How Long Does It Take to Get Cresemba (Isavuconazole) Approved by Blue Cross Blue Shield in Pennsylvania? Complete Timeline & Appeals Guide
Answer Box: Quick Start Guide
Getting Cresemba (isavuconazole) approved by Blue Cross Blue Shield in Pennsylvania typically takes 5-15 business days for standard prior authorization, or 72 hours for expedited urgent requests. Your fastest path: Have your infectious disease specialist submit a complete prior authorization through the BCBS provider portal with diagnosis confirmation (invasive aspergillosis/mucormycosis), lab results, and documentation of voriconazole failure or contraindication. If denied, Pennsylvania's new external review program has overturned about 50% of specialty drug denials in 2024. Start today: Contact your prescriber to begin the PA process and gather your medical records showing failed antifungal treatments.
Table of Contents
- What Affects Cresemba Approval Timing
- Pre-Submission Preparation (0-2 Days)
- Submission to Initial Review (1-5 Days)
- Additional Information Requests (1-7 Days)
- Decision Window & Outcomes
- If Denied: Pennsylvania Appeal Process
- Renewal Cycles & Maintenance
- Timeline Visual & Milestones
- Time-Saving Tips
- Common Denial Reasons & Solutions
- Costs & Patient Support
- FAQ
What Affects Cresemba Approval Timing
Several factors determine how quickly Blue Cross Blue Shield approves Cresemba in Pennsylvania:
Plan Type & Coverage
- Highmark Blue Shield (western PA) and Independence Blue Cross (Philadelphia area) are the dominant BCBS plans, each with slightly different formulary requirements
- Commercial plans typically process faster than Medicare Advantage
- Specialty tier placement means higher copays but established review pathways
Medical Complexity
- Invasive aspergillosis cases often approve faster due to clear diagnostic criteria
- Invasive mucormycosis may require additional pathology documentation
- Off-label uses face stricter scrutiny and longer review times
Documentation Completeness Complete initial submissions average 7-10 days; incomplete requests can add 5-14 days for back-and-forth communication.
Pre-Submission Preparation (0-2 Days)
Essential Documentation Checklist
Patient Information
- Current BCBS member ID and policy details
- Confirmed diagnosis with ICD-10 codes (B44.0-B44.7 for aspergillosis; B46.0-B46.9 for mucormycosis)
- Age verification (≥1 year for IV; ≥6 years and ≥16 kg for oral/NG)
Clinical Evidence
- Laboratory confirmation: cultures, histopathology, or galactomannan results
- Imaging studies (CT/MRI showing characteristic lesions)
- Infectious disease consultation notes
- Complete antifungal treatment history with specific failure/intolerance details
Prior Authorization Requirements
- Documented trial of voriconazole with clear reasons for discontinuation
- Contraindication documentation if voriconazole wasn't tried
- Prescriber NPI/DEA numbers and specialty credentials
Tip: Create a comprehensive treatment timeline showing drug names, dates, dosages, and specific adverse events or treatment failures. This single document often makes the difference between approval and denial.
Submission to Initial Review (1-5 Days)
BCBS Pennsylvania Submission Process
Electronic Submission (Fastest)
- Use the BCBS provider portal or Availity platform
- Standard processing: 5-15 business days
- Expedited processing: 72 hours with urgent medical justification
Required Forms
- Highmark Blue Shield: Drug exception form via provider portal
- Independence Blue Cross: Formulary exception prior authorization form (fax: 1-888-671-5285)
What Reviewers Check First
- Diagnosis confirmation against FDA-approved indications
- Prescriber credentials (infectious disease specialist preferred)
- Step therapy compliance (voriconazole trial documentation)
- Age and dosing appropriateness
- Drug interaction screening
Additional Information Requests (1-7 Days)
When BCBS requests additional information, respond within 72 hours to avoid processing delays.
Common Information Requests
- More detailed treatment history
- Recent lab values or imaging
- Specialist consultation notes
- Pharmacy benefit vs. medical benefit clarification
Response Strategy
- Fax or upload documents immediately
- Include a cover letter summarizing key points
- Reference the original PA request number
- Follow up within 2 business days to confirm receipt
Decision Window & Outcomes
Typical Approval Outcomes
Approval (60-70% of complete submissions)
- Initial approval typically covers 90 days
- Notification sent to prescriber and patient
- Specialty pharmacy coordination begins
Conditional Approval
- May require specific dosing limits
- Site-of-care restrictions (hospital vs. outpatient)
- Regular monitoring requirements
Denial
- Notification includes specific denial reasons
- Appeal rights and deadlines clearly stated
- Instructions for additional documentation
If Denied: Pennsylvania Appeal Process
Pennsylvania residents have robust appeal rights, including a new state-supervised external review program launched in 2024.
Internal Appeals (First Step)
Timeline: Must file within 180 days of denial Process: Submit written appeal with additional clinical evidence Decision: Typically within 30 days
Pennsylvania External Review (Final Step)
Pennsylvania's new Independent External Review Program has achieved remarkable success for patients:
Eligibility: Available after completing internal appeals Timeline: Must request within 4 months of final denial Process:
- Submit request online at pa.gov
- Independent medical reviewers evaluate the case
- Standard review: 45 days; Expedited: 72 hours
Success Rate: Over 50% of external reviews were overturned in favor of patients in 2024, with insurers required to provide coverage immediately upon reversal.
Cost: Free to patients; insurers pay all review costs
From our advocates: We've seen Pennsylvania's external review process work particularly well for specialty antifungal cases. One patient's Cresemba denial was overturned within 6 weeks when the independent reviewers found the medical evidence clearly supported the treatment despite the insurer's initial rejection. The key was submitting comprehensive infectious disease consultation notes and peer-reviewed literature supporting isavuconazole as appropriate therapy.
Renewal Cycles & Maintenance
Initial Authorization
- Duration: 90 days typical
- Renewal timing: Submit 2-3 weeks before expiration
- Required documentation: Updated clinical status, continued medical necessity, recent lab values
Ongoing Approvals
- Frequency: Every 90-180 days depending on clinical stability
- Streamlined process: Established cases often approve faster (3-7 days)
- Treatment response documentation: Include fungal culture results, imaging improvements, clinical status
Timeline Visual & Milestones
| Phase | Timeline | Key Actions | Expected Outcome |
|---|---|---|---|
| Preparation | 0-2 days | Gather documentation, verify diagnosis | Complete submission packet |
| Initial Submission | Day 1 | Submit via portal/fax | Confirmation receipt |
| Under Review | Days 2-15 | BCBS medical review | Approval, denial, or info request |
| Additional Info | Days 3-7 | Respond to requests | Review continuation |
| Decision | Days 5-15 | Final determination | Coverage begins or appeal needed |
| Internal Appeal | 30-60 days | Submit appeal documentation | Overturn or proceed to external |
| External Review | 45-72 days | PA state review process | Final binding decision |
Time-Saving Tips
Portal Optimization
- Use electronic submission exclusively when possible
- Upload all documents as single PDF files
- Include detailed cover letters summarizing medical necessity
Documentation Bundling
- Create a master file with all required elements
- Use consistent formatting and clear section headers
- Include page numbers and patient identifiers on every page
Direct Specialty Routing
- Ensure infectious disease specialist is the prescriber of record
- Include specialist's credentials and contact information
- Reference relevant treatment guidelines in submission
Proactive Communication
- Call BCBS within 48 hours of submission to confirm receipt
- Establish direct contact with the reviewing pharmacist when possible
- Track all communications with reference numbers
Common Denial Reasons & Solutions
| Denial Reason | Solution | Required Documentation |
|---|---|---|
| Step therapy not met | Document voriconazole failure/intolerance | Treatment dates, adverse events, clinical notes |
| Insufficient diagnosis documentation | Provide lab/pathology confirmation | Culture results, histopathology, imaging |
| Age/weight restrictions | Verify FDA labeling compliance | Patient demographics, dosing calculations |
| Prescriber specialty | Obtain ID specialist prescription | NPI verification, consultation notes |
| Off-label use | Provide evidence-based rationale | Peer-reviewed studies, guidelines, compendia |
Costs & Patient Support
Financial Assistance Options
Manufacturer Support
- Astellas Pharma Support Solutions offers copay assistance and patient access programs
- Income-based eligibility with potential significant cost reduction
Pennsylvania State Resources
- Pennsylvania Insurance Department Consumer Services: 1-877-881-6388
- Free assistance with appeals and coverage disputes
Foundation Grants
- Patient Advocate Foundation
- HealthWell Foundation
- Leukemia & Lymphoma Society (for applicable conditions)
When navigating complex prior authorization challenges, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. The platform analyzes denial letters and plan policies, then creates targeted, evidence-backed appeals that align with each insurer's specific requirements, significantly improving approval rates for specialty medications like Cresemba.
FAQ
How long does Blue Cross Blue Shield PA take in Pennsylvania? Standard prior authorization typically takes 5-15 business days. Expedited reviews for urgent cases can be completed within 72 hours with proper medical justification.
What if Cresemba is non-formulary on my BCBS plan? Submit a formulary exception request with documentation showing medical necessity and failure of formulary alternatives. Both Highmark and Independence Blue Cross have established exception processes.
Can I request an expedited appeal in Pennsylvania? Yes, both internal appeals and Pennsylvania's external review process offer expedited timelines (72 hours) when your health could be seriously jeopardized by standard timeframes.
Does step therapy apply if I failed voriconazole outside Pennsylvania? Yes, treatment failures from any location count toward step therapy requirements. Ensure you have complete documentation of the previous treatment and failure reasons.
What happens if my appeal is successful? If Pennsylvania's external review overturns the denial, BCBS must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal process.
Who can help me with the appeals process? The Pennsylvania Insurance Department offers free consumer assistance at 1-877-881-6388. The Pennsylvania Health Law Project also provides advocacy support for complex cases.
Sources & Further Reading
- Pennsylvania Insurance Department External Review Process
- Highmark Blue Shield Provider Resources
- Independence Blue Cross Prior Authorization Guidelines
- Cresemba FDA Prescribing Information
- Astellas Patient Support Programs
Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about your specific medical condition and treatment options. Insurance coverage decisions depend on individual policy terms and medical circumstances.
For personalized assistance with prior authorizations and appeals, Counterforce Health provides specialized support in turning insurance denials into successful approvals through evidence-based advocacy and comprehensive appeals documentation.
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.