By Counterforce Health Team in Givlaari (givosiran) —

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

Answer Box: Getting Givlaari Covered by UnitedHealthcare in Washington

Givlaari (givosiran) requires prior authorization from UnitedHealthcare OptumRx, with potential step therapy requirements. Washington state law (RCW 48.43.420) provides strong protections for step therapy exceptions when medically necessary. First step: Have your specialist submit a prior authorization request with documented AHP diagnosis, attack history, and biochemical confirmation (elevated ALA/PBG levels). If denied, you have 180 days to appeal internally, followed by external review through Washington's Office of Insurance Commissioner. Call OptumRx at 1-800-711-4555 to start the PA process today.

Table of Contents

Why Washington State Rules Matter

Washington provides some of the strongest consumer protections in the nation for insurance appeals and step therapy overrides. These state laws apply to most UnitedHealthcare plans sold in Washington, including individual marketplace plans and fully-insured employer coverage.

Important exception: If you have UnitedHealthcare through a self-funded employer plan, federal ERISA law may limit your appeal rights to federal processes rather than Washington state protections. Check your Summary Plan Description or contact your HR department to confirm your plan type.

Washington's Office of Insurance Commissioner (OIC) actively helps consumers navigate denials and provides free advocacy services at 1-800-562-6900.

Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means How to Submit Timeline
Prior Authorization Required before filling OptumRx PA portal or 1-800-711-4555 5-15 business days standard; 24-72 hours expedited
Step Therapy May require hemin trial first Exception request with medical necessity 3 business days (WA law)
Specialist Prescriber Often required for rare diseases Hepatologist, hematologist, or geneticist Immediate
Biochemical Proof Elevated ALA/PBG levels Lab results in PA submission With initial request

Fastest Path to Approval

  1. Confirm Coverage: Check your 2025 UnitedHealthcare formulary to see Givlaari's tier status and any restrictions
  2. Gather Documentation:
    • Confirmed AHP diagnosis (genetic testing or biochemical proof)
    • Attack history (≥2 qualifying attacks in past 6-12 months)
    • Prior therapy failures or contraindications to hemin
    • Current lab values (ALA, PBG levels)
  3. Submit PA Request: Your specialist submits via OptumRx portal or fax with complete documentation
  4. Request Peer-to-Peer: If initial denial, request immediate peer-to-peer review with UnitedHealthcare medical director
  5. File Step Therapy Exception: If step therapy applies, cite Washington RCW 48.43.420 for medical necessity exception
  6. Appeal if Denied: Submit internal appeal within 180 days with additional supporting evidence
  7. External Review: If internal appeal fails, request external review through Washington OIC

Step Therapy Protections in Washington

Washington's RCW 48.43.420 requires UnitedHealthcare to approve step therapy exceptions when specific criteria are met. This law applies to non-grandfathered health plans issued after January 1, 2023.

Exception Criteria (Any One Qualifies)

UnitedHealthcare must approve a step therapy exception if:

  • The required step therapy drug (typically hemin) is contraindicated
  • The required drug causes adverse reactions or ineffective treatment
  • The step therapy regimen would cause treatment delays risking serious harm
  • The prescriber documents medical necessity for Givlaari

Exception Request Process

Timeline: 3 business days for standard requests; 1 business day for urgent cases

How to Submit: Include these key phrases in your exception request:

  • "Medical necessity exception under Washington RCW 48.43.420"
  • "Step therapy delay would risk serious harm due to acute hepatic porphyria attacks"
  • "Patient requires immediate prophylactic therapy to prevent life-threatening complications"
Tip: Washington's step therapy law is among the most comprehensive in the U.S. Unlike other states that only protect against contraindications, Washington explicitly covers medical necessity determinations.

Appeals Process and Timelines

Internal Appeals (First Level)

Deadline: 180 days from denial date (60 days for UnitedHealthcare Community Plan members)

How to Submit:

  • Online: UnitedHealthcare member portal
  • Phone: 1-877-542-8997
  • Fax: 1-801-994-1082
  • Mail: P.O. Box 31364, Salt Lake City, UT 84131-0364

Timeline:

  • Standard: 30 days (pre-service), 60 days (post-service)
  • Expedited: 72 hours if health at risk

Required Documents:

  • Original denial letter
  • Medical records supporting Givlaari necessity
  • Physician letter of medical necessity
  • Lab results showing AHP biochemical markers
  • Documentation of attack frequency and severity

When to Request Expedited Review

Request expedited appeals if:

  • You're experiencing active AHP attacks
  • Delay in treatment could worsen your condition
  • You're currently hospitalized or at risk of hospitalization

Call UnitedHealthcare immediately at 1-877-542-8997 and state: "I need an expedited appeal for a life-saving medication denial due to acute hepatic porphyria."

External Review Rights

If UnitedHealthcare denies your internal appeal, Washington law guarantees external review by an independent organization.

External Review Process

Eligibility: After exhausting internal appeals; for denials based on medical necessity Deadline: 180 days from final internal denial Cost: Free to you Timeline: 20 days standard; 72 hours expedited

How to Request:

  1. Submit written request to UnitedHealthcare (they'll forward to Washington OIC)
  2. Include all medical records and denial letters
  3. Add any new clinical evidence supporting Givlaari necessity

Success Rate: Approximately 50% of specialty drug denials are overturned on external review when comprehensive documentation proves FDA-approved indications.

Washington OIC Consumer Support

The Office of Insurance Commissioner provides free assistance throughout the appeals process:

Contact: 1-800-562-6900 or [email protected] Services:

  • Appeal guidance and template letters
  • Help filing external review requests
  • Complaint investigation if insurer violates state law
  • Direct advocacy with insurers

Common Denial Reasons & Solutions

Denial Reason How to Overturn
"Not medically necessary" Submit detailed attack history, genetic testing, and specialist letter explaining AHP severity
"Step therapy required" File Washington RCW 48.43.420 exception citing medical necessity and attack prevention
"Experimental/investigational" Cite FDA approval date (November 2019) and include FDA prescribing information
"Quantity limits exceeded" Provide weight-based dosing calculation (2.5 mg/kg monthly) with prescriber attestation
"Non-formulary drug" Request formulary exception with comparative effectiveness documentation vs. hemin

Clinician Corner: Medical Necessity Documentation

Essential Elements for PA Success

Diagnosis Documentation:

  • Confirmed AHP subtype (AIP, VP, HCP, or ADP)
  • Genetic testing results or biochemical confirmation
  • ICD-10 codes: E80.21 (AIP), E80.29 (other AHP subtypes)

Attack History:

  • Number of attacks in past 12 months
  • Severity and duration of each episode
  • Emergency department visits or hospitalizations
  • Impact on daily functioning and quality of life

Prior Therapy Documentation:

  • Hemin trials and outcomes (if applicable)
  • Reasons for hemin failure or contraindication
  • Trigger avoidance measures attempted
  • Other supportive care provided

Clinical Rationale:

  • Why Givlaari is medically necessary for this patient
  • Expected clinical outcomes (attack reduction)
  • Monitoring plan for hepatic/renal function
  • Weight-based dosing rationale (2.5 mg/kg monthly)

Key Clinical References

Include these evidence sources in medical necessity letters:

From our advocates: "We've seen the strongest approvals when specialists include both the attack frequency data AND the patient's specific biochemical markers (ALA/PBG levels). Payers want to see objective evidence that matches the clinical picture."

Cost Assistance Programs

Manufacturer Support

Alnylam Assist: Patient support program offering:

  • Insurance navigation and prior authorization support
  • Copay assistance for eligible commercial insurance patients
  • Free drug program for uninsured patients meeting income criteria

Contact: 1-833-256-9526 or alnylamassist.com

Additional Resources

  • National Organization for Rare Disorders (NORD): Rare Disease Patient Assistance Programs
  • HealthWell Foundation: May offer copay assistance for AHP patients
  • Patient Advocate Foundation: Free case management for insurance appeals

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and drafting point-by-point rebuttals aligned to payer policies.

FAQ

How long does UnitedHealthcare prior authorization take in Washington? Standard PA decisions: 5-15 business days. Expedited requests: 24-72 hours. Washington law requires step therapy exception decisions within 3 business days.

What if Givlaari is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and lack of effective alternatives. Include comparative effectiveness data vs. formulary options.

Can I get expedited review for AHP attacks? Yes. Active attacks or imminent risk qualifies for expedited PA and appeal review. Emphasize the emergency nature of AHP and potential for life-threatening complications.

Does Washington step therapy protection apply to all UnitedHealthcare plans? RCW 48.43.420 applies to non-grandfathered plans issued after January 1, 2023. Self-funded employer plans may be exempt under ERISA. Check your plan documents.

What happens if UnitedHealthcare doesn't respond within required timeframes? File a complaint with Washington OIC at 1-800-562-6900. The state can investigate violations of response time requirements and advocate on your behalf.

How much does Givlaari cost without insurance? The list price is approximately $575,000 annually, with individual vials around $41,375. Patient assistance programs may help reduce out-of-pocket costs significantly.

When to Escalate

Contact Washington's Office of Insurance Commissioner if:

  • UnitedHealthcare misses response deadlines
  • Your step therapy exception is improperly denied
  • You need help with the external review process
  • The insurer violates Washington state insurance laws

OIC Contact: 1-800-562-6900 or file online at insurance.wa.gov

For complex cases involving multiple denials or procedural violations, consider working with Counterforce Health, which specializes in transforming insurance denials into successful appeals through targeted, evidence-based advocacy.

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 documents for specific coverage details. Appeal rights and timelines may vary based on your specific plan type and circumstances.

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