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

How to Renew Evkeeza (Evinacumab-dgnb) Coverage with Cigna in Pennsylvania: 2025 Requirements and Timeline

Quick Answer: Cigna typically grants Evkeeza (evinacumab-dgnb) renewals for one year if you submit updated clinical documentation showing continued benefit and medical necessity. Start your renewal 60-90 days before your current authorization expires. Submit through Cigna's provider portal or Express Scripts with recent lipid panels, adherence records, and a brief medical necessity update. If denied, Pennsylvania's new external review program has overturned about 50% of denials in 2024.

Table of Contents

Renewal Triggers: When to Start the Process

Cigna typically approves Evkeeza (evinacumab-dgnb) for one-year periods for patients with confirmed homozygous familial hypercholesterolemia (HoFH). Here's when you should begin preparing for renewal:

Start Early Warning Signs

  • 90 days before expiration: Begin gathering updated lab results and clinical notes
  • 60 days before expiration: Submit renewal request to avoid gaps in coverage
  • 30 days before expiration: Follow up if you haven't received a decision
  • Authorization expires: Contact your specialty pharmacy immediately about temporary supplies
Note: Cigna processes standard renewals within 7 days, but expedited reviews are available within 72 hours for urgent cases.

Red Flags That Require Immediate Action

  • You've missed multiple infusions (adherence concerns)
  • Your LDL cholesterol levels have increased significantly
  • You've experienced serious adverse events
  • Your insurance plan has changed or you've switched employers
  • Cigna has updated their formulary or coverage policies

Evidence Update: What Documentation You Need

For Evkeeza renewal, Cigna requires proof that the therapy remains medically necessary and clinically beneficial. The key is demonstrating continued response to treatment.

Required Clinical Evidence

Lipid Panel Results (within 3 months):

  • LDL cholesterol showing sustained reduction from baseline
  • Target: maintain the initial response (typically 47-49% reduction from pre-treatment levels)
  • Total cholesterol, HDL, triglycerides, and ApoB if available

Treatment Response Documentation:

  • Comparison to pre-treatment baseline values
  • Evidence of continued benefit despite maximized background therapy
  • Documentation that LDL-C remains above target despite other interventions

Adherence Records:

  • Infusion appointment logs from your specialty pharmacy or clinic
  • Documentation of any missed doses and reasons
  • Confirmation of every-4-week dosing schedule compliance

What Constitutes Treatment Success

According to clinical studies, Evkeeza should maintain approximately 47-49% LDL cholesterol reduction from baseline. If your reduction has fallen below 25-30%, Cigna may question continued medical necessity.

Clinician Corner: Document any factors affecting response, such as concurrent medications, dietary changes, or intercurrent illnesses. Include a brief statement about why alternative therapies remain inadequate for this patient's HoFH management.

Renewal Packet: Must-Include Documents

Core Documentation Checklist

  • Updated prior authorization form (Cigna CNF 665 or current version)
  • Recent lipid panel (within 90 days)
  • Prescriber attestation of continued medical necessity
  • Infusion records showing adherence to treatment schedule
  • Brief clinical update addressing response and any changes

Medical Necessity Letter Structure

Your healthcare provider should include:

  1. Current diagnosis confirmation: Genetic or clinical HoFH documentation
  2. Treatment history: Initial response data and current status
  3. Continued need: Why Evkeeza remains necessary despite other therapies
  4. Safety profile: Any adverse events and how they're managed
  5. Treatment goals: Ongoing cardiovascular risk reduction objectives

Supporting Documents

  • Laboratory results showing sustained LDL-C reduction
  • Specialist consultation notes (cardiologist, lipidologist, or endocrinologist)
  • Documentation of maximized background therapy (statins, ezetimibe, PCSK9 inhibitors)
  • Any genetic testing results confirming HoFH diagnosis

Timeline: Submission Windows and Decision Deadlines

Optimal Submission Timeline

Timeline Action Required Who Does It
90 days before expiration Order updated labs, schedule specialist visit Patient/Provider
60 days before expiration Submit complete renewal packet Provider/Specialty Pharmacy
45 days before expiration Follow up if no acknowledgment received Provider office
30 days before expiration Escalate to peer-to-peer review if needed Provider
15 days before expiration File expedited appeal if denied Patient/Provider
At expiration Contact specialty pharmacy for bridge supply Patient

Cigna Review Process

  • Standard review: 7 business days from complete submission
  • Expedited review: 72 hours for urgent medical situations
  • Incomplete submissions: Additional 5-10 days for missing documentation
Tip: Submit through Express Scripts or Accredo specialty pharmacy when possible—they often have streamlined workflows with Cigna for complex specialty medications.

If Coverage Lapses: Bridge Options and Next Steps

Immediate Actions When Authorization Expires

  1. Contact your specialty pharmacy (usually Accredo for Cigna patients)
  2. Request emergency supply (typically 30-day bridge while appealing)
  3. File expedited internal appeal within 180 days of denial
  4. Consider temporary alternatives if bridge therapy is needed

Bridge Therapy Considerations

While waiting for renewal approval, discuss these options with your specialist:

LDLR-Independent Options:

  • Lomitapide (if available and tolerated)
  • Intensified LDL apheresis schedule
  • Maximized PCSK9 inhibitor therapy

Important: These are temporary measures only. Evkeeza's unique mechanism (ANGPTL3 inhibition) provides benefits that other therapies cannot fully replace for HoFH patients.

Financial Assistance During Gaps

  • Regeneron Patient Assistance Program: May provide temporary drug supply
  • Specialty pharmacy bridge programs: Contact Accredo about emergency supplies
  • State pharmaceutical assistance: Pennsylvania PACE/PACENET for eligible seniors

Annual Changes: What to Re-verify Each Year

Cigna Formulary Updates

Cigna reviews its formulary annually, with potential mid-year changes. For 2025:

  • Evkeeza remains on specialty tier requiring prior authorization
  • Step therapy requirements may be updated—verify current criteria
  • Quantity limits and site-of-care restrictions may change
  • Cost-sharing tiers can shift with formulary updates

Plan Design Changes to Monitor

  • New prior authorization requirements
  • Changes to specialty pharmacy networks
  • Updates to medical necessity criteria
  • Modifications to appeal processes and timelines
Note: Counterforce Health helps patients and providers navigate these changing requirements by automatically updating appeals with the latest payer policies and clinical evidence standards.

Personal Tracker: Template for Logging Progress

Renewal Tracking Template

Current Authorization Details:

  • Authorization number: ________________
  • Expiration date: ________________
  • Approved dose/frequency: ________________
  • Specialty pharmacy: ________________

Renewal Milestones:

  • Labs ordered (date: ________)
  • Specialist appointment scheduled (date: ________)
  • Renewal packet submitted (date: ________)
  • Cigna acknowledgment received (date: ________)
  • Decision received (date: ________)
  • Appeal filed if needed (date: ________)

Key Contacts:

  • Prescribing physician: ________________
  • Specialty pharmacy coordinator: ________________
  • Cigna member services: ________________
  • Pennsylvania Insurance Department: 1-877-881-6388

Appeals Process for Pennsylvania Patients

Cigna Internal Appeals

If your renewal is denied, you have 180 days to file an internal appeal with Cigna:

  1. First-level internal appeal: Decision within 30 days
  2. Second-level internal appeal: Additional 30 days if first level is denied
  3. Expedited appeals: 72 hours for urgent situations

Pennsylvania External Review Program

After exhausting Cigna's internal appeals, Pennsylvania residents can access the state's Independent External Review Program:

Key Benefits:

  • 50% success rate in 2024—259 of 517 appeals were overturned
  • Independent medical review by specialists familiar with rare diseases
  • Binding decisions that Cigna must follow
  • No cost to patients for the review process

Timeline:

  • 4 months to request external review after final Cigna denial
  • 45 days for standard review decision
  • 72 hours for expedited reviews (serious health risks)

How to File: Submit online at pa.gov or call Pennsylvania Insurance Department at 1-877-881-6388.

FAQ: Common Renewal Questions

How long does Cigna take to process Evkeeza renewals? Standard renewals are processed within 7 business days of receiving complete documentation. Expedited reviews are completed within 72 hours for urgent medical situations.

What if my LDL cholesterol has increased since starting Evkeeza? Document any factors that might affect response (medication adherence, concurrent illnesses, dietary changes). Your provider should explain why continued therapy is appropriate and whether dose adjustments are needed.

Can I switch specialty pharmacies during renewal? Yes, but coordinate the timing carefully to avoid coverage gaps. Ensure your new pharmacy has the updated authorization before discontinuing with your current pharmacy.

What happens if Cigna changes their formulary mid-year? You have rights to continue current therapy or request exceptions. Cigna must provide adequate notice of formulary changes and offer alternative coverage or exception processes.

Does Pennsylvania's external review apply to all Cigna plans? The state external review program applies to commercial insurance plans but not to self-funded employer plans (governed by federal ERISA law). Check with your HR department to determine your plan type.

How do I know if my renewal was approved? You should receive written notification from Cigna within their standard review timeframe. Your specialty pharmacy will also be notified directly and can confirm authorization status.

This guide provides educational information about insurance coverage processes and should not be considered medical advice. For personalized guidance about your specific situation, consult with your healthcare provider and contact Counterforce Health for assistance with complex prior authorization and appeal processes.

Need Help? Contact the Pennsylvania Insurance Department's consumer assistance line at 1-877-881-6388 or visit pa.gov for additional resources and support with insurance appeals.

Sources & Further Reading

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