How to Get Xospata (gilteritinib) Covered by Aetna (CVS Health) in Virginia: Complete Timeline and Appeal Guide
Answer Box: Getting Xospata (gilteritinib) Covered by Aetna (CVS Health) in Virginia
Aetna (CVS Health) requires prior authorization for Xospata (gilteritinib) in Virginia. You'll need: confirmed FLT3 mutation via FDA-approved test, relapsed/refractory AML diagnosis, complete prior therapy history, and hematologist/oncologist prescription. Submit through Aetna's provider portal with all documentation. If denied, Virginia offers external review via Form 216-A within 120 days. First step today: Contact your oncologist to gather FLT3 mutation report and treatment history, then submit PA request through CVS Specialty or Aetna's portal.
Table of Contents
- Coverage at a Glance
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & Solutions
- Appeals Process in Virginia
- Medical Necessity Documentation
- Cost and Patient Support
- When to Escalate
- FAQ
Coverage at a Glance
Requirement | What It Means | Where to Find It | Source |
---|---|---|---|
Prior Authorization | Required for all Xospata prescriptions | Aetna provider portal | Aetna Specialty Drug List |
FLT3 Mutation Test | FDA-approved LeukoStrat CDx assay required | Lab report from treating facility | FDA Approval |
Disease Status | Relapsed/refractory AML only | Medical records, pathology reports | FDA Label |
Prescriber | Hematologist/oncologist required | Provider credentials | Aetna PA criteria |
Appeals Deadline | 180 days from denial (internal) | Denial letter | Aetna member materials |
External Review | 120 days via Virginia SCC | Form 216-A | Virginia SCC |
Step-by-Step: Fastest Path to Approval
1. Gather Required Documentation
Who: Patient and oncology team
Timeline: 1-2 business days
Documents needed:
- FLT3 mutation test results (LeukoStrat CDx or equivalent FDA-approved assay)
- Complete AML treatment history with dates, drugs, and outcomes
- Current pathology confirming relapsed/refractory status
- Hematologist/oncologist credentials and prescription
2. Submit Prior Authorization Request
Who: Prescriber or CVS Specialty
How: Aetna provider portal or CVS Specialty enrollment
Timeline: Submit within 1 business day of gathering documents
Include: All documentation from Step 1 plus clinical rationale letter
Tip: CVS Specialty can handle the entire PA process. Fax completed enrollment form to 1-800-323-2445 or email to [email protected].
3. Monitor Decision Timeline
Standard review: 24-72 hours for complete submissions
Expedited review: Available for urgent cases
Follow up: If no response within 3 business days, call Aetna Provider Services
4. If Approved: Coordinate Specialty Pharmacy
CVS Specialty will contact patient directly for delivery coordination and support program enrollment.
5. If Denied: Immediate Appeal Strategy
Timeline: Within 5 business days of denial
Actions:
- Request peer-to-peer review with Aetna medical director
- Submit formal appeal with additional evidence
- Consider expedited appeal if clinically urgent
Common Denial Reasons & Solutions
Denial Reason | Solution | Required Documentation |
---|---|---|
Missing FLT3 mutation documentation | Submit FDA-approved test results | LeukoStrat CDx report showing ITD/TKD mutation |
Insufficient prior therapy history | Provide detailed treatment chronology | Medical records with drug names, dates, responses |
Non-specialist prescriber | Transfer prescription to hematologist/oncologist | Board certification documentation |
"Not medically necessary" | Submit clinical rationale with guidelines | NCCN guidelines, FDA label excerpts |
Non-formulary status | Request formulary exception | Comparative effectiveness data, intolerance history |
Appeals Process in Virginia
Internal Appeals (Aetna)
- Deadline: 180 days from denial notice
- Timeline: 30 days for standard review, 72 hours for expedited
- Submit to: Aetna Appeals Department via provider portal or mail
- Required: Appeal letter, additional clinical evidence, denial notice
External Review (Virginia SCC)
Virginia offers robust external review protection through the State Corporation Commission Bureau of Insurance.
Eligibility: Denials based on medical necessity, experimental/investigational determinations
Deadline: 120 days from final internal denial
Form: Form 216-A External Review Request
Timeline: 45 days standard, 72 hours expedited
Cost: Free to consumers
Contact Information:
- Phone: 1-877-310-6560
- Email: [email protected]
- Fax: (804) 371-9915
Note: Virginia allows expedited external review for cancer treatment denials without completing internal appeals in certain circumstances.
Medical Necessity Documentation
Essential Elements for Approval
Your hematologist/oncologist should include these components in the clinical rationale:
- AML Diagnosis Confirmation
- Pathology report with WHO classification
- Bone marrow biopsy results
- Cytogenetics and molecular findings
- FLT3 Mutation Documentation
- FDA-approved test results (LeukoStrat CDx preferred)
- Mutation type specification (ITD, D835, I836)
- Laboratory accreditation information
- Relapsed/Refractory Status
- Previous treatment regimens with specific dates
- Response assessment (complete remission, partial response, progressive disease)
- Reasons for treatment changes (progression, intolerance, toxicity)
- Clinical Rationale
- Current performance status
- Treatment goals and expected outcomes
- Alternative therapy considerations
- NCCN guideline alignment
Sample Medical Necessity Statement
"This 65-year-old patient with relapsed AML and confirmed FLT3-ITD mutation (LeukoStrat CDx, [date]) has failed two prior regimens including 7+3 induction and salvage therapy with FLAG-IDA. Current bone marrow shows 40% blasts with persistent FLT3-ITD. Per NCCN guidelines, gilteritinib represents standard-of-care targeted therapy for this indication, offering superior outcomes compared to conventional chemotherapy in this molecular subgroup."
Cost and Patient Support
Financial Assistance Options
Astellas Patient Support Program
- Copay assistance for eligible commercially insured patients
- Free drug program for uninsured patients meeting income criteria
- Phone: 1-800-477-6472
- Website: Astellas Patient Support
Average Costs (2025)
- WAC price: $28,979 per 30-day supply (120 mg daily)
- Patient copay varies by plan tier and coverage
- Specialty pharmacy coordination included with CVS Specialty
When navigating complex insurance approvals for specialty medications like Xospata, many patients and providers turn to specialized support services. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each payer's specific requirements.
When to Escalate
Virginia Consumer Protection Resources
Virginia SCC Bureau of Insurance
- Consumer Services: 1-877-310-6560
- Online complaint filing available
- Managed Care Ombudsman for HMO issues
When to Contact Virginia Regulators:
- Repeated inappropriate denials
- Failure to follow appeal timelines
- Suspected bad faith claim handling
- Procedural violations in review process
Additional Support:
- Virginia Poverty Law Center Health Assistance Program
- Legal aid for complex appeals
- Patient advocacy organizations
FAQ
How long does Aetna prior authorization take for Xospata in Virginia? Standard PA decisions are typically made within 24-72 hours for complete submissions. Incomplete requests may take 5-10 business days. Expedited reviews are available for urgent cases and decided within 72 hours.
What if Xospata is not on my Aetna formulary? You can request a formulary exception through Aetna's standard process. Provide documentation showing medical necessity and lack of suitable formulary alternatives. The appeal should include comparative effectiveness data and clinical rationale from your oncologist.
Can I get an expedited appeal in Virginia? Yes, both Aetna and Virginia's external review process offer expedited appeals. For Aetna, request expedited review if delay could seriously jeopardize your health. Virginia offers 72-hour expedited external review with physician certification.
Does Virginia have special protections for cancer patients? Virginia law includes provisions for expedited external review of cancer treatment denials and allows external review without completing all internal appeal levels in certain urgent circumstances.
What documentation do I need for a successful appeal? Key documents include: FDA-approved FLT3 mutation test results, complete prior treatment history, current pathology showing relapsed/refractory disease, hematologist/oncologist clinical rationale, and relevant NCCN guideline excerpts.
How much does external review cost in Virginia? External review through the Virginia SCC Bureau of Insurance is free for consumers. There are no filing fees or administrative costs.
From our advocates: "We've seen many Xospata approvals succeed when the initial submission includes all four key elements: confirmed FLT3 mutation via FDA-approved testing, clear documentation of relapsed/refractory status, complete prior therapy history, and a strong clinical rationale from a board-certified hematologist/oncologist. Taking time to gather comprehensive documentation upfront often prevents denials entirely."
The key to success with Aetna coverage for Xospata in Virginia lies in thorough preparation and understanding your appeal rights. Virginia's external review process provides an additional layer of protection, with independent medical experts reviewing denials and binding decisions that favor patients in many cases.
For complex cases requiring additional support, services like Counterforce Health can help coordinate appeals by pulling the right medical citations, weaving evidence into targeted rebuttals, and ensuring all procedural requirements are met according to Virginia's specific regulations.
Sources & Further Reading
- Aetna Specialty Drug List 2024
- FDA Approval: Xospata for Relapsed/Refractory AML
- Virginia External Review Process (Form 216-A)
- CVS Specialty Enrollment Forms
- Astellas Patient Support Solutions
- Virginia SCC Consumer Services
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for specific coverage determinations. For assistance with Virginia insurance regulations, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.
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