By Counterforce Health Team in Ofev (nintedanib) —

How to Get Ofev (nintedanib) Covered by Aetna (CVS Health) in New Jersey: Complete Appeals Guide with Templates

Answer Box: Getting Ofev (nintedanib) Covered by Aetna (CVS Health) in New Jersey

If Aetna (CVS Health) denied your Ofev (nintedanib) prescription for IPF, SSc-ILD, or progressive fibrosing ILD in New Jersey, you have strong appeal rights. First step: Gather your HRCT report, pulmonary function tests, and specialist consultation notes. Second step: Submit a medical necessity appeal within 180 days through Aetna's member portal or by fax to 1-877-309-8077. Third step: If denied again, file an external review with New Jersey's IHCAP program through Maximus (njihcap.maximus.com) within 4 months. New Jersey's external review process is free and binding on insurers, with decisions typically issued within 45 days.

Table of Contents

  1. Understanding Your Denial
  2. Aetna (CVS Health) Prior Authorization Requirements
  3. Step-by-Step: Fastest Path to Approval
  4. Medical Necessity Letter Template
  5. Internal Appeals Process
  6. New Jersey External Review (IHCAP)
  7. Patient Assistance Programs
  8. Common Denial Reasons & Solutions
  9. Frequently Asked Questions

Understanding Your Denial

When Aetna (CVS Health) denies coverage for Ofev (nintedanib), the denial letter will specify the exact reason. Common denial codes include:

  • Prior authorization required: Your doctor must submit clinical documentation proving medical necessity
  • Non-formulary: Ofev isn't on your plan's preferred drug list
  • Step therapy: You must try and fail other medications first
  • Medical necessity: Clinical criteria weren't met or documentation was insufficient
Tip: Look for the denial date and appeals deadline in your letter. Aetna (CVS Health) typically allows 180 days to file an internal appeal, but acting quickly improves your chances.

Aetna (CVS Health) Prior Authorization Requirements

Based on Aetna's 2024 clinical policy, Ofev (nintedanib) requires prior authorization with specific documentation:

Coverage at a Glance

Requirement What It Means Where to Find It
FDA-approved indications only IPF, SSc-ILD, or progressive fibrosing ILD FDA label, physician diagnosis
Pulmonologist involvement Prescribed by or in consultation with lung specialist Specialist consultation notes
HRCT imaging High-resolution CT showing fibrosis pattern Radiology report
Pulmonary function tests FVC ≥50% (IPF), ≥40% (SSc-ILD), ≥45% (progressive) Recent PFT results
Exclusion of other causes Rule out environmental, drug-induced, or autoimmune causes Clinical workup documentation

Required Clinical Documentation

Your pulmonologist must submit:

  • High-resolution CT (HRCT) report showing usual interstitial pneumonia pattern or other compatible findings
  • Pulmonary function tests within the last 12 months meeting threshold requirements
  • Specialist consultation confirming diagnosis and treatment rationale
  • Exclusion workup ruling out other causes of lung fibrosis
  • Treatment history if step therapy requirements apply

Step-by-Step: Fastest Path to Approval

  1. Contact your pulmonologist's office (Patient action): Request they submit a prior authorization with complete documentation including HRCT, PFTs, and medical necessity letter.
  2. Gather supporting documents (Patient/clinic): Collect all imaging reports, lab results, and previous treatment records showing disease progression.
  3. Submit PA request (Clinic): Use Aetna's provider portal or fax to 1-877-309-8077 with all required documentation. Timeline: 5-14 business days for standard review.
  4. Request peer-to-peer review if denied (Clinic): Call 1-866-638-1232 to schedule a discussion between your doctor and Aetna's medical director.
  5. File internal appeal (Patient/clinic): If still denied, submit appeal within 180 days through member portal or by fax. Include additional clinical evidence and updated medical necessity letter.
  6. Pursue external review (Patient): If internal appeals fail, file with New Jersey's IHCAP program through Maximus within 4 months of final denial.
  7. Apply for patient assistance (Patient): Contact Boehringer Ingelheim's programs while appeals are pending to ensure continuous access.

Medical Necessity Letter Template

Clinician Corner: Medical Necessity Documentation

A strong medical necessity letter should address Aetna's specific criteria and include:Confirmed diagnosis with ICD-10 codesHRCT findings consistent with fibrosisPulmonary function test results meeting thresholdsExclusion of alternative causesTreatment goals and expected outcomesReferences to FDA labeling and clinical guidelines

Sample Letter Structure

Dear Aetna Medical Review Team,

I am writing to request coverage for Ofev (nintedanib) 150mg twice daily for [Patient Name, DOB, Member ID] diagnosed with [specific condition].

DIAGNOSIS: [Patient] has biopsy-proven/HRCT-confirmed [IPF/SSc-ILD/progressive fibrosing ILD] diagnosed on [date]. High-resolution CT dated [date] shows [specific findings consistent with UIP pattern/fibrosis]. All environmental, occupational, and drug-induced causes have been excluded through comprehensive workup.

PULMONARY FUNCTION: Most recent PFTs show FVC [X]% predicted and DLCO [Y]% predicted, meeting Aetna's coverage criteria for this indication.

MEDICAL NECESSITY: Despite optimal supportive care, the patient demonstrates progressive functional decline. Ofev is FDA-approved for this exact indication and represents standard of care per ATS/ERS guidelines. Without antifibrotic therapy, continued decline in lung function and quality of life is expected.

PRESCRIBER QUALIFICATIONS: I am a board-certified pulmonologist with extensive experience treating interstitial lung diseases.

All clinical criteria outlined in Aetna policy [reference number] are met. I am available for peer-to-peer discussion if needed.

Sincerely,
[Physician name, credentials, contact information]

Internal Appeals Process

Level 1 Appeal

  • Timeline: Submit within 180 days of denial
  • Decision timeframe: 30 days (standard), 72 hours (expedited)
  • How to submit:
    • Online: Aetna member portal
    • Fax: 1-877-309-8077
    • Mail: Address on denial letter

Level 2 Appeal

If Level 1 is denied, you can request a second internal review:

  • Timeline: 60 days from Level 1 denial
  • Decision timeframe: 30 days (standard), 72 hours (expedited)
  • Additional evidence: Include any new clinical information, peer-reviewed studies, or specialist opinions

Peer-to-Peer Review

Request a clinical discussion between your doctor and Aetna's medical director:

  • How to request: Call 1-866-638-1232 or note on appeal form
  • Best practices: Prepare talking points addressing specific denial reasons
  • Timeline: Usually scheduled within 5-7 business days

New Jersey External Review (IHCAP)

If internal appeals fail, New Jersey's Independent Health Care Appeals Program provides binding external review through Maximus.

Eligibility Requirements

  • Completed all internal appeal levels with Aetna
  • Denial based on medical necessity or similar coverage determination
  • NJ-regulated health plan (not self-funded employer plans)
  • Filed within 4 months of final internal denial

How to File

  1. Submit application through Maximus IHCAP portal
  2. Required documents:
    • External appeal application form
    • All internal denial letters
    • Medical records supporting necessity
    • Physician letter of medical necessity
  3. Contact for help: NJ DOBI Consumer Hotline at 1-888-393-1062

Timeline and Process

  • Preliminary review: 5 business days to confirm eligibility
  • Full review: 45 days for standard cases, 48 hours for expedited
  • Decision: Binding on Aetna if overturned
  • Cost: Free to patients
From Our Advocates: We've seen many Ofev denials overturned at external review when patients included comprehensive HRCT reports and clear documentation of disease progression. The key is presenting a complete clinical picture that demonstrates medical necessity according to established guidelines.

Patient Assistance Programs

While pursuing appeals, several programs can help with Ofev access and costs:

Manufacturer Programs

  • Boehringer Ingelheim Cares Foundation: Free medication for eligible uninsured patients. Call 1-800-556-8317
  • Ofev Open Doors: Coverage navigation and appeal support. Call 866-673-6366
  • Copay cards: May reduce out-of-pocket costs for commercially insured patients (Medicare/Medicaid excluded)

Independent Foundations

  • HealthWell Foundation: 1-800-675-8416
  • Patient Access Network (PAN) Foundation: Online application available
  • The Assistance Fund: 1-855-845-3663
  • Patient Services, Inc.: 1-800-366-7741

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to identify the specific basis for denial, then drafts point-by-point rebuttals aligned to each payer's requirements, complete with the right clinical evidence and procedural documentation.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
Missing HRCT documentation Submit complete radiology report showing fibrosis pattern
Insufficient pulmonary function data Provide recent PFTs meeting Aetna's threshold requirements
Lack of specialist involvement Include pulmonologist consultation notes and prescription
Step therapy not completed Document contraindications or failures of required medications
"Experimental/investigational" Cite FDA approval and inclusion in treatment guidelines
Non-formulary status Request formulary exception with medical necessity justification

Frequently Asked Questions

How long does Aetna (CVS Health) prior authorization take in New Jersey? Standard prior authorization decisions are typically made within 5-14 business days. Expedited reviews (for urgent situations) must be completed within 72 hours per New Jersey regulations.

What if Ofev (nintedanib) is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and that preferred alternatives are inappropriate or ineffective for your condition.

Can I request an expedited appeal? Yes, if a delay in treatment would seriously jeopardize your health or ability to regain maximum function, you can request expedited review at both internal and external levels.

Does step therapy apply if I've tried other medications outside New Jersey? Previous treatment history from other states should be accepted as long as it's properly documented in your medical records.

What happens if IHCAP overturns Aetna's denial? The decision is binding, and Aetna must provide coverage for Ofev according to the external reviewer's determination.

Can my doctor file the external appeal for me? Yes, New Jersey allows providers to file external appeals on behalf of patients with proper consent.

How much does Ofev cost without insurance? Cash prices typically range from $13,000-$15,000 for a 30-day supply, making patient assistance programs crucial if coverage is denied.

What should I do while appeals are pending? Apply for manufacturer patient assistance programs immediately to maintain access to treatment during the appeals process.

For additional support navigating these complex coverage requirements, Counterforce Health provides specialized expertise in turning insurance denials into successful appeals through targeted, evidence-based advocacy.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact official sources for the most current forms and requirements. For personalized assistance with insurance appeals, consider consulting with patient advocacy services or legal professionals specializing in healthcare coverage.

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