By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by Blue Cross Blue Shield in Pennsylvania: Appeals Process, Forms & Timeline

Answer Box: To get Givlaari (givosiran) covered by Blue Cross Blue Shield in Pennsylvania, you need prior authorization with documented acute hepatic porphyria diagnosis, elevated urinary porphobilinogen/ALA or genetic testing, and at least 2 qualifying attacks in 6 months. If denied, use Pennsylvania's new external review process—50% of appeals succeed. First step: gather attack history, lab results, and genetic testing, then submit through your plan's PA portal within required timeframes.

Table of Contents

Why Pennsylvania State Rules Matter

Pennsylvania's healthcare landscape has significantly strengthened patient protections for specialty drug coverage. The state's Act 146 of 2022 created new step therapy exception requirements, while the Pennsylvania Insurance Department's external review program launched in January 2024 has already overturned about 50% of insurance denials.

For Givlaari (givosiran)—a $575,000/year RNA therapy for acute hepatic porphyria—these state protections interact with Blue Cross policies in important ways. Pennsylvania's major Blue Cross plans (Highmark, Independence Blue Cross, and Capital Blue Cross) must follow both their internal coverage criteria and state-mandated appeal timelines and exception processes.

Note: Self-funded employer plans (ERISA) may not be subject to all state protections, but commercial individual and group plans purchased in Pennsylvania must comply with state regulations.

Coverage Requirements at a Glance

Requirement What It Means Blue Cross Documentation Source
Prior Authorization Required for all PA Blue Cross plans Submit through provider portal with clinical records Highmark Policy
Age ≥18 years Adult indication only Birth date verification in medical records Capital Blue Cross Policy
AHP Diagnosis Confirmed acute hepatic porphyria ICD-10 codes + clinical symptoms IBC Policy
Biochemical/Genetic Evidence Elevated PBG/ALA OR genetic mutation Lab results within 12 months OR genetic test report All PA Blue Cross plans
Attack History ≥2 documented attacks in 6 months Hospital records, urgent care visits, or hemin use All PA Blue Cross plans
Dose Limits 2.5 mg/kg monthly subcutaneous Weight-based calculation documentation FDA-approved dosing
No Liver Transplant Current or anticipated transplant excludes coverage Transplant evaluation records if applicable Clinical documentation

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient + Clinic)

  • Complete attack history for past 6-12 months
  • Recent urinary porphobilinogen and ALA levels (within 12 months)
  • Genetic testing results if available
  • Previous hemin therapy records
  • Current weight for dosing calculations

2. Confirm Your Blue Cross Plan Type (Patient) Call member services to verify: Is this a commercial plan subject to PA state rules? What's your specific formulary tier for Givlaari?

3. Submit Prior Authorization (Clinic)

  • Use your Blue Cross provider portal
  • Include all clinical documentation from step 1
  • Request expedited review if attacks are frequent/severe
  • Expected timeline: 2-5 business days for standard PA

4. If Approved (Clinic + Patient)

  • Coordinate with specialty pharmacy
  • Verify site of care requirements (healthcare provider administration)
  • Schedule monthly injection appointments

5. If Denied (Patient + Clinic)

  • Request internal appeal within 180 days (commercial plans)
  • Submit additional supporting documentation
  • Consider peer-to-peer review with medical director

6. Escalate to State External Review (Patient)

7. Access Patient Support (Patient)

  • Contact Alnylam Assist for copay assistance
  • Explore foundation grants for rare disease treatments

Pennsylvania's Appeal Turnaround Standards

Pennsylvania law requires specific timelines for Blue Cross Blue Shield appeals:

Standard Appeals: 30 days for pre-service denials, 60 days for post-service denials

Expedited Appeals: 48 hours maximum when delay could seriously jeopardize health or ability to regain maximum function

Filing Deadlines:

  • Commercial plans: 180 days from denial date
  • Medicaid/CHIP: 60 days from denial date
  • ACA marketplace plans: 60 days from denial date
Tip: Request "continuing benefits" if appealing a current therapy denial. You must file within 10 days of the denial to maintain coverage during the appeal process.

Step Therapy Protections

Pennsylvania's Act 146 requires Blue Cross plans to grant step therapy exceptions when:

  • The required drug is contraindicated or likely to cause adverse reactions based on patient history
  • Patient has already tried and failed the step therapy drug or similar medication
  • Patient is stable on current medication and switching poses health risks
  • Provider believes delay would cause harm with supporting clinical evidence

For Givlaari, this is particularly relevant since some Blue Cross plans may require hemin trial first. Document previous hemin use, intolerance, or contraindications clearly in exception requests.

Required Documentation for Step Therapy Exceptions:

  • Previous medication trials with specific drugs, dosages, and duration
  • Clinical outcomes and adverse reactions
  • Medical rationale for bypassing step therapy
  • Evidence-based guidelines supporting direct access to Givlaari

Continuity of Care During Plan Changes

If you're transitioning between Blue Cross plans or your provider leaves the network while on Givlaari, Pennsylvania protections include:

90-Day Grace Period: Under federal continuity of care rules, you're entitled to continued coverage with same benefits and cost-sharing for up to 90 days after plan changes, provided you qualify as a "continuing care patient" with a serious, complex condition requiring specialized treatment.

Notification Requirements: Plans must notify eligible members of their rights and provide an election process.

Coverage Terms: During the grace period, your new plan must cover Givlaari under the same terms as your previous coverage.

From Our Advocates: "We've seen patients successfully use continuity of care protections when switching between Highmark and Independence Blue Cross. The key is promptly notifying the new plan that you qualify as a continuing care patient and formally electing transitional coverage. Don't assume it happens automatically."

External Review & State Complaint Process

Pennsylvania's Independent External Review Program launched in January 2024 and has achieved remarkable success for patients:

Eligibility: You must first exhaust your insurer's internal appeal process and receive a Final Adverse Benefit Determination letter.

Timeline to File: 4 months from final denial date

Review Process:

  • PID assigns independent review organization (IRO) within 1 business day
  • You can submit additional supporting information within 15 days
  • Standard reviews: Final decision within 45 days
  • Expedited reviews: Final decision within 72 hours

Success Rate: Approximately 50% of external reviews result in coverage approval

Required Documentation:

  • Final denial letter from Blue Cross
  • All medical records supporting medical necessity
  • Provider statement of clinical rationale
  • Relevant clinical guidelines or studies

Contact Information:

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Insufficient attack history" Provide detailed attack documentation Hospital records, urgent care visits, hemin administration records, provider attestation of attack frequency
"Missing biochemical confirmation" Submit recent lab results Urinary porphobilinogen >10 mg/g creatinine, elevated ALA levels within 12 months
"No genetic testing" Provide genetic test results OR stronger clinical evidence Pathogenic mutation in ALAS, PBGD, or other heme synthesis genes
"Still on prophylactic hemin" Document plan to discontinue hemin after stabilization Provider statement about hemin tapering plan post-Givlaari initiation
"Non-specialist prescriber" Transfer care or obtain specialist consultation Referral to hematologist, hepatologist, or metabolic specialist

Patient Scripts for Blue Cross Calls

When Calling Member Services: "I need to check the prior authorization status for Givlaari, generic name givosiran, for acute hepatic porphyria. My provider submitted the PA on [date]. Can you tell me the current status and any missing requirements?"

When Requesting Expedited Appeal: "I'm requesting an expedited appeal for my Givlaari denial. My acute hepatic porphyria attacks are frequent and severe, and delays in treatment could seriously jeopardize my health. Pennsylvania law requires a decision within 48 hours for expedited appeals."

When Citing State Protections: "Under Pennsylvania Act 146, I'm requesting a step therapy exception because I've previously tried and failed hemin therapy. I have documentation of adverse reactions and lack of efficacy."

When to Escalate Beyond Your Insurer

Contact these resources when Blue Cross denials persist:

Pennsylvania Health Law Project: 1-800-274-3258

  • Free consumer assistance for health insurance appeals
  • Specialized expertise in Pennsylvania insurance law
  • Direct advocacy and representation services

Pennsylvania Insurance Department: 1-877-881-6388

  • External review program administration
  • Consumer complaint investigations
  • Regulatory enforcement actions

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify specific denial reasons, then drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements. For complex cases like Givlaari denials involving rare disease criteria, having expert appeal support can significantly improve approval odds.

FAQ

How long does Blue Cross PA take for Givlaari in Pennsylvania? Standard prior authorization: 2-5 business days. Expedited PA (when medically urgent): 48 hours maximum under Pennsylvania law.

What if Givlaari is non-formulary on my Blue Cross plan? Request a formulary exception with medical necessity documentation. Pennsylvania requires clear exception criteria and appeal rights for non-formulary drugs.

Can I get an expedited appeal if my attacks are frequent? Yes. If delays could seriously jeopardize your health, request expedited appeal citing Pennsylvania's 48-hour decision requirement for urgent cases.

Does step therapy apply if I failed hemin outside Pennsylvania? Yes, document out-of-state hemin trials and failures. Pennsylvania step therapy protections apply regardless of where previous treatments occurred.

What's the cost without insurance coverage? Givlaari's list price is approximately $575,000 annually. Alnylam Assist offers copay assistance and patient access programs.

Who can prescribe Givlaari for Blue Cross PA approval? While any licensed physician can prescribe, Blue Cross often prefers specialists (hematologists, hepatologists, or metabolic specialists) for rare disease medications.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance plan directly for coverage decisions. For personalized assistance with complex appeals, consider consulting with Counterforce Health or the Pennsylvania Health Law Project.

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