By Counterforce Health Team in Zanzalintinib (XL092) [investigational] —

Getting Zanzalintinib (XL092) Covered by Blue Cross Blue Shield in New Jersey: Appeal Rights, State Protections & Forms

Quick Answer: Your Path to Coverage in New Jersey

Zanzalintinib (XL092) is investigational and typically denied by Blue Cross Blue Shield plans as "not medically necessary." However, New Jersey's strong patient protection laws give you powerful appeal rights. Your fastest path: 1) Request a formulary exception with robust clinical documentation, 2) If denied, file an internal appeal citing step therapy override criteria under NJ Assembly Bill 1825, and 3) Use New Jersey's Independent Health Care Appeals Program (IHCAP) for external review—it's free and overturned 800+ denials in 2024 alone.

Start today: Contact your prescriber to gather prior treatment records and prepare a medical necessity letter citing published clinical trial data from Exelixis's STELLAR program.

Table of Contents

Why New Jersey's Rules Give You an Edge

New Jersey has some of the strongest patient protection laws in the country, especially for investigational cancer treatments. Unlike many states, New Jersey's Health Care Quality Act and recent Assembly Bill 1825 create specific timelines and override criteria that work in your favor.

Key advantages in New Jersey:

  • 72-hour response requirement for step therapy exception requests
  • Free external appeals through IHCAP (filing fees eliminated in 2025)
  • Medical necessity reviews by independent physicians, not just insurance administrators
  • Continuity of care protections if you're already receiving treatment
From our advocates: We've seen New Jersey patients successfully appeal investigational drug denials by combining strong clinical documentation with the state's step therapy override provisions. The key is framing your request around prior treatment failures and citing the specific criteria in NJ law—insurers often reverse their decisions rather than face an external review they're likely to lose.

Understanding BCBS Coverage Policies

Blue Cross Blue Shield plans in New Jersey—primarily Horizon Blue Cross Blue Shield—follow strict criteria for investigational drugs:

Coverage Requirements at a Glance

Requirement What It Means How to Meet It
FDA Approval Drug must have FDA approval for your condition Not applicable for Zanzalintinib—focus on exception process
Medical Necessity Treatment must be clinically appropriate Document failed standard therapies, contraindications
Prior Authorization Pre-approval required for specialty drugs Submit PA request with clinical justification
Step Therapy Try preferred drugs first Request exception citing NJ law criteria

Important: Horizon BCBS contracts with Carelon for oncology management, so your request will be reviewed by their clinical team using nationally accepted guidelines like NCCN.

Step Therapy Protections Under New Jersey Law

New Jersey's Assembly Bill 1825 requires insurers to grant step therapy exceptions when specific criteria are met. For Zanzalintinib, you can request an override if:

Exception Criteria

  • Contraindication: Standard TKIs (cabozantinib, lenvatinib) are medically inappropriate
  • Previous failure: You've tried and failed first-line therapies
  • Ineffectiveness: Approved alternatives are expected to be inadequate
  • Stability: You're already stable on current treatment and switching could be harmful

Required Response Times

  • Non-urgent requests: 72 hours
  • Emergency situations: 24 hours

Documentation tip: Frame your request using the exact language from NJ law. State that approved alternatives are "contraindicated," "previously tried and discontinued due to adverse events," or "not medically necessary for the patient."

Formulary Exception Process

Since Zanzalintinib isn't on any formulary, you'll need a formulary exception. Here's your step-by-step approach:

Step 1: Gather Clinical Documentation

  • Diagnosis and staging with ICD-10 codes
  • Prior treatment history including dates, doses, and outcomes
  • Contraindications to standard therapies
  • Clinical trial data supporting Zanzalintinib use
  • Treatment goals and monitoring plan

Step 2: Submit Exception Request

Your prescriber must complete Horizon's formulary exception form and include:

  • Detailed medical necessity letter
  • Chart notes documenting treatment failures
  • Published literature supporting off-label or investigational use
  • Expected duration and monitoring plan

Step 3: Follow Up Within 72 Hours

New Jersey law requires a decision within 72 hours. If you don't hear back, call Horizon's pharmacy department to confirm receipt and status.

Pro tip: Counterforce Health specializes in turning insurance denials into targeted appeals for investigational cancer drugs. Their platform can help identify the specific denial basis and draft evidence-backed rebuttals aligned to your plan's own rules.

Appeals Playbook for New Jersey

If your initial request is denied, New Jersey's appeal process gives you multiple levels of protection:

Internal Appeals (Required First Step)

  • Timeline: Must be filed within 180 days of denial
  • Process: Submit written appeal with additional clinical evidence
  • Decision deadline: Plans must respond within specific timeframes based on urgency

Documentation for Appeals

  • Original denial letter with specific reason codes
  • Medical necessity letter addressing each denial point
  • Clinical evidence from peer-reviewed sources
  • Guideline citations (NCCN, FDA guidance, specialty society recommendations)

Sample Appeal Language

"This denial appears inconsistent with New Jersey Assembly Bill 1825 requirements. The patient has documented contraindications to preferred therapies and has failed standard treatment options. We request reconsideration based on the medical necessity criteria outlined in your own policy."

External Review Through IHCAP

New Jersey's Independent Health Care Appeals Program (IHCAP) is your most powerful tool for overturning denials:

IHCAP Process

  1. Complete internal appeals first
  2. File within 180 days of final internal denial
  3. Submit to Maximus Federal Services (the contracted review organization)
  4. Include all medical records and supporting documentation

Timeline & Costs

  • Standard review: Decision within 45 days
  • Urgent review: Decision within 72 hours
  • Cost to you: $0 (fees eliminated in 2025)
  • Success rate: Over 800 reversals in 2024

Key advantage: IHCAP reviews are conducted by independent physicians with appropriate specialty expertise, not insurance company employees.

Continuity of Care Protections

If you're already receiving Zanzalintinib through a clinical trial or compassionate use program, New Jersey law provides continuity of care protections when changing insurance plans.

Transition Coverage Requirements

  • 180-day window to submit new prior authorization
  • No interruption in medically necessary ongoing treatment
  • Clinical review based on medical necessity, not just network status

This is particularly important if you're transitioning from a clinical trial to seeking commercial coverage.

Common Denial Reasons & How to Counter Them

Denial Reason Counter Strategy Documentation Needed
"Investigational/Experimental" Cite compassionate use criteria and published efficacy data Clinical trial results, FDA breakthrough therapy designation
"Not medically necessary" Document failed standard therapies and contraindications Treatment history, adverse event reports
"Not FDA approved" Request exception based on medical necessity and lack of alternatives Literature review, specialty guidelines
"Step therapy not completed" File step therapy override request citing NJ law Prior authorization exception form

When to Contact State Regulators

If your appeals are unsuccessful, contact New Jersey's Department of Banking and Insurance:

Consumer Hotline: 1-800-446-7467
IHCAP Specific: 1-888-393-1062
Online: DOBI Consumer Services

You can also file a complaint if you believe Horizon BCBS isn't following New Jersey's appeal timelines or step therapy override requirements.

FAQ

How long does prior authorization take for investigational drugs in New Jersey? Horizon BCBS must respond within 72 hours for standard requests, 24 hours for urgent cases under New Jersey law.

Can I appeal if Zanzalintinib isn't on the formulary? Yes. File a formulary exception request first, then appeal if denied. New Jersey's external review process applies to all medical necessity denials.

What if I'm already in a clinical trial? New Jersey's continuity of care laws protect ongoing treatment. If transitioning to commercial coverage, you have 180 days to get new authorization without interruption.

Does step therapy apply to investigational drugs? Technically no, but insurers often require you to try standard therapies first. You can request a step therapy override citing medical necessity.

How much does the external review cost? Nothing. New Jersey eliminated all IHCAP filing fees in 2025.

What happens if IHCAP overturns the denial? Horizon must provide coverage within 10 business days. The decision is binding.

Navigating insurance coverage for investigational treatments is complex, but New Jersey's patient protection laws provide powerful tools for appeal. Counterforce Health helps patients and clinicians turn denials into successful appeals by identifying specific policy requirements and drafting targeted rebuttals with the right clinical evidence.

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 specific coverage decisions. For additional assistance with New Jersey insurance appeals, contact the Department of Banking and Insurance Consumer Hotline at 1-800-446-7467.

Sources & Further Reading

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