By Counterforce Health Team in Cerezyme (imiglucerase) —

How to Get Cerezyme (Imiglucerase) Covered by Cigna in Washington: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Cerezyme (Imiglucerase) Covered by Cigna in Washington

Fastest Path to Approval: Submit Cigna's Cerezyme/Elelyso/VPRIV prior authorization form with documented Gaucher disease (enzyme assay or genetic testing), prescription from a metabolic/lysosomal storage disorder specialist, and clinical notes showing symptoms. No step therapy required. If denied, appeal within 60 days internally, then request external IRO review within 4 months.

First Step Today: Call your prescribing specialist to initiate the prior authorization through Cigna's provider portal or fax the completed form with all required documentation.

Table of Contents

Cigna's Coverage Policy Overview

Cigna requires prior authorization for Cerezyme (imiglucerase) across all plan types—commercial, Medicare, and Medicaid managed care. The approval lasts one year and mandates prescription by or in consultation with a physician specializing in metabolic disorders, lysosomal storage disorders, or hematology/oncology, according to Cigna's coverage policy.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Cerezyme prescriptions Cigna provider portal PA Form
Specialist Prescription Must be prescribed by metabolic/lysosomal specialist Provider credentials verification Coverage Policy
Diagnosis Confirmation Documented Gaucher disease via testing Lab reports, genetic testing Coverage Policy
Step Therapy None required for Cerezyme N/A Coverage Policy
Specialty Pharmacy Express Scripts/Accredo required Member portal Specialty Pharmacy Info

Unlike some other enzyme replacement therapies, Cigna doesn't require patients to try alternative treatments first. This streamlined approach recognizes that Cerezyme is often the most appropriate first-line therapy for many Gaucher disease patients.

Medical Necessity Requirements

To meet Cigna's medical necessity criteria for Cerezyme, you'll need documented proof of Gaucher disease and appropriate clinical oversight. Here's what counts:

Diagnosis Confirmation

  • Enzyme Testing: Beta-glucosidase leukocyte (BGL) assay showing deficient enzyme activity
  • Genetic Testing: Biallelic pathogenic variants in the GBA gene via sequencing
  • Clinical Symptoms: Splenomegaly, anemia, thrombocytopenia, or bone involvement

Prescriber Requirements

Your prescribing physician must specialize in:

  • Metabolic disorders
  • Lysosomal storage disorders
  • Hematology/oncology
  • Pediatric genetics (for pediatric patients)
Clinician Corner: Medical Necessity Letter Checklist

Your letter should include: confirmed Gaucher disease diagnosis with test results, current symptoms and disease manifestations, rationale for Cerezyme over alternatives, dosing plan based on FDA labeling (2.5-60 units/kg), monitoring plan, and treatment goals. Reference the International Collaborative Gaucher Group guidelines for evidence-based support.

Step-by-Step: Fastest Path to Approval

  1. Confirm Specialist Credentials (Patient/Clinic)
    • Verify your physician specializes in metabolic or lysosomal disorders
    • If not, request referral to appropriate specialist
    • Timeline: 1-2 weeks for new patient appointments
  2. Gather Diagnostic Documentation (Clinic)
    • Obtain enzyme testing results showing deficient glucocerebrosidase activity
    • Include genetic testing confirming biallelic GBA mutations
    • Document: Lab reports with reference ranges and patient values
    • Timeline: 1-2 weeks if testing needed
  3. Complete Prior Authorization Form (Prescriber)
    • Download Cigna's Cerezyme PA form
    • Include clinical rationale and dosing justification
    • Submit: Via Cigna provider portal or fax
    • Timeline: Same day submission possible
  4. Submit Supporting Documentation (Clinic)
    • Medical necessity letter from specialist
    • Recent clinical notes documenting symptoms
    • Lab results and imaging if applicable
    • Timeline: 24-48 hours to compile
  5. Follow Up on Determination (Patient/Clinic)
    • Cigna has 15 days for standard PA decisions
    • Request expedited review if urgent (72-hour decision)
    • Contact: Cigna provider services for status updates
  6. Set Up Specialty Pharmacy (Patient)
    • Call Accredo at 877-826-7657 once approved
    • Arrange home infusion or clinic administration
    • Timeline: 3-5 business days for first shipment
  7. Begin Treatment (Patient/Clinic)
    • First infusion typically in clinical setting
    • Transition to home infusion if appropriate
    • Monitoring: Regular follow-ups per specialist recommendations

Required Documentation Checklist

Before submitting your prior authorization, ensure you have:

Essential Documents:

  • ✅ Completed Cigna PA form with prescriber signature
  • ✅ Medical necessity letter from qualified specialist
  • ✅ Enzyme testing results (beta-glucosidase activity)
  • ✅ Genetic testing results (GBA gene analysis)
  • ✅ Recent clinical notes documenting Gaucher symptoms
  • ✅ Current lab values (CBC, comprehensive metabolic panel)
  • ✅ Imaging studies if bone involvement present

Supporting Evidence:

  • ✅ Previous treatment history and responses
  • ✅ Dosing rationale based on patient weight and severity
  • ✅ Treatment goals and monitoring plan
  • ✅ Contraindications to alternative therapies (if applicable)
Tip: Request expedited review if your condition is rapidly progressing or if delayed treatment could result in irreversible complications. Include documentation of urgency in your submission.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Diagnosis Not Confirmed Submit complete enzyme and genetic testing BGL assay results, GBA sequencing
Non-Specialist Prescriber Transfer care or obtain co-signature Specialist consultation notes, credentials verification
Insufficient Clinical Information Provide detailed symptom documentation Recent clinic notes, imaging, lab trends
Dosing Outside Guidelines Justify with clinical rationale FDA label reference, specialist letter
Missing Prior Therapy History Document previous treatments Treatment timeline, response documentation

Appeals Process in Washington

If Cigna denies your Cerezyme prior authorization, Washington state provides robust appeal rights under RCW 48.43.535.

Internal Appeals (First Step)

  • Deadline: 60 days from denial notice
  • Timeline: 30 days for pre-service, 60 days for post-service determinations
  • Expedited: 72 hours if delay jeopardizes health
  • How to File: Call Cigna member services or submit written appeal

External Review (Independent Review Organization)

After exhausting internal appeals, you can request external review:

  • Deadline: 4 months from final internal denial
  • Timeline: 30 days for standard, 72 hours for expedited
  • Process: Submit request to Washington Office of the Insurance Commissioner
  • Cost: Free to patients
  • Binding: IRO decision overrides Cigna's determination
Washington Advantage: The state's external review process is particularly valuable for rare diseases like Gaucher disease, where IRO medical experts can override unreasonable payer standards based on current medical evidence.

Getting Help with Appeals

  • Washington OIC Consumer Advocacy: 1-800-562-6900
  • Appeal Templates: Available on OIC website
  • Professional Support: Consider using Counterforce Health for evidence-backed appeal letters

Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer rules. Their platform pulls appropriate citations from FDA labeling, peer-reviewed studies, and specialty guidelines to strengthen your case.

Specialty Pharmacy and Infusion Requirements

Cigna requires Cerezyme to be dispensed through Express Scripts' Accredo specialty pharmacy. This exclusive arrangement includes several benefits:

Home Infusion Services

  • Eligibility: Most stable patients qualify for home administration
  • Safety: 4.5% reaction rate (mostly mild), lower than manufacturer's 9% rate
  • Nursing: Trained Gaucher disease specialists available
  • Cost: 40-60% lower than outpatient infusion centers

Getting Started with Accredo

  1. Initial Setup: Call 877-826-7657 after PA approval
  2. Delivery: Free shipping, including refrigerated medications
  3. Scheduling: Coordinate infusion timing with home nursing
  4. Support: 24/7 pharmacist access for questions
Note: First infusion typically occurs in a clinical setting with appropriate monitoring equipment, per FDA labeling requirements.

Cost Support and Patient Assistance

Even with insurance coverage, Cerezyme costs can be substantial. Several programs can help reduce your out-of-pocket expenses:

Manufacturer Support

  • Sanofi Patient Connection: Income-based assistance for eligible patients
  • Copay Cards: Available for commercially insured patients
  • Application: Contact Sanofi at 1-888-847-4877

Foundation Assistance

  • National Gaucher Foundation: Provides grants and resources
  • HealthWell Foundation: Covers copays for qualifying patients
  • Patient Advocate Foundation: Helps navigate insurance and financial challenges

State Resources

Washington residents may qualify for additional support through:

  • Apple Health (Medicaid): Covers Cerezyme with prior authorization
  • Prescription Drug Assistance Programs: Available through local health departments

Frequently Asked Questions

How long does Cigna prior authorization take for Cerezyme in Washington? Standard PA decisions take up to 15 days. Expedited reviews (for urgent cases) are completed within 72 hours. Submit complete documentation to avoid delays.

What if Cerezyme is non-formulary on my Cigna plan? You can request a formulary exception using the same PA process. Include medical necessity justification and evidence that formulary alternatives are inappropriate.

Can I request an expedited appeal in Washington? Yes, both internal appeals and external IRO reviews can be expedited if delay would jeopardize your health. Include urgency documentation with your request.

Does step therapy apply if I've failed other treatments outside Washington? Cigna doesn't require step therapy for Cerezyme, but document any prior treatment failures to strengthen your case for medical necessity.

What happens if my appeal is denied by the IRO? IRO decisions are binding on Cigna, but you can file a complaint with the Washington Office of the Insurance Commissioner if you believe the process was flawed.

How do I transfer my prescription to Accredo specialty pharmacy? Once PA is approved, call Accredo at 877-826-7657. They'll coordinate the transfer and set up delivery/infusion services.

Can I continue treatment while appealing a denial? You may be able to get temporary coverage during appeals, especially for expedited cases. Contact Cigna member services to discuss options.

What if my employer plan is self-funded? Self-funded ERISA plans may not follow Washington state appeal laws. Contact the U.S. Department of Labor for ERISA plan appeals guidance.

Medical Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Always consult with your healthcare provider about treatment decisions and follow their clinical recommendations.

Sources & Further Reading

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