By Counterforce Health Team in Onpattro (patisiran) —

The Requirements Checklist to Get Onpattro (patisiran) Covered by Cigna in Ohio

Answer Box: Getting Onpattro (patisiran) Covered by Cigna in Ohio

Cigna requires prior authorization for Onpattro (patisiran) with genetic confirmation of pathogenic TTR variant, neurologist evaluation, and baseline functional assessments. The fastest path: Submit PA via CoverMyMeds with genetic test results, mNIS+7/6MWT scores, and clinical notes documenting hATTR-PN. If denied, Ohio allows 180 days for internal appeals and external review through the Ohio Department of Insurance. Start today: Download Cigna's Onpattro PA form and coordinate with Accredo specialty pharmacy enrollment.

Table of Contents

Who Should Use This Guide

This comprehensive checklist is designed for patients diagnosed with hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN) who have Cigna insurance coverage in Ohio, along with their healthcare providers. You'll need this guide if:

  • Your neurologist has recommended Onpattro (patisiran) for confirmed hATTR-PN
  • You have genetic testing confirming a pathogenic TTR variant
  • You're preparing a prior authorization request or appealing a denial
  • Your specialty pharmacy needs enrollment documentation

Expected outcome: With proper documentation following this checklist, most patients with clear clinical indication and genetic confirmation can achieve coverage approval within 5-15 business days.

Member & Plan Basics

Coverage Requirements

Requirement Details Verification
Active Cigna Coverage Medical and prescription benefits current Check member ID card, call customer service
Plan Type Commercial, Medicare Advantage, or Medicaid managed Confirm formulary tier via Cigna formulary lookup
Specialty Drug Coverage Express Scripts/Accredo network Verify specialty pharmacy benefits in plan documents
Prior Authorization Required for all Onpattro prescriptions Standard across Cigna plans per policy documents
Note: Self-funded employer plans may have different appeal rights under ERISA, but most follow similar PA requirements.

Clinical Criteria Checklist

Essential Medical Requirements

✓ Confirmed Diagnosis

  • Genetic testing showing pathogenic TTR variant via CLIA-certified laboratory
  • Symptomatic polyneuropathy documented by neurologist
  • ICD-10 code E85.1 (hereditary amyloidosis)

✓ Patient Eligibility

  • Age ≥18 years
  • No concurrent use with Tegsedi (inotersen) or tafamidis
  • Baseline functional assessment completed (mNIS+7 or 6-minute walk test)

✓ Prescriber Requirements

  • Prescription by or in consultation with neurologist or amyloidosis specialist
  • Documentation of hATTR-PN stage (typically FAP stage I-II for approval)
  • Exclusion of AL amyloidosis via serum/urine immunofixation

Functional Assessment Baselines

Assessment Purpose Documentation Required
mNIS+7 Polyneuropathy severity (0-304 scale) Baseline score with date, trained assessor
6-Minute Walk Test Ambulatory function Distance in meters, testing conditions
Norfolk QoL Quality of life impact Baseline questionnaire results
Tip: Baseline scores <350m on 6MWT or elevated mNIS+7 help demonstrate disease burden for payer review.

Coding & Documentation Requirements

Required Diagnostic Codes

Primary ICD-10:

  • E85.1 - Hereditary amyloidosis
  • G63 - Polyneuropathy in diseases classified elsewhere

Supporting Codes:

  • Z87.891 - Personal history of nicotine dependence (if applicable)
  • Z15.89 - Genetic susceptibility to other disease (family history)

Drug Coding Information

Code Type Details
NDC 71336-1003-1 (10 mg/5 mL vial)
HCPCS J9999 (unclassified drug)
Administration 96365 (IV infusion, first hour)

Documentation Packet Essentials

Provider Note Requirements

Your neurologist's clinical note must include:

  1. Diagnosis confirmation with genetic test results
  2. Symptom progression timeline and severity
  3. Prior treatments attempted and outcomes
  4. Functional status with objective measures
  5. Treatment rationale for Onpattro specifically
  6. Monitoring plan for efficacy and safety

Letter of Medical Necessity Components

A strong medical necessity letter should address:

  • Clinical presentation: Progressive polyneuropathy symptoms
  • Genetic confirmation: Specific TTR variant identified
  • Disease stage: FAP staging or equivalent functional assessment
  • Treatment history: Prior therapies tried/failed or contraindicated
  • Onpattro rationale: Why this specific treatment is medically necessary
  • Monitoring plan: How treatment response will be assessed

Required Attachments

Essential Documents:

  • Genetic test report (pathogenic TTR variant)
  • Neurologist consultation notes
  • Baseline functional assessments (mNIS+7, 6MWT)
  • Insurance card copies (front and back)
  • Prior treatment documentation (if applicable)

Supporting Evidence:

  • Family history documentation
  • Tissue biopsy results (if available)
  • Cardiac imaging (if cardiac involvement)

Submission Process

Step-by-Step Submission Guide

1. Download Current PA Form

  • Access Cigna's Onpattro PA form (verify with source linked)
  • Alternative: Use CoverMyMeds platform for electronic submission

2. Complete All Required Fields

  • Patient demographics and insurance information
  • Prescriber details including NPI and DEA numbers
  • Clinical justification with supporting documentation

3. Submit via Preferred Method

  • Primary: CoverMyMeds electronic portal
  • Fax: 855-840-1678 (standard review)
  • Urgent: Call 800-882-4462 for expedited processing

4. Coordinate with Specialty Pharmacy

  • Enroll patient with Accredo simultaneously
  • Fax enrollment form to 888-454-8488
  • Specify infusion site (home, office, or outpatient center)

Timeline Expectations

Review Type Processing Time When to Use
Standard PA 5 business days Routine requests
Expedited PA 72 hours Urgent clinical need
Coverage Duration Typically 1 year Renewal required annually

Specialty Pharmacy Coordination

Accredo Enrollment Process

Cigna members must use Accredo (Express Scripts specialty pharmacy) for Onpattro. Counterforce Health helps streamline this coordination by managing both PA submissions and specialty pharmacy enrollment simultaneously, reducing delays and ensuring all required documentation is properly aligned.

Enrollment Requirements:

  • Completed Accredo enrollment form
  • Prescriber signature (no stamps accepted)
  • Patient weight and dosing calculations
  • Infusion site details and contact information

Submission Details:

  • Fax: 888-454-8488
  • Phone support: 844-516-3319
  • Online portal: MyAccredoPatients.com
Important: Ohio requires e-prescribing compliance where applicable. Ensure prescriber follows state-specific requirements to avoid processing delays.

After Submission: What to Expect

Tracking Your Request

Confirmation Steps:

  1. Record PA reference number from submission
  2. Set calendar reminder for follow-up (day 3 for standard, day 1 for urgent)
  3. Monitor status via CoverMyMeds or call Cigna customer service
  4. Coordinate with Accredo for shipment preparation

Status Check Schedule:

  • Day 3: Verify receipt and initial review status
  • Day 5: Standard decision deadline
  • Day 7: Follow up if no decision received
  • Beyond 7 days: Consider filing appeal for processing delay

What to Document

Keep detailed records of:

  • All submission confirmations and reference numbers
  • Phone calls with dates, times, and representative names
  • Email communications and responses
  • Any additional information requests

Common Denial Reasons & How to Avoid Them

Denial Reason Prevention Strategy Appeal Documentation
Missing genetic confirmation Submit CLIA-certified TTR variant test results Include lab report with pathogenic variant details
Inadequate specialist evaluation Ensure neurologist or amyloidosis specialist assessment Provide detailed consultation notes with credentials
Insufficient functional documentation Complete baseline mNIS+7 and 6MWT properly Submit standardized assessment scores with dates
Non-formulary status Request formulary exception with medical necessity Document why formulary alternatives are inappropriate
Step therapy requirements Show prior treatment failures or contraindications Provide trial history with outcomes and intolerances
From our advocates: We've seen cases where initial denials for "experimental" use were overturned by clearly documenting FDA-approved indication for hATTR-PN versus cardiac amyloidosis (ATTR-CM), which isn't FDA-approved. Always specify the exact indication in your submission.

Appeals Process in Ohio

Internal Appeals with Cigna

Ohio law provides strong consumer protections with a 180-day window for appeals—longer than most states.

Level 1 Internal Appeal:

  • Deadline: 180 days from denial notice
  • Decision timeline: 30 days (72 hours if expedited)
  • How to file: Submit via Cigna appeal form or customer portal
  • Required documents: Denial letter, medical records, provider statement

Expedited Internal Appeals:

  • Available when delay could seriously jeopardize health
  • Requires provider attestation of urgency
  • Decision within 72 hours

External Review in Ohio

If internal appeals are unsuccessful, Ohio offers independent external review through the Ohio Department of Insurance.

Key Details:

  • Deadline: 180 days from final internal denial
  • Cost: Free to patients
  • Timeline: 30 days standard, 72 hours expedited
  • Decision: Binding on Cigna if favorable
  • Contact: 1-800-686-1526 for assistance
Ohio Advantage: Even if Cigna claims your case isn't eligible for external review, the Ohio Department of Insurance can independently determine eligibility and order a review.

Printable Checklist

Pre-Submission Checklist

Clinical Documentation:

  • ☐ Genetic test confirming pathogenic TTR variant
  • ☐ Neurologist evaluation with hATTR-PN diagnosis
  • ☐ Baseline mNIS+7 or 6MWT assessment
  • ☐ ICD-10 code E85.1 documented
  • ☐ Prior treatment history (if applicable)

Administrative Requirements:

  • ☐ Current Cigna insurance verification
  • ☐ Prescriber NPI and DEA numbers
  • ☐ Patient weight for dosing calculations
  • ☐ Infusion site details specified
  • ☐ Medical necessity letter completed

Submission Process:

  • ☐ PA form completed in full
  • ☐ All attachments included
  • ☐ Accredo enrollment form submitted
  • ☐ Reference numbers recorded
  • ☐ Follow-up schedule established

FAQ

How long does Cigna prior authorization take for Onpattro in Ohio? Standard PA review takes 5 business days. Expedited reviews (for urgent clinical need) are completed within 72 hours. Ohio law requires decisions within these timeframes.

What if Onpattro is non-formulary on my Cigna plan? Request a formulary exception by demonstrating medical necessity. Include documentation showing why formulary alternatives (like Tegsedi) are inappropriate or contraindicated for your specific case.

Can I request an expedited appeal if my initial PA is denied? Yes. Have your neurologist document that delay would seriously jeopardize your health. Submit expedited appeal requests via phone (customer service number on ID card) and follow up in writing.

Does step therapy apply to Onpattro in Ohio? Some Cigna plans may require trial of other hATTR treatments first. Document any contraindications or prior failures with alternative therapies to support step therapy exceptions.

What genetic testing does Cigna accept for Onpattro approval? CLIA-certified laboratory testing with >99% sensitivity for TTR gene variants. Tests must identify specific pathogenic variants (not variants of uncertain significance). Include full genetic report with your PA submission.

How do I coordinate with Accredo if I live in rural Ohio? Accredo ships nationwide and provides nursing support for home infusions. Specify your preferred infusion location (home, local infusion center, or prescriber office) on the enrollment form.

Counterforce Health specializes in helping patients navigate complex prior authorization processes for specialty medications like Onpattro. Their platform analyzes denial patterns and creates targeted appeals that address specific payer requirements, potentially improving approval rates and reducing time to treatment.

Sources & Further Reading

Disclaimer: This guide is for informational purposes only and does not constitute medical advice. Coverage decisions depend on individual circumstances and plan details. Consult your healthcare provider and insurance plan documents for personalized guidance. For assistance with appeals in Ohio, contact the Ohio Department of Insurance at 1-800-686-1526.

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