By Counterforce Health Team in Tracleer (bosentan) —

How to Get Tracleer (Bosentan) Covered by Cigna in Texas: Complete PA Guide and Appeals Process

Answer Box: Getting Tracleer (Bosentan) Covered by Cigna in Texas

Tracleer (bosentan) requires prior authorization from Cigna and enrollment in the mandatory Bosentan REMS program. Coverage is approved for 1 year when you have WHO Group 1 PAH confirmed by right heart catheterization and are prescribed by a cardiologist or pulmonologist. The fastest path: (1) Enroll in Bosentan REMS at bosentanremsprogram.com, (2) Have your specialist submit PA through Cigna's provider portal with catheterization results and monthly monitoring plan, (3) If denied, file internal appeal within 180 days. Texas residents can request external review through the Texas Department of Insurance if internal appeals fail.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Medical Necessity Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals in Texas
  7. REMS Enrollment Requirements
  8. Specialty Pharmacy Transfer
  9. Renewal and Re-authorization
  10. Troubleshooting Common Issues

Coverage Basics

Is Tracleer (Bosentan) Covered by Cigna?

Yes, but with restrictions. Cigna covers Tracleer through its specialty pharmacy network (typically Express Scripts/Accredo) with prior authorization for approved indications. Coverage requires:

  • Prior authorization approval for all patients
  • REMS program enrollment (mandatory FDA requirement)
  • Specialist prescription (cardiologist or pulmonologist)
  • Annual re-authorization after initial approval

Which Cigna Plans Cover Tracleer?

Most Cigna commercial plans cover Tracleer as a specialty medication, but formulary placement varies. The medication is typically:

  • Tier 3-4 specialty drug with higher copays/coinsurance
  • Managed through specialty pharmacy (not retail)
  • Subject to quantity limits and step therapy requirements
Note: Medicare Part D and Medicaid managed care plans have separate coverage rules and appeal processes.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Complete REMS Enrollment (Patient + Prescriber)
  2. Gather Required Documentation
    • Right heart catheterization results showing WHO Group 1 PAH
    • Baseline liver function tests (ALT, AST, bilirubin)
    • Monthly monitoring plan for LFTs and pregnancy tests (if applicable)
    • Prior therapy documentation (step therapy requirements)
  3. Prescriber Submits PA
    • Through Cigna provider portal or CoverMyMeds
    • Include all diagnostic and monitoring documentation
    • Specify monthly LFT monitoring plan
  4. Cigna Review Process
    • Standard review: 3-5 business days
    • Expedited review: 24-72 hours (if medically urgent)
  5. Approval and Specialty Pharmacy Setup
    • Cigna coordinates with Express Scripts/Accredo
    • Patient receives enrollment call from specialty pharmacy

Who Submits the Prior Authorization?

Your prescribing physician (cardiologist or pulmonologist) must submit the PA request. Patients cannot submit directly, but you can:

  • Confirm your doctor has submitted the request
  • Provide additional documentation if requested
  • Track status through Cigna member portal or by calling the number on your insurance card

Timing and Urgency

Standard Timeline

  • PA submission to decision: 3-5 business days
  • Approval to first shipment: 2-3 business days
  • Total time: 5-8 business days typically

Expedited Review Process

Available when delay would jeopardize your health. Your physician must:

  • Submit expedited PA request
  • Provide clinical justification for urgency
  • Document that delay may worsen your condition

Expedited timeline: 24-72 hours for decision

Tip: If you're currently hospitalized or experiencing rapid PAH progression, ask your doctor to request expedited review and mention this in the clinical justification.

Medical Necessity Criteria

WHO Group 1 PAH Requirements

Cigna approves Tracleer for patients meeting ALL of these criteria:

Requirement Documentation Needed Source
WHO Group 1 PAH diagnosis Right heart catheterization results Cigna PAH Policy
Specialist prescription Cardiologist or pulmonologist Same policy
Baseline monitoring LFTs, pregnancy test plan FDA REMS requirements
REMS enrollment Patient and prescriber certified Bosentan REMS

Step Therapy Requirements

For certain conditions, you may need to try other medications first:

Chronic Thromboembolic Pulmonary Hypertension (CTEPH):

  • Must try one phosphodiesterase inhibitor (sildenafil or tadalafil) first
  • OR currently receiving bosentan
  • OR documented hypotension/nitrate use contraindication

Digital Ulcers in Systemic Sclerosis:

  • Must try one calcium channel blocker first

Clinician Corner: Medical Necessity Letter Checklist

Healthcare providers should include these elements in PA submissions:

✓ Diagnostic confirmation: Right heart catheterization with specific hemodynamics (mPAP >20 mmHg, PAWP ≤15 mmHg, PVR >3 Wood Units)
✓ WHO Functional Class: Document current symptoms and functional limitations
✓ Prior therapies: Detail previous treatments tried and outcomes/intolerances
✓ Monitoring plan: Monthly LFT and pregnancy testing protocol
✓ Clinical rationale: Why bosentan is medically necessary for this patient
✓ Guideline support: Reference ESC/ERS PAH guidelines or FDA labeling

Costs and Financial Assistance

Cigna Coverage Costs

  • Tier 3-4 specialty copay: Typically $50-$150+ per fill
  • Coinsurance plans: 20-40% of drug cost after deductible
  • Out-of-pocket maximum: Applies to annual spending cap

Financial Assistance Programs

Janssen CarePath Oral PAH Savings Program

  • Reduces copay to $5 per fill for eligible patients
  • Must be commercially insured, 18+, enrolled in REMS
  • Call 866-228-3546 to enroll
  • Program details

Generic Bosentan Copay Card (Teva)

  • $0 out-of-pocket per fill for generic version
  • Commercial insurance required
  • Teva copay card

Additional Support Options

  • Prescription Hope: $60/month regardless of insurance status
  • QuickRx Specialty: Up to $1,000 savings, call (917) 830-2525
Important: Government insurance (Medicare, Medicaid, TRICARE) patients are not eligible for manufacturer copay programs but may qualify for other assistance.

Denials and Appeals in Texas

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
REMS not enrolled Complete enrollment REMS confirmation
Non-specialist prescriber Transfer to cardiologist/pulmonologist Specialist prescription
Missing step therapy Document prior failures or contraindications Medical records, intolerance notes
Insufficient monitoring plan Submit detailed LFT/pregnancy testing protocol Monthly monitoring schedule

Texas Appeals Process

Internal Appeal (First Level)

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for standard, 72 hours for expedited
  • How to file: Cigna member portal, mail, or fax with denial letter and supporting records
  • Required: Physician statement supporting medical necessity

External Review (Texas Department of Insurance)

  • When: After internal appeal denial
  • Deadline: 4 months from final internal denial
  • Timeline: 45 days standard, 72 hours expedited
  • Cost: Free to patient
  • Contact: Texas DOI at 1-800-252-3439
  • Result: Binding on Cigna if approved

Appeal Scripts for Patients

Calling Cigna about PA Status: "I'm calling to check the status of a prior authorization request for Tracleer, generic name bosentan, submitted by Dr. [Name] on [Date]. My member ID is [Number]. Can you tell me if any additional information is needed?"

Requesting Expedited Review: "My doctor needs to request an expedited prior authorization review for Tracleer because my pulmonary arterial hypertension is worsening and any delay in treatment could jeopardize my health. What's the fastest way for my doctor to submit this request?"

REMS Enrollment Requirements

Mandatory for All Patients

The FDA requires all bosentan patients to enroll in the Bosentan REMS program due to serious risks of liver damage and birth defects.

Patient Enrollment Steps:

  1. Visit bosentanremsprogram.com
  2. Complete patient enrollment form
  3. Acknowledge understanding of liver and pregnancy risks
  4. Provide contact information for monthly reminders

Prescriber Requirements:

  • Complete prescriber certification
  • Review Tracleer Prescriber Essentials guide
  • Document patient enrollment
  • Re-enroll patients annually after first 12 months

Monitoring Requirements:

  • Monthly liver function tests (ALT, AST, bilirubin)
  • Monthly pregnancy tests for women of childbearing potential
  • Baseline testing before starting therapy
Critical: Pharmacies cannot dispense bosentan without confirmed REMS enrollment for both patient and prescriber.

Specialty Pharmacy Transfer

Why Cigna Uses Specialty Pharmacies

Tracleer requires special handling due to:

  • REMS program coordination
  • Monthly monitoring requirements
  • Temperature-controlled shipping
  • Prior authorization management

What to Expect

Express Scripts/Accredo Process:

  1. Cigna transfers your prescription after PA approval
  2. Specialty pharmacy calls to complete enrollment
  3. Medication ships directly to your home
  4. Refill reminders and monitoring coordination

Timeline: 2-3 business days from PA approval to first shipment

Services like Counterforce Health help patients and providers navigate complex specialty pharmacy requirements by turning insurance denials into targeted, evidence-backed appeals. Their platform identifies denial reasons and drafts point-by-point rebuttals aligned with payer policies, potentially reducing approval delays.

Renewal and Re-authorization

Annual Re-authorization Required

Cigna approves Tracleer for 1-year periods. Before your approval expires:

60 days before expiration:

  • Your specialty pharmacy will contact your doctor
  • Prescriber submits renewal PA with updated clinical information
  • Include current functional status, lab results, and treatment response

Required for Renewal:

  • Continued WHO Group 1 PAH diagnosis
  • Evidence of treatment benefit or stable disease
  • Ongoing specialist care
  • Current REMS enrollment status
  • Updated monitoring lab results

REMS Re-enrollment

After the first 12 months, both patient and prescriber must re-enroll in the REMS program annually.

Troubleshooting Common Issues

PA Portal Problems

  • Portal down: Call Cigna provider services directly
  • Missing forms: Contact your doctor's prior authorization specialist
  • Incomplete submission: Cigna will request additional information within 3 business days

REMS Enrollment Issues

  • Can't access website: Call 866-359-2612 for phone enrollment
  • Prescriber not enrolled: Doctor must complete certification first
  • Annual re-enrollment: Both parties must re-enroll after 12 months

Specialty Pharmacy Delays

  • No enrollment call: Contact Express Scripts/Accredo directly
  • Shipping delays: Verify current address and contact information
  • Refill issues: Ensure REMS compliance and PA is current

FAQ: Tracleer (Bosentan) Coverage by Cigna in Texas

Q: How long does Cigna prior authorization take for Tracleer in Texas?
A: Standard review takes 3-5 business days. Expedited review (when medically urgent) takes 24-72 hours.

Q: What if Tracleer is not on my Cigna formulary?
A: Your doctor can request a formulary exception with clinical justification for why Tracleer is medically necessary compared to covered alternatives.

Q: Can I get expedited appeal if Cigna denies my Tracleer?
A: Yes, if your doctor certifies that delay would jeopardize your health. Submit expedited internal appeal, then expedited external review through Texas DOI if needed.

Q: Does step therapy apply if I tried other PAH medications outside Texas?
A: Yes, prior therapy trials from any state count toward step therapy requirements. Provide complete medical records documenting previous treatments and outcomes.

Q: What happens if I miss my monthly REMS monitoring?
A: Your pharmacy may hold your next refill until monitoring is current. Contact your doctor immediately to schedule required lab work.

Q: Are there income limits for Janssen's copay assistance program?
A: No specific income limits, but you must have commercial insurance and cannot be enrolled in government programs like Medicare or Medicaid.

Sources and Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult your healthcare provider regarding treatment decisions and insurance coverage questions. Coverage policies and requirements may change; verify current information with Cigna and your healthcare team.

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