How to Get Lamzede (Velmanase Alfa-Tycv) Approved by Cigna in California: Complete Prior Authorization Guide
Answer Box: Getting Lamzede Covered by Cigna in California
Cigna requires prior authorization for Lamzede (velmanase alfa-tycv) in California. Submit via eviCore, CoverMyMeds, or Accredo's iAssist with confirmed alpha-mannosidosis diagnosis (enzyme/genetic testing), specialist letter, and clinical documentation. Standard review: 5 business days; expedited: 24 hours for urgent cases. If denied, file internal appeal within 180 days, then California Independent Medical Review (IMR) through DMHC—61% of medical necessity denials are overturned. Start today: Verify your plan is DMHC-regulated and gather diagnostic reports.
Table of Contents
- Before You Start: Plan Verification
- Coverage Requirements at a Glance
- Gather What You Need
- Submit the Prior Authorization Request
- Follow-Up and Timeline Expectations
- Common Denial Reasons and Solutions
- Appeals Process in California
- Renewal and Re-Authorization
- FAQ: Lamzede Coverage in California
- Checklist: Quick Reference
Before You Start: Plan Verification
Confirm Your Plan Type
First, determine if your Cigna plan is regulated by California's Department of Managed Health Care (DMHC). Most HMOs and many PPOs fall under DMHC, giving you access to California's Independent Medical Review (IMR) process. Check your insurance card or call Cigna at 1-800-882-4462 to confirm.
Check Lamzede's Formulary Status
Log into your myCigna account and search for "Lamzede" or "velmanase alfa-tycv" in the drug lookup tool. Lamzede typically requires prior authorization and must be filled through Accredo Specialty Pharmacy, Cigna's preferred specialty pharmacy.
Verify Medical vs. Pharmacy Benefit
Lamzede is usually covered under the pharmacy benefit managed by Express Scripts. This means your prior authorization will go through Express Scripts' eviCore system, not Cigna's medical benefit precertification process.
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required before coverage | Express Scripts PA FAQ | |
| Confirmed Diagnosis | Alpha-mannosidosis via enzyme/genetic testing | ICD-10: E77.1 | Cigna Policy IP0563 |
| Specialist Oversight | Metabolic/genetic specialist involvement | Provider letter | Cigna Policy IP0563 |
| FDA-Approved Dosing | 1 mg/kg IV weekly | Prescription | FDA Label |
| Specialty Pharmacy | Accredo dispensing required | Prescription routing | Cigna Specialty Pharmacy Guide |
Gather What You Need
Diagnostic Documentation
Your specialist will need to provide:
- Enzyme activity results: Alpha-mannosidase activity <0.54 nmol/min/mg protein in leukocytes
- Genetic testing: MAN2B1 gene variants (if available)
- Urine oligosaccharides: Elevated mannose-rich oligosaccharides
- Clinical features: Documentation of non-CNS manifestations (skeletal, cardiac, pulmonary, immunologic)
Clinical Information Package
Clinician Corner: Your medical necessity letter should address each criterion in Cigna's Lamzede policy. Include baseline functional assessments (6-minute walk test, pulmonary function), infection history, and treatment goals. Reference the pivotal rhLAMAN-05 trial and emphasize that Lamzede is the only FDA-approved therapy for alpha-mannosidosis.
Essential documents include:
- Complete diagnostic workup with enzyme/genetic confirmation
- Specialist consultation notes
- Baseline functional assessments
- Prior therapy attempts and outcomes
- Proposed monitoring plan
Submit the Prior Authorization Request
Electronic Submission Options
Option 1: eviCore (Express Scripts)
- Go to the eviCore portal
- Register as a provider
- Select "Pharmacy Drugs (Express Scripts Coverage)"
- Enter Lamzede (velmanase alfa-tycv) as requested medication
- Complete all clinical questions with supporting documentation
Option 2: CoverMyMeds
- Start an ePA at CoverMyMeds
- Select patient's Express Scripts/Cigna plan
- Enter drug: Lamzede
- Upload clinical documentation
Option 3: Accredo iAssist
- Log into MyAccredoPatients.com
- Use iAssist to submit electronic referral plus ePA
- Bundle prescription and prior authorization
Phone/Fax Backup
If electronic submission isn't feasible, call 1-800-882-4462 for Express Scripts drug prior authorization assistance.
Follow-Up and Timeline Expectations
California-Mandated Timelines
| Review Type | Cigna Timeline | California Law |
|---|---|---|
| Standard | 5 business days | 2-3 business days |
| Expedited/Urgent | 24 hours | 24 hours |
Tracking Your Request
Monitor status through:
- Express Scripts member portal → "Prior Authorizations"
- Call 1-800-882-4462 for updates
- Accredo patient services if using their iAssist system
Sample Follow-Up Script
"Hi, I'm calling to check on prior authorization status for Lamzede for [patient name], member ID [number]. The request was submitted on [date] with reference number [if available]. Can you provide the current status and any additional information needed?"
Common Denial Reasons and Solutions
| Denial Reason | How to Overturn | Supporting Evidence |
|---|---|---|
| Insufficient diagnostic proof | Submit complete enzyme activity and genetic testing | Mayo Clinic testing guidelines |
| Not medically necessary | Emphasize progressive nature, lack of alternatives | BIMDG clinical guidance |
| Experimental/investigational | Highlight FDA approval for exact indication | Cigna Policy IP0563 |
| Site of care issues | Justify infusion setting based on monitoring needs | Clinical letter addressing anaphylaxis risk |
From Our Advocates: We've seen multiple California cases where Cigna initially denied Lamzede as "experimental" despite FDA approval. In each instance, a comprehensive appeal package with genetic confirmation, specialist letters emphasizing the progressive nature of alpha-mannosidosis, and clear citation of FDA labeling led to approval—either during internal appeal or at IMR. The key was addressing every line of Cigna's denial letter point-by-point.
Appeals Process in California
Internal Appeal with Cigna
Timeline: File within 180 days of denial Decision: 15 business days (standard); 24-72 hours (expedited) What to include:
- Point-by-point rebuttal of denial reasons
- Updated specialist letter
- Additional clinical evidence
- Copy of Cigna's Lamzede policy with criteria mapping
California Independent Medical Review (IMR)
If Cigna upholds the denial, California residents can request IMR through the DMHC.
Success Rates:
- Medical necessity denials: ~61% overturned
- Experimental/investigational: ~36% overturned
- Additional ~25% of cases are approved by plans after IMR is filed
How to File:
- Call DMHC Help Center: 888-466-2219
- Submit online at healthhelp.ca.gov
- Include all Cigna correspondence and clinical documentation
Timelines:
- Standard IMR: 45 days
- Expedited IMR: 7 days (often 72 hours for urgent cases)
Cost: Free to patients; binding on Cigna
When Counterforce Health analyzed California IMR outcomes for similar ultra-rare enzyme replacement therapies, they found that well-documented cases with confirmed genetic diagnoses and specialist support had significantly higher success rates, particularly when the appeal clearly demonstrated the progressive nature of the condition and lack of therapeutic alternatives.
Renewal and Re-Authorization
When to Start
Begin renewal process 60 days before current authorization expires. Cigna typically approves Lamzede for 12-month periods.
Required Documentation for Renewal
- Updated clinical assessment showing stability or improvement
- Functional testing results (6-minute walk test, pulmonary function)
- Infection frequency and hospitalization data
- Specialist letter confirming continued medical necessity
- Documentation of adherence to therapy
FAQ: Lamzede Coverage in California
How long does Cigna prior authorization take for Lamzede in California? Standard review: 5 business days; expedited review: 24 hours for urgent medical necessity cases.
What if Lamzede is non-formulary on my plan? Request a formulary exception through Cigna's standard process. Emphasize that Lamzede is the only FDA-approved therapy for alpha-mannosidosis.
Can I request an expedited appeal? Yes, if your physician certifies that delay would seriously jeopardize your life, health, or ability to function. California law requires 24-hour decisions for urgent requests.
Does step therapy apply to Lamzede? Typically no, since Lamzede is the only FDA-approved disease-modifying therapy for alpha-mannosidosis.
What happens if I move to California from another state? Your new Cigna California plan may require fresh prior authorization. Start the process immediately upon enrollment.
How much does Lamzede cost without insurance? Approximately $1.46 million annually for a 70kg patient. Manufacturer support programs may be available—contact Chiesi Global Rare Diseases for assistance.
Checklist: Quick Reference
Before Submitting PA:
- Confirm DMHC-regulated plan status
- Verify Accredo specialty pharmacy requirement
- Gather enzyme activity results (<0.54 nmol/min/mg protein)
- Obtain genetic testing (MAN2B1) if available
- Collect specialist consultation notes
- Document baseline functional assessments
During PA Process:
- Submit via eviCore, CoverMyMeds, or Accredo iAssist
- Include complete diagnostic documentation
- Request expedited review if medically urgent
- Track status through Express Scripts portal
- Document all reference numbers and contact dates
If Denied:
- File internal appeal within 180 days
- Submit point-by-point rebuttal with new evidence
- Request California IMR if internal appeal fails
- Contact DMHC Help Center: 888-466-2219
- Consider Counterforce Health for appeal assistance
This guide provides general information about insurance coverage processes and should not be considered medical advice. For specific medical questions, consult your healthcare provider. For insurance-specific questions, contact Cigna directly or the California Department of Managed Health Care at 888-466-2219.
Sources & Further Reading
- Cigna Lamzede Coverage Policy IP0563 (PDF)
- Express Scripts Prior Authorization FAQ
- California DMHC Independent Medical Review
- Accredo Prior Authorization Resources
- BIMDG Alpha-Mannosidosis Clinical Guidance
- Lamzede Prescribing Information
- Mayo Clinic Alpha-Mannosidase Testing
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