By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by Aetna (CVS Health) in Texas: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Givlaari (givosiran) Covered by Aetna (CVS Health) in Texas

Givlaari requires prior authorization from Aetna (CVS Health) in Texas. You'll need documented acute hepatic porphyria with elevated ALA/PBG levels, evidence of ≥2 qualifying attacks in 6 months or hemin use, and specialist involvement. Submit through CVS Caremark Specialty at 866-814-5506. Standard approval takes 30 days; expedited reviews complete within 72 hours. If denied, you have 180 days to appeal internally, then 4 months for external review through Texas Department of Insurance. First step today: Contact your specialist to gather attack documentation and biochemical confirmation.

Table of Contents

Coverage Basics

Is Givlaari (givosiran) covered by Aetna (CVS Health)?

Yes, Givlaari is covered under all Aetna (CVS Health) plans in Texas, including employer-sponsored plans, individual marketplace plans, and Aetna Better Health Texas (Medicaid). However, it requires prior authorization and is typically classified as a specialty medication requiring step therapy documentation.

Which plans include coverage?

  • Commercial employer plans through Aetna
  • Individual and family plans purchased through the Health Insurance Marketplace
  • Aetna Better Health Texas (Medicaid managed care)
  • Medicare Advantage plans with Part D prescription coverage
Note: ERISA self-funded employer plans may have different appeal processes and follow federal rather than Texas state regulations.

Prior Authorization Process

Who submits the prior authorization?

Your prescribing physician or their office staff must submit the prior authorization request. Patients cannot submit PA requests directly to Aetna (CVS Health).

How to check status

  • Providers: Call CVS Caremark Specialty at 866-814-5506 or use the Availity provider portal
  • Patients: Call the member services number on your Aetna ID card
  • Online: Check your Aetna member portal for PA status updates

Timing and Deadlines

How long does approval take?

Review Type Timeline When to Use
Standard Review 30 days maximum Routine requests with complete documentation
Expedited Review 72 hours Urgent medical situations where delay could harm health
Incomplete Submissions Additional 14 days When missing required documentation

What if it's urgent?

Request expedited review if:

  • You're currently experiencing frequent porphyria attacks
  • Delay in treatment could worsen your condition
  • You're hospitalized or require urgent care

Contact CVS Caremark Specialty at 866-814-5506 to request expedited processing.

Medical Necessity Criteria

What documentation is required?

Biochemical Confirmation

  • Elevated urine ALA and PBG levels documented during or after an attack
  • Levels must be at least 4 times above normal range
  • Genetic testing confirming specific AHP subtype (AIP, VP, or HCP)

Attack History Documentation

  • Evidence of ≥2 qualifying attacks in the prior 6-12 months, OR
  • 4 or more porphyria attacks per year, OR
  • Current use of prophylactic hemin therapy

Qualifying attacks include:

  • Hospitalizations for porphyria symptoms
  • Emergency department visits
  • Urgent care visits requiring IV hemin administration

Step therapy requirements

Aetna typically requires documented failure or intolerance of hemin (Panhematin) before approving Givlaari. Acceptable documentation includes:

  • Hospital or infusion center records showing hemin administration
  • Continued attacks despite adequate hemin therapy
  • Adverse reactions to hemin (iron overload, vascular access issues)
  • Medical contraindications to hemin therapy
Important: Once Givlaari is approved, patients cannot receive concomitant prophylactic hemin but may still receive hemin for breakthrough acute attacks.

Specialist requirements

Documentation from specialists carries additional weight in PA reviews:

  • Hematologists
  • Gastroenterologists
  • Neurologists
  • Physicians with documented porphyria expertise

Costs and Patient Assistance

Copay and coinsurance

Givlaari is typically covered under your medical benefit (not pharmacy) and may require:

  • Specialist copays for administration visits
  • Coinsurance based on your plan's specialty drug tier
  • Potential deductible requirements

Alnylam Assist Program

Patients may qualify for reduced out-of-pocket costs through the manufacturer's patient assistance program:

  • Phone: 1-833-256-2748
  • Website: alnylamassist.com
  • Eligibility based on insurance type and income

Denials and Appeals

Common denial reasons and solutions

Denial Reason Solution Required Documentation
Missing biochemical confirmation Submit lab results Elevated ALA/PBG levels during attacks
Insufficient attack history Provide detailed records Hospital records, ED visits, hemin use
No step therapy documentation Show hemin failure/intolerance Treatment records, adverse reactions
Non-specialist prescriber Involve specialist Consultation notes, referral documentation

Appeals process in Texas

Internal Appeal (First Level)

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for pre-service requests, 60 days for post-service
  • How to file: Call member services or submit written request

External Review (Independent Review Organization)

  • Deadline: 4 months from final adverse benefit determination
  • Timeline: 20 days for standard review, 5 days for urgent cases
  • Process: Texas Department of Insurance coordinates IRO review
  • Cost: Free to patient (insurer pays IRO fee)
Texas Advantage: You can request expedited external review concurrently with expedited internal appeal for urgent situations.

When to escalate

Contact Texas Department of Insurance if:

  • Aetna fails to meet appeal deadlines
  • You believe the denial violates Texas insurance law
  • You need assistance with the IRO process

TDI Consumer Help Line: 1-800-252-3439
IRO Information Line: 1-866-554-4926

Renewal Requirements

When to reauthorize

Submit renewal requests 30-45 days before your current authorization expires. Most Givlaari authorizations are approved for 6-12 months.

What documentation is needed for renewal

  • Updated clinical response data showing attack frequency reduction
  • Current patient weight for dosing calculations
  • Recent liver function tests (monthly monitoring required)
  • Documentation of ≥85% medication adherence
  • Specialist attestation of continued medical necessity

CVS Specialty Pharmacy

Why was my prescription transferred?

Aetna (CVS Health) requires most specialty medications, including Givlaari, to be dispensed through CVS Specialty Pharmacy or other contracted specialty pharmacies. This ensures:

  • Proper handling and storage of temperature-sensitive medications
  • Clinical monitoring and support services
  • Coordination with prior authorization approvals

Enrollment process

Contact Information:

Required Information:

  • Complete patient demographics and insurance details
  • Prescriber information including NPI and DEA numbers
  • Clinical information including allergies and concomitant medications

Troubleshooting Common Issues

Portal or system problems

If you encounter technical issues:

  • Providers: Contact Availity support or call CVS Caremark directly
  • Patients: Call member services for status updates when online portals are unavailable

Missing forms or documentation

Common missing documents that delay approval:

  • Genetic testing results confirming AHP subtype
  • Complete attack history with dates and treatments
  • Baseline liver and kidney function tests
  • Specialist consultation notes

Communication gaps

Ensure all parties have current contact information:

  • Patient's preferred contact method (phone, email, text)
  • Prescriber's direct line for urgent communications
  • Specialty pharmacy coordinator contact

FAQ

How long does Aetna (CVS Health) prior authorization take in Texas?
Standard PA requests take up to 30 days, with most complete submissions approved within 24-72 hours. Expedited requests are processed within 72 hours for urgent situations.

What if Givlaari is non-formulary on my plan?
Even if non-formulary, Aetna must consider medical necessity exceptions. Your doctor can request a formulary exception with supporting clinical documentation.

Can I request an expedited appeal in Texas?
Yes, Texas allows expedited appeals for urgent situations. You can request expedited internal and external review simultaneously if delay could jeopardize your health.

Does step therapy apply if I failed hemin treatment outside Texas?
Yes, documented hemin failure or intolerance from any location is typically accepted. Ensure you have complete medical records from previous treatments.

What happens if my appeal is denied?
After exhausting Aetna's internal appeals, you can request external review through the Texas Department of Insurance IRO process. The IRO decision is binding on Aetna.

How often do I need to renew authorization?
Most Givlaari authorizations are valid for 6-12 months. Submit renewal requests 30-45 days before expiration with updated clinical data.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for patients, clinicians, and specialty pharmacies. Our platform analyzes denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals that address specific denial reasons with the right clinical documentation and regulatory citations.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may vary by specific plan and can change over time. Always verify current requirements with your insurance carrier and consult with your healthcare provider for medical decisions.

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