurologist evaluation findings
  • Baseline mNIS+7 score with date performed
  • 6-minute walk test results (distance, assistance needed)
  • Family history of hATTR amyloidosis if applicable

Treatment Rationale:

  • FDA approval for hATTR polyneuropathy in adults
  • Clinical trial data supporting efficacy (APOLLO study)
  • Why Onpattro is medically necessary for this patient
  • Anticipated treatment goals and monitoring plan

Dosing and Administration:

  • 0.3 mg/kg IV every 3 weeks per FDA labeling
  • Administration at certified infusion center
  • Premedication protocol to prevent infusion reactions

Supporting Evidence:

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn
No genetic confirmation Submit pathogenic TTR variant test results from certified lab
Missing specialist evaluation Provide neurologist assessment with EMG/nerve conduction studies
Insufficient baseline measurements Add mNIS+7 score and 6-minute walk test performed by certified assessor
Request for non-FDA use Confirm diagnosis is hATTR polyneuropathy, not cardiomyopathy alone
Incomplete prior therapy documentation List all previous treatments for neuropathy symptoms with doses and outcomes
Missing functional status Document stage I-II hATTR with preserved ambulation

Appeals Process for Humana in Ohio

Internal Appeal (First Level)

Deadline: 65 days from denial notice
How to submit: Online through Humana member portal, mail, or fax
Required form: Request for Redetermination of Medicare Prescription Drug Denial Form
Timeline: 7 calendar days for standard review
Who can appeal: Member, appointed representative, prescribing physician

External Review (Ohio Department of Insurance)

When to use: After internal appeal denial
Deadline: 180 days from final internal denial
How to file: Submit request to your health plan, which notifies Ohio DOI
Timeline: 30 days for standard review, 72 hours for expedited
Contact: Ohio Department of Insurance Consumer Services at 1-800-686-1526

Note: External review decisions are binding on Humana if the denial is overturned.

Expedited Appeals

Request expedited review if delay would seriously endanger your health. Include physician statement supporting urgency.

Cost Savings and Support Programs

Alnylam Assist Program

  • Financial assistance for eligible patients
  • Copay support for commercially insured patients
  • Free drug program for uninsured qualifying patients
  • Contact: alnylamassist.com or 1-833-256-2747

Medicare Extra Help

  • Helps with Part D costs including copays
  • Apply at ssa.gov or 1-800-772-1213

Patient Advocate Foundation

  • Copay relief program for qualifying patients
  • Contact: 1-866-512-3861

When to Escalate to Ohio Regulators

Contact the Ohio Department of Insurance if:

  • Humana improperly denies external review eligibility
  • Appeal deadlines are not met by the insurer
  • You suspect unfair claim handling practices

Ohio Department of Insurance Consumer Services

  • Phone: 1-800-686-1526
  • Website: insurance.ohio.gov
  • File complaints online through their consumer portal

For self-funded employer plans (ERISA), contact the U.S. Department of Labor instead.

Frequently Asked Questions

How long does Humana prior authorization take for Onpattro? Standard review takes up to 30 days. Expedited review (with physician attestation of urgency) takes up to 72 hours.

What if Onpattro isn't on Humana's formulary? You can request a formulary exception as part of the prior authorization process. Include medical necessity letter explaining why covered alternatives aren't appropriate.

Can I get peer-to-peer review if initially denied? Yes, your physician can request to speak directly with Humana's medical director. Request this through the provider portal or customer service.

Does step therapy apply to Onpattro? Step therapy requirements vary by plan. Check your specific Humana formulary or call member services to confirm current requirements.

What happens if I move from Ohio while on treatment? Coverage continues under your existing Humana plan. Appeal rights may change if you switch to a different state's Humana plan.

How often does Onpattro need reauthorization? Most plans require annual reauthorization with updated functional assessments (mNIS+7, 6MWT) showing treatment benefit or disease stabilization.

About Coverage Support

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. The platform analyzes denial letters and plan policies, then drafts targeted, evidence-backed appeals that address each payer's specific requirements. For complex cases like Onpattro approvals, having expert support can significantly improve your chances of coverage approval.

For additional assistance navigating Humana's prior authorization process, consider working with your specialty pharmacy's benefits investigation team or connecting with Counterforce Health for personalized appeal support.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For official appeals assistance in Ohio, contact the Ohio Department of Insurance Consumer Services at 1-800-686-1526.

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