By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (patisiran) Covered by UnitedHealthcare in Michigan: Complete Renewal Guide with Appeals Process

Answer Box: Getting Onpattro Covered by UnitedHealthcare in Michigan

Onpattro (patisiran) requires prior authorization from UnitedHealthcare in Michigan for hereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR-PN). Submit requests through the UHC Provider Portal with genetic testing, neurologist evaluation, and functional scores (mNIS+7, 6MWT, PND ≤IIIb). UnitedHealthcare must respond within 15 days under Michigan law. If denied, file an internal appeal within 60 days, then pursue Michigan DIFS external review within 127 days for a binding decision.

First step today: Call UnitedHealthcare member services (number on your insurance card) to confirm your plan's formulary status and prior authorization requirements for Onpattro.

Table of Contents

Renewal Triggers: When to Start the Process

UnitedHealthcare's RNA-Targeted Therapies policy provides Onpattro authorization for up to 12 months at a time. Start your renewal process 60-90 days before expiration to avoid treatment gaps.

Key Renewal Triggers:

  • Approaching authorization expiration (check your approval letter for the exact date)
  • Change in functional status requiring updated measurements
  • Plan year changes (January 1st) that may affect formulary placement
  • Provider changes if you switch neurologists or infusion centers
Tip: Set a calendar reminder 90 days before your current authorization expires. This gives you time to schedule updated assessments and gather documentation.

Evidence Update: Documenting Treatment Response

For Onpattro renewal, UnitedHealthcare requires objective evidence of maintained function. The RNA-Targeted Therapies policy specifies these continuation criteria:

Required Functional Measurements:

Measurement Acceptable Range Frequency
PND Score ≤ IIIb At renewal
FAP Stage 1-2 At renewal
NIS Score 5-130 At renewal
Karnofsky Performance Status ≥ 60% At renewal

Your neurologist must document stabilization or improvement in at least one of these measures compared to baseline. The modified Neuropathy Impairment Score +7 (mNIS+7) and 6-minute walk test (6MWT) are primary monitoring tools.

What Counts as Treatment Response:

  • Stability: No significant worsening in neuropathy scores
  • Improvement: Better functional scores than baseline
  • Symptom control: Reduced pain, improved mobility, maintained independence
  • Quality of life: Preserved daily activities and work capacity

Renewal Packet: Must-Include Documents

Your renewal submission must include comprehensive clinical documentation. Missing any key element can trigger a denial.

Essential Documents Checklist:

Medical Records:

  • Current neurologist evaluation (within 3-6 months)
  • Updated mNIS+7 and 6MWT results
  • Baseline scores from initial approval for comparison
  • Genetic testing confirming pathogenic TTR mutation
  • Infusion center records showing adherence

Administrative Forms:

  • UnitedHealthcare prior authorization form
  • Provider attestation of medical necessity
  • Current insurance card and member ID
  • Previous authorization approval letter

Clinical Evidence:

  • Progress notes documenting symptom stability/improvement
  • Any hospitalizations or emergency visits related to hATTR-PN
  • Vitamin A levels (Onpattro can cause deficiency)
  • Documentation of no concurrent TTR-targeted therapies

Medical Necessity Letter Template

Your neurologist should include a letter addressing these key points:

  1. Confirmed hATTR-PN diagnosis with genetic variant identification
  2. Current functional status compared to baseline measurements
  3. Treatment response with specific metrics (mNIS+7, 6MWT improvements)
  4. Rationale for continuation vs. alternative therapies
  5. Monitoring plan for ongoing assessment

Counterforce Health helps clinicians draft evidence-backed medical necessity letters that align with UnitedHealthcare's specific policy requirements, increasing approval rates by addressing each denial criterion systematically.

Timeline: Submission and Decision Windows

Michigan law establishes specific timeframes that UnitedHealthcare must follow for prior authorization decisions.

Michigan Prior Authorization Timeline:

Stage Deadline Details
Standard Review 15 days From complete submission
Expedited Review 72 hours For urgent medical needs
Additional Information 72 hours After providing requested docs
Deemed Approved Automatic If UHC exceeds deadlines

Under Michigan's Prescription Drug Prior Authorization Request Form (FIS 2288), if UnitedHealthcare requests additional information and then fails to respond within 72 hours of receiving it, your prior authorization is considered automatically approved.

Submission Methods:

  • UnitedHealthcare Provider Portal (fastest for electronic submissions)
  • OptumRx Prior Authorization for Part D coverage
  • Fax submission (verify current fax number with customer service)
  • Mail (allow extra time for processing)

If Coverage Lapses: Bridge Options

If your authorization expires before renewal approval, several options can prevent treatment interruption:

Immediate Steps:

  1. Request expedited review citing medical urgency
  2. Peer-to-peer consultation between your neurologist and UHC medical director
  3. Temporary supply through specialty pharmacy (typically 30 days)
  4. Case management coordination for complex situations

Bridge Therapy Resources:

  • Alnylam Assist Program provides temporary access while appeals are pending
  • Specialty pharmacy coordination for urgent refills
  • Provider samples (if available through your infusion center)
From our advocates: We've seen patients successfully obtain 30-day bridge supplies by having their neurologist call UnitedHealthcare's provider services line and emphasize that treatment interruption could lead to irreversible neuropathy progression. Document all calls with reference numbers and follow up in writing.

Annual Changes: Staying Current

UnitedHealthcare updates formularies and policies annually, typically effective January 1st. Stay informed about changes that could affect your Onpattro coverage.

2025 Updates to Monitor:

  • Specialty tier placement (currently SP - Specialty)
  • Prior authorization criteria changes in RNA-Targeted Therapies policy
  • Step therapy requirements for new patients
  • Quantity limits and administration site restrictions

The 2025 formulary updates maintain Onpattro's specialty tier status with the new $2,000 annual out-of-pocket cap for Medicare Part D beneficiaries, significantly reducing cost burden for eligible patients.

Annual Verification Checklist:

  • Confirm Onpattro remains on formulary
  • Check for new prior authorization requirements
  • Verify preferred infusion centers
  • Review copay/coinsurance changes
  • Update provider network status

Appeals Playbook for UnitedHealthcare in Michigan

If UnitedHealthcare denies your Onpattro prior authorization, Michigan provides robust appeal rights with specific deadlines and procedures.

Internal Appeals Process:

Level 1: Standard Internal Appeal

  • Deadline: 60 days from denial date
  • Timeline: UHC has 30 days to decide (15 days for urgent appeals)
  • Submission: UHC Provider Portal, member services phone, or mail
  • Required: Denial letter, additional clinical evidence, provider support

Level 2: Expedited Internal Appeal

  • When to use: Treatment delay would seriously jeopardize health
  • Timeline: 72 hours for decision
  • Requirements: Physician letter stating urgency

External Review Through Michigan DIFS:

After exhausting internal appeals, you have 127 days to file for external review with the Michigan Department of Insurance and Financial Services (DIFS).

DIFS External Review Process:

  • Cost: Free to patients
  • Timeline: 60 days maximum (often faster)
  • Decision: Binding on UnitedHealthcare
  • Expedited option: 72 hours for urgent cases
  • Success rate: Independent medical experts review based on medical necessity

How to File:

  1. Complete DIFS External Review Request form online
  2. Include all denial letters and clinical records
  3. Submit via email, fax, or mail to DIFS
  4. DIFS assigns to Independent Review Organization (IRO)

Contact DIFS: 877-999-6442 (toll-free consumer assistance)

Common Denial Reasons & How to Fix Them

Understanding why UnitedHealthcare denies Onpattro requests helps you prepare stronger submissions and appeals.

Denial Reason How to Fix Required Documentation
No genetic confirmation Submit pathogenic TTR variant test Certified lab genetic report
Missing neurologist evaluation Obtain specialist consultation Board-certified neurologist note
Inadequate functional staging Update scoring assessments Current mNIS+7, 6MWT, PND scores
Off-label use request Confirm hATTR-PN indication only ICD-10 E85.1 diagnosis code
Lack of baseline measures Provide initial assessment data Pre-treatment functional scores
Concurrent therapies Discontinue conflicting medications Medication reconciliation

Strengthening Your Appeal:

  1. Address each denial reason point-by-point in your appeal letter
  2. Include peer-reviewed literature supporting Onpattro's efficacy
  3. Request peer-to-peer review between your neurologist and UHC medical director
  4. Emphasize irreversible progression if treatment is delayed
  5. Reference UHC's own policy criteria and show how you meet them

Counterforce Health's platform analyzes denial letters and automatically generates targeted appeals that address UnitedHealthcare's specific objections while incorporating the right clinical evidence and policy citations.

Costs & Savings Options

Onpattro's annual cost can exceed $450,000, making financial assistance crucial for most patients.

Manufacturer Support:

  • Alnylam Assist: Copay assistance, free drug programs, prior authorization support
  • Bridge programs: Temporary supply during appeals
  • Case management: Dedicated support coordinators

Foundation Grants:

  • HealthWell Foundation: Rare disease grants for eligible patients
  • Patient Advocate Foundation: Copay relief and case management
  • National Organization for Rare Disorders (NORD): Financial assistance programs

Medicare Part D 2025 Changes:

The new $2,000 annual out-of-pocket cap significantly reduces costs for Medicare beneficiaries. The optional Medicare Prescription Payment Plan spreads costs as monthly payments (~$167/month).

FAQ: Michigan-Specific Questions

Q: How long does UnitedHealthcare prior authorization take in Michigan? A: Standard reviews must be completed within 15 days under Michigan law. Expedited reviews require 72-hour decisions for urgent cases.

Q: What if Onpattro is non-formulary on my UnitedHealthcare plan? A: Request a formulary exception with medical necessity documentation. Your neurologist must show why formulary alternatives are inappropriate or contraindicated.

Q: Can I request an expedited appeal in Michigan? A: Yes, both UnitedHealthcare internal appeals and DIFS external reviews offer expedited processes when treatment delays would jeopardize your health.

Q: Does step therapy apply if I've tried other treatments outside Michigan? A: UnitedHealthcare generally accepts documented treatment failures from other states. Ensure your neurologist includes detailed records of prior therapies and outcomes.

Q: What happens if UnitedHealthcare doesn't respond within Michigan's deadlines? A: Under Michigan law, prior authorization requests are "deemed approved" if the insurer exceeds statutory deadlines after receiving complete information.

Q: Can my family member file appeals for me? A: Yes, with proper authorization forms. Michigan law allows designated representatives to file appeals on your behalf.

Q: How do I know if my UnitedHealthcare plan is subject to Michigan insurance laws? A: Fully-insured plans sold in Michigan must comply with state regulations. Self-funded employer plans may have different rules - check your Summary Plan Description.

Q: What if I need Onpattro for cardiomyopathy instead of polyneuropathy? A: Onpattro is only FDA-approved for hATTR polyneuropathy. Cardiomyopathy requests would be considered off-label and face additional coverage barriers.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage determinations. Coverage policies and appeal procedures may vary by plan type and can change without notice. For personalized assistance with UnitedHealthcare prior authorization and appeals, consult qualified healthcare advocates or legal professionals familiar with Michigan insurance law.

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