By Counterforce Health Team in Orfadin (nitisinone) —

How to Get Orfadin (nitisinone) Covered by Cigna in Georgia: Prior Authorization, Appeals, and State Protections

Answer Box: Getting Orfadin (nitisinone) Covered by Cigna in Georgia

Orfadin (nitisinone) requires prior authorization through Cigna's specialty pharmacy (Accredo/Express Scripts) for hereditary tyrosinemia type 1 (HT-1). Georgia law provides strong protections including 24-hour step therapy override decisions and 60-day external review rights.

Fastest path to approval:

  1. Submit PA with confirmed HT-1 diagnosis (elevated succinylacetone, ICD-10 E70.29)
  2. Include metabolic specialist attestation and dietary management plan
  3. If denied, use Georgia's step therapy exception criteria within 2 business days

Start today: Contact Cigna member services at 1-800-Cigna24 to confirm your specialty pharmacy benefit and request PA forms.

Table of Contents

  1. Why Georgia State Rules Matter
  2. Prior Authorization Requirements for Orfadin
  3. Georgia's Step Therapy Protections
  4. Appeal Turnaround Standards
  5. Continuity of Care Protections
  6. External Review Process
  7. Practical Scripts and Templates
  8. Common Denial Reasons and Solutions
  9. When to Escalate
  10. FAQ

Why Georgia State Rules Matter

Georgia's insurance laws create specific protections for patients seeking specialty drug coverage that go beyond federal minimums. These rules apply to fully-insured commercial plans (including marketplace plans) but may not cover self-funded employer plans governed by ERISA.

Key Georgia protections include:

  • Mandatory 24-hour response times for urgent step therapy exceptions
  • 60-day external review rights through the Georgia Department of Insurance
  • Continuity of care protections during plan transitions
  • Specific medical exception criteria that override standard step therapy
Note: If you're covered through a large employer's self-funded plan, these Georgia protections may not apply. Check with your HR department about your plan type.

Prior Authorization Requirements for Orfadin

Orfadin (nitisinone) is covered under Cigna's specialty pharmacy benefit and requires mandatory prior authorization. The medication must be dispensed through Accredo or Express Scripts, not retail pharmacies.

Coverage Requirements Table

Requirement What It Means Documentation Needed Source
HT-1 Diagnosis Confirmed hereditary tyrosinemia type 1 Elevated succinylacetone levels, genetic testing ICD-10 E70.29
Specialist Involvement Metabolic specialist or physician with HT-1 expertise Prescription and attestation from specialist Cigna specialty requirements
Dietary Management Tyrosine/phenylalanine restricted diet Dietitian plan or specialist co-signature FDA labeling requirement
Dosing Limits Up to 2 mg/kg/day per FDA guidance Weight-based calculation documentation Cigna dosing policy

Step-by-Step: Fastest Path to Approval

  1. Gather documentation (Patient/Clinic): Collect lab results showing elevated succinylacetone, genetic testing if available, and current dietary plan
  2. Contact Cigna specialty pharmacy (Patient): Call 1-800-Cigna24 to request PA forms and confirm Accredo/Express Scripts enrollment
  3. Complete PA submission (Clinic): Submit via Cigna provider portal with ICD-10 E70.29 and HCPCS J8499
  4. Await determination (5 business days standard, 24 hours if urgent)
  5. If approved: Medication ships from specialty pharmacy within 2-3 business days
  6. If denied: Proceed immediately to appeal using Georgia's step therapy protections

Georgia's Step Therapy Protections

Georgia Code § 33-24-59.25 provides strong protections for patients who need to bypass step therapy requirements. For Orfadin, this is particularly relevant when insurers require trying generic nitisinone first.

Medical Exception Criteria

Georgia law requires insurers to grant step therapy exceptions when clinical documentation shows:

  • Contraindication: Step therapy drug will cause adverse reaction or harm
  • Expected ineffectiveness: Based on patient's clinical condition and drug characteristics
  • Prior failure: Patient previously tried the step therapy drug (or same class) with lack of efficacy or adverse events
  • Current stability: Patient is stable on non-step therapy drug and switching would be harmful

Response Timelines

Request Type Response Time What Happens If No Response
Urgent cases 24 hours Exception automatically granted
Non-urgent cases 2 business days Exception automatically granted
Tip: Always mark requests as urgent if any delay could worsen the patient's condition. Georgia law supports this for HT-1 cases where liver function is at risk.

Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing plan policies and crafting evidence-backed rebuttals. Their platform helps identify the specific denial basis and draft point-by-point responses aligned to each plan's own rules, which can be particularly valuable when navigating Georgia's step therapy exception process.

Appeal Turnaround Standards

Georgia requires specific timelines for appeal responses, with stronger protections for urgent cases:

Internal Appeals

  • Urgent appeals: 72 hours maximum
  • Standard appeals: 30 calendar days
  • Filing deadline: 60 days from denial notice (for Medicaid plans)

Documentation Requirements

  • Original denial letter
  • Medical records supporting necessity
  • Specialist attestation letter
  • Previous treatment history
  • Appeal form from insurer

Continuity of Care Protections

Georgia mandates continuity of care protections for patients on ongoing specialty drug therapy during insurance transitions.

Key Protections

  • 45-day minimum: Previously approved PAs must be honored for at least 45 days after plan change
  • Chronic conditions: Up to 6 months protection for ongoing therapies like HT-1 treatment
  • No repeated step therapy: Patients can't be forced to retry failed medications from previous plans
Important: These protections apply during transitions between Georgia Medicaid plans or when changing commercial insurers, but documentation of prior authorization and treatment history is essential.

External Review Process

If Cigna denies your internal appeal, Georgia's external review process provides independent medical review through the Georgia Department of Insurance.

Eligibility and Timeline

  • Filing deadline: 60 days from final internal denial
  • Expedited option: Available if delay would jeopardize health
  • Cost: Free to consumers
  • Decision timeline: 30 days standard, 72 hours for urgent cases

How to File

Contact the Georgia Department of Insurance:

Required Documents

  • Final internal denial letter from Cigna
  • All medical records and specialist letters
  • Documentation of medical necessity
  • Previous treatment attempts and outcomes

Practical Scripts and Templates

Patient Phone Script for Cigna

"Hi, I need to request prior authorization for Orfadin for hereditary tyrosinemia type 1. My doctor says this requires specialty pharmacy. Can you transfer me to the specialty pharmacy PA department and confirm whether I need to enroll with Accredo or Express Scripts first?"

Medical Necessity Letter Checklist

For clinicians writing appeals:

  • ✓ Confirmed HT-1 diagnosis with lab values (succinylacetone levels)
  • ✓ Clinical presentation and liver function status
  • ✓ Dietary management plan compliance
  • ✓ Why generic alternatives are insufficient (if applicable)
  • ✓ Reference to FDA labeling and HT-1 treatment guidelines
  • ✓ Dosing rationale based on patient weight/BSA

Common Denial Reasons and Solutions

Denial Reason How to Overturn Key Documentation
"No confirmed HT-1 diagnosis" Submit lab results showing elevated succinylacetone Biochemical testing evidence
"Try generic nitisinone first" File Georgia step therapy exception Prior failure documentation or contraindication letter
"Not medically necessary" Specialist letter citing FDA labeling Reference FDA-approved indication for HT-1
"Quantity limits exceeded" Weight-based dosing justification BSA calculation and specialist attestation

When to Escalate

Contact Georgia Department of Insurance if:

  • Cigna misses response deadlines (24 hours urgent, 2 days standard for step therapy)
  • Internal appeal exceeds 30 days without urgent circumstances
  • You believe the denial violates Georgia insurance law

Georgia DOI Consumer Services: 1-800-656-2298

Additional consumer assistance:

Clinician Corner: Medical Necessity Documentation

Essential elements for HT-1 treatment justification:

Diagnosis confirmation:

  • Elevated succinylacetone (>20 μmol/L typically diagnostic)
  • Clinical presentation (hepatomegaly, failure to thrive, liver dysfunction)
  • Genetic testing results if available (FAH gene mutations)

Treatment rationale:

  • FDA-approved indication for HT-1 as adjunct to dietary restriction
  • Prevention of hepatocellular carcinoma and liver failure
  • Monitoring plan for succinylacetone and tyrosine levels

Guideline support:

  • Reference FDA labeling for nitisinone
  • Cite metabolic specialist society recommendations where available
  • Include dietary management compliance documentation

FAQ

How long does Cigna prior authorization take for Orfadin in Georgia? Standard PA review is 5 business days, but urgent cases must be decided within 24 hours under Georgia law. If Cigna misses these deadlines, the request is deemed approved.

What if Orfadin is non-formulary on my Cigna plan? You can request a formulary exception through the same PA process. Include medical necessity documentation and evidence that formulary alternatives are inappropriate for HT-1.

Can I request an expedited appeal in Georgia? Yes, if any delay could seriously jeopardize your health. For HT-1 patients with liver dysfunction, this often qualifies for expedited review (72-hour decision timeline).

Does step therapy apply if I've been stable on Orfadin with another insurer? Georgia's continuity of care protections should prevent requiring step therapy for at least 45 days after plan change. Document your prior authorization and treatment history.

What happens if my external review is denied? The external review decision is binding on Cigna and ends the administrative process. Further disputes would require legal action, though this is rare for clearly indicated HT-1 treatment.

How do I know if Georgia protections apply to my plan? These protections apply to fully-insured commercial plans and Georgia Medicaid. Large employer self-funded plans may be exempt. Check with your HR department about your plan type.

From Our Advocates

"We've seen many HT-1 families successfully appeal Orfadin denials in Georgia by emphasizing the urgent nature of treatment and citing specific state protections. The key is often demonstrating that any delay risks liver damage progression. One family's appeal was approved within 24 hours after their specialist clearly documented how interrupting treatment could lead to hepatic crisis. While every case is different, Georgia's strong consumer protections often work in favor of patients with well-documented medical necessity."

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify the specific denial basis, then drafts point-by-point rebuttals aligned to each plan's own rules, incorporating the right clinical evidence and procedural requirements for maximum appeal success.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For assistance with appeals and prior authorization challenges, visit www.counterforcehealth.org.

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