By Counterforce Health Team in Evkeeza (evinacumab-dgnb) —

How to Get Evkeeza (Evinacumab) Covered by UnitedHealthcare in Michigan: Prior Authorization, Appeals, and State Protections

Quick Answer: Getting Evkeeza Covered by UnitedHealthcare in Michigan

Evkeeza (evinacumab) requires prior authorization from UnitedHealthcare through OptumRx, typically with step therapy requirements. For homozygous familial hypercholesterolemia (HoFH) patients in Michigan, the fastest path involves: 1) Having your specialist submit a PA request with genetic confirmation and documented failures of statins, ezetimibe, and PCSK9 inhibitors, 2) Requesting a step therapy exception if you haven't tried all preferred therapies, citing the rare disease nature of HoFH, and 3) If denied, filing an internal appeal within 180 days, followed by Michigan's external review process through DIFS within 127 days. Michigan's Patient's Right to Independent Review Act provides strong protections for rare disease treatments.

Table of Contents

  1. Why Michigan State Rules Matter for Evkeeza Coverage
  2. UnitedHealthcare Prior Authorization Requirements
  3. Michigan Step Therapy Protections for Rare Diseases
  4. Appeal Process and Timelines
  5. Michigan External Review Rights
  6. Practical Scripts and Documentation
  7. ERISA and Self-Funded Plan Differences
  8. Cost Support Options
  9. FAQ
  10. Sources and Further Reading

Why Michigan State Rules Matter for Evkeeza Coverage

Michigan's insurance regulations provide crucial protections that can help you secure coverage for Evkeeza, especially when dealing with UnitedHealthcare's stringent prior authorization requirements. The state's Patient's Right to Independent Review Act gives you binding external review rights that go beyond what federal law requires.

Key Michigan advantages:

  • 127-day deadline for external appeals (longer than the federal 120-day standard)
  • 72-hour expedited review available when delays could seriously harm your health
  • Strong step therapy exception protections for rare diseases like HoFH
  • Independent medical review by specialists familiar with your condition

However, these protections vary by plan type. Fully insured commercial plans get full Michigan protections, while self-funded ERISA plans may have different rules.

UnitedHealthcare Prior Authorization Requirements

Coverage at a Glance

Requirement Details Where to Submit Source
Prior Authorization Required for all plans OptumRx Provider Portal or 1-800-711-4555 UHC Provider Resources
Step Therapy Likely required Exception requests through same portal Michigan PDL 2025
Formulary Tier Specialty (Tier 4-5) Check plan's formulary Plan documents
Supply Limit 1-month fills Specialty pharmacy required OptumRx policies
Diagnosis Requirements HoFH with genetic confirmation Include with PA request Clinical documentation

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Clinic)
    • Genetic test confirming HoFH diagnosis
    • Complete lipid panels showing LDL-C levels
    • Documentation of prior therapies tried and failed
    • Current medication list and dosing
  2. Submit Prior Authorization (Prescriber)
    • Use OptumRx provider portal or call 1-800-711-4555
    • Include medical necessity letter (see checklist below)
    • Expected timeline: 3-5 business days for standard review
  3. Request Step Therapy Exception (If Needed)
    • Cite HoFH as a rare disease requiring specialized treatment
    • Document why standard therapies are inappropriate
    • Reference Michigan's step therapy exception protections

Clinician Corner: Medical Necessity Letter Checklist

When submitting your PA request, ensure your medical necessity letter includes:

✓ Diagnosis and Severity

  • Confirmed HoFH with genetic testing results
  • Current LDL-C levels despite maximum therapy
  • Family history and cardiovascular risk factors

✓ Prior Treatment History

  • Trials of high-intensity statins (atorvastatin 80mg, rosuvastatin 40mg)
  • Ezetimibe trial and response
  • PCSK9 inhibitor trial (evolocumab or alirocumab) if appropriate
  • Reasons for discontinuation (inefficacy, intolerance, contraindications)

✓ Clinical Rationale

  • Why Evkeeza is medically necessary for this patient
  • Treatment goals (target LDL-C reduction)
  • Reference to FDA prescribing information
  • Cite HoFH treatment guidelines from major cardiology societies

Michigan Step Therapy Protections for Rare Diseases

Michigan law provides strong protections for patients with rare diseases like HoFH. Step therapy exception criteria allow overrides when:

  • Preferred therapies are likely to be ineffective based on the patient's clinical condition
  • Patient has already tried and failed the preferred therapies
  • The condition requires specialized treatment that makes standard step therapy inappropriate

Documentation Phrases That Help

When requesting a step therapy exception, use specific language that aligns with Michigan's criteria:

"This patient has homozygous familial hypercholesterolemia, a rare genetic disorder affecting fewer than 1 in 300,000 people. Standard step therapy protocols designed for typical hypercholesterolemia are inappropriate due to the unique pathophysiology of HoFH, where LDL receptors are absent or severely defective."
"Enforcing step therapy for this rare disease patient could result in irreversible cardiovascular harm during the delay period, as HoFH patients typically develop severe atherosclerosis in childhood without aggressive lipid-lowering therapy."

Appeal Process and Timelines

UnitedHealthcare Internal Appeals

Standard Appeals:

  • Deadline: 180 days from denial notice
  • Timeline: Up to 30 days for decision (pre-service), 60 days (post-service)
  • How to file: UnitedHealthcare member portal or written request
  • Required documents: Denial letter, medical records, prescriber letter

Expedited Appeals:

  • When available: Urgent medical situations where delay could harm health
  • Timeline: 72 hours for decision
  • Requirements: Physician attestation of urgency

Common Denial Reasons & How to Overturn Them

Denial Reason How to Overturn Key Documents
"Not medically necessary" Provide genetic confirmation of HoFH, current LDL-C levels Genetic testing, lipid panels, cardiology notes
"Step therapy not completed" Request medical exception citing rare disease Exception request form, clinical rationale
"Quantity limits exceeded" Justify weight-based dosing requirements Dosing calculations, FDA label reference
"Non-formulary drug" Request formulary exception with clinical justification Medical necessity letter, alternative failures

Michigan External Review Rights

If UnitedHealthcare upholds their denial after internal appeal, Michigan's Department of Insurance and Financial Services (DIFS) provides independent external review.

Key Deadlines and Requirements

  • Filing deadline: 127 days from final denial notice
  • Standard review: Completed within 60 days
  • Expedited review: 72 hours (requires physician letter stating serious jeopardy)
  • Cost: No fee to patient
  • Decision: Binding on the insurance company

How to File External Review

  1. Complete DIFS external review form (available online)
  2. Attach required documents:
    • Final denial letter from UnitedHealthcare
    • Your reasons for disagreeing with the denial
    • Supporting medical records
    • Physician letters
  3. Submit via:
Tip: For expedited review of Evkeeza denials, your physician should specifically state that delaying this rare disease treatment could seriously jeopardize your cardiovascular health, given the progressive nature of HoFH.

Practical Scripts and Documentation

Patient Phone Script for UnitedHealthcare

"Hello, I'm calling about a prior authorization denial for Evkeeza, evinacumab, for my homozygous familial hypercholesterolemia. My reference number is [X]. I'd like to understand the specific denial reasons and request information about filing an appeal. I also want to request a peer-to-peer review between my cardiologist and your medical director, as this is a rare disease requiring specialized treatment."

Clinic Staff Script for Peer-to-Peer Request

"I'm requesting a peer-to-peer review for [patient name] regarding the denial of Evkeeza for confirmed HoFH. Dr. [name] is available [days/times] to discuss the medical necessity with your medical director. This patient has a rare genetic disorder with limited treatment options, and we have documentation of failed conventional therapies."

ERISA and Self-Funded Plan Differences

Important: If your UnitedHealthcare plan is self-funded by your employer (common for large companies), different rules may apply:

  • Michigan external review may not be available due to ERISA preemption
  • Federal external review may be required instead
  • Check your Summary Plan Description for specific appeal procedures
  • Contact your HR benefits administrator to confirm plan type

To determine if you have an ERISA plan, look for language like "self-funded," "self-insured," or "administrative services only" in your plan documents.

Cost Support Options

Even with insurance coverage, Evkeeza can have significant out-of-pocket costs. Consider these support programs:

Note: Copay assistance may not be available for government-funded plans (Medicare, Medicaid).

At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific denial basis, and drafts point-by-point rebuttals using the right medical evidence and payer-specific requirements. For complex cases like Evkeeza approvals, having professional support can significantly improve your chances of success.

From Our Advocates: We've seen HoFH patients successfully overturn UnitedHealthcare denials by emphasizing three key points: genetic confirmation of the diagnosis, documented failure of conventional therapies despite maximum doses, and the urgent cardiovascular risk posed by delays in treatment. The combination of strong clinical documentation and understanding Michigan's step therapy exception process has proven particularly effective in these rare disease cases.

FAQ

How long does UnitedHealthcare prior authorization take in Michigan? Standard PA decisions typically take 3-5 business days. Expedited reviews (for urgent situations) are completed within 72 hours.

What if Evkeeza is non-formulary on my plan? You can request a formulary exception with medical justification. Document why formulary alternatives are inappropriate for HoFH and provide clinical evidence supporting Evkeeza's necessity.

Can I request an expedited appeal if my Evkeeza is denied? Yes, if your physician can document that delaying treatment would seriously jeopardize your health. Given HoFH's progressive cardiovascular risks, this is often appropriate.

Does step therapy apply if I failed these medications outside Michigan? Yes, prior treatment failures from other states should count. Ensure your medical records clearly document the trials, doses, durations, and reasons for discontinuation.

What's the difference between Medicare Advantage and commercial UnitedHealthcare appeals? Medicare Advantage plans follow federal Medicare appeal rules with 5 levels of review, while commercial plans use Michigan state procedures with external review through DIFS.

How much does Evkeeza cost without insurance? The manufacturer's stated average wholesale acquisition cost is approximately $450,000 per year, though actual costs vary by weight and dosing frequency.

Can Counterforce Health help with my Evkeeza appeal? Yes, our platform specializes in turning complex specialty drug denials into successful appeals by identifying the specific denial reasons and crafting evidence-based responses that meet payer requirements.

What happens if I miss the appeal deadline? Missing internal appeal deadlines may forfeit your right to external review. Contact UnitedHealthcare immediately to discuss options, and consider filing a complaint with Michigan DIFS for guidance.

Sources and 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 decisions. Appeal processes and requirements may vary by plan type and can change over time. Verify current procedures with your insurer and Michigan DIFS before taking action.

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