By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by Cigna in Ohio: Complete Appeals Guide with Forms and Timelines

Quick Answer: Getting Givlaari (givosiran) Covered by Cigna in Ohio

Cigna requires prior authorization for Givlaari (givosiran) with strict medical necessity criteria: confirmed acute hepatic porphyria diagnosis, at least one documented severe attack in the past 6 months, elevated ALA/PBG lab values, and prescription by a porphyria specialist. If denied, Ohio law gives you 180 days to appeal internally, then request external review through an Independent Review Organization. Start today: Gather your attack history, lab results, and specialist notes, then submit your PA request through CoverMyMeds or the Cigna provider portal.

Table of Contents

  1. Why Ohio State Rules Matter for Your Cigna Coverage
  2. Cigna's Prior Authorization Requirements
  3. Step Therapy Protections in Ohio
  4. Continuity of Care During Plan Transitions
  5. External Review and Consumer Protections
  6. Step-by-Step: Fastest Path to Approval
  7. Appeals Playbook for Cigna Denials
  8. Common Denial Reasons and How to Fix Them
  9. When to Escalate to State Regulators
  10. FAQ: Your Top Questions Answered

Why Ohio State Rules Matter for Your Cigna Coverage

Ohio's insurance laws provide crucial protections that work alongside Cigna's internal policies. While Cigna (including Express Scripts and Accredo) sets the clinical criteria for Givlaari coverage, Ohio law determines your appeal rights, timelines, and external review options.

Key Ohio protections include:

  • 180-day appeal window after any denial
  • Binding external review by independent medical experts
  • Step therapy override rights when clinically justified
  • Continuity of care protections during plan transitions
Note: Self-funded employer plans (ERISA) may have different procedures, but many voluntarily follow Ohio's external review process.

Cigna's Prior Authorization Requirements

Cigna requires prior authorization for Givlaari through Express Scripts with these specific criteria:

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed
Age ≥18 years Adult patients only Birth date verification
Confirmed AHP diagnosis Any AHP subtype Genetic testing or family history
≥1 severe attack (6 months) Hospitalization, ER, IV hemin, or urgent care Medical records, discharge summaries
Elevated ALA/PBG Lab evidence of active disease Recent lab results
Specialist involvement Porphyria specialist prescription/consultation Specialist notes and credentials
Accredo pharmacy Specialty pharmacy requirement Prescription routing

Source: Cigna Coverage Position Criteria for Givosiran

Submission Process

Preferred methods:

  1. CoverMyMeds (electronic PA portal)
  2. Cigna provider portal
  3. SureScripts EHR integration
  4. Fax: 1-800-882-4462 (verify current number with Cigna)

Step Therapy Protections in Ohio

Ohio Revised Code Section 3901.832 requires insurers to grant step therapy exceptions when clinically appropriate. For Givlaari, this is particularly relevant since it's the only FDA-approved chronic preventive therapy for AHP.

When Cigna Must Grant an Exception

Ohio law requires approval if your provider documents that:

  • Required step therapy drug is contraindicated or would cause adverse reactions
  • Step therapy would be ineffective and delay would cause harm
  • You previously tried the required drug and it failed or caused problems
  • Step therapy is not in your best medical interest
  • You're stable on your current treatment

Actionable tip: Reference Ohio Revised Code 3901.832 in your exception request and include detailed clinical rationale from your specialist.

Continuity of Care During Plan Transitions

If you're switching to Cigna while already on Givlaari, Ohio provides transition protections:

Grace Periods by Plan Type

  • Commercial plans: Minimum 60-day continuation recommended by industry standards
  • Medicaid/MyCare Ohio: Until planned course is completed for specialty medications
  • Medicare Advantage: Plan-specific, typically 30-90 days

What to do immediately:

  1. Notify Cigna at enrollment about ongoing Givlaari therapy
  2. Request formal continuity of care coverage
  3. Submit new PA before grace period expires

External Review and Consumer Protections

Ohio's external review process provides a crucial safety net when Cigna denies coverage.

Ohio External Review Timeline

Review Type Filing Deadline Decision Timeline Who Reviews
Standard 180 days after denial 30 days Independent Review Organization
Expedited 180 days (urgent cases) 72 hours Independent Review Organization

How to Request External Review

  1. Complete internal appeals with Cigna first (unless urgent)
  2. Submit written request to Cigna within 180 days
  3. Include supporting documentation: medical records, specialist letters, clinical studies
  4. Indicate urgency if delay would jeopardize your health

Contact for help: Ohio Department of Insurance Consumer Services at 1-800-686-1526

Source: Ohio Department of Insurance External Review Process

Step-by-Step: Fastest Path to Approval

Before You Start: Gather These Documents

  • Insurance card and member ID
  • Complete attack history (dates, treatments, outcomes)
  • Lab results showing elevated ALA/PBG
  • Specialist consultation notes
  • Previous therapy documentation (if any)

The 7-Step Process

1. Confirm Specialty Pharmacy Requirements (Day 1)

  • Call Cigna to verify Accredo is required
  • Set up Accredo account if needed
  • Timeline: Same day

2. Submit Prior Authorization (Day 1-2)

  • Use CoverMyMeds or Cigna provider portal
  • Include all required documentation
  • Request expedited review if urgent
  • Timeline: 1-2 business days to submit

3. Follow Up on PA Status (Day 7-10)

  • Check portal or call Cigna
  • Standard PA decisions: 15 business days
  • Expedited decisions: 72 hours
  • Timeline: Varies by urgency

4. If Denied: File Internal Appeal (Within 180 days)

  • Submit detailed medical necessity letter
  • Include additional clinical evidence
  • Reference Ohio step therapy protections
  • Timeline: 30 days for decision

5. Request Peer-to-Peer Review (During appeal)

  • Have your specialist speak directly with Cigna's medical director
  • Schedule through Cigna provider services
  • Timeline: 1-3 business days to arrange

6. If Still Denied: External Review (Within 180 days of final denial)

  • File with Ohio Department of Insurance
  • Submit comprehensive clinical package
  • Timeline: 30 days for standard, 72 hours for expedited

7. Consider Additional Support (Ongoing)

  • Contact manufacturer patient assistance programs
  • Explore foundation grants
  • Consult with Counterforce Health for expert appeal assistance

Appeals Playbook for Cigna Denials

Internal Appeal Process

First-Level Internal Appeal:

  • Deadline: 180 days from denial date
  • Submission: Cigna member portal, mail, or fax
  • Decision timeline: 30 days (15 days for expedited)
  • Required: Medical necessity letter from specialist

Second-Level Internal Appeal:

  • When available: After first-level denial
  • Same timelines as first-level
  • Consider: Independent medical review or peer-to-peer

Medical Necessity Letter Checklist

Your specialist should include:

  • ✓ Confirmed AHP diagnosis with subtype
  • ✓ Detailed attack history with dates and severity
  • ✓ Lab values (ALA/PBG) with reference ranges
  • ✓ Previous treatments tried and outcomes
  • ✓ Clinical rationale for Givlaari specifically
  • ✓ Treatment goals and monitoring plan
  • ✓ References to FDA labeling and clinical guidelines
From our advocates: "We've seen the strongest appeals include a timeline showing attack frequency before and after other treatments, with specific dates and hospital records. Quantifying the impact—days missed from work, ER visits, quality of life scores—helps medical directors understand the true necessity."

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Key Documents
"Insufficient attack history" Provide detailed records of all attacks, including those treated at home Hospital records, ER visits, urgent care, specialist notes
"Missing lab confirmation" Submit ALA/PBG results from attack periods Lab reports with elevated values and reference ranges
"Not prescribed by specialist" Get consultation from porphyria specialist Specialist credentials, consultation notes, ongoing care plan
"Experimental/investigational" Reference FDA approval and clinical guidelines FDA label, prescribing information, porphyria society guidelines
"Step therapy required" File Ohio step therapy exception Clinical rationale why alternatives are inappropriate

Scripts for Common Situations

Calling Cigna about PA status: "I'm calling about prior authorization request [number] for Givlaari for acute hepatic porphyria. Can you tell me the current status and if any additional documentation is needed?"

Requesting expedited review: "My patient has acute hepatic porphyria with frequent severe attacks. Delays in starting Givlaari could result in life-threatening complications. I'm requesting expedited prior authorization review under your urgent care protocols."

When to Escalate to State Regulators

Contact the Ohio Department of Insurance if:

  • Cigna doesn't respond within required timeframes
  • You're denied external review eligibility
  • Procedural violations occur during appeals
  • Pattern of inappropriate denials

Ohio Department of Insurance Consumer Services:

  • Phone: 1-800-686-1526
  • Website: insurance.ohio.gov
  • File complaint: Online complaint form available

UHCAN Ohio (Consumer Assistance):

  • Helpline: (614) 456-0060 ext 233
  • Email: [email protected]
  • Services: Free help with insurance denials and appeals

FAQ: Your Top Questions Answered

Q: How long does Cigna prior authorization take for Givlaari in Ohio? A: Standard PA decisions take up to 15 business days. Expedited reviews (for urgent cases) must be completed within 72 hours.

Q: What if Givlaari isn't on Cigna's formulary? A: You can request a formulary exception with clinical justification. Since Givlaari is the only FDA-approved chronic AHP preventive therapy, exceptions are often granted with proper documentation.

Q: Can I request an expedited appeal if my attacks are worsening? A: Yes. If delay would seriously jeopardize your health, request expedited internal appeal (15 days) and expedited external review (72 hours).

Q: Does step therapy apply if I failed treatments in another state? A: Ohio law requires recognition of prior treatment failures regardless of where they occurred. Document all previous therapies with medical records.

Q: What's the cost of Givlaari with Cigna coverage? A: Costs vary by plan. Givlaari is typically on specialty tier with higher copays. Check manufacturer copay assistance programs and patient foundation grants.

Q: How do I find a porphyria specialist in Ohio? A: Contact the American Porphyria Foundation for specialist referrals. Major medical centers like Cleveland Clinic and Ohio State often have specialists.

Q: What if my employer plan is self-funded (ERISA)? A: Self-funded plans may follow different procedures but often use Ohio's external review process voluntarily. Check your plan documents or contact HR.

Q: Can Counterforce Health help with my Cigna appeal? A: Yes, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps identify denial reasons and drafts point-by-point rebuttals aligned to payer policies, including Cigna's specific requirements for Givlaari coverage.

Sources & Further Reading

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes, then identifies the denial basis and drafts point-by-point rebuttals aligned to the plan's own rules. For Givlaari appeals with Cigna, Counterforce Health can help identify specific coverage criteria gaps and develop compelling clinical arguments that address Ohio's regulatory requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan terms. Always consult with your healthcare provider about treatment options and contact your insurance plan directly for coverage verification. For personalized assistance with appeals, consider consulting with qualified patient advocates or legal professionals.

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