By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (patisiran) Covered by Cigna in Michigan: Complete Prior Authorization and Appeal Guide

Quick Answer: Getting Onpattro (patisiran) Covered by Cigna in Michigan

Eligibility: Adults with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy, confirmed by genetic testing showing a pathogenic TTR variant. Fastest path: Submit prior authorization with neurologist evaluation, genetic test results, and clinical documentation via Cigna's provider portal. Start today: Call Cigna at the number on your insurance card to confirm your plan's specialty pharmacy requirements and request PA forms. If denied, Michigan residents have strong appeal rights through DIFS external review with ~40% success rates for specialty drug appeals.

Table of Contents

  1. Cigna's Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exceptions
  4. Specialty Pharmacy and Site of Care
  5. Required Documentation Checklist
  6. Appeals Process in Michigan
  7. Cost Support Programs
  8. FAQ
  9. Sources and Further Reading

Cigna's Coverage Policy Overview

Cigna covers Onpattro (patisiran) for hereditary transthyretin-mediated amyloidosis with polyneuropathy under their specialty drug benefit, but prior authorization is always required. The drug typically falls under medical benefit coverage rather than pharmacy benefit, meaning it's administered by healthcare providers rather than dispensed for home use.

Plan Types and Coverage:

  • Commercial HMO/PPO: Standard PA requirements apply
  • Medicare Advantage: May have additional step therapy requirements
  • Medicaid (through Cigna): Similar criteria but may route through different specialty pharmacies

All Cigna plans in Michigan must follow the same basic medical necessity criteria, though specific forms and submission processes may vary slightly by plan type.

Note: Onpattro is manufactured by Alnylam Pharmaceuticals and costs approximately $450,000-$500,000 annually, making thorough documentation essential for approval.

Medical Necessity Requirements

Cigna requires all of the following criteria to be met for Onpattro approval:

Core Eligibility Criteria

Requirement Documentation Needed Source
Age 18+ Patient demographics in medical record Cigna Policy
hATTR-PN diagnosis Genetic test showing pathogenic TTR variant Cigna Policy
Symptomatic polyneuropathy Clinical exam, EMG, or nerve conduction studies Cigna Policy
Specialist involvement Neurologist, geneticist, or amyloidosis expert Cigna Policy
No contraindicated combinations Not with Tegsedi or tafamidis Cigna Policy

Genetic Testing Requirements

The genetic test must:

  • Be performed by a CLIA-certified laboratory
  • Clearly identify a pathogenic TTR gene variant (not just a variant of unknown significance)
  • Include interpretation by a qualified geneticist or specialist
  • Be recent enough to support current treatment (typically within 2 years)

Clinical Documentation

Your neurologist's evaluation must document:

  • Polyneuropathy symptoms: Reduced motor strength, impaired sensation (pain, temperature, vibration, touch)
  • Functional assessment: Often includes mNIS+7 scores, 6-minute walk test results
  • Disease stage: Typically FAP Stage 1-2 or PND score IIIb or better
  • Exclusion of other causes: Rule out diabetic neuropathy, B12 deficiency, etc.

Step Therapy and Exceptions

Good news: Cigna typically does not require step therapy for Onpattro when used for FDA-approved hATTR polyneuropathy. This differs from many other specialty medications.

However, if your plan does have step therapy requirements, you may need to try:

  1. Supportive care measures
  2. Other TTR-targeted therapies (if appropriate for your specific variant)

Medical exceptions are available if:

  • Previous treatments caused intolerable side effects
  • Contraindications exist to required step therapy drugs
  • Clinical urgency makes delays inappropriate

Specialty Pharmacy and Site of Care

Specialty Pharmacy Requirements

Cigna routes Onpattro through designated specialty pharmacies, most commonly:

  • Accredo Specialty Pharmacy (most Cigna commercial plans)
  • Express Scripts Specialty Pharmacy (some employer plans)

Your prescriber will coordinate with the specialty pharmacy for:

  • Prior authorization submission
  • Drug procurement and delivery to infusion site
  • Patient education and support services

Site of Care Preferences

Cigna has strong preferences for cost-effective infusion sites:

Preferred (in order):

  1. Home infusion (when medically appropriate)
  2. Physician's office
  3. Independent infusion center

Requires special justification:

  • Hospital outpatient department (only if medical necessity documented)

Common justifications for hospital outpatient include:

  • First infusion or restart after 6+ month gap
  • History of severe infusion reactions
  • Significant comorbidities requiring hospital-level monitoring

Required Documentation Checklist

Before submitting your prior authorization, ensure you have:

Clinical Documentation:

  • Genetic test results showing pathogenic TTR variant
  • Neurologist consultation note with hATTR-PN diagnosis
  • Clinical exam documenting polyneuropathy symptoms
  • Functional assessment scores (mNIS+7, 6MWT if available)
  • Medical history ruling out other neuropathy causes
  • Current medications list (to check for contraindications)

Administrative Documentation:

  • Completed Cigna prior authorization form
  • Patient demographics and insurance information
  • Prescriber DEA and NPI numbers
  • Proposed infusion site information
  • ICD-10 code E85.1 (hereditary amyloidosis)

Supporting Evidence:

  • FDA prescribing information for Onpattro
  • Relevant clinical guidelines (if applicable)
  • Previous treatment history and outcomes

Appeals Process in Michigan

If Cigna denies your Onpattro request, Michigan residents have robust appeal rights with good success rates for well-documented cases.

Step 1: Cigna Internal Appeal

Timeline: Must file within 180 days of denial notice Decision time: 60 days (standard) or 72 hours (expedited) How to file: Call Cigna customer service or submit written appeal

Address for written appeals: Cigna Appeals Unit
PO Box 188011
Chattanooga, TN 37422

Step 2: Michigan External Review (DIFS)

After completing Cigna's internal appeal, you can request external review through Michigan's Department of Insurance and Financial Services.

Key Details:

  • Filing deadline: 127 days after final internal denial
  • Review timeline: 60 days (standard) or 72 hours (expedited)
  • Contact: Michigan DIFS at 877-999-6442
  • Decision: Binding on Cigna (not on you)
Success Rate: Approximately 40% of Cigna specialty drug denials are overturned when comprehensive clinical evidence and specialist support are provided.

When to Request Expedited Review

Request expedited appeals when:

  • Disease progression would worsen significantly with delay
  • Current symptoms are severely impacting quality of life
  • Your physician certifies that delay would seriously jeopardize your health

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, identifying specific policy gaps, and crafting evidence-backed rebuttals. Their platform helps patients and clinicians navigate complex prior authorization requirements and appeal processes for specialty medications like Onpattro. Learn more about their services.

Cost Support Programs

Even with Cigna coverage, out-of-pocket costs for Onpattro can be substantial. Consider these support options:

Manufacturer Programs:

  • Alnylam Assist: Patient support program offering copay assistance and case management
  • Website: alnylamassist.com
  • Eligibility: Varies by insurance type and income

Foundation Support:

  • Patient advocacy organizations often provide grants for rare disease treatments
  • Contact organizations like the Amyloidosis Foundation for potential assistance

State Programs:

  • Michigan residents may qualify for additional state-based prescription assistance programs
  • Contact Michigan DIFS for information about available resources

FAQ

How long does Cigna prior authorization take for Onpattro in Michigan? Standard PA decisions are typically made within 15 business days. Expedited requests (when physician certifies urgency) are decided within 72 hours.

What if Onpattro is non-formulary on my Cigna plan? You can request a formulary exception by demonstrating medical necessity and that formulary alternatives are inappropriate for your condition.

Can I appeal if I live in Michigan but have a Cigna plan from another state? Yes, Michigan residents can use DIFS external review regardless of where their insurance plan is based, as long as they receive care in Michigan.

Do I need to try other treatments first? Generally no - Cigna typically doesn't require step therapy for FDA-approved hATTR polyneuropathy treatment with Onpattro.

What happens if my appeal is denied? After exhausting internal and external appeals, you may have additional options including state insurance commissioner complaints or legal consultation, depending on your specific circumstances.

How often do I need to renew prior authorization? Typically annually, with renewal requiring documentation of continued medical necessity and treatment response.

When navigating complex insurance requirements, platforms like Counterforce Health can help by automatically generating evidence-backed appeals and ensuring all necessary documentation is included in your submission.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on your specific insurance plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for guidance on your individual situation. For official Michigan insurance appeals information, contact DIFS at 877-999-6442.

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