How to Get Turalio (pexidartinib) Covered by Blue Cross Blue Shield in New Jersey: Complete Prior Authorization and Appeals Guide
Answer Box: Getting Turalio Covered by Blue Cross Blue Shield in New Jersey
Turalio (pexidartinib) requires prior authorization from all Blue Cross Blue Shield plans in New Jersey. Here's your fastest path to approval:
- Enroll in TURALIO REMS first - both prescriber and patient must complete enrollment at www.turaliorems.com before any coverage request
- Call Prime Therapeutics at 1-888-214-1784 (Horizon BCBS NJ's pharmacy manager) to initiate prior authorization and get the correct forms
- Submit comprehensive documentation including TGCT diagnosis, surgical consultation notes explaining why surgery isn't feasible, baseline liver tests, and REMS enrollment proof
If denied: You have 180 days to appeal internally, then can request binding external review through New Jersey's IHCAP program. Success rates for specialty drug appeals reach 68% with proper documentation.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Required Documentation Checklist
- Common Denial Reasons & How to Fix Them
- Appeals Process in New Jersey
- Cost and Financial Assistance
- FAQ
- Sources & Further Reading
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required for all BCBS plans | Call Prime Therapeutics 1-888-214-1784 | Horizon Provider Guidelines |
| REMS Enrollment | Mandatory FDA safety program | www.turaliorems.com or 1-833-887-2546 | FDA REMS Document |
| Diagnosis | Symptomatic TGCT with severe morbidity | MRI + pathology confirmation required | FDA Label |
| Surgical Status | Not amenable to surgery | Surgical consultation notes needed | VA Criteria |
| Baseline Labs | Normal liver function tests | AST, ALT, bilirubin, alkaline phosphatase | UHC Policy |
| Appeal Deadline | 180 days from denial | Internal appeal first, then IHCAP | NJ Appeals Info |
Step-by-Step: Fastest Path to Approval
1. Complete REMS Enrollment First
Who: Prescriber and patient
Timeline: 1-3 business days
Action: Visit www.turaliorems.com or call 1-833-887-2546. Both prescriber and patient must enroll before any coverage request can proceed.
2. Gather Required Clinical Documentation
Who: Healthcare team
Timeline: 1-2 weeks
Action: Collect MRI showing TGCT, pathology report, surgical consultation explaining why surgery isn't feasible, and baseline liver function tests.
3. Contact Prime Therapeutics
Who: Prescriber or office staff
Timeline: Same day
Action: Call 1-888-214-1784 to initiate prior authorization and obtain the correct drug-specific form for your patient's plan type.
4. Submit Complete Prior Authorization Packet
Who: Prescriber
Timeline: 1-2 business days
Action: Fax completed form with all supporting documentation to the number provided by Prime (often 1-973-274-2285 for formulary exceptions).
5. Follow Up on Decision Timeline
Who: Patient or provider
Timeline: 72 hours for standard requests, 24 hours for urgent
Action: If no response within the required timeframe, call Prime at the number on your insurance card.
6. Appeal if Denied
Who: Patient with provider support
Timeline: Must start within 180 days
Action: Follow internal appeal process first, then request external review through New Jersey's IHCAP if needed.
Required Documentation Checklist
Clinical Evidence
- MRI report showing TGCT with specific mention of hemosiderin deposits and extent of disease
- Pathology report confirming tenosynovial giant cell tumor diagnosis
- Surgical consultation note explicitly stating why surgery is not feasible or would cause severe morbidity
- Functional assessment documenting severe limitations (pain scores, range of motion, activities of daily living)
- ICD-10 code M12.2 for villonodular synovitis
Safety Requirements
- REMS enrollment confirmation for both prescriber and patient with enrollment dates
- Baseline liver function tests (AST, ALT, total bilirubin, alkaline phosphatase) - all must be ≤ upper limit of normal
- Monitoring plan for ongoing liver function surveillance per REMS requirements
- Certified specialty pharmacy confirmation for dispensing
Prior Therapy Documentation
- Previous treatments tried and their outcomes (surgery, physical therapy, pain management)
- Contraindications to alternative treatments if applicable
- Duration of symptoms and progression despite other interventions
Clinician Corner: Your medical necessity letter should explicitly address the FDA indication language: "symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery." Use this exact phrasing and explain how your patient meets each criterion.
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| Missing TGCT diagnosis | Submit complete pathology and imaging | MRI report with hemosiderin findings, pathology confirming TGCT |
| Surgery not addressed | Provide surgical consultation | Written opinion from orthopedic surgeon explaining why surgery isn't feasible |
| REMS not enrolled | Complete enrollment process | REMS enrollment confirmation with dates for prescriber and patient |
| Baseline labs missing | Submit normal liver tests | AST, ALT, bilirubin, alkaline phosphatase ≤ ULN |
| Not medically necessary | Strengthen clinical justification | Detailed letter addressing FDA indication criteria point-by-point |
| Experimental/investigational | Cite FDA approval | FDA label and approval letter showing indication for TGCT |
Appeals Process in New Jersey
Internal Appeal (Required First Step)
Timeline: Must file within 180 days of denial
Process: Call the number on your denial letter or contact Prime Therapeutics member services
Decision time: 72 hours for standard appeals, 24 hours for urgent cases
Required: All original documentation plus additional evidence addressing denial reason
External Review Through IHCAP
When to use: After completing internal appeal process
Timeline: 4 months (180 days) from final internal denial to submit
Cost: Free to patients - insurers pay all costs
Process: Submit directly to Maximus Federal Services (New Jersey's contracted review organization)
Success rate: External appeals nationwide favor consumers about 50% of the time, with higher rates for well-documented specialty drug cases
IHCAP Contact Information:
- Phone: 1-888-393-1062
- NJ Department of Banking and Insurance Consumer Hotline: 1-800-446-7467
Required for External Appeal
- All internal appeal denial letters
- Complete medical records and provider letters
- BCBS policy used to deny coverage
- Detailed explanation of why the denial was inappropriate
From our advocates: In cases we've supported, external appeals for Turalio have been most successful when the provider letter explicitly maps the patient's case to the FDA indication criteria and includes recent clinical literature showing sustained functional improvement with treatment. Success often hinges on demonstrating that surgical alternatives would cause greater morbidity than medical management.
Cost and Financial Assistance
Manufacturer Support
Daiichi Sankyo Access Central: Provides insurance navigation and potential copay assistance
Contact: Visit dsaccesscentral4u.com or call for current programs
Eligibility: Varies by insurance type and income
Typical Costs
Cash price: Approximately $23,850 for a 28-day supply (verify with GoodRx for current pricing)
With insurance: Varies significantly by plan; specialty tier copays typically range from $100-500 per month
State Resources
New Jersey pharmaceutical assistance programs: Contact NJ Department of Human Services for income-based prescription assistance programs
Hospital charity care: Many New Jersey hospitals offer financial assistance for expensive medications
FAQ
How long does BCBS prior authorization take in New Jersey?
Standard requests must be decided within 72 hours, urgent requests within 24 hours. Prime Therapeutics manages this process for Horizon BCBS NJ.
What if Turalio is non-formulary on my plan?
You can request a formulary exception using Horizon's Form 6592. This requests coverage at the preferred tier level despite non-formulary status.
Can I request an expedited appeal?
Yes, if delay would seriously jeopardize your health or ability to regain function. Your prescriber must support the urgency request with clinical documentation.
Does step therapy apply if I've failed treatments outside New Jersey?
Yes, prior treatment failures from other states count toward step therapy requirements. Include all medical records showing previous interventions and their outcomes.
What happens if IHCAP overturns the denial?
The decision is binding on BCBS - they must provide coverage as directed by the independent medical reviewers. This is required by New Jersey statute.
How do I prove surgery isn't an option?
You need a written consultation from an orthopedic surgeon or orthopedic oncologist explaining why surgical resection would not improve function or would cause severe morbidity. General statements aren't sufficient - specific clinical reasoning is required.
When to Get Help
If you're struggling with the prior authorization or appeals process, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps identify the specific denial basis and drafts point-by-point rebuttals aligned to your plan's own rules, pulling the right citations and clinical evidence to support your case.
Consider professional advocacy help if:
- Your initial prior authorization was denied
- You're facing tight appeal deadlines
- The denial reason isn't clear or seems inconsistent with coverage policies
- You need help organizing complex medical documentation
Sources & Further Reading
- FDA TURALIO REMS Program
- Horizon BCBS NJ Pharmacy Guidelines
- Prime Therapeutics Prior Authorization Process
- New Jersey Appeals Process Overview
- VA Turalio Coverage Criteria
- TGCT Patient Support Organization
Disclaimer: This information is for educational purposes only and is not medical advice. Always work with your healthcare provider to determine the most appropriate treatment plan. Coverage policies and requirements may change; verify current information with your specific insurance plan and the sources linked above. For personalized help with your specific situation, contact Counterforce Health or the New Jersey Department of Banking and Insurance Consumer Hotline at 1-800-446-7467.
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