By Counterforce Health Team in Symdeko / Symkevi (tezacaftor/ivacaftor) —

Getting Symdeko/Symkevi (Tezacaftor/Ivacaftor) Covered by Cigna in Pennsylvania: Complete Prior Authorization and Appeals Guide

Answer Box: Quick Path to Coverage

Symdeko/Symkevi (tezacaftor/ivacaftor) requires prior authorization from Cigna in Pennsylvania. Submit genetic testing showing F508del mutation, CF diagnosis, and specialist prescription via Cigna's provider portal. If denied, use internal appeals within 180 days, then Pennsylvania's Independent External Review (50% overturn rate). Start today: Contact your CF specialist to gather genetic test results and complete the PA submission. Most approvals come within 5 business days with complete documentation.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Cigna plans Submit via provider portal Cigna Policy cnf_355
Age Requirement ≥6 years old Birth records/medical chart FDA Label
Genetic Testing F508del mutation confirmed FDA-cleared CFTR analysis Cigna Policy ip_0433
Specialist Prescription CF specialist or pulmonologist CF center attestation Cigna Policy cnf_355
Annual Cost ~$323,491 list price Triggers PA requirement Vertex Pricing

Why Pennsylvania State Rules Matter

Pennsylvania's insurance landscape offers unique protections for patients fighting coverage denials. The state launched its Independent External Review Program in January 2024, giving residents a powerful tool that has overturned 50% of appealed denials in its first year.

Here's how Pennsylvania differs from other states:

Commercial Insurance: Fully-insured plans must follow Pennsylvania's external review process after internal appeals are exhausted. You have 4 months to request external review after receiving your final denial letter.

Medicare Advantage: These plans follow federal Medicare appeals rules, not Pennsylvania state processes. Contact Medicare directly at 1-800-MEDICARE for appeals guidance.

ERISA Self-Funded Plans: Unfortunately, these employer plans are exempt from state external review. You're limited to the plan's internal appeal process only.

Note: Pennsylvania's success rate of 50% for external reviews is significantly higher than many other states, making it crucial to understand your eligibility.

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Clinic)

  • What you need: CF diagnosis records, genetic test showing F508del mutation, birth certificate
  • Timeline: 1-2 days if records are current
  • Submit via: Prepare for provider portal submission
  • Source: Cigna PA Requirements

2. Confirm Specialist Prescriber (Clinic)

  • What you need: CF specialist or pulmonologist on file
  • Timeline: Same day if established patient
  • Submit via: Include credentials in PA submission
  • Source: Cigna Policy Requirements

3. Submit Prior Authorization (Clinic)

  • What you need: Complete PA form with all documentation
  • Timeline: Submit within 24 hours of gathering docs
  • Submit via: Cigna provider portal or fax
  • Source: Contact Cigna provider services for current portal access

4. Track PA Status (Patient/Clinic)

  • What you need: PA reference number
  • Timeline: Check daily after 48 hours
  • Submit via: Cigna member portal or provider line
  • Source: Cigna Member Resources

5. Request Peer-to-Peer if Needed (Clinic)

  • What you need: Denial letter with medical director contact
  • Timeline: Within 5 business days of denial
  • Submit via: Phone call to Cigna medical director
  • Source: Denial letter instructions

Turnaround Standards and Timelines

Standard Prior Authorization:

  • Cigna Timeline: Up to 5 business days from complete submission
  • Incomplete Submission: Additional 5 business days after missing info provided
  • Tracking: Use Cigna provider portal or call member services

Expedited/Urgent Requests:

  • Timeline: 24-72 hours if health is at risk
  • Requirement: Physician must certify urgent medical need
  • Documentation: Letter stating delay would jeopardize health or function

Appeal Deadlines:

  • Internal Appeal: 180 days from denial date
  • External Review (PA): 4 months from final internal denial
  • Medicare Advantage: 60 days for redetermination
Tip: Pennsylvania's external review program processes standard cases within 45 days and expedited cases within 72 hours.

Step Therapy Protections and Medical Exceptions

Pennsylvania follows federal and state guidelines that often allow step therapy exceptions for cystic fibrosis medications when genetic testing supports specific drug therapy.

Medical Exception Criteria

Documentation that helps override step therapy:

  • "Patient has confirmed F508del mutation responsive to tezacaftor/ivacaftor per FDA labeling"
  • "Alternative CFTR modulators contraindicated due to [specific reason]"
  • "Prior therapy with [drug name] resulted in inadequate response/intolerance"
  • "Delay in appropriate therapy poses risk to pulmonary function"

Required Supporting Evidence

  • Genetic Testing: FDA-cleared CFTR mutation analysis
  • Pulmonary Function Tests: Recent FEV1 measurements
  • Treatment History: Documentation of prior therapy failures or contraindications
  • Specialist Assessment: CF center physician letter supporting medical necessity

Counterforce Health specializes in helping patients and providers compile exactly this type of evidence-backed documentation to overturn insurance denials and secure coverage for specialty medications.

Appeals Playbook for Cigna in Pennsylvania

Internal Appeals Process

First-Level Internal Appeal:

  • Deadline: 180 days from denial date
  • How to file: Cigna member portal, phone, or written request
  • Timeline: 30 days for standard, 72 hours for expedited
  • Required: Copy of denial letter, medical records, physician letter

Second-Level Internal Appeal:

  • Automatic: If first level upheld
  • Timeline: Additional 30 days
  • Review: Different medical director than first level

Pennsylvania External Review

Eligibility Requirements:

  • Must have exhausted internal appeals
  • Received Final Adverse Benefit Determination letter
  • Commercial fully-insured plan (not ERISA self-funded)
  • Request within 4 months of final denial

How to File:

  • Online: PA External Review Portal
  • Phone: 1-877-881-6388
  • Mail: Pennsylvania Insurance Department, 1209 Strawberry Square, Harrisburg, PA 17120

What to Include:

  • Final denial letter from Cigna
  • All medical records supporting necessity
  • Physician letter explaining why drug is medically necessary
  • Any additional evidence (research studies, CF Foundation guidelines)
From our advocates: We've seen Pennsylvania external reviews succeed when families include a clear timeline of the patient's CF progression and how previous treatments failed to achieve adequate symptom control. The independent medical reviewers particularly value documentation showing the specific genetic mutation and how it responds to the requested medication.

Common Denial Reasons and Fixes

Denial Reason How to Overturn Required Documentation
Missing genetic testing Resubmit with FDA-cleared results CFTR mutation analysis report
Non-responsive mutation Verify against current FDA labeling Updated prescribing information
Age requirement not met Provide birth certificate Official age verification
Non-specialist prescriber Transfer to CF specialist Specialist credentials and referral
Lack of medical necessity Submit comprehensive clinical letter CF diagnosis, PFTs, treatment history
Step therapy not attempted Document contraindications/failures Prior therapy records and outcomes

Most Effective Fix: Complete resubmission with all missing elements rather than piecemeal responses. Include a cover letter summarizing how the submission now meets all Cigna policy requirements.

External Review and State Complaints

When to Use Pennsylvania's External Review

  • Best for: Medical necessity denials, experimental treatment exclusions
  • Not for: Premium disputes, network issues, non-medical coverage exclusions
  • Success rate: 50% of cases overturned in 2024
  • Cost: Free to consumers

Filing a State Complaint

Beyond external review, you can file complaints about insurer practices:

Pennsylvania Insurance Department Consumer Services:

What to include:

  • Policy number and member ID
  • Timeline of events and communications
  • Copies of all denial letters and appeals
  • Description of how insurer violated Pennsylvania law or policy

ERISA and Self-Funded Plan Limitations

Important Limitation: If your employer's health plan is self-funded (many large employers), it's governed by federal ERISA law, which preempts Pennsylvania's external review process.

How to Identify ERISA Plans

  • Check your Summary Plan Description (SPD)
  • Look for language like "self-funded" or "self-insured"
  • Ask HR if the company pays claims directly vs. through an insurance company

ERISA Appeal Options

  • Internal appeals only: Usually 2 levels within the plan
  • Federal court: Only option after exhausting internal appeals (rarely practical for drug coverage)
  • Department of Labor: Can investigate ERISA violations but doesn't overturn individual denials
Note: Even ERISA plans often follow similar medical necessity criteria, so the same documentation strategies apply to internal appeals.

Costs and Patient Assistance

Annual Cost Impact:

  • List price: ~$323,491 annually
  • Typical copay: $50-$500/month depending on plan tier
  • Deductible: May apply before copay assistance

Patient Assistance Options:

  • Vertex Pathways: Copay assistance and patient support (Vertex Patient Support)
  • CF Foundation Compass: Insurance navigation and financial assistance
  • State Programs: Pennsylvania may have additional CF-specific assistance

When dealing with insurance challenges, Counterforce Health helps patients navigate the complex prior authorization and appeals process, turning denials into targeted, evidence-backed appeals that align with payer requirements.

FAQ

How long does Cigna PA take in Pennsylvania? Standard PA decisions take up to 5 business days. Expedited requests (when health is at risk) are decided within 24-72 hours. Track status via Cigna's provider or member portal.

What if Symdeko/Symkevi is non-formulary on my plan? Request a formulary exception through Cigna's standard process. Include medical necessity documentation and evidence that formulary alternatives are inappropriate for your specific CFTR mutation.

Can I request an expedited appeal in Pennsylvania? Yes, both Cigna internal appeals and Pennsylvania external reviews offer expedited processes when a physician certifies that delays would jeopardize health or function.

Does step therapy apply if I've tried other CFTR modulators outside Pennsylvania? Yes, document any prior CFTR modulator trials regardless of where they occurred. Include medical records showing inadequate response, intolerance, or contraindications.

What's the difference between Medicare Advantage and commercial appeals? Medicare Advantage plans follow federal Medicare appeals (redetermination, reconsideration, ALJ hearing). Commercial fully-insured plans can use Pennsylvania's external review after internal appeals.

How do I know if my employer plan is ERISA self-funded? Check your Summary Plan Description or ask HR. ERISA plans are exempt from Pennsylvania's external review and limited to internal appeals only.

What happens if Pennsylvania external review overturns my denial? Cigna must provide coverage immediately and retroactively. If you paid out-of-pocket during the appeal, you're entitled to reimbursement.

Can I get help with the appeals process? Yes. Contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388, or consider working with advocacy organizations that specialize in insurance appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes and not medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan directly for guidance specific to your situation.

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