How Long Does It Take to Get Krystexxa (Pegloticase) Approved by Aetna (CVS Health) in New Jersey? Timeline & Appeal Process
Answer Box: Fastest Path to Approval
Getting Krystexxa (pegloticase) approved by Aetna (CVS Health) in New Jersey typically takes 3-15 business days for prior authorization, depending on documentation completeness. Key requirements include rheumatologist prescriber, documented failure of allopurinol and febuxostat (3+ months each), G6PD test results, and methotrexate co-therapy plan. Submit via Aetna provider portal with complete clinical records. If denied, New Jersey's IHCAP external review through Maximus provides binding decisions within 45 days.
Start today: Verify your Aetna plan requires PA for J2507, gather failure documentation for oral urate-lowering therapies, and schedule G6PD testing if not completed.
Table of Contents
- What Affects Krystexxa Approval Timeline
- Pre-Submission Preparation (0-2 Days)
- Initial Review Process (1-5 Days)
- Additional Information Requests (1-7 Days)
- Decision Window & Outcomes
- If Denied: New Jersey Appeal Timeline
- Renewal Cycles & Reauthorization
- Timeline Visual & Milestones
- Time-Saving Tips
- Common Denial Reasons & Solutions
- New Jersey IHCAP External Review
- FAQ
What Affects Krystexxa Approval Timeline
Several factors influence how quickly Aetna (CVS Health) processes your Krystexxa (pegloticase) prior authorization in New Jersey:
Benefit Design Factors:
- Plan type: Commercial plans typically process faster than Medicaid (Aetna Better Health)
- Formulary tier: Krystexxa is a specialty medication requiring precertification as of November 2024
- Site of care restrictions: Aetna's infusion site policy may require lower-cost settings
Clinical Complexity:
- Prescriber specialty: Rheumatologist involvement expedites approval
- Documentation quality: Complete failure trials for allopurinol and febuxostat
- Lab requirements: Recent G6PD testing and serum uric acid levels
Administrative Factors:
- Submission method: Provider portal submissions process faster than fax
- CVS Specialty coordination: Post-approval pharmacy enrollment adds 2-3 days
Pre-Submission Preparation (0-2 Days)
Essential Documentation Checklist
Before submitting your prior authorization, gather these required documents:
| Document | Purpose | Where to Obtain |
|---|---|---|
| G6PD Test Results | Rule out deficiency (contraindication) | Lab report within past year |
| Allopurinol Trial Records | Document failure at max dose ≥3 months | Clinic notes, pharmacy records |
| Febuxostat Trial Records | Document failure at max dose ≥3 months | Clinic notes, pharmacy records |
| Serum Uric Acid Trends | Show levels >6 mg/dL despite therapy | Lab reports over 6+ months |
| Methotrexate Plan | Co-therapy requirement per FDA labeling | Prescriber attestation |
| Rheumatology Consultation | Specialist evaluation preferred | Consult notes, treatment plan |
Coding Verification
Ensure proper HCPCS coding for billing:
- J2507: Injection, pegloticase, 1 mg (bill 8 units for standard 8 mg dose)
- Modifiers: JW (wastage) or JZ (no wastage)
- Administration: 96365 (IV infusion, first hour)
Initial Review Process (1-5 Days)
Standard Processing Timeline
Business Days 1-2:
- Aetna receives PA request via provider portal or fax
- Initial eligibility and benefits verification
- Assignment to clinical reviewer
Business Days 3-5:
- Clinical criteria review against Aetna's Krystexxa policy
- Pharmacy benefits manager (CVS Caremark) consultation
- Decision rendered or additional information requested
What Reviewers Check First
Aetna's initial review focuses on these key criteria:
- Age requirement: Patient ≥18 years old
- Diagnosis: Chronic gout with documented severity
- Step therapy compliance: Adequate trials of conventional therapy
- Prescriber qualification: Board-certified rheumatologist preferred
- Safety screening: G6PD test completed
Additional Information Requests (1-7 Days)
If Aetna requests additional documentation, respond within 5 business days to avoid delays:
Common Information Requests
Clinical Documentation:
- Detailed failure notes for oral urate-lowering therapies
- Serum uric acid levels with dates
- Contraindication documentation for alternative therapies
Administrative Items:
- Updated prior authorization form
- Prescriber credentials verification
- Site of care justification
How to Respond Quickly
- Use Aetna's provider portal for fastest submission
- Include all requested items in a single submission
- Contact CVS Specialty at 1-800-237-2767 for coordination
Tip: Set up automatic notifications in your provider portal to receive real-time updates on PA status changes.
Decision Window & Outcomes
Typical Decision Timeline
Standard Reviews: 3-15 business days from complete submission Expedited Reviews: 24-72 hours for urgent medical situations
Reading Your Approval Letter
Full Approval:
- Authorization number for CVS Specialty
- Approved quantity and refill authorization
- Site of care specifications
- Reauthorization date
Conditional Approval:
- Additional requirements (lab monitoring, specialist follow-up)
- Restricted quantity or frequency
- Time-limited authorization
If Denied: New Jersey Appeal Timeline
Aetna Internal Appeal Process
| Appeal Level | Filing Deadline | Decision Timeline | How to File |
|---|---|---|---|
| Level 1 Internal | 180 days from denial | 30 days (pre-service) | Aetna member portal or mail |
| Level 2 Internal | 60 days from Level 1 | 30 days standard | Same as Level 1 |
| Expedited Appeal | Same as above | 72 hours | Phone: 1-800-ASK-AETNA |
Required Appeal Documentation
- Original denial letter
- Medical records supporting necessity
- Prescriber statement addressing denial reasons
- Evidence of allopurinol/febuxostat failures with doses and dates
Renewal Cycles & Reauthorization
Initial Authorization Period
Most Aetna approvals for Krystexxa provide:
- 6-month initial authorization for new patients
- 12-month renewals for established responders
What Speeds Up Renewals
Clinical Response Documentation:
- Serum uric acid levels <6 mg/dL
- Reduction in gout flares
- Tophi improvement (if applicable)
- Continued specialist oversight
Administrative Efficiency:
- Submit renewal 30 days before expiration
- Use same provider portal account
- Include updated lab results
Timeline Visual & Milestones
Expected Timeline Ranges
Day 0: Submit complete PA
├── Day 1-2: Initial processing
├── Day 3-5: Clinical review
├── Day 6-10: Additional info (if needed)
├── Day 11-15: Final decision
└── Day 16-18: CVS Specialty enrollment
Expedited Timeline:
- Day 0: Submit urgent PA
- Day 1: Clinical review
- Day 2-3: Decision rendered
Time-Saving Tips
Portal Optimization
- Create provider portal accounts before needing PA
- Upload all documents in PDF format <10MB each
- Use portal messaging for status updates
Bundled Evidence Strategy
Submit comprehensive documentation packages including:
- Complete treatment history timeline
- All relevant lab results in chronological order
- Specialist consultation notes
- Patient response documentation
Direct Specialty Routing
- Contact CVS Specialty early in the process
- Coordinate delivery logistics during PA review
- Establish infusion center relationships
Common Denial Reasons & Solutions
| Denial Reason | Solution | Required Documentation |
|---|---|---|
| Incomplete step therapy | Document adequate trials | Allopurinol ≥300mg x3mo, Febuxostat ≥80mg x3mo |
| Missing G6PD test | Submit lab results | G6PD level within past year |
| Unqualified prescriber | Rheumatology consultation | Board-certified specialist evaluation |
| Insufficient medical necessity | Enhanced clinical documentation | Flare frequency, tophi presence, functional impact |
| Non-formulary status | Request formulary exception | Medical necessity letter, alternative failures |
From Our Advocates: We've seen cases where initial denials for "experimental" status were quickly overturned by submitting the FDA approval letter and current prescribing information. The key is addressing the specific denial reason with targeted evidence rather than resubmitting the same documentation.
New Jersey IHCAP External Review
If Aetna's internal appeals are exhausted, New Jersey residents have access to independent external review through the Independent Health Care Appeals Program (IHCAP).
IHCAP Process Overview
Eligibility: Fully-insured New Jersey plans, completed internal appeals Timeline: File within 4 months of final denial Decision: Binding decision within 45 days (standard) or 48 hours (expedited) Cost: Free to patients
How to File IHCAP Appeal
Submit directly to Maximus Federal Services (the contracted IURO):
- Complete IHCAP application form
- Include all internal appeal decisions
- Provide medical records and prescriber support
- Authorization for medical record release
Contact Information:
- IHCAP Hotline: 1-888-393-1062
- New Jersey DOBI Consumer Hotline: 1-800-446-7467
For complex cases, Counterforce Health specializes in turning insurance denials into evidence-backed appeals by analyzing denial letters and crafting targeted rebuttals that address payer-specific criteria. Their platform helps patients and clinicians navigate the appeals process with documentation that meets procedural requirements and tracks critical deadlines.
FAQ
How long does Aetna prior authorization take for Krystexxa in New Jersey? Standard processing is 3-15 business days with complete documentation. Expedited reviews for urgent situations process within 24-72 hours.
What if Krystexxa is non-formulary on my Aetna plan? Request a formulary exception with medical necessity documentation. Include evidence of conventional therapy failures and specialist support.
Can I request an expedited appeal in New Jersey? Yes, both Aetna internal appeals and IHCAP external reviews offer expedited processes for urgent medical situations where delays could cause serious harm.
Does step therapy apply if I failed treatments outside New Jersey? Yes, documented failures from other states count toward step therapy requirements. Include complete medical records and pharmacy documentation.
Who can prescribe Krystexxa for Aetna coverage? While various specialists can prescribe, board-certified rheumatologists have the highest approval rates. Non-rheumatologists should consider peer-to-peer reviews.
What happens if I miss the appeal deadline? Contact the New Jersey Department of Banking and Insurance at 1-800-446-7467 for guidance. Some circumstances may allow late filing.
How much does Krystexxa cost with Aetna coverage? Costs vary by plan design. Expect specialty tier copays (25-40% coinsurance) or separate deductibles. Manufacturer copay assistance may apply.
Can my doctor file appeals on my behalf? Yes, New Jersey allows providers to file external appeals with patient consent. Many practices handle this process for their patients.
Sources & Further Reading
- Aetna Krystexxa Clinical Policy Bulletin
- New Jersey IHCAP Information
- Krystexxa Prior Authorization Criteria
- Aetna 2025 Precertification List
- CVS Specialty Pharmacy Services
Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on individual plan benefits and medical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For additional assistance with insurance appeals and prior authorizations, Counterforce Health provides specialized support in developing evidence-based appeals for complex specialty medications.
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