By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (lomitapide) Covered by Humana in California: Prior Authorization, Appeals, and Cost Assistance

Answer Box: Getting Juxtapid (lomitapide) Covered by Humana in California

Juxtapid requires prior authorization from Humana with strict clinical documentation. Key requirements include genetic confirmation of homozygous familial hypercholesterolemia (HoFH), documented failure or intolerance to maximum-dose statins and ezetimibe, enrollment in the REMS program, and dispensing through certified specialty pharmacies only. First step: Have your prescriber submit a complete prior authorization packet through CenterWell Specialty Pharmacy or Humana's provider portal with genetic testing results, prior therapy documentation, and liver monitoring plan. If denied, California residents can appeal through Medicare's process (for Medicare Advantage) or request an Independent Medical Review through DMHC (for commercial plans).

Table of Contents

  1. What Drives Juxtapid Coverage Costs
  2. Investigating Your Humana Benefits
  3. Prior Authorization Requirements
  4. Copay Assistance and Financial Support
  5. Specialty Pharmacy Coordination
  6. Appeals Process in California
  7. Annual Renewal Planning
  8. Conversation Scripts
  9. FAQ

What Drives Juxtapid Coverage Costs

Juxtapid (lomitapide) is a high-cost specialty oral medication that typically costs in the mid-five figures per 28-day supply. Several factors determine your out-of-pocket costs with Humana:

Formulary Tier Placement: Juxtapid is covered under Humana Medicare Advantage plans but requires prior authorization. The medication is classified as a specialty drug, placing it on higher-cost tiers with percentage-based coinsurance rather than flat copays.

REMS Program Requirements: The FDA mandates that Juxtapid be dispensed only through certified specialty pharmacies enrolled in the Risk Evaluation and Mitigation Strategy (REMS) program due to hepatotoxicity risks. This limits your pharmacy options but ensures proper monitoring.

Step Therapy Protocols: Humana enforces step therapy requirements, meaning you must try and fail (or have contraindications to) preferred lipid-lowering therapies before Juxtapid approval. This includes maximum-dose statins and ezetimibe.

Investigating Your Humana Benefits

Before starting the prior authorization process, gather this information about your specific Humana plan:

Call Member Services: Use the number on your insurance card to verify:

  • Your current formulary tier for Juxtapid
  • Prior authorization requirements specific to your plan
  • Your specialty pharmacy benefit details
  • Annual out-of-pocket maximums

Key Questions to Ask:

  • "Is Juxtapid covered under my pharmacy or medical benefit?"
  • "What's my coinsurance percentage for specialty tier medications?"
  • "Do I need to use CenterWell Specialty Pharmacy specifically?"
  • "What's the prior authorization form number for Juxtapid?"

Document Everything: Record the representative's name, date, and reference number for your call. Request written confirmation of coverage details if possible.

Prior Authorization Requirements

Humana requires comprehensive clinical documentation for Juxtapid approval. Based on their clinical policy, you'll need:

Essential Documentation

Genetic Confirmation: Bi-allelic pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes confirming homozygous familial hypercholesterolemia. Clinical diagnosis criteria include:

  • Untreated LDL-C ≥250 mg/dL in adults (or ≥190 mg/dL with family history)
  • Untreated LDL-C ≥190 mg/dL in children (or ≥160 mg/dL with affected first-degree relative)
  • Exclusion of secondary causes of hypercholesterolemia

Prior Therapy Documentation: Evidence of trial and failure or contraindication to:

  • Maximum-dose statin therapy (rosuvastatin 20-40 mg or atorvastatin 40-80 mg daily)
  • Ezetimibe 10 mg daily
  • Medical justification if PCSK9 inhibitors (Praluent, Repatha) weren't tried first

REMS Enrollment: Confirmation that both prescriber and patient are enrolled in the Juxtapid REMS program with ongoing liver monitoring plan.

Pregnancy Prevention: For females of childbearing potential, documented negative pregnancy test and contraception counseling.

Step-by-Step: Fastest Path to Approval

  1. Prescriber obtains genetic testing confirming HoFH diagnosis (if not already done)
  2. Complete prior therapy trials or document contraindications/intolerance to required medications
  3. Enroll in REMS program at juxtapid.com
  4. Submit prior authorization using Humana's PCSK9/Lipotropics form
  5. Coordinate with CenterWell Specialty Pharmacy for prescription fulfillment
  6. Establish liver monitoring plan with baseline and ongoing LFTs
  7. Follow up within 30 days if no response from Humana
Clinician Corner: Your medical necessity letter should specifically reference Humana's clinical criteria and include: confirmed HoFH genetic diagnosis, detailed prior therapy history with dates and outcomes, contraindication documentation for any skipped therapies, current LDL-C levels despite maximum therapy, and your monitoring plan for hepatotoxicity. Include references to the FDA label and current HoFH treatment guidelines.

Copay Assistance and Financial Support

Chiesi Total Care Program: Eligible patients with commercial insurance can access copay assistance through Chiesi Total Care. The program covers 100% of copayment/coinsurance up to annual maximums. Key eligibility requirements:

  • Valid Juxtapid prescription
  • U.S. resident
  • Commercial (private) insurance only
  • NOT eligible: Medicare, Medicaid, TRICARE, VA, or state programs

Application Process:

  • Complete the enrollment form
  • Fax to 1-855-898-2498 or call 1-855-898-2743
  • Include insurance card copies (front and back)
  • Annual renewal required by December 31

Medicare Patients: Since Chiesi's copay program excludes government insurance, Medicare Advantage members should explore:

  • State pharmaceutical assistance programs
  • Nonprofit patient assistance foundations
  • Medicare's Extra Help program for prescription costs

Specialty Pharmacy Coordination

Juxtapid is only available through certified specialty pharmacies - it cannot be dispensed at retail locations due to REMS requirements.

Humana's Preferred Option: CenterWell Specialty Pharmacy handles Humana's specialty medications and coordinates prior authorizations.

Coordination Steps:

  1. Your prescriber sends the prescription directly to CenterWell Specialty
  2. CenterWell contacts you to verify insurance and shipping preferences
  3. They coordinate prior authorization submission with Humana
  4. Once approved, medications ship via overnight delivery
  5. CenterWell provides ongoing refill coordination and clinical support

REMS Compliance: The specialty pharmacy will ensure you receive required educational materials and coordinate with your prescriber for liver monitoring requirements.

Tip: CenterWell can often expedite prior authorization reviews by submitting complete clinical packets upfront. Ask them to include all required documentation in the initial submission rather than waiting for Humana to request additional information.

Appeals Process in California

If your initial prior authorization is denied, California offers robust appeal options depending on your plan type:

For Humana Medicare Advantage Plans

Medicare Advantage appeals follow federal Medicare rules, not California state processes:

Level 1 - Plan Appeal:

  • File within 60 days of denial
  • Standard appeals decided within 30 days
  • Expedited appeals (if health is at risk) decided within 72 hours
  • Submit via Humana member portal or mail

Level 2 - Independent Review:

  • Automatic if Level 1 is denied
  • External contractor reviews your case
  • Same timelines as Level 1

Levels 3-5: Administrative Law Judge, Medicare Appeals Council, and Federal Court (for appeals over $1,730 in 2024)

For Commercial Humana Plans (DMHC-Regulated)

California residents with DMHC-regulated plans can use the state's Independent Medical Review (IMR) process:

Internal Appeal First:

  • File grievance with Humana within 180 days
  • Plan has 30 days to respond (expedited available for urgent cases)

Independent Medical Review:

  • Available after internal appeal denial
  • File with DMHC within 6 months
  • Independent physicians review medical necessity
  • Standard IMR decided within 45 days, expedited within 72 hours
  • No cost to patient
  • Plan must comply with favorable IMR decisions

DMHC Help Center: Call 888-466-2219 for assistance with complaints or IMR applications. The healthhelp.ca.gov website has online IMR applications in multiple languages.

Appeals Documentation

For any appeal, include:

  • Complete denial letter from Humana
  • All clinical records supporting medical necessity
  • Genetic testing confirming HoFH diagnosis
  • Documentation of prior therapy failures/contraindications
  • Prescriber letter specifically addressing denial reasons
  • Relevant medical literature and treatment guidelines

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing the denial basis and crafting point-by-point rebuttals aligned to the plan's own rules, helping patients get prescription drugs approved more efficiently.

Annual Renewal Planning

Plan ahead for annual changes that could affect your Juxtapid coverage:

October-November: Review Humana's Annual Notice of Change for:

  • Formulary tier changes
  • Prior authorization requirement updates
  • Specialty pharmacy network changes
  • Cost-sharing modifications

December:

  • Renew Chiesi Total Care enrollment before December 31
  • Confirm CenterWell Specialty Pharmacy is still in-network
  • Review your plan's out-of-pocket maximum progress

January:

  • Expect potential re-authorization requirements
  • Budget for deductible restart
  • Confirm your prescriber's REMS enrollment is current

Conversation Scripts

Calling Humana Member Services

"Hi, I'm calling about prior authorization requirements for Juxtapid, spelled J-U-X-T-A-P-I-D. My member ID is [number]. I have homozygous familial hypercholesterolemia and my doctor wants to prescribe this medication. Can you tell me:

  • What prior authorization form is needed?
  • What clinical documentation is required?
  • How long does the review typically take?
  • Do I need to use CenterWell Specialty Pharmacy specifically?"

Requesting Peer-to-Peer Review

"This is [clinic name] calling to request a peer-to-peer review for a Juxtapid prior authorization denial. The patient has genetically confirmed HoFH and has failed maximum statin and ezetimibe therapy. We have all required REMS documentation. Can we schedule a clinical review with one of your medical directors?"

Following Up on Pending Authorization

"I'm calling to check the status of a prior authorization for Juxtapid submitted [date] for member [ID]. It's been [number] days and we haven't received a determination. This is for a rare genetic condition and the patient needs to start treatment. Can you provide an update and expedite if possible?"

FAQ

How long does Humana's prior authorization take for Juxtapid? Standard prior authorizations are typically decided within 15 business days. Expedited reviews (when health is at risk) must be completed within 72 hours. Submit complete documentation upfront to avoid delays.

What if Juxtapid isn't on Humana's formulary? Juxtapid is covered under Humana Medicare Advantage plans as of December 2024. If you have a commercial plan where it's non-formulary, request a formulary exception with medical necessity documentation.

Can I get an expedited appeal if my Juxtapid is denied? Yes, if your health would be seriously jeopardized by delay. Your prescriber must document that standard timelines would significantly increase health risks. Expedited appeals are decided within 72 hours.

Does step therapy apply if I tried these medications with a previous insurer? Yes, document prior therapy attempts regardless of where they occurred. Include medical records showing specific medications, doses, duration, and reasons for discontinuation from any provider or plan.

What happens if I move from California to another state? Your Humana coverage terms remain the same, but state appeal rights change. You'll lose access to California's IMR process and must use the appeals procedures in your new state or federal Medicare appeals for Medicare Advantage.

How often do I need to renew prior authorization for Juxtapid? This varies by plan, but typically annually or when your clinical status changes. Humana may require periodic re-authorization to confirm ongoing medical necessity and REMS compliance.

When navigating complex prior authorization requirements like those for Juxtapid, many patients and providers benefit from specialized support. Counterforce Health helps turn insurance denials into successful appeals by identifying the specific denial basis and crafting targeted responses with the right clinical evidence and regulatory citations.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for the most current requirements and procedures. For assistance with insurance complaints or appeals in California, contact the DMHC Help Center at 888-466-2219 or visit healthhelp.ca.gov.

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