How to Get Evkeeza (Evinacumab-dgnb) Covered by Cigna in New Jersey: Prior Authorization, Appeals, and State Protections
Answer Box: Getting Evkeeza Covered by Cigna in New Jersey
Evkeeza (evinacumab-dgnb) requires strict prior authorization from Cigna for homozygous familial hypercholesterolemia (HoFH). New Jersey law mandates 72-hour response times for non-urgent requests and 24-hour for urgent cases. First step: Have your specialist submit the Cigna PA form with genetic confirmation of HoFH, recent lipid panels, and documentation of maximized background therapy (statins, ezetimibe, PCSK9 inhibitors). If denied, New Jersey's Independent Health Care Appeals Program (IHCAP) through Maximus provides external review within 60 days.
Table of Contents
- Why New Jersey State Rules Matter
- Prior Authorization Turnaround Standards
- Step Therapy Protections for Rare Diseases
- Continuity of Care During Coverage Changes
- External Review & Complaints Process
- Fastest Path to Approval: Step-by-Step
- Common Denial Reasons & How to Fix Them
- Appeals Playbook for Cigna in New Jersey
- Costs & Financial Assistance
- When to Escalate to State Regulators
- FAQ: Evkeeza Coverage in New Jersey
Why New Jersey State Rules Matter
New Jersey's insurance regulations create powerful protections for patients needing specialty drugs like Evkeeza. Unlike federal guidelines that apply broadly, New Jersey's specific laws govern how quickly Cigna must respond to prior authorization requests and what medical exceptions they must grant.
Key New Jersey Advantages:
- Accelerated PA timelines: 72 hours for standard requests, 24 hours for urgent cases
- Step therapy override protections: Clear medical exception criteria taking effect January 2026
- Robust external review: Independent physician panels can overturn Cigna denials
- Continuity of care: 90-day grace periods for ongoing specialty therapy
Note: These protections apply to New Jersey state-regulated plans. Self-funded employer plans (ERISA) may follow different federal rules, though many voluntarily adopt state standards.
Prior Authorization Turnaround Standards
New Jersey law establishes some of the fastest PA response times in the nation for specialty drugs:
Request Type | Response Time | Submission Method |
---|---|---|
Urgent | 24 hours (calendar) | Electronic preferred |
Non-urgent | 72 hours (calendar) | Electronic or paper |
Renewal | Same timelines apply | 60-90 days before expiration |
What happens if Cigna misses the deadline? Under New Jersey law, your Evkeeza request is automatically deemed authorized. Keep detailed records of submission dates and times.
Making requests "urgent": Your prescriber can designate a request as urgent if delay would seriously jeopardize your health. For HoFH patients with extremely high LDL levels despite maximal therapy, this designation is often appropriate.
Step Therapy Protections for Rare Diseases
Starting January 1, 2026, New Jersey's step therapy reform law (Assembly Bill A1825) provides clear medical exception criteria that directly benefit Evkeeza patients. A step therapy override must be granted if:
- The required drug is contraindicated or likely to cause adverse reactions
- The drug is expected to be ineffective for your condition
- You've previously tried and stopped the required drug due to lack of efficacy or adverse events
- Based on documented medical necessity, step therapy is not in your best interest
- You're currently stable on Evkeeza and switching could cause harm
Actionable tip: When requesting a step therapy exception, reference these specific N.J.S.A. criteria in your appeal letter and provide clinical documentation supporting each applicable point.
Continuity of Care During Coverage Changes
If your provider leaves Cigna's network or your coverage changes while you're on Evkeeza, New Jersey law provides a 90-day transitional coverage period for ongoing specialty therapy. This protection applies to serious and complex conditions like HoFH.
Your rights include:
- Continued access to your current provider at in-network rates
- Uninterrupted Evkeeza infusions during the transition
- Written notice of your continuity rights from Cigna
Action required: Contact Cigna immediately upon receiving any network change notice to formally request continuity of care protection for your ongoing Evkeeza therapy.
External Review & Complaints Process
New Jersey's Independent Health Care Appeals Program (IHCAP), managed by Maximus Federal Services, provides an independent medical review when Cigna denies Evkeeza for medical necessity.
IHCAP Eligibility & Process
You can file an external appeal when:
- Cigna has denied Evkeeza due to medical necessity, experimental status, or plan exclusion
- You've completed Cigna's internal appeal levels (or they've been waived)
- It's been less than 60 days since your final denial letter
Required documents:
- Completed NJ IHCAP External Appeal Application
- Copy of Cigna's final adverse determination
- Supporting medical records and provider rationale
- Any additional clinical evidence
Filing methods:
- Online: Maximus NJ IHCAP Portal
- Mail: Maximus Federal-NJ IHCAP, 3750 Monroe Avenue, Suite 705, Pittsford, NY 14534
- Fax: 1-585-425-5296
- Email: [email protected]
Timeline: 45 days for standard review, 48 hours for expedited (urgent) cases.
Fastest Path to Approval: Step-by-Step
Step 1: Confirm HoFH Diagnosis
Who: Your lipid specialist or cardiologist
Document needed: Genetic testing results or clinical criteria confirmation
Timeline: Complete before PA submission
Step 2: Optimize Background Therapy
Who: Your prescriber
Document needed: Trial records of maximally tolerated statins, ezetimibe, PCSK9 inhibitors
Timeline: May take 3-6 months if not already done
Step 3: Gather Recent Labs
Who: Your clinic
Document needed: Lipid panel within 90 days showing persistently elevated LDL-C
Timeline: Results available within 1-2 days
Step 4: Submit PA Request
Who: Your prescriber or specialty pharmacy
Document needed: Cigna PA form CNF 665 with all supporting documentation
Timeline: Submit electronically for fastest processing
Step 5: Track Response
Who: You and your clinic
Expected timeline: 72 hours for standard, 24 hours if marked urgent
Follow-up: If no response by deadline, request automatic approval per New Jersey law
Step 6: Appeal if Denied
Who: Your prescriber with your input
Document needed: Detailed medical necessity letter addressing specific denial reasons
Timeline: File internal appeal within Cigna's specified timeframe
Step 7: External Review if Needed
Who: You or your provider (with consent)
Document needed: IHCAP application and all supporting records
Timeline: File within 60 days of final Cigna denial
Common Denial Reasons & How to Fix Them
Denial Reason | How to Overturn | Required Documentation |
---|---|---|
HoFH not confirmed | Provide genetic testing or clinical criteria | Genetic panel results, family history, clinical assessment |
Background therapy not maximized | Document trials, failures, or contraindications | Medication history, adverse event reports, contraindication notes |
Recent LDL-C not provided | Submit current lab results | Lipid panel within 90 days |
Not medically necessary | Provide specialist rationale and guidelines | Medical necessity letter citing FDA label, guidelines |
Quantity limits exceeded | Justify weight-based dosing | Patient weight, dosing calculation, infusion records |
Appeals Playbook for Cigna in New Jersey
Internal Appeals with Cigna
Level 1 (Standard):
- Timeline: File within 180 days of denial
- Response time: Varies by plan type, typically 15-30 days
- How to file: Cigna member portal or written request
- Include: Medical necessity letter, additional clinical evidence
Level 2 (if applicable):
- Timeline: File within specified timeframe after Level 1 denial
- Process: Independent physician review
- Peer-to-peer: Request if available for your plan
Expedited Appeals:
- When to use: If delay could seriously harm your health
- Timeline: Much faster response, typically 72 hours
- Justification: Document why delay poses serious risk
External Review Through IHCAP
After completing Cigna's internal appeals:
- File within: 60 days of final denial
- Review by: Independent physician panel with appropriate specialty
- Decision: Binding on Cigna if overturned
- Cost: Free to you (Cigna pays all fees)
Contact for help: Maximus NJ IHCAP at 888-866-6205
Costs & Financial Assistance
Evkeeza's annual cost averages around $450,000, making financial assistance crucial for most patients.
Manufacturer Support:
- Regeneron MyPath: Copay assistance and patient support services
- Eligibility: Commercial insurance patients (income and insurance restrictions may apply)
- Coverage: May reduce out-of-pocket costs significantly
Foundation Grants:
- Patient Advocate Foundation, HealthWell Foundation, and other organizations may provide grants for HoFH treatments
- Applications typically require financial documentation and clinical information
State Programs:
- New Jersey may have additional assistance through pharmaceutical assistance programs
- Check with NJ Department of Health for current offerings
When to Escalate to State Regulators
Contact New Jersey regulators if:
- Cigna violates PA response time requirements
- Appeals process isn't followed properly
- You suspect inappropriate bulk denials
- IHCAP procedures aren't honored
New Jersey Department of Banking and Insurance:
- Consumer Hotline: 1-800-446-7467
- IHCAP Questions: 1-888-393-1062
- Online: nj.gov/dobi
Document all interactions with dates, names, and reference numbers when filing complaints.
FAQ: Evkeeza Coverage in New Jersey
How long does Cigna prior authorization take in New Jersey? Under New Jersey law, Cigna must respond within 72 hours for standard requests and 24 hours for urgent cases. If they miss these deadlines, your request is automatically approved.
What if Evkeeza is non-formulary on my Cigna plan? You can request a formulary exception citing medical necessity. Provide documentation that formulary alternatives are inappropriate for your HoFH, contraindicated, or have failed.
Can I request an expedited appeal? Yes, if delay in accessing Evkeeza would seriously jeopardize your health. For HoFH patients with extremely high LDL levels, this designation is often appropriate.
Does step therapy apply if I've failed treatments outside New Jersey? Yes, prior treatment failures from any location count toward step therapy requirements. Provide documentation of previous trials and outcomes.
How much does external review cost? Nothing. New Jersey law requires insurers to pay all costs for IHCAP external reviews.
What happens if IHCAP overturns Cigna's denial? Cigna must comply with the IHCAP decision and provide coverage. The decision is legally binding.
Counterforce Health: Streamlining Your Appeal Process
When facing complex prior authorization requirements and potential appeals for Evkeeza, having expert support can make the difference between approval and denial. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific requirements.
The platform pulls the right clinical evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—while ensuring all procedural requirements are met, from coverage determinations to external review submissions. For HoFH patients navigating Cigna's complex approval process in New Jersey, this targeted approach can significantly improve approval odds while saving valuable time for both patients and providers.
Sources & Further Reading
- Cigna Evkeeza Prior Authorization Policy CNF 665 (PDF)
- New Jersey IHCAP External Appeals (Maximus)
- NJ Step Therapy Reform Law Analysis
- New Jersey Department of Banking and Insurance
- Evkeeza Prescribing Information (FDA)
- NJ Prior Authorization Turnaround Requirements
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms, medical circumstances, and state regulations. Always consult with your healthcare provider and insurance plan directly for coverage determinations. For personalized assistance with appeals and prior authorization, consider consulting with healthcare coverage advocates or legal professionals familiar with New Jersey insurance law.
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