How to Get Onpattro (Patisiran) Covered by Aetna CVS Health in Michigan: Complete Prior Authorization and Appeal Guide
Answer Box: Getting Onpattro (Patisiran) Covered by Aetna CVS Health in Michigan
Fastest path to approval: Submit prior authorization with confirmed TTR gene mutation, neurologist evaluation, and clinical documentation showing hATTR polyneuropathy. First step today: Contact your prescribing neurologist to initiate the PA request through CVS Caremark. Michigan advantage: If denied, you have 127 days to file external review with DIFS, which decides within 32 days on average. Success rates reach 40% for well-documented hATTR cases with proper genetic testing and specialist support.
Table of Contents
- Why Michigan State Rules Matter
- Aetna CVS Health Prior Authorization Requirements
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & How to Fix Them
- Michigan Appeals Process & Timelines
- Step Therapy Protections & Medical Exceptions
- Continuity of Care During Plan Changes
- External Review Through Michigan DIFS
- Scripts & Practical Templates
- Cost Assistance Programs
- FAQ
Why Michigan State Rules Matter
Michigan's insurance regulations provide stronger consumer protections than many states, particularly for specialty medications like Onpattro (patisiran). The state's Patient's Right to Independent Review Act gives you 127 days to file external appeals—longer than the federal 120-day standard—and mandates decisions within specific timeframes.
For Aetna CVS Health members, this means:
- Extended appeal windows beyond what your plan offers internally
- Independent medical review by specialists familiar with hATTR amyloidosis
- Binding decisions that Aetna must follow if you win
- Expedited reviews (72 hours) for urgent cases with physician support
Note: Michigan's protections apply to all Aetna plans sold in the state, including employer-sponsored coverage, though self-funded ERISA plans may have different procedures.
Aetna CVS Health Prior Authorization Requirements
Onpattro requires prior authorization through CVS Caremark for all Aetna members. Here's what Aetna's medical policy requires:
Coverage at a Glance
| Requirement | What It Means | Where to Find It |
|---|---|---|
| Genetic Testing | Confirmed TTR gene mutation | Lab results showing pathogenic variant |
| Specialist Prescriber | Neurologist, geneticist, or amyloidosis specialist | Provider credentials and consultation notes |
| Diagnosis Confirmation | Clinical manifestations of hATTR-PN | Biopsy, protein variants, or neuropathy progression |
| Combination Restrictions | Cannot use with other hATTR drugs | Current medication list and prior treatments |
| Outcome Measures | mNIS+7, Norfolk QoL-DN scores for renewals | Baseline and follow-up assessments |
Source: Aetna Medical Policy 0939
Step-by-Step: Fastest Path to Approval
1. Confirm Your Diagnosis Documentation
Who does it: Your neurologist or geneticist
What's needed: TTR gene mutation test results
Timeline: 1-2 weeks if testing needed
Submit via: Include with PA request
2. Gather Required Clinical Evidence
Who does it: Medical team
What's needed:
- Clinical notes showing hATTR polyneuropathy
- Baseline mNIS+7 and Norfolk QoL-DN scores
- Documentation of disease stage (preferably I-II) Timeline: Same visit as PA initiation
3. Submit Prior Authorization Request
Who does it: Prescribing physician's office
Submit via: CVS Caremark provider portal or fax
Timeline: 30-45 days for standard review
Required forms: Aetna PA request form with clinical attachments
4. Track Your Request Status
Who does it: You or your clinic
How: Call CVS Caremark member services or check online portal
Timeline: Check after 2 weeks, then weekly
5. If Approved: Schedule Infusion
Who does it: Your infusion center
What's needed: Prior authorization number
Timeline: 1-2 weeks to schedule first infusion
6. If Denied: Initiate Internal Appeal
Who does it: You or your physician
Timeline: Within 180 days of denial
Submit via: Aetna appeals process (see scripts below)
7. If Still Denied: File Michigan External Review
Who does it: You
Timeline: Within 127 days of final internal denial
Submit via: Michigan DIFS online form or mail
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| No genetic confirmation | Submit TTR gene test results | Lab report showing pathogenic variant |
| Not prescribed by specialist | Get neurologist consultation | Referral letter and specialist evaluation |
| Insufficient neuropathy evidence | Provide detailed clinical assessment | mNIS+7 scores, nerve conduction studies |
| Experimental/investigational | Cite FDA approval for hATTR-PN | FDA label and clinical trial data |
| Step therapy not met | Request medical exception | Documentation of contraindications to alternatives |
Michigan Appeals Process & Timelines
Internal Appeals with Aetna CVS Health
- Standard appeals: 30 days for decision
- Expedited appeals: 72 hours with physician urgency letter
- Required: Complete Aetna's internal process before external review
External Review Through Michigan DIFS
Michigan's external review process provides independent medical evaluation when Aetna denies coverage.
Timeline: Recent case example shows 32-day average from filing to final decision Success rates: Approximately 40% for specialty drug appeals with comprehensive documentation Cost: Free to patients
From our advocates: We've seen the strongest appeals combine genetic testing results with detailed neurologist evaluations and baseline functional assessments. One composite case involved a patient whose initial denial was overturned after providing TTR variant confirmation and demonstrating Stage II polyneuropathy with documented progression—the external reviewer agreed the treatment was medically necessary despite Aetna's initial position.
Step Therapy Protections & Medical Exceptions
Michigan doesn't mandate specific step therapy protections for commercial plans, but Aetna's policy allows medical exceptions when:
- Alternative treatments contraindicated: Document allergies or medical reasons other hATTR drugs won't work
- Prior treatment failures: Show inadequate response or intolerance to other options
- Disease severity: Demonstrate rapid progression requiring immediate intervention
Key documentation: Include specialist letter explaining why step therapy would be inappropriate or harmful.
Continuity of Care During Plan Changes
Commercial Plan Transitions
Michigan does not mandate continuity of care for commercial Aetna plans during formulary changes, but you have options:
- Transition fills: Request 30-day supply while seeking prior authorization
- Formulary exceptions: Apply for coverage of non-formulary medications
- Grace periods: Some Aetna plans provide 30-day notice before removing drugs
Medicaid/Medicare Dual Eligible Plans
If you have MI Health Link or MICH coverage, you're entitled to:
- 90-180 days of continuity with current providers
- Specialty medication protections through provider continuity rules
External Review Through Michigan DIFS
When Aetna's final internal appeal denies your Onpattro coverage, Michigan's Department of Insurance and Financial Services (DIFS) provides independent review.
How to File
- Online: Use DIFS External Review Request form
- Mail/Fax: Submit paper form to DIFS
- Phone support: Call 877-999-6442 for assistance
What Happens Next
- DIFS notifies Aetna within 2 days
- Independent Review Organization (IRO) assigned
- Medical experts review your case
- Standard decision: Within 60 days maximum
- Expedited decision: Within 72 hours with physician urgency letter
Required Documents
- Final denial letter from Aetna
- All medical records related to your condition
- Physician statement of medical necessity
- Any additional clinical evidence
Source: Michigan DIFS External Review Process
Scripts & Practical Templates
Patient Phone Script for Aetna CVS Health
"Hi, I'm calling about prior authorization for Onpattro, generic name patisiran, for hereditary transthyretin amyloidosis. My member ID is [number]. I have confirmed genetic testing showing a TTR mutation and my neurologist has documented hATTR polyneuropathy. Can you tell me the status of my PA request submitted on [date]?"
Medical Necessity Letter Checklist for Clinicians
✓ Confirmed diagnosis: TTR gene mutation with variant details
✓ Clinical presentation: Specific neuropathy symptoms and progression
✓ Baseline assessments: mNIS+7 score, Norfolk QoL-DN, disease stage
✓ Treatment rationale: Why Onpattro is appropriate for this patient
✓ Alternative considerations: Why other hATTR treatments aren't suitable
✓ Monitoring plan: How you'll track treatment response
Cost Assistance Programs
Manufacturer Support
- Alnylam Assist: Patient support program offering copay assistance and case management
- Eligibility: Most commercial insurance plans
- Contact: Visit alnylamassist.com or call program directly
Foundation Grants
- Patient Access Network (PAN) Foundation: Rare disease assistance
- HealthWell Foundation: Specialty medication copay support
- National Organization for Rare Disorders (NORD): Patient assistance programs
Tip: Apply for manufacturer and foundation assistance simultaneously—you may qualify for multiple programs.
FAQ
Q: How long does Aetna CVS Health prior authorization take in Michigan?
A: Standard PA decisions take 30-45 days. You can request expedited review (72 hours) with physician documentation of urgency.
Q: What if Onpattro is non-formulary on my Aetna plan?
A: Request a formulary exception with medical necessity documentation. Include genetic testing and specialist evaluation showing why covered alternatives won't work.
Q: Can I get an expedited external review in Michigan?
A: Yes, if your physician writes a letter stating that waiting for standard review (up to 60 days) would seriously jeopardize your health. DIFS will decide within 72 hours.
Q: Does Michigan require step therapy for specialty medications?
A: Michigan doesn't mandate step therapy protections for commercial plans, but Aetna allows medical exceptions when alternatives are inappropriate or contraindicated.
Q: What happens if I move from Michigan to another state during treatment?
A: Your coverage continues under your current Aetna plan, but appeal rights will follow your new state's laws. Contact Aetna to confirm continuity procedures.
Q: How much does Onpattro cost with Aetna coverage?
A: Costs vary by plan design. The medication's list price exceeds $450,000 annually, but your out-of-pocket costs depend on your specific benefits and any assistance programs you qualify for.
Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with payer requirements, pulling the right clinical evidence and procedural documentation to maximize approval chances.
Sources & Further Reading
- Aetna Medical Policy 0939 - Patisiran Coverage Criteria
- Michigan DIFS External Review Process
- Michigan Patient's Right to Independent Review Act Guidance
- FDA Onpattro Prescribing Information
- Alnylam Assist Patient Support Program
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 guidance regarding your treatment and coverage. Insurance policies and state regulations may change; verify current requirements with official sources.
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