By Counterforce Health Team in Opfolda (miglustat) —

Get Opfolda (miglustat) Covered by Cigna in California: Forms, Appeals & Support Contacts

Answer Box: Fast Path to Opfolda Coverage

Opfolda (miglustat) is only approved with Pombiliti for adults with late-onset Pompe disease (≥40 kg) not improving on current enzyme replacement therapy. For Cigna approval in California:

  1. Submit PA electronically via CoverMyMeds or call 1-800-882-4462 for urgent cases
  2. Include required documentation: LOPD diagnosis, weight verification, ERT failure history, and specialist notes
  3. If denied, appeal within 180 days using Cigna's Customer Appeal Request form, then escalate to California's Independent Medical Review if needed

First step today: Verify your plan uses Accredo specialty pharmacy (844-516-3319) and confirm Opfolda requires prior authorization on your specific formulary.

Table of Contents

Verify Your Plan & Coverage Requirements

Before starting your prior authorization, confirm these essential details about your Cigna coverage:

Check Your Formulary Status

  • Download your current Cigna Prescription Drug List to verify if Opfolda requires prior authorization
  • Most Cigna plans manage specialty drugs like Opfolda through Express Scripts/Accredo with PA requirements
  • Call the member services number on your insurance card to confirm your specific formulary tier and requirements

Verify Specialty Pharmacy Network

  • Cigna typically requires Opfolda to be dispensed through Accredo Specialty Pharmacy
  • Confirm this requirement before your doctor writes the prescription to avoid delays
Note: Opfolda is never prescribed alone—it must be used with Pombiliti infusions every other week. Both medications require coordination through specialty pharmacy networks.

Prior Authorization Forms & Submission

Required Clinical Documentation

Your healthcare provider must submit a prior authorization request with comprehensive documentation proving medical necessity:

Essential Requirements:

  • Diagnosis confirmation: Late-onset Pompe disease (LOPD) with appropriate ICD-10 codes
  • Weight verification: Patient weighs ≥40 kg (required for FDA approval)
  • ERT failure documentation: Records showing inadequate improvement on current enzyme replacement therapy
  • Specialist involvement: Notes from neuromuscular specialist or geneticist familiar with Pompe disease
  • Dosing justification: Weight-based calculation (195 mg for 40-<50 kg; 260 mg for ≥50 kg)

Medical Necessity Letter Checklist

Clinician Corner: Your medical necessity letter should address these key points to strengthen approval odds:Problem statement: Current functional decline or lack of improvement on existing ERTPrior treatments: Specific ERTs tried (Lumizyme, Nexviazyme), duration, and measurable outcomesClinical rationale: Why Pombiliti + Opfolda combination is appropriate based on FDA labelingMonitoring plan: How you'll assess treatment response and safetyGuideline citations: Reference FDA prescribing information and Pompe disease treatment guidelines

Electronic Submission Portals

Primary Submission Methods (Recommended)

Portal Use Case Access Processing Time
CoverMyMeds Cigna & Accredo PA requests Free provider account Often real-time
EviCore ePA Portal Express Scripts managed benefits Register at evicore.com Up to 5 business days
MyAccredoPatients.com Direct Accredo submissions Provider registration required Standard timeline

Fax Backup Option

  • Pre-service appeals fax: 1-866-567-2474 (verify on your specific denial letter)
  • Standard PA fax: Numbers vary by plan—check your formulary or call member services
  • Always include a cover sheet with patient name, member ID, and "URGENT" if applicable

Phone Support for Urgent Cases

  • Cigna urgent PA line: 1-800-882-4462
  • Use this for situations where delays could jeopardize patient health or function

Specialty Pharmacy Enrollment

Accredo Enrollment Process

For Providers:

  1. Download the Accredo Prescription & Enrollment Form
  2. Complete all patient, prescriber, and clinical information sections
  3. Fax completed form to 888-302-1028
  4. Accredo will handle benefit investigation and PA coordination

For Patients:

  • Call 844-516-3319 to initiate enrollment and case management
  • Create an account at MyAccredoPatients.com to track orders and communicate with your care team
  • Accredo provides 24/7 access to specialty-trained pharmacists and nurses

What Accredo Handles

  • Prior authorization coordination with Cigna
  • Benefit investigation and copay assistance program enrollment
  • Delivery scheduling coordinated with your infusion center
  • Refill management and adherence support
  • Insurance appeals assistance if needed

Appeals Process for California

Step 1: Internal Appeal with Cigna

Timeline: Must be filed within 180 days of denial

Required Documents:

  • Cigna Customer Appeal Request Form
  • Copy of original denial letter or Explanation of Benefits
  • Updated medical records supporting medical necessity
  • Provider letter explaining why Opfolda + Pombiliti is appropriate

Submission Address:

Cigna HealthCare of California, Inc.
National Appeals Unit
PO Box 188011
Chattanooga, TN 37422

Cigna Response Timeline:

  • Standard appeals: 30 calendar days
  • Urgent appeals: 24-72 hours (for situations affecting health/recovery)

Step 2: External Review (After Internal Denial)

If Cigna upholds the denial, you can request independent external review:

  • Cigna will provide instructions for external review with their final internal decision
  • The external reviewer's decision is binding on Cigna
  • No cost to you for this review

Step 3: California Department of Managed Health Care (DMHC)

When to Contact DMHC:

  • Cigna fails to respond within required timelines
  • You believe Cigna isn't following proper procedures
  • You need assistance with the appeals process

DMHC Contact Information:

  • Help Center: 1-888-466-2219
  • Complaint fax: 1-916-255-5241
  • Online complaint: Available at healthhelp.ca.gov
California Advantage: California has one of the most patient-friendly appeal processes in the country. The state's Independent Medical Review system has a high success rate for overturning denials of medically necessary treatments, especially for rare diseases like Pompe disease.

Support Contact Directory

Cigna Member Services

  • Main line: Number on your insurance card
  • Pharmacy benefits: 1-800-244-6224
  • Urgent PA requests: 1-800-882-4462

Accredo Specialty Pharmacy

  • Patient support: 844-516-3319
  • Provider enrollment: 888-302-1028 (fax)
  • Online portal: MyAccredoPatients.com

Manufacturer Support

  • Amicus Assist Program: Contact through your healthcare provider for patient support services
  • Clinical information: Available at pombilitiopfoldahcp.com

California State Resources

  • DMHC Help Center: 1-888-466-2219
  • Health Consumer Alliance: Independent consumer assistance organization
  • Legal aid: Contact local legal aid societies for complex cases

California Regulatory Resources

California offers robust protections for patients seeking coverage of medically necessary treatments:

Independent Medical Review (IMR)

  • Available after completing Cigna's internal appeal process
  • Decided by independent physician experts in relevant specialties
  • Standard IMR: 45 days; Expedited IMR: 72 hours for urgent cases
  • High success rate for rare disease treatments with proper documentation

Patient Rights

  • No fee to request IMR
  • Right to expedited review for urgent medical situations
  • Binding decision on insurance companies
  • Assistance available in multiple languages

Getting Help California's Health Consumer Alliance provides free assistance with insurance appeals and can help prepare documentation for complex cases involving rare diseases.

Common Questions

How long does Cigna prior authorization take for Opfolda? Standard PA review takes up to 5 business days. Urgent requests submitted by phone (1-800-882-4462) may be processed faster if clinical urgency is documented.

What if Opfolda isn't on my formulary? Your doctor can request a formulary exception using Cigna's exception process. Include documentation showing medical necessity and why formulary alternatives aren't appropriate.

Can I get expedited appeals in California? Yes. Both Cigna and California's DMHC offer expedited review for urgent situations where delays could jeopardize your health or recovery ability.

Does step therapy apply to Opfolda? Opfolda is only approved with Pombiliti for patients already failing on other enzyme replacement therapies, so step therapy requirements are typically built into the medical necessity criteria.

What if I'm switching from another insurance plan? Document your prior ERT trials and outcomes from your previous plan. This history supports medical necessity even if treatments were covered elsewhere.

How much will Opfolda cost with Cigna coverage? Costs vary by plan. Accredo will conduct a benefit investigation and help you understand your out-of-pocket costs. Patient assistance programs may be available through Amicus Therapeutics.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals that address specific denial reasons with appropriate clinical evidence and regulatory citations. For complex cases like Opfolda approvals, having systematic appeal support can significantly improve approval odds and reduce the time clinicians spend on administrative tasks.

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 about treatment decisions and contact your insurance company or a qualified patient advocate for specific coverage questions. Coverage policies and requirements may change—verify current information with official sources before taking action.

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