By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (Givosiran) Covered by Blue Cross Blue Shield in Washington: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Givlaari Covered by Blue Cross Blue Shield in Washington

To get Givlaari (givosiran) approved by Blue Cross Blue Shield in Washington: Submit prior authorization with documented AHP diagnosis, elevated PBG/ALA levels, and ≥2 attacks in 6 months requiring hospitalization or hemin treatment. If denied, file internal appeal within 180 days, then request external review through Washington's Office of the Insurance Commissioner. First step today: Contact your specialist to gather attack documentation and biochemical proof, then submit PA through your BCBS provider portal.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. When Alternatives Make Sense
  4. Common Denial Reasons & Solutions
  5. Appeals Process in Washington
  6. Costs & Patient Support
  7. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all BCBS plans Provider portal or member services BCBS PA Requirements
Age Requirement 18 years or older Plan formulary BCBS Coverage Criteria
Diagnosis Confirmed AHP with genetic/biochemical proof Medical records FDA Label
Attack History ≥2 documented attacks in 6 months Hospital/clinic records Arkansas BCBS Policy
Specialist Prescriber Hepatologist, hematologist, or geneticist Provider credentials BCBS Michigan Policy
Appeals Deadline 180 days from denial Denial letter Washington State Law

Step-by-Step: Fastest Path to Approval

1. Gather Essential Documentation

Who does it: Your specialist and clinic staff
What you need:

  • Confirmed AHP diagnosis (genetic testing preferred)
  • Elevated urinary PBG/ALA levels within past year
  • Documentation of ≥2 attacks requiring hospitalization or hemin in past 6 months
  • Previous treatment attempts and outcomes

Timeline: 1-2 weeks to collect records

2. Submit Prior Authorization

Who does it: Your prescriber
How to submit: Through BCBS provider portal or fax to plan-specific number
Required forms: BCBS PA form with clinical justification letter
Timeline: Submit within 30 days of prescription

3. Follow Up on Decision

Standard review: 14 calendar days in Washington
Expedited review: 2 business days for urgent cases
What to expect: Written determination with specific denial reasons if not approved

4. Appeal if Denied

Internal appeal: File within 180 days of denial
External review: Request through Washington OIC if internal appeal fails
Success rate: Many specialty drug denials are overturned with proper documentation

Tip: Submit electronically when possible for faster processing and automatic tracking through your BCBS provider portal.

When Alternatives Make Sense

Before pursuing a formulary exception for Givlaari, consider whether alternatives might be appropriate based on your specific situation and BCBS coverage criteria.

Hemin (Panhematin) - Standard First-Line Therapy

When it makes sense:

  • Acute attack management
  • Prophylaxis for recurrent attacks (≥4 per year)
  • Initial treatment before considering Givlaari

Coverage considerations:

  • Usually covered with prior authorization
  • Requires IV administration in clinical setting
  • May require step therapy documentation before Givlaari approval

Limitations:

  • Venous access challenges with repeated use
  • Risk of iron overload
  • Injection site reactions and phlebitis

Supportive Care Measures

Covered options:

  • IV glucose for mild attacks
  • Pain management protocols
  • Trigger avoidance strategies
  • Nutritional counseling

When to document failure:

  • Keep detailed records of breakthrough attacks
  • Document hospitalizations despite optimal supportive care
  • Note quality of life impacts and functional limitations

Exception Strategy: Building Your Case

When standard alternatives haven't worked or aren't appropriate, a formulary exception becomes necessary. 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 with each insurer's specific requirements.

Key evidence to include:

  • Biochemical confirmation of AHP with elevated porphyrin precursors
  • Genetic testing results when available
  • Detailed attack history with dates, severity, and interventions
  • Documentation of hemin treatment failures or intolerance
  • Specialist letters supporting medical necessity

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing biochemical proof Submit lab results showing elevated PBG/ALA Porphyria Foundation Guidelines
Insufficient attack history Provide hospital records, ER visits, hemin use Medical records with ICD-10 E80.2
Non-specialist prescriber Transfer care or obtain consultation Specialist evaluation letter
Concurrent hemin use Document plan to discontinue prophylactic hemin Treatment modification plan
Not medically necessary Submit peer-reviewed evidence and FDA labeling Clinical studies and guidelines

Appeals Process in Washington

Washington state provides robust consumer protections for insurance appeals, with multiple levels of review available.

Internal Appeals (Required First Step)

Timeline: File within 180 days of denial
Process: Submit appeal letter with additional clinical evidence
Decision time: 30 days for standard appeals, 72 hours for urgent
Success factors: New clinical information, specialist support, guideline citations

External Review Through Washington OIC

If your internal appeal is denied, Washington law provides access to independent external review.

How to request: Contact the Office of the Insurance Commissioner at 1-800-562-6900
Timeline: 180 days from final internal denial to request external review
Process: Independent Review Organization (IRO) conducts impartial medical review
Decision time: 30 days for standard review, 72 hours for expedited
Binding result: IRO decision is binding on the insurer if approved

Note: Washington's external review process is particularly effective for rare disease medications, with medical experts from research institutions often serving as IRO reviewers.

Clinician Corner: Medical Necessity Letter Checklist

Essential elements for your specialist to include:

✓ Diagnosis confirmation: AHP subtype with genetic or biochemical proof
✓ Attack history: Frequency, severity, hospitalizations, hemin use
✓ Treatment failures: Document inadequate response to hemin prophylaxis
✓ Clinical rationale: Why Givlaari is medically necessary for this patient
✓ Monitoring plan: Lab surveillance and safety protocols
✓ Guideline support: Reference FDA labeling and specialty society recommendations

Costs & Patient Support

Manufacturer Assistance

Alnylam Assist Program:

  • Coverage investigation and prior authorization support
  • Copay assistance for eligible patients
  • Free drug program for qualifying uninsured patients
  • Contact: 1-833-256-9526

Foundation Support

National Organization for Rare Disorders (NORD):

  • Rare Disease Assistance Programs
  • Patient assistance grants
  • Insurance advocacy support

State Resources

Washington Apple Health (Medicaid):

  • May cover Givlaari for eligible patients
  • Different appeal process through state fair hearing system
  • Contact: Washington Health Care Authority

For patients navigating complex insurance requirements, Counterforce Health offers specialized support in preparing comprehensive appeals that address each insurer's specific coverage criteria and procedural requirements.

FAQ

How long does BCBS prior authorization take in Washington? Standard PA decisions are made within 14 calendar days under Washington state law. Expedited reviews for urgent cases must be completed within 2 business days.

What if Givlaari is not on my BCBS formulary? You can request a formulary exception with supporting clinical documentation. The process is similar to prior authorization but requires additional justification for why formulary alternatives aren't appropriate.

Can I request an expedited appeal? Yes, if your health could be in serious jeopardy from delays. Expedited appeals must be decided within 72 hours in Washington.

Does step therapy apply if I've tried hemin outside Washington? Documentation of previous treatment attempts should be accepted regardless of where they occurred, as long as medical records are available to verify the trials and outcomes.

What happens if my external review is denied? While external review is typically the final step, you can contact the Washington OIC for additional guidance or consider legal consultation for complex cases.

How much does Givlaari cost without insurance? The wholesale acquisition cost is approximately $41,375 per vial, with total annual costs varying based on patient weight (dosing is 2.5 mg/kg monthly).

Can my primary care doctor prescribe Givlaari? Most BCBS plans require prescription by a specialist (hepatologist, hematologist, or geneticist) or documented specialist consultation.

What if I'm on a self-funded employer plan? Self-funded ERISA plans may not be subject to Washington state appeal laws, but many voluntarily use similar processes. Contact your plan administrator or the U.S. Department of Labor for ERISA plan appeals.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice or a guarantee of coverage outcomes. Always consult with your healthcare provider about treatment decisions and contact your specific insurance plan for current coverage requirements and procedures. For additional support with insurance appeals, the Washington Office of the Insurance Commissioner provides free consumer assistance at 1-800-562-6900.

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