How to Get Givlaari (Givosiran) Covered by Blue Cross Blue Shield in Georgia: Complete Appeals Guide with Forms and Timelines
Quick Answer: Getting Givlaari Approved in Georgia
Blue Cross Blue Shield Georgia requires prior authorization for Givlaari (givosiran) with strict clinical criteria. You'll need documented acute hepatic porphyria diagnosis, elevated ALA/PBG levels, and at least 2 attacks in 6 months. Submit through the BCBS provider portal with specialist involvement. If denied, Georgia's strong step therapy laws and free external review process offer excellent appeal options—with 40-50% overturn rates nationally.
Start today: Call BCBS member services at 855-641-4862 to verify your plan's formulary status and get the current PA form.
Table of Contents
- Verify Your Plan and Find the Right Forms
- Required Prior Authorization Documentation
- Submission Portals and Process
- Common Denial Reasons and Solutions
- Appeals Process: Internal and External
- Georgia State Protections and Rights
- Specialty Pharmacy Setup
- Member Services and Support Contacts
- Cost Savings and Patient Assistance
- Frequently Asked Questions
Verify Your Plan and Find the Right Forms
Before starting your Givlaari approval process, confirm your specific BCBS Georgia plan details:
Step 1: Check Your Coverage
- Log into your Anthem BCBS Georgia member portal
- Call member services at 855-641-4862 (TTY: 711)
- Have your member ID ready and ask specifically about:
- Givlaari's formulary tier
- Prior authorization requirements
- Step therapy protocols
- In-network specialty pharmacy options
Step 2: Identify Your Plan Type Different BCBS Georgia plans have varying requirements:
- Commercial/Employer plans: Standard PA process
- Individual marketplace plans: May have additional restrictions
- Medicare Advantage: Different forms and timelines
- Federal Employee Program (FEP): Special PA requirements as of 2024
Required Prior Authorization Documentation
BCBS Georgia requires comprehensive clinical evidence for Givlaari approval. Here's exactly what you need:
Clinical Requirements Checklist
| Requirement | Documentation Needed | Source/Notes |
|---|---|---|
| AHP Diagnosis | ICD-10 codes + clinical notes | Must specify subtype (AIP, HCP, VP, ADP) |
| Age Verification | Patient must be 18+ | Standard across all BCBS plans |
| Biochemical Evidence | Elevated ALA/PBG levels (within 12 months) | Lab results with reference ranges |
| Attack History | 2+ attacks in past 6 months OR 1 severe attack with CNS/PNS involvement | Hospital records, urgent care visits, hemin use |
| Specialist Involvement | Hematologist, hepatologist, or neurologist consultation | Required for initial approval |
| Liver Status | No current/planned liver transplant | Exclusion criterion |
| Weight Documentation | Current weight for dosing (2.5 mg/kg monthly) | Required for quantity calculations |
Medical Necessity Letter Components
Your prescriber's letter should include:
- Diagnosis details: Specific AHP subtype with supporting genetics/biochemistry
- Attack pattern: Frequency, severity, hospitalizations, impact on quality of life
- Prior treatments: Hemin trials, outcomes, tolerability issues
- Clinical rationale: Why Givlaari is medically necessary vs. alternatives
- Monitoring plan: Liver function, renal function, homocysteine levels
- Treatment goals: Expected reduction in attack frequency
Tip: Reference FDA labeling and clinical trial data showing 70% reduction in attack rates with Givlaari treatment.
Submission Portals and Process
For Providers
Primary Submission Method:
- Submit through the BCBS Georgia provider portal
- Electronic PA requests typically process faster than fax submissions
- Upload all supporting documentation as PDF attachments
Alternative Submission:
- Fax: Use the provider services fax number (verify current number through portal)
- Include a detailed cover sheet listing all attached documents
Timeline Expectations
- Standard review: 2-5 business days
- Expedited review: 24 hours (for urgent cases)
- Complex cases: May take up to 14 days with additional clinical review
Common Denial Reasons and Solutions
| Denial Reason | Solution | Required Documentation |
|---|---|---|
| Insufficient attack history | Document all attacks, including outpatient management | ER records, urgent care visits, hemin infusions |
| Missing biochemical confirmation | Submit recent lab work | ALA/PBG levels within 12 months |
| Non-specialist prescriber | Add specialist consultation | Hematology/hepatology consultation note |
| Step therapy not met | Request exception under Georgia law | Document contraindications or prior failures |
| "Experimental" designation | Provide FDA approval evidence | FDA label, clinical guidelines |
Overturning Step Therapy Requirements
Georgia law (§ 33-24-59.25) provides strong protections. BCBS must grant exceptions if:
- Required drug is contraindicated
- Previous step therapy drug failed or caused adverse effects
- Patient is stable on current therapy and switching would be harmful
- Step therapy drug is expected to be ineffective
Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific denial basis and crafting evidence-backed rebuttals aligned to each plan's criteria.
Appeals Process: Internal and External
Internal Appeal (First Level)
Timeline: File within 60 days of denial Process:
- Submit written appeal through BCBS member portal or by mail
- Include additional clinical evidence addressing denial reasons
- Request peer-to-peer review if appropriate
- BCBS has 30 days to respond (15 days for urgent cases)
Georgia External Review (Second Level)
Georgia offers one of the strongest external review processes in the nation:
Eligibility: After internal appeal denial or for urgent situations Timeline:
- File within 60 days of final internal denial
- Standard review: 30 business days
- Expedited review: 72 hours
How to File:
- Contact Georgia Department of Insurance at 1-800-656-2298
- Email: [email protected]
- Submit external review application with all supporting documentation
Success Rates: External reviews overturn 40-50% of insurer denials nationally, with specialty drug appeals often having higher success rates.
Georgia State Protections and Rights
Step Therapy Override Rights
Georgia law provides automatic override rights when:
- Drug samples don't count as adequate trials
- Previous insurance covered different step therapy drugs
- Clinical contraindications exist
- Current therapy is working and switch poses risks
Response Time Requirements
BCBS Georgia must respond to:
- Urgent requests: 24 hours
- Routine requests: 2 business days
- Appeals: 30 days (15 for urgent)
Continuity of Care
During plan transitions or formulary changes, you're entitled to:
- 30-day transition fills for chronic conditions
- Maintenance of current therapy while appeals are pending
Specialty Pharmacy Setup
Givlaari must be dispensed through an approved specialty pharmacy:
BCBS Georgia In-Network Options:
- CVS Specialty Pharmacy
- BioPlus Specialty Pharmacy
- Other approved specialty networks
Setup Process:
- Your prescriber sends the prescription to the designated specialty pharmacy
- Specialty pharmacy coordinates with BCBS for PA approval
- Pharmacy handles delivery and injection training
- Ongoing monitoring and refill coordination
Note: Using an out-of-network specialty pharmacy may result in coverage denial.
Member Services and Support Contacts
Primary Contacts
Member Services: 855-641-4862 (TTY: 711)
- Hours: Monday-Friday, 8 AM - 8 PM ET
- For PA status, appeals, specialty pharmacy questions
General Inquiries: 1-800-331-1476
- Hours: Monday-Friday, 8 AM - 5 PM ET
24/7 NurseLine: 866-787-6361
- For clinical questions and urgent guidance
What to Ask When You Call
- "What's the status of my Givlaari prior authorization?"
- "Can you connect me to specialty drug case management?"
- "What specific documentation is missing for approval?"
- "How do I request an expedited review?"
- "What's my plan's appeals timeline?"
Cost Savings and Patient Assistance
Manufacturer Support
Alnylam Assist: Patient support program offering:
- Copay assistance (eligibility restrictions apply)
- Prior authorization support
- Appeals assistance
- Financial hardship programs
Additional Resources
- Patient Advocate Foundation: Free copay relief programs
- NeedyMeds: Database of patient assistance programs
- Georgia 211: State resource directory for healthcare assistance
The annual cost of Givlaari can exceed $575,000, making patient assistance programs crucial for most families.
Frequently Asked Questions
Q: How long does BCBS Georgia take to approve Givlaari? A: Standard reviews take 2-5 business days, expedited reviews within 24 hours. Complex cases may take up to 14 days.
Q: What if Givlaari isn't on my formulary? A: Request a formulary exception with medical necessity documentation. Georgia law supports exceptions for medically necessary treatments.
Q: Can I get an expedited appeal in Georgia? A: Yes, both internal appeals and external reviews offer expedited options for urgent medical situations.
Q: Does step therapy apply if I've tried hemin outside Georgia? A: Previous treatment history follows you between states. Document all prior therapies regardless of location.
Q: What happens if my external review is approved? A: The decision is binding on BCBS Georgia. They must provide coverage as determined by the independent review.
Q: How much will I pay out-of-pocket? A: Depends on your plan's specialty tier copay/coinsurance. With manufacturer assistance, many patients pay $10-50 per month.
From our advocates: We've seen many AHP patients initially denied for Givlaari get approved on appeal by providing comprehensive attack documentation and specialist letters emphasizing quality of life impact. The key is thorough preparation and understanding your Georgia appeal rights.
Counterforce Health helps patients navigate complex prior authorization and appeal processes by analyzing denial letters, identifying coverage gaps, and drafting targeted rebuttals that align with each payer's specific criteria. Our platform streamlines the appeals process for both patients and providers, improving approval rates for specialty medications like Givlaari.
Sources & Further Reading
- Georgia Insurance Code § 33-24-59.25 (Step Therapy)
- Georgia Department of Insurance External Review Process
- BCBS Georgia Provider News
- Givlaari FDA Prescribing Information
- Alnylam Assist Patient Support
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and medical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For additional help with insurance appeals in Georgia, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.
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