By Counterforce Health Team in Orkambi (lumacaftor/ivacaftor) —

How to Get Orkambi (lumacaftor/ivacaftor) Covered by Humana in Georgia: Prior Authorization, Appeals, and Cost Assistance

Answer Box: Getting Orkambi Covered by Humana in Georgia

Orkambi requires prior authorization from Humana with documented F508del homozygosity and specialist evaluation. If denied, you have 65 days to file an internal appeal and can request external review through the Georgia Department of Insurance within 60 days of final denial. Start by contacting your CF care center to initiate the prior authorization process and gather genetic testing results. Vertex offers copay assistance up to $20,000 annually for commercially insured patients.

Table of Contents

  1. What Drives Orkambi Coverage Costs
  2. Benefit Investigation: What to Ask Humana
  3. Financial Assistance Options
  4. Prior Authorization Requirements
  5. Appeals Process in Georgia
  6. Specialty Pharmacy Coordination
  7. Annual Renewal Considerations
  8. Conversation Scripts
  9. FAQ

What Drives Orkambi Coverage Costs

Orkambi (lumacaftor/ivacaftor) carries a list price of approximately $302,106 annually, making it one of the most expensive specialty medications. Humana's coverage decisions hinge on several factors:

Formulary Placement: Specialty medications like Orkambi typically land on the highest tier, requiring significant cost-sharing even when covered. Humana's formulary varies by plan, so your specific tier and copay depend on your exact coverage type.

Prior Authorization Requirements: Nearly all Humana plans require prior authorization for Orkambi, focusing on genetic confirmation and specialist documentation. The approval rate for properly documented requests is generally high, but missing documentation causes delays.

Medical Necessity Standards: Humana requires documented F508del homozygosity, age-appropriate prescribing per FDA labeling, and specialist evaluation from a cystic fibrosis care center.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Pre-approval required before dispensing Humana provider portal Humana PA Process
Genetic Testing F508del homozygosity documentation CF care center records FDA Orkambi Label
Specialist Evaluation CF pulmonologist assessment CF care center CFF Care Center Directory
Age Requirements Per FDA-approved age ranges Prescriber documentation FDA Label
Appeals Deadline 65 days from denial Denial letter Medicare Appeals Process

Benefit Investigation: What to Ask Humana

Before starting treatment, contact Humana to understand your specific coverage. Call the member services number on your insurance card and ask:

  1. "Is Orkambi covered on my specific plan's formulary?"
  2. "What tier is it on, and what's my copay or coinsurance?"
  3. "What prior authorization requirements apply?"
  4. "Are there quantity limits or step therapy requirements?"
  5. "Which specialty pharmacies are in-network for dispensing?"

Document the representative's name, date, and reference number for future appeals if needed.

Financial Assistance Options

Vertex GPS Co-pay Assistance Program

Vertex Pharmaceuticals offers the most significant cost reduction for commercially insured patients. The program provides up to $20,000 annually in copay assistance with no income limits.

Eligibility Requirements:

  • Commercial insurance coverage (not Medicare or Medicaid)
  • Valid U.S. or Puerto Rico residency
  • Enrollment through prescriber or online portal

How to Apply:

  • Call or text 1-877-752-5933 (press 2)
  • Enroll online at vertexgpsportal.com
  • Have your doctor fax enrollment forms to 1-888-952-5933

Georgia-Specific Assistance Programs

BreatheStrong CF — Susan C. Burroughs Critical Needs Initiative provides financial assistance for CF patients in Georgia experiencing hardship. While not specific to medication costs, the program offers grocery and fuel gift cards to help with living expenses.

Contact: 1-770-765-6508 or [email protected]

CF Foundation Compass offers free case management services nationwide, including help navigating insurance coverage and identifying additional assistance programs.

Contact: 1-844-COMPASS (1-844-266-7277)

Prior Authorization Requirements

Humana requires comprehensive documentation for Orkambi approval. Your CF specialist must submit:

Required Documentation Checklist

  • Genetic testing results confirming F508del homozygosity
  • Current pulmonary function tests (FEV1)
  • Documentation of cystic fibrosis diagnosis with ICD-10 code E84.9
  • Prescriber attestation of medical necessity
  • Patient age verification within FDA-approved range
  • Previous treatment history (if applicable)

Submission Process

Your prescriber can submit prior authorization requests through:

  • Phone: 1-800-555-CLIN (2546) (Monday–Friday, 8 a.m.–8 p.m.)
  • Fax: 1-877-486-2621
  • Online: Humana provider portal

Humana must respond within 72 hours for standard requests or 24 hours for expedited requests.

Clinician Corner: Medical Necessity Letter Elements

Include these key components in your prior authorization request:Patient's specific CF genotype (F508del homozygosity)Current pulmonary function and clinical statusRationale for Orkambi over other CFTR modulatorsTreatment goals and monitoring planReferences to FDA labeling and CF Foundation guidelines

Appeals Process in Georgia

If Humana denies your Orkambi request, Georgia law provides multiple appeal levels with specific timelines.

Step-by-Step Appeals Process

Step 1: Internal Appeal (First Level)

  • Timeline: File within 65 days of denial
  • How: Submit through Humana member portal or mail written request
  • Decision: Humana responds within 30 days (7 days for expedited)
  • Required: Copy of denial letter, additional medical documentation

Step 2: External Review (Georgia Department of Insurance)

  • Timeline: File within 60 days of final internal denial
  • How: Submit application to Georgia DOI Consumer Services
  • Decision: 30 business days (72 hours for expedited)
  • Cost: Free to consumers
  • Contact: 1-800-656-2298

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing genetic testing Submit F508del homozygosity results Laboratory report from CLIA-certified lab
Age restrictions Verify FDA-approved age range Birth certificate, medical records
Lack of specialist evaluation CF center assessment Letter from accredited CF care center
Step therapy required Document contraindications to alternatives Medical records showing adverse reactions
From Our Advocates

We've seen many Georgia families successfully overturn initial denials by working closely with their CF care center's social worker to compile complete genetic testing documentation. The key is submitting everything together rather than piecemeal responses.

Specialty Pharmacy Coordination

Orkambi requires dispensing through Humana's specialty pharmacy network. Approved specialty pharmacies include ACCREDO, ACARIA, WALGREENS, OPTUM, and others.

Coordination Tips

  • Choose one primary pharmacy to avoid coordination issues
  • Provide complete insurance information including group numbers
  • Set up automatic refills to prevent treatment gaps
  • Maintain contact with pharmacy case managers for ongoing support

CenterWell Specialty Pharmacy offers clinical support services for complex therapies like Orkambi, including refill coordination and educational resources.

For patients seeking comprehensive support navigating these complex requirements, Counterforce Health helps families turn insurance denials into successful appeals by analyzing denial letters, identifying missing documentation, and drafting evidence-based responses that align with each payer's specific requirements.

Annual Renewal Considerations

Humana can modify formulary coverage annually, affecting your Orkambi access and costs.

What Can Change

  • Formulary tier placement (affecting copays)
  • Prior authorization requirements (additional documentation)
  • Preferred pharmacy networks (limiting dispensing options)
  • Quantity limits (affecting supply duration)

Renewal Preparation

  • Review annual plan materials sent each fall
  • Contact your CF care center to update prior authorizations
  • Verify continued specialty pharmacy network participation
  • Update financial assistance program enrollments

Conversation Scripts

Calling Humana Member Services

"Hi, I need to verify coverage for Orkambi, generic name lumacaftor-ivacaftor, for cystic fibrosis. Can you tell me if this medication is covered on my plan, what tier it's on, my expected copay, and any prior authorization requirements? I'd also like the reference number for this call."

Requesting Expedited Review

"I'm requesting expedited review for my Orkambi prior authorization because any delay in treatment poses serious health risks for my cystic fibrosis. My doctor can provide documentation of medical urgency if needed."

Pharmacy Coordination Call

"I need to transfer my Orkambi prescription to your specialty pharmacy. I have Humana insurance and need to verify you're in-network, set up my patient profile, and arrange for automatic refills with case management support."

FAQ

How long does Humana prior authorization take for Orkambi in Georgia? Standard requests receive decisions within 72 hours, while expedited requests are processed within 24 hours. Submit through Humana Clinical Pharmacy Review for fastest processing.

What if Orkambi isn't on Humana's formulary? You can request a formulary exception by demonstrating medical necessity. Your prescriber must show that covered alternatives would be less effective or cause adverse effects.

Can I get expedited appeals in Georgia? Yes, both internal appeals with Humana (24-72 hours) and external reviews through Georgia DOI (72 hours) offer expedited processing when health is at immediate risk.

Does Vertex copay assistance work with Humana? Yes, the Vertex GPS program provides up to $20,000 annually for commercially insured patients, including those with Humana coverage.

What genetic testing documentation does Humana require? Humana requires laboratory confirmation of F508del homozygosity from a CLIA-certified laboratory, typically performed at CF care centers during initial diagnosis.

How do I contact Georgia insurance regulators for help? Call the Georgia Department of Insurance Consumer Services at 1-800-656-2298 for assistance with appeals, complaints, or questions about your rights under Georgia insurance law.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by individual plan and circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional support with complex insurance appeals, Counterforce Health provides specialized assistance in turning denials into successful approvals through evidence-based appeal strategies.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.