By Counterforce Health Team in Helixate (antihemophilic factor, rFVIII) —

How to Get Helixate (Antihemophilic Factor, rFVIII) Covered by Aetna CVS Health in Michigan: Complete Coverage Guide with Appeals Process

Quick Answer: Getting Helixate Covered by Aetna CVS Health in Michigan

Important Update: Helixate (antihemophilic factor, rFVIII) has been discontinued by the manufacturer. Aetna CVS Health now covers alternative factor VIII products like Kovaltry, Advate, and Jivi with prior authorization. First step: Contact your hematologist to select an alternative and submit PA documentation through Aetna's Availity portal at least 2 weeks before your current supply runs out. If denied, Michigan offers external review through DIFS within 127 days.

Table of Contents

  1. Understanding Helixate Discontinuation and Alternatives
  2. Aetna CVS Health Coverage Requirements
  3. Prior Authorization Process
  4. Medical Necessity Documentation
  5. Appeals Process in Michigan
  6. Alternative Factor VIII Products
  7. Cost-Saving Resources
  8. FAQ

Understanding Helixate Discontinuation and Alternatives

Helixate (including Helixate NexGen and the related Kogenate FS) has been permanently discontinued by manufacturers. Bayer announced Kogenate FS discontinuation with supplies depleting through 2023, while Helixate NexGen's EU marketing authorization was withdrawn in December 2019.

What this means for patients: If you're currently on Helixate, you'll need to transition to an alternative factor VIII product. Don't wait until your supply runs out – start the transition process now.

From our advocates: "We've seen patients successfully transition from discontinued factor products when they work closely with their hematologist and submit complete documentation showing medical necessity for their preferred alternative. The key is starting early and being thorough with the paperwork."

Aetna CVS Health Coverage Requirements

Coverage at a Glance

Requirement Details Where to Find
Prior Authorization Required for all factor VIII products Aetna 2025 Precert List
Prescriber Must be hematologist or HTC specialist Aetna clinical policy
Submission Method Electronic via Availity portal (mandatory) Aetna provider portal
Timeline 24-48 hours for complete submissions CVS Health internal data
Appeals Window 180 days from denial Aetna dispute process

Michigan-Specific Plans

For Aetna Better Health Michigan (Medicaid): Submit PA forms with approval required before service. Standard decisions take 30 days; expedited requests are processed within 7 days if health would be jeopardized. Contact through the Aetna Better Health Michigan pharmacy portal.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Choose Your Alternative (Patient + Hematologist)
    • Review options: Kovaltry, Advate, Jivi, or other rFVIII products
    • Consider dosing frequency, infusion schedule, and past responses
    • Timeline: 1 clinic visit
  2. Gather Required Documentation (Clinic Staff)
    • Confirmed hemophilia A diagnosis with factor VIII levels
    • Treatment history showing Helixate use and need for continuation
    • Bleeding history and current regimen
    • Timeline: 3-5 business days
  3. Submit Electronic PA (Prescriber)
    • Use Availity provider portal (mandatory since June 2023)
    • Include all supporting documentation
    • Timeline: Same day submission
  4. Monitor Status (Patient)
    • Track via Aetna Health app or provider portal
    • Most complete submissions approved within 24-48 hours
    • Timeline: 1-2 business days

Medical Necessity Documentation

Essential Elements for Approval

Your hematologist's letter must include:

  • Diagnosis confirmation: Hemophilia A with specific factor VIII deficiency level
  • Prior therapy history: Documentation of Helixate use, dosing, and clinical response
  • Medical necessity for transition: Clear explanation of why alternative factor VIII product is needed
  • Dosing rationale: Weight-based calculations and prophylaxis schedule
  • Inhibitor status: Recent Bethesda assay results (within 6-12 months)

Sample Documentation Checklist

✓ Clinical records (6-12 months) showing hemophilia management
✓ Laboratory results: Factor VIII levels, inhibitor testing
✓ Bleeding history: Frequency, severity, target joints
✓ Prior factor utilization: Infusion logs, breakthrough bleeds
✓ Treatment goals: Prophylaxis vs. on-demand therapy rationale

Appeals Process in Michigan

Internal Appeals with Aetna CVS Health

If your initial PA is denied:

Standard Appeal:

  • Timeline: File within 180 days of denial
  • Decision: Within 15-30 days for pre-service appeals
  • Submission: Via Aetna provider portal or member services

Expedited Appeal:

  • Timeline: 72 hours for urgent cases
  • Requirements: Physician letter stating delay would jeopardize health
  • Use when: Current factor supply is running out or bleeding risk is high

Michigan External Review Process

After exhausting Aetna's internal appeals, Michigan offers independent review through the Department of Insurance and Financial Services (DIFS):

Key Details:

  • Filing window: 127 days from final internal denial
  • Standard timeline: Up to 60 days for decision
  • Expedited timeline: 72 hours with physician certification of urgency
  • Cost: Free to patients
  • Decision: Binding on Aetna if favorable

How to file:

  1. Use DIFS online external review form
  2. Call DIFS at 877-999-6442 for assistance
  3. Include denial letters, medical records, and physician statements

Alternative Factor VIII Products

Since Helixate is no longer available, Aetna CVS Health typically covers these alternatives with prior authorization:

Standard Half-Life Options

  • Kovaltry (octocog alfa, Bayer) – Primary Bayer alternative to discontinued products
  • Advate (octocog alfa, Takeda) – Widely covered standard option

Extended Half-Life Options

  • Jivi (PEGylated rFVIII, Bayer) – Less frequent dosing
  • Adynovate (PEGylated rFVIII, Takeda) – Extended half-life companion to Advate
Note: Each alternative requires separate prior authorization with medical necessity documentation specific to that product.

Cost-Saving Resources

Manufacturer Support Programs

Most factor VIII manufacturers offer patient assistance:

  • Bayer (Kovaltry, Jivi): Patient support programs available
  • Takeda (Advate, Adynovate): Copay assistance and foundation grants

Michigan-Specific Resources

  • Healthy Michigan Plan (Medicaid expansion): Covers specialty medications with PA
  • Michigan Department of Health and Human Services: Additional support for qualifying families

Contact your specialty pharmacy or Counterforce Health for assistance navigating manufacturer programs and insurance appeals.

FAQ

How long does Aetna CVS Health PA take in Michigan?
Complete electronic submissions typically receive decisions within 24-48 hours. Incomplete submissions may take 15-30 days.

What if my preferred alternative is non-formulary?
Request a formulary exception with documentation of medical necessity, prior failures, or contraindications to preferred alternatives.

Can I request an expedited appeal?
Yes, if your physician certifies that delay would jeopardize your health. Expedited appeals receive decisions within 72 hours.

Does step therapy apply when transitioning from discontinued Helixate?
Typically no – discontinuation of your current product usually exempts you from step therapy requirements, but document this in your PA request.

What happens if Aetna misses their decision deadline?
Under federal ERISA regulations, missed deadlines for internal appeals result in automatic approval.

How do I know if my Michigan plan includes external review rights?
Most commercial and ACA plans include external review. Contact DIFS at 877-999-6442 to confirm eligibility for your specific plan.

Should I involve my specialty pharmacy in the PA process?
Yes – CVS Specialty can assist with PA submissions and often has dedicated prior authorization coordinators for complex cases like hemophilia.

What if I need factor VIII while appeals are pending?
Request expedited processing and consider temporary bridge therapy. Your hematologist may be able to provide samples or arrange temporary coverage through the manufacturer.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation.

For additional support with insurance appeals and prior authorization assistance, 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 compelling appeals that align with payer criteria and increase approval rates.

Sources & Further Reading

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