How to Get Juxtapid (Lomitapide) Covered by Aetna CVS Health in Pennsylvania: Complete Prior Authorization Guide
Answer Box: Getting Juxtapid (Lomitapide) Covered by Aetna CVS Health in Pennsylvania
Juxtapid (lomitapide) requires prior authorization from Aetna CVS Health for homozygous familial hypercholesterolemia (HoFH) treatment in Pennsylvania. Submit requests through CVS Caremark's ePA portal at Availity.com or fax to 1-866-249-6155. Key requirements: genetic HoFH confirmation, documented failures of prior lipid-lowering therapies, baseline liver function tests, and REMS program enrollment. If denied, Pennsylvania's new external review program has a 50% overturn rate for specialty drug appeals.
First step today: Call CVS Caremark at 1-800-294-5979 with your member ID to verify formulary status and specific step therapy requirements.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Required Documentation
- Common Denial Reasons & How to Fix Them
- Appeals Process for Pennsylvania Residents
- Coding and Billing Information
- Cost-Saving Options
- When to Escalate
- Frequently Asked Questions
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required for all Juxtapid prescriptions | CVS Caremark PA portal | CVS Caremark |
| Formulary Status | Specialty Tier 3-4 drug | Member portal or call 1-800-294-5979 | Aetna |
| REMS Program | Mandatory enrollment due to liver toxicity | JuxtapidREMSprogram.com | FDA/Chiesi |
| Diagnosis Code | ICD-10: E78.01 (HoFH) | Provider documentation | ICD-10 |
| Site of Care | Specialty pharmacy only (Accredo/CVS Specialty) | CVS Caremark network | CVS Health |
| Appeals Deadline | 180 days for internal; 4 months for PA external review | PA Insurance Department | PA DOI |
Step-by-Step: Fastest Path to Approval
1. Verify Coverage and Requirements
Who: Patient or clinic staff
Action: Call CVS Caremark at 1-800-294-5979 with member ID
Timeline: Same day
What to ask: Formulary tier, step therapy requirements, quantity limits, preferred specialty pharmacy
2. Enroll in REMS Program
Who: Prescriber and patient
Action: Complete Prescriber Enrollment Form and Patient-Prescriber Acknowledgement Form
Timeline: 1-2 business days
Submit to: Fax 1-855-898-2498 or email [email protected]
3. Gather Clinical Documentation
Who: Healthcare team
Documents needed:
- Genetic testing confirming HoFH (biallelic LDLR mutations)
- Lipid panel showing LDL-C ≥190 mg/dL despite maximum therapy
- Documentation of prior therapy failures (statins, ezetimibe, PCSK9 inhibitors)
- Baseline liver function tests (ALT/AST <3x upper limit normal)
- Medical necessity letter
4. Submit Prior Authorization
Who: Prescriber or clinic staff
Fastest method: CVS Caremark ePA portal via Availity
Alternative: Fax to 1-866-249-6155
Timeline: 24-48 hours acknowledgment; 3-5 business days decision
5. Use Prescription Authorization Form (PAF)
Who: Prescriber
Action: Complete PAF for each new prescription (up to 11 refills)
Submit to: Fax 1-855-898-2498
Required: Confirms REMS enrollment, LFTs, pregnancy status
6. Track and Follow Up
Who: Patient or clinic
Action: Use reference number to track status
Follow-up: Weekly calls if no response within expected timeframe
7. Appeal if Denied
Who: Patient with provider support
Action: Request peer-to-peer review first, then formal appeal
Pennsylvania advantage: State external review available with 50% success rate
Required Documentation
Medical Necessity Letter Template
Your prescriber should include these elements:
Patient Information:
- Full name, DOB, Aetna member ID
- Diagnosis: Homozygous familial hypercholesterolemia (ICD-10: E78.01)
Clinical Justification: "Requesting prior authorization for lomitapide (Juxtapid) for [Patient Name], a [age]-year-old with genetically confirmed homozygous familial hypercholesterolemia. Current LDL cholesterol is [value] mg/dL despite maximum tolerated lipid-lowering therapy including [list medications with doses and durations]. Patient has documented intolerance/inadequate response to [specific therapies]. Untreated HoFH carries significant risk of premature cardiovascular disease."
Supporting Evidence:
- Genetic test results confirming biallelic mutations
- Recent lipid panel (within 3 months)
- Documentation of prior therapy trials with specific reasons for discontinuation
- Baseline liver function tests
- Treatment goals and monitoring plan
From Our Advocates: We've seen denials overturned when providers include specific LDL-C values before and after each prior therapy trial, along with exact dates of treatment periods. This concrete evidence of inadequate response strengthens medical necessity arguments significantly.
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn |
|---|---|
| "Not medically necessary" | Submit genetic testing confirming HoFH diagnosis; include cardiovascular risk assessment |
| "Experimental/investigational" | Reference FDA approval for HoFH as adjunct therapy |
| Missing step therapy | Document specific failures of statins, ezetimibe, PCSK9 inhibitors with dates and reasons |
| Inadequate liver monitoring plan | Submit baseline LFTs and detailed monitoring protocol per prescribing information |
| REMS non-compliance | Provide completed enrollment forms and PAF documentation |
| Off-label use | Confirm on-label HoFH indication; include genetic testing if questioned |
Appeals Process for Pennsylvania Residents
Pennsylvania residents benefit from a robust appeals system with multiple levels:
Internal Appeals (Aetna CVS Health)
- Timeline: 180 days from denial date
- Standard review: 30-45 days
- Expedited review: 72 hours for urgent cases
- Submit to: Aetna member portal or address on denial letter
Pennsylvania External Review (New 2024 Process)
Pennsylvania's Independent External Review Program offers significant advantages:
- Success rate: 50% of appeals overturned in first year
- Timeline: 45 days standard; 72 hours expedited
- Cost: Free to consumers
- Binding: Insurers must comply with IRO decisions
How to File:
- Complete Aetna's internal appeal first
- Receive Final Adverse Benefit Determination letter
- Submit request within 4 months at pa.gov/reviewmyclaim
- Provide additional medical records within 15 days of IRO assignment
Contact for Help: Pennsylvania Insurance Department Consumer Services at 1-877-881-6388
Coding and Billing Information
HCPCS/J-Codes
- Primary: J8499 ("Prescription drug, oral, non-chemotherapeutic, NOS")
- Alternative: J3490 (unclassified drugs) for some payers
ICD-10 Codes
- Primary: E78.010 (homozygous familial hypercholesterolemia) - effective 2025
- Alternative: E78.00 (pure hypercholesterolemia)
NDC Codes
NDC codes vary by capsule strength (5mg, 10mg, 20mg, 60mg, 80mg). Verify current NDCs through the REMS program as they must be dispensed through certified pharmacies.
Billing Units
- Bill as number of capsules
- Common limit: 28 capsules per 28 days
- Include exact strength and NDC on all submissions
Cost-Saving Options
Manufacturer Support
- Chiesi Total Care: Copay assistance for commercially insured patients
- Contact: chiesitotalcare.com/juxtapid
- Eligibility: Commercial insurance only (not Medicare/Medicaid)
Foundation Programs
Contact patient advocacy organizations for rare disease funding:
- National Organization for Rare Disorders (NORD)
- HealthWell Foundation
- Patient Access Network Foundation
State Programs
Pennsylvania residents may qualify for additional assistance through state pharmaceutical assistance programs. Contact Pennsylvania PACE at 1-800-225-7223.
When to Escalate
If standard appeals fail, consider these escalation options:
Pennsylvania Insurance Department Complaint
File a complaint if you believe Aetna violated state insurance laws:
- Online: pa.gov insurance complaint portal
- Phone: 1-877-881-6388
- Include: All denial letters, medical records, correspondence
Federal Resources
For Medicare Advantage plans:
- Medicare.gov complaint system
- 1-800-MEDICARE
Frequently Asked Questions
Q: How long does Aetna CVS Health prior authorization take in Pennsylvania? A: Standard decisions typically take 3-5 business days via electronic submission, up to 14 days for fax submissions. Expedited reviews for urgent cases are completed within 72 hours.
Q: What if Juxtapid is non-formulary on my plan? A: Request a formulary exception by demonstrating medical necessity and providing documentation of failed formulary alternatives. Pennsylvania law requires insurers to have exception processes.
Q: Can I request an expedited appeal? A: Yes, if delays would seriously jeopardize your health. Both Aetna's internal process and Pennsylvania's external review offer expedited timelines (72 hours) for urgent cases.
Q: Does step therapy apply if I tried medications before moving to Pennsylvania? A: Yes, document all prior therapy trials regardless of where they occurred. Provide complete medical records and pharmacy records as evidence.
Q: What happens if my appeal is approved? A: Aetna must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal process.
Q: How often do I need to renew prior authorization? A: Most approvals are valid for 12 months. Renewal requires updated clinical documentation, including recent liver function tests and treatment response data.
Getting specialty medications approved can be complex, but Pennsylvania residents have strong appeal rights and support systems. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer requirements.
For complex cases requiring additional support, consider working with patient advocates or organizations specializing in rare disease coverage. The Pennsylvania Insurance Department Consumer Services (1-877-881-6388) provides free assistance with insurance questions and appeals.
Sources & Further Reading
- CVS Caremark Prior Authorization Information
- Aetna Precertification Overview
- Juxtapid REMS Program
- Pennsylvania External Review Process
- FDA Juxtapid Prescribing Information
- Pennsylvania Insurance Department Consumer Services
Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider regarding treatment decisions and insurance coverage questions. Insurance policies and requirements may change; verify current information with your specific plan.
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