By Counterforce Health Team in Givlaari (givosiran) —

How Long Does It Take to Get Givlaari (givosiran) Approved by Blue Cross Blue Shield in California? Complete Timeline and Fast-Track Guide

Answer Box: Fastest Path to Givlaari Approval

Getting Givlaari (givosiran) approved by Blue Cross Blue Shield in California typically takes 14 calendar days for standard review or 2 business days for expedited review when urgent medical necessity is documented. Your hepatologist must submit prior authorization through Blue Shield's AuthAccel portal with biochemical confirmation of acute hepatic porphyria (elevated ALA/PBG levels), genetic testing results, and documentation of ≥2 attacks in the past 6 months requiring hospitalization or hemin treatment.

Start today: Have your specialist gather your AHP diagnosis proof, recent lab results, and attack history, then submit the PA request marking it as expedited if you're at risk of imminent attacks.

Table of Contents

  1. What Affects Givlaari Approval Timeline
  2. Pre-Submission Preparation (0-2 Days)
  3. Submission to Initial Review (1-5 Days)
  4. Decision Window and Outcomes
  5. If Denied: California Appeal Process
  6. Annual Renewal Requirements
  7. Timeline Visual and Milestones
  8. Time-Saving Tips for Faster Approval
  9. Frequently Asked Questions

What Affects Givlaari Approval Timeline

Several factors determine how quickly Blue Cross Blue Shield of California processes your Givlaari prior authorization:

Benefit Type Matters

  • Medical benefit: Givlaari is covered under the medical benefit as a physician-administered drug, requiring prior authorization through Blue Shield's AuthAccel system
  • Specialty pharmacy coordination: Some cases require additional specialty pharmacy network verification

Documentation Completeness The most common delays stem from incomplete submissions. Blue Shield requires:

  • Confirmed AHP diagnosis with genetic testing results
  • Elevated urinary PBG and/or ALA levels (ideally measured during or shortly after an attack)
  • Documentation of ≥2 qualifying attacks in the past 6 months
  • Evidence of failed or inappropriate alternative treatments (like hemin)
  • Specialist prescriber (hepatologist, hematologist, or geneticist)

Urgency Classification

  • Standard review: 14 calendar days (California law maximum)
  • Expedited review: 2 business days when immediate treatment prevents severe attacks or hospitalization
Note: Blue Shield of California's prior authorization requirements are updated regularly. Always verify current criteria through the AuthAccel portal.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

Before your doctor submits the prior authorization, gather these critical documents:

✅ AHP Diagnosis Confirmation

  • Genetic testing results showing HMBS, PPOX, or CPOX gene mutations
  • Elevated urinary PBG/ALA levels (normalize to creatinine to avoid false negatives)
  • ICD-10 diagnosis code E80.2 (Other porphyria)

✅ Attack History Documentation

  • Hospital records, ER visits, or urgent care documentation from ≥2 attacks in past 6 months
  • Hemin treatment records if applicable
  • Symptom diary showing attack frequency and severity

✅ Prior Treatment Failures

  • Documentation of hemin use and any limitations or failures
  • Records of trigger avoidance strategies attempted
  • Any adverse reactions to alternative treatments

✅ Current Clinical Status

  • Recent liver function tests
  • Kidney function assessment (eGFR)
  • Weight for dosing calculations (2.5 mg/kg monthly)
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to draft point-by-point rebuttals aligned to each plan's specific requirements.

Submission to Initial Review (1-5 Days)

How Blue Shield Processes PA Requests

Your specialist submits the prior authorization through Blue Shield's provider portal:

  1. Day 1: PA request entered into AuthAccel system with all supporting documentation
  2. Days 1-2: Initial completeness review—Blue Shield checks for required forms and basic documentation
  3. Days 2-5: Medical necessity review by clinical staff or external reviewers

What Reviewers Check First

  • Specialist prescriber credentials (must be hepatologist, hematologist, or geneticist)
  • AHP diagnosis confirmation with both genetic and biochemical evidence
  • Attack frequency meeting the ≥2 attacks in 6 months threshold
  • Appropriate dosing based on patient weight

Common Reasons for Additional Information Requests

  • Missing recent PBG/ALA lab values
  • Insufficient attack documentation
  • Unclear prior treatment history
  • Need for peer-to-peer review with prescribing specialist
From our advocates: "We've seen cases where genetic testing was done years ago but recent biochemical confirmation was missing. Having both genetic results AND recent PBG/ALA levels from within the past 6 months significantly speeds approval, especially if levels were measured during an actual attack."

Decision Window and Outcomes

Typical Timeline Expectations

Review Type Timeline When to Use
Standard PA 14 calendar days Stable patients, preventive treatment
Expedited PA 2 business days Recent attacks, high risk of hospitalization
Peer-to-peer review Additional 3-5 days Complex cases requiring specialist discussion

Reading Your Approval Letter

  • Approved: Look for authorization number, approved duration (typically 12 months), and any quantity limits
  • Approved with conditions: May require specific monitoring or reporting requirements
  • Denied: Review reason codes and required additional documentation

If Additional Information is Requested Respond within 5 business days to avoid delays. Common requests include:

  • Updated attack frequency documentation
  • Recent specialist consultation notes
  • Clarification on why hemin is inappropriate or has failed

If Denied: California Appeal Process

California's Strong Patient Protection System

California offers one of the most patient-friendly appeal systems in the country, with Independent Medical Review (IMR) success rates of 68.6% for Blue Cross Blue Shield medical necessity denials.

Internal Appeal (Required First Step)

  • Timeline: File within 180 days of denial
  • Review period: 30 days for standard, 3 days for expedited
  • Required: Denial letter, updated medical necessity letter addressing specific denial reasons

Independent Medical Review (IMR)

  • When: After internal appeal denial or 30-day non-response
  • Timeline: File within 6 months of final internal denial
  • Review period: 45 days standard, 7 days expedited
  • Cost: Free to patients
  • Success rate: 68.6% for Blue Cross Blue Shield medical necessity cases

How to File IMR

  1. Visit HealthHelp.ca.gov or call 888-466-2219
  2. Submit online application with all supporting documents
  3. Include comprehensive evidence package with peer-reviewed studies supporting Givlaari use
  4. DMHC assigns independent physician experts in hepatology/hematology for review
Note: IMR decisions are binding on insurance plans. If approved, Blue Shield must authorize and pay for treatment.

Annual Renewal Requirements

Planning for Reauthorization

Givlaari typically requires annual reauthorization. Start the renewal process 30-60 days before your current authorization expires.

Renewal Documentation Needed

  • Updated medical necessity letter from your specialist
  • Treatment response data showing attack reduction
  • Recent PBG/ALA levels demonstrating biochemical response
  • Continued AHP management plan
  • Any changes in clinical status or other treatments

Tracking Your Authorization

  • Note your authorization expiration date
  • Set calendar reminders 60 days before expiration
  • Monitor for any plan formulary changes that might affect coverage

Timeline Visual and Milestones

Givlaari Approval Timeline

Day 0: Specialist gathers documentation
↓
Days 1-2: PA submission and completeness review
↓
Days 3-14: Medical necessity review
↓
Day 14: Decision (or earlier for expedited)
↓
If denied: Internal appeal (30 days)
↓
If still denied: IMR filing (within 6 months)
↓
IMR decision (45 days standard, 7 days expedited)

Expedited Track for Urgent Cases

  • Day 0: Submit with urgency documentation
  • Day 1: Expedited review begins
  • Day 2: Decision rendered (2 business days maximum)

Time-Saving Tips for Faster Approval

Portal Optimization

  • Use Blue Shield's AuthAccel system for fastest processing
  • Upload all documents in a single submission to avoid back-and-forth
  • Include cover letter summarizing medical necessity

Documentation Best Practices

  • Submit genetic testing and recent biochemical confirmation together
  • Include attack diary with specific dates, symptoms, and interventions
  • Provide clear timeline of failed alternative treatments

Specialist Coordination

  • Ensure prescriber is board-certified in hepatology, hematology, or genetics
  • Have specialist available for peer-to-peer review if requested
  • Include specialist's direct contact information for follow-up questions

Proactive Communication When working with Counterforce Health, specialists get time-saving templates and patients receive plain-language guidance on next steps, while specialty pharmacies benefit from cleaner submissions that reduce back-and-forth with payers.

Frequently Asked Questions

How long does Blue Cross Blue Shield prior authorization take for Givlaari in California? Standard review takes up to 14 calendar days, while expedited review for urgent medical necessity takes 2 business days maximum under California law.

What if Givlaari is denied as "not medically necessary"? File an internal appeal within 180 days with updated clinical documentation. If denied again, request Independent Medical Review (IMR) through DMHC, which has a 68.6% success rate for Blue Cross Blue Shield medical necessity denials.

Can I get expedited approval if I'm having frequent attacks? Yes, if you can document recent attacks requiring hospitalization, ER visits, or hemin treatment, your specialist can request expedited review citing imminent health risk.

What genetic testing is required for Givlaari approval? Testing for HMBS (AIP), PPOX (VP), or CPOX (HCP) gene mutations, along with elevated urinary PBG/ALA levels, preferably measured during or shortly after an acute attack.

Does Blue Shield require step therapy before approving Givlaari? Most policies require documentation of hemin use or explanation of why hemin is inappropriate, but California's step therapy override laws (AB 374/AB 347) allow exceptions for contraindications or prior failures.

How much does Givlaari cost if approved? With insurance approval, your out-of-pocket costs depend on your specific plan's specialty drug tier. The manufacturer offers patient assistance programs for eligible patients.

What happens if my authorization expires? Start renewal 30-60 days before expiration. If it lapses, you may need to restart the prior authorization process, potentially interrupting treatment.

Can I appeal to the state if Blue Shield denies my Givlaari request? Yes, California's Independent Medical Review system allows appeals through DMHC (for HMO plans) or CDI (for PPO plans), with binding decisions that plans must follow.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies and requirements may change; verify current information with your insurer.

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