By Counterforce Health Team in Evkeeza (evinacumab-dgnb) —

Renewing Evkeeza (evinacumab-dgnb) Approval with Blue Cross Blue Shield in New Jersey: 2025 Requirements & Timeline

Answer Box: Renewing Evkeeza Coverage in New Jersey

Blue Cross Blue Shield (BCBS) requires annual prior authorization renewal for Evkeeza (evinacumab-dgnb) in New Jersey. Key requirements include documented HoFH diagnosis, updated LDL-C labs showing ongoing need, and evidence of maximum tolerated lipid-lowering therapy. Start renewal 60-90 days before expiration. If denied, New Jersey's IHCAP external review through Maximus Federal Services provides binding decisions within 45 days.

First step today: Contact your prescriber to schedule LDL-C labs and begin gathering required documentation for your renewal packet.

Table of Contents

  1. When to Start Your Renewal Process
  2. Required Evidence Updates
  3. Building Your Renewal Packet
  4. Submission Timeline & Decision Windows
  5. If Your Coverage Lapses
  6. Annual Plan Changes to Watch
  7. Personal Progress Tracker
  8. Appeals Process in New Jersey
  9. FAQ

When to Start Your Renewal Process

Start 60-90 days before your current authorization expires. Most Blue Cross Blue Shield plans in New Jersey require annual renewal for specialty medications like Evkeeza, with authorization periods typically running 12 months from the initial approval date.

Early Warning Signs to Act

  • Authorization expiration notice from your insurer (usually sent 30-60 days prior)
  • Pharmacy notification that your next refill requires new approval
  • Specialty pharmacy outreach about upcoming renewal requirements
  • Provider office reminder about annual review scheduling
Tip: Mark your calendar for renewal prep 90 days before expiration. This buffer allows time for lab scheduling, documentation gathering, and potential appeals if needed.

Blue Cross Blue Shield Renewal Triggers

According to Horizon Blue Cross Blue Shield of New Jersey policy, annual renewals must demonstrate:

  • Continued diagnosis of homozygous familial hypercholesterolemia (HoFH)
  • Patient remains ≥5 years of age
  • Ongoing clinical necessity despite standard therapies

Required Evidence Updates

Your renewal packet must include fresh clinical evidence demonstrating continued need for Evkeeza therapy.

Essential Lab Work

LDL-C Monitoring Requirements:

  • Baseline comparison: Include original pre-treatment LDL-C levels
  • Current LDL-C: Labs within 30-60 days of renewal submission
  • Treatment response: Document percent reduction from baseline
  • Ongoing elevation: Show LDL-C remains ≥70 mg/dL despite therapy or document intolerance to PCSK9 inhibitors
Note: Clinical protocols recommend LDL-C monitoring every 4-12 weeks during treatment, with comprehensive documentation for renewal periods.

Clinical Response Documentation

Required Element What to Include Source
Diagnosis Confirmation Genetic testing results or clinical HoFH criteria Medical records
Treatment Response LDL-C percent reduction (aim for >15-25%) Lab reports
Adherence Assessment Infusion dates, missed appointments, compliance Clinic notes
Concurrent Therapies All lipid-lowering medications and dosing Medication list
Safety Monitoring Infusion reactions, adverse events Provider notes

Adverse Events & Safety Updates

Document any:

  • Infusion reactions and management strategies
  • Treatment interruptions and reasons
  • Dose modifications based on tolerability
  • Contraceptive counseling for women of reproductive potential (required during treatment and 5 months after last dose)

Building Your Renewal Packet

Core Documents Checklist

Patient Information:

  • Current insurance card and member ID
  • Updated demographics and contact information
  • Pharmacy preference (specialty pharmacy required)

Clinical Documentation:

  • Provider renewal form (plan-specific)
  • Updated medical necessity letter
  • Recent LDL-C lab results (within 60 days)
  • Comprehensive medication list
  • Treatment timeline with infusion dates

Supporting Evidence:

  • Original HoFH diagnosis documentation
  • Prior therapy trials and outcomes
  • Baseline vs. current LDL-C comparison
  • Safety monitoring notes

Medical Necessity Letter Structure

Your prescriber's letter should address:

  1. Patient identification and confirmed HoFH diagnosis
  2. Treatment history including failed/contraindicated therapies
  3. Current clinical status with recent labs and response data
  4. Continued need justification with specific LDL-C targets
  5. Safety profile during current treatment course
  6. Treatment plan for the upcoming authorization period
Clinician Corner: Include specific citations to FDA labeling and relevant clinical guidelines. Reference the patient's specific response data and why alternative therapies remain inadequate.

Submission Timeline & Decision Windows

Optimal Submission Schedule

Timeline Action Required Responsible Party
90 days before expiration Schedule renewal planning visit Patient
60 days before Complete lab work and clinical assessment Patient + Provider
45 days before Submit complete renewal packet Provider/Specialty Pharmacy
30 days before Follow up on pending decision Patient
15 days before Initiate expedited review if needed Provider

Decision Timeframes

Standard Review: Blue Cross Blue Shield typically responds within 14-30 days for renewal requests with complete documentation.

Expedited Review: Available when treatment interruption would cause serious harm to health. Decision required within 72 hours for urgent cases.

Incomplete Submissions: Plans may request additional information, extending the review period. Respond promptly to avoid delays.

If Your Coverage Lapses

Immediate Bridge Options

Regeneron's myRARE Program:

  • Bridge therapy available during coverage gaps
  • Patient assistance for eligible individuals
  • Contact: 1-877-EVKEEZA (1-877-385-3392)
  • Application through myRARE Start Form

Coverage Gap Management

  1. Contact your specialty pharmacy immediately about bridge programs
  2. Request expedited appeal if renewal was denied
  3. Apply for patient assistance through manufacturer programs
  4. Consider temporary LDL apheresis if clinically appropriate
From our advocates: "One patient's renewal was delayed due to missing lab work during the holidays. Their specialty pharmacy coordinator helped secure a 30-day bridge supply through the manufacturer program while we expedited the lab collection and resubmission. The key was immediate communication with all parties when we realized the gap was approaching."

Annual Plan Changes to Watch

2025 Formulary Updates

Specialty Tier Placement: Evkeeza remains on Specialty Tier (Tier 5/6) for most Blue Cross Blue Shield plans, requiring highest cost-sharing and prior authorization.

Policy Changes: Review your plan's 2025 formulary for:

  • Modified prior authorization criteria
  • New step therapy requirements
  • Quantity limit adjustments
  • Site of care restrictions

Benefits Verification

Annual Tasks:

  • Confirm Evkeeza remains on formulary
  • Review updated cost-sharing (copay/coinsurance)
  • Verify specialty pharmacy network
  • Check for new coverage restrictions

Mid-Year Changes: Plans must provide 30-day notice for adverse formulary changes affecting current users.

Personal Progress Tracker

Renewal Checklist Template

Current Authorization Details:

  • Approval date: ___________
  • Expiration date: ___________
  • Authorized quantity: ___________
  • Specialty pharmacy: ___________

Renewal Preparation:

  • Renewal planning visit scheduled: ___________
  • LDL-C labs completed: ___________
  • Medical necessity letter requested: ___________
  • Prior authorization form submitted: ___________
  • Decision received: ___________

Key Contacts:

  • Prescriber office: ___________
  • Specialty pharmacy: ___________
  • Insurance member services: ___________
  • myRARE program: 1-877-385-3392

Appeals Process in New Jersey

Internal Appeals with Blue Cross Blue Shield

Level 1: Standard internal review (14-30 days) Level 2: Second-level internal review (additional 30 days) Expedited: 72-hour decision for urgent cases

External Review Through IHCAP

New Jersey's Independent Health Care Appeals Program (IHCAP) provides binding external review through Maximus Federal Services.

Filing Requirements:

  • Must complete internal appeals first
  • File within 90 days of final internal denial
  • Submit via Maximus IHCAP portal

Timeline:

  • Preliminary review: 5 business days
  • Final decision: 45 calendar days
  • Binding on insurer if overturned

Contact: IHCAP Hotline at 1-888-393-1062

When preparing for appeals, Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to create point-by-point rebuttals aligned with the insurer's own criteria.

FAQ

Q: How long does Blue Cross Blue Shield prior authorization take in New Jersey? A: Standard renewals typically take 14-30 days with complete documentation. Expedited reviews are completed within 72 hours for urgent cases.

Q: What if my LDL-C levels have improved significantly? A: Document the improvement but emphasize ongoing elevation above target levels and the risk of rebound if treatment is discontinued. Include your prescriber's clinical judgment about continued need.

Q: Can I switch Blue Cross Blue Shield plans mid-year if denied? A: Generally no, unless you qualify for a special enrollment period. Focus on appeals processes and manufacturer assistance programs instead.

Q: Does step therapy apply to Evkeeza renewals? A: Yes, if you haven't previously met step therapy requirements. Document all prior lipid-lowering therapies, including reasons for discontinuation or inadequate response.

Q: What counts as medical necessity for Evkeeza? A: Horizon BCBSNJ policy requires confirmed HoFH diagnosis, age ≥5 years, LDL-C ≥70 mg/dL despite maximum tolerated lipid-lowering therapy, and appropriate monitoring.

Q: How do I request an expedited appeal? A: Contact Blue Cross Blue Shield member services immediately and have your prescriber document that delay in treatment would cause serious harm to your health.

Q: What if I move to another state during treatment? A: Contact your new Blue Cross Blue Shield plan immediately to initiate coverage transfer. Each state affiliate has different policies that may require new prior authorization.

Q: Are there income limits for manufacturer assistance? A: Regeneron's myRARE program typically assists households with annual income up to $100,000 or 500% of Federal Poverty Level, though specific criteria may vary.

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 and insurance plan for personalized guidance. Coverage policies and appeal procedures may vary by specific Blue Cross Blue Shield plan and can change over time.

For personalized assistance with insurance appeals and prior authorization strategies, Counterforce Health provides specialized support in turning denials into successful approvals through evidence-based appeal letters tailored to each insurer's specific requirements.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.