By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (Patisiran) Covered by Humana in California: Prior Authorization Guide with Appeals Process

Answer Box: Getting Onpattro (Patisiran) Covered by Humana in California

Onpattro (patisiran) requires prior authorization from Humana in California. Your fastest path to approval: (1) Confirm genetic testing shows a pathogenic TTR variant and neurologist has documented hATTR-PN, (2) Submit Humana's "Request for Medicare Prescription Drug Coverage Determination" form with complete clinical documentation to fax 877-486-2621, and (3) Follow up within 7 days if no response. If denied, you have 65 days to appeal and can request California's Independent Medical Review (IMR) for binding external review.

Table of Contents

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Humana plans Humana PA Search Tool Humana Provider Portal
Formulary Tier Specialty tier placement Humana Drug Lists Humana Pharmacy
Genetic Testing Pathogenic TTR variant required Neurologist or genetics clinic FDA Label
Diagnosis Documentation hATTR-PN confirmed by specialist Neurology consultation notes Clinical Guidelines
Appeals Deadline 65 days from denial notice Denial letter Humana Appeals

Before You Start: Verify Your Coverage

Check your plan type first. Humana offers Medicare Advantage, Medicare Part D, and commercial plans—each with different prior authorization processes. Log into your Humana member portal or call the number on your insurance card to confirm:

  • Your specific plan name and formulary year
  • Whether Onpattro is on your drug list and at what tier
  • If you need to use a specific specialty pharmacy
Tip: New Humana enrollees with active treatment don't need prior authorization for the first 90 days. Keep documentation of your current treatment to avoid claim issues during this transition period.

What You Need to Gather

Before submitting your prior authorization request, collect these essential documents:

Medical Documentation:

  • Genetic test results showing pathogenic TTR variant
  • Neurologist consultation confirming hATTR-PN diagnosis
  • Baseline mNIS+7 score and 6-minute walk test results
  • Prior therapy trials and outcomes (if applicable)
  • Current clinical notes documenting disease progression

Insurance Information:

  • Member ID and group number
  • Prescribing physician's NPI and contact information
  • Previous denial letters (if resubmitting)

Prescription Details:

  • Exact dosing based on patient weight
  • Planned infusion schedule and site of care
  • NDC number for Onpattro vials

Step-by-Step: Fastest Path to Approval

1. Download the Official Form

Get Humana's "Request for Medicare Prescription Drug Coverage Determination" from the Humana pharmacy prior authorization portal. This is the standard form for all specialty drug requests.

2. Complete Clinical Documentation

Your prescribing physician must provide:

  • Confirmed diagnosis of hATTR-PN with ICD-10 code
  • Documentation of pathogenic TTR gene variant
  • Clinical rationale for Onpattro vs. alternatives
  • Baseline functional assessments (mNIS+7, 6MWT)

3. Submit Your Request

Primary submission method: Fax to 877-486-2621

Alternative methods:

  • Availity Essentials portal (for providers)
  • Voice response line: 800-523-0023
  • Mail (check current address on form)

4. Document Your Submission

Keep records of:

  • Fax confirmation receipt
  • Date and time submitted
  • Reference number (if provided)

5. Follow Up Within 7 Days

Call Humana at 800-867-6601 if you haven't received acknowledgment. Standard review timeline is 7 calendar days for Part D requests.

6. Track Your Decision

Humana will send written notification of approval or denial. Approvals typically include:

  • Initial authorization period (usually 6 months)
  • Approved quantity and refill limitations
  • Specialty pharmacy requirements

7. Plan for Renewal

Calendar renewal requests 30 days before expiration. Include updated clinical assessments showing stability or improvement.

Clinician Corner: Medical Necessity Letter

Essential elements for your medical necessity letter:

Patient Background:

  • Age, weight, and confirmed hATTR-PN diagnosis
  • Specific TTR variant identified through genetic testing
  • Disease stage and functional status

Clinical Rationale:

  • Current symptoms and progression rate
  • Impact on activities of daily living
  • Why Onpattro is appropriate vs. other TTR therapies

Supporting Evidence:

  • Reference to FDA-approved indication
  • Baseline mNIS+7 and functional assessments
  • Treatment goals and monitoring plan
Note: Include vitamin A supplementation plan, as TTR knockdown can lead to vitamin A deficiency requiring monitoring.

Key Guidelines to Reference:

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
No genetic confirmation Submit molecular genetic testing results showing pathogenic TTR variant
Missing specialist evaluation Provide neurology consultation documenting polyneuropathy
Insufficient functional assessment Include baseline mNIS+7 score and 6-minute walk test results
Request for off-label use Confirm diagnosis is FDA-approved hATTR-PN, not cardiac amyloidosis
Incomplete prior therapy documentation Document contraindications or failures of other treatments (if applicable)

Appeals Process for Humana in California

Level 1: Internal Appeal (Redetermination)

  • Deadline: 65 days from denial notice
  • Timeline: 7 calendar days for Humana decision
  • How to file: Same methods as initial PA request
  • Required: Original denial letter and new supporting evidence

Expedited Appeals Available If waiting could seriously harm your health, request expedited review:

  • Phone: 800-867-6601
  • Timeline: 72 hours for decision
  • Fax: Include "EXPEDITED" on appeal form

Who Can Appeal:

  • Patient (member)
  • Appointed representative with signed authorization
  • Prescribing physician
Tip: Your doctor can request a peer-to-peer review with Humana's medical director during the appeal process. This often resolves complex cases faster than written appeals alone.

California's Independent Medical Review (IMR)

If Humana upholds their denial, California residents have additional appeal rights through the state's Independent Medical Review process.

When IMR Applies:

  • Denial based on "not medically necessary"
  • Experimental/investigational determination
  • Out-of-network or emergency service disputes

How to Request IMR:

  1. Complete internal appeal with Humana first
  2. Contact the Department of Managed Health Care (DMHC) at 888-466-2219
  3. Submit IMR application within 6 months of final internal denial
  4. No cost to patient—insurer pays for review

IMR Timeline:

  • Standard: 45 days for decision
  • Expedited: 7 days (or 72 hours for urgent cases)

IMR Success Rates: California has high overturn rates for rare disease treatments when proper medical evidence is submitted. The independent physicians reviewing your case specialize in the relevant medical area.

DMHC Resources:

  • Online IMR application at healthhelp.ca.gov
  • Multilingual assistance available
  • Help Center can intervene if Humana isn't following timelines

Timeline Expectations

Standard Prior Authorization Process:

  • Day 0: Submit complete PA request
  • Day 1-7: Humana reviews and decides
  • Day 8: Written decision sent to patient and provider

If Additional Information Requested:

  • Humana may pause the clock to request more documentation
  • You typically have 14 days to respond
  • Review timeline restarts once information is received

Appeals Timeline:

  • Internal appeal: 7 days
  • External review (if applicable): 30-45 days
  • California IMR: 45 days standard, 7 days expedited

Cost Assistance Options

Alnylam Assist Program The manufacturer offers comprehensive support including:

  • Insurance navigation assistance
  • Copay support for eligible patients
  • Free drug program for uninsured qualifying patients
  • Contact: alnylamassist.com or 833-256-9526

Other Resources:

  • Patient Access Network (PAN) Foundation rare disease grants
  • National Organization for Rare Disorders (NORD) patient assistance
  • California's Medicaid (Medi-Cal) may cover if eligible

Getting help with the appeals process is crucial for expensive specialty medications like Onpattro. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters and crafting evidence-backed rebuttals that align with each payer's specific requirements. Their platform helps patients and providers navigate complex prior authorization and appeals processes more effectively.

FAQ

How long does Humana prior authorization take for Onpattro in California? Standard timeline is 7 calendar days. Expedited reviews for urgent cases are completed within 72 hours.

What if Onpattro isn't on my Humana formulary? You can request a formulary exception with medical necessity documentation. If denied, this decision can be appealed through the same process.

Can I start treatment while waiting for approval? New Humana enrollees with active treatment have a 90-day transition period. Otherwise, starting without approval risks full cost responsibility.

Does step therapy apply to Onpattro? Step therapy requirements vary by plan. Some may require trials of other TTR therapies first, though contraindications can override this requirement.

What genetic testing is required? Molecular genetic testing confirming a pathogenic or likely pathogenic TTR variant. The test must be performed by a certified laboratory.

How often do I need reauthorization? Initial approvals are typically for 6 months, with annual renewals requiring updated clinical assessments showing continued benefit.

Printable Checklist

Before You Submit:

  • Genetic test results (pathogenic TTR variant)
  • Neurology consultation confirming hATTR-PN
  • Baseline mNIS+7 and 6-minute walk test
  • Completed Humana PA form
  • Medical necessity letter from prescriber
  • Insurance card and member ID

Submission:

  • Fax to 877-486-2621 with confirmation receipt
  • Document submission date and reference number
  • Calendar follow-up call for day 7

If Denied:

  • Review denial reason carefully
  • Gather additional supporting documentation
  • Submit appeal within 65 days
  • Consider peer-to-peer review request
  • Know your California IMR rights

For complex cases requiring appeals expertise, Counterforce Health provides specialized support in crafting targeted, evidence-backed appeals that address specific payer denial reasons and procedural requirements.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan benefits, medical circumstances, and payer policies. Always consult with your healthcare provider about appropriate treatment options and work directly with your insurance company for coverage determinations. For personalized assistance with California insurance regulations, contact the Department of Managed Health Care at 888-466-2219.

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