By Counterforce Health Team in Alecensa (alectinib) —

How to Get Alecensa (Alectinib) Covered by UnitedHealthcare in Ohio: Appeals, Forms & Success Strategies

Answer Box: Getting Alecensa Covered by UnitedHealthcare in Ohio

Alecensa (alectinib) requires prior authorization from UnitedHealthcare and is often subject to step therapy requiring crizotinib first. To get coverage in Ohio: 1) Submit complete ALK-positive test results and clinical documentation through the UnitedHealthcare provider portal, 2) If denied, file an internal appeal within 180 days with detailed medical necessity letter, 3) Request Ohio external review through the Department of Insurance if internal appeals fail. Success requires comprehensive pathology reports, treatment history, and oncologist support letters citing NCCN guidelines.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all specialty oncology drugs UnitedHealthcare Provider Portal UHC Commercial PA Requirements
Step Therapy May require crizotinib trial first OptumRx formulary guidelines OptumRx Formulary
ALK Testing FDA-approved test showing ALK rearrangement Pathology report FDA Alecensa Label
Formulary Status Covered but requires PA Plan-specific formulary UHC Commercial PDL
Appeals Deadline 180 days from denial Ohio insurance law Ohio DOI External Review

When Alternatives Make Sense

If UnitedHealthcare initially denies Alecensa, understanding when alternatives might be appropriate can help you and your oncologist develop the strongest coverage strategy. Alternatives may be considered when:

  • Step therapy requirements mandate trying crizotinib first unless contraindicated
  • Cost considerations make other ALK inhibitors more accessible initially
  • Clinical factors suggest a different ALK inhibitor might be better tolerated
  • Prior treatment history shows response to other agents in the class

However, if your oncologist determines Alecensa is medically necessary as first-line therapy, you have strong grounds for a step therapy exception request.

Typical ALK Inhibitor Alternatives

UnitedHealthcare's formulary typically includes these ALK inhibitors with varying coverage requirements:

First-Generation ALK Inhibitors

  • Crizotinib (Xalkori): Often preferred by insurers for initial therapy due to step therapy protocols
  • Ceritinib (Zykadia): May be covered as alternative first-line option

Second-Generation ALK Inhibitors

  • Brigatinib (Alunbrig): Available for progression on crizotinib
  • Lorlatinib (Lorbrena): Typically reserved for later lines or CNS involvement

Each has different prior authorization requirements and may require documentation of failure or intolerance to earlier agents.

Pros and Cons Overview

Access Considerations

Crizotinib advantages:

  • Usually first-tier ALK inhibitor for insurance approval
  • Extensive clinical data supporting use
  • May have lower copay due to formulary placement

Crizotinib limitations:

  • Higher rates of visual disturbances and GI toxicity
  • Less effective for brain metastases compared to Alecensa
  • May require more frequent monitoring

Alecensa advantages:

  • Superior CNS penetration and control
  • Better tolerability profile with fewer severe side effects
  • Longer progression-free survival in clinical trials

Alecensa limitations:

  • Higher cost may trigger step therapy requirements
  • More complex prior authorization process
  • May require extensive documentation for first-line use

Exception Strategy

When requesting a step therapy exception for Alecensa, focus on these key areas:

Medical Necessity Documentation

Your oncologist should provide detailed rationale addressing:

  • CNS involvement: If brain metastases are present or suspected, Alecensa's superior CNS activity supports first-line use
  • Contraindications to crizotinib: Document any factors making crizotinib inappropriate (cardiac issues, visual problems, drug interactions)
  • Treatment goals: Explain why Alecensa specifically meets your treatment objectives

Supporting Evidence

Include references to:

  • NCCN Guidelines supporting Alecensa as preferred first-line therapy
  • Clinical trial data showing superior outcomes
  • Patient-specific factors favoring Alecensa over alternatives
From our advocates: We've seen step therapy exceptions succeed when oncologists clearly document why the preferred drug (like crizotinib) would be clinically inappropriate or inferior for the specific patient's situation. The key is making the medical case compelling and guideline-based, not just stating preference.

Switching Logistics

If you start with an alternative ALK inhibitor and later need to switch to Alecensa, coordinate carefully:

Timing Considerations

  • Prior authorization timing: Submit Alecensa PA before discontinuing current therapy
  • Bridge therapy: Request samples or temporary supply to avoid treatment gaps
  • Monitoring: Schedule labs and assessments during transition period

Documentation Requirements

  • Evidence of progression or intolerance on current ALK inhibitor
  • Updated staging and assessment
  • Clear rationale for switching to Alecensa specifically

The transition typically involves immediate discontinuation of the previous ALK inhibitor and prompt initiation of Alecensa once approved.

Re-trying for Alecensa Later

If initially denied, document everything during your trial of alternative therapy:

Key Documentation

  • Response assessments: Regular imaging and clinical evaluations
  • Toxicity monitoring: Detailed records of side effects and tolerability issues
  • Quality of life impacts: Document how alternative therapy affects daily functioning
  • Disease progression: Any evidence of progression warrants immediate Alecensa reconsideration

This documentation becomes crucial for future appeals or step therapy exception requests.

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Clinic)

What you need:

  • ALK-positive test results (FISH, IHC, or NGS)
  • Complete pathology report with staging
  • Treatment history and prior therapy records
  • Current imaging and clinical notes

Timeline: 1-2 business days
Submit via: Compile for oncologist's PA submission

2. Submit Prior Authorization (Oncologist)

Process: Complete UnitedHealthcare PA form through provider portal Required elements:

  • ICD-10 diagnosis codes
  • Clinical justification letter
  • Supporting test results and records

Timeline: Same day submission possible
Portal: UnitedHealthcare Provider Portal

3. Track PA Status (Patient/Clinic)

Monitor: Check portal for updates and requests for additional information Response time: 3-5 business days for standard review Expedited option: Available if treatment delay poses health risk

4. Address Denials Immediately (Patient/Clinic)

If denied: Request peer-to-peer review within 72 hours Appeal deadline: 180 days from denial notice Documentation: Add any missing clinical justification

5. File Internal Appeal (Patient with Oncologist Support)

Submit: Written appeal with comprehensive medical necessity letter Include: All supporting documentation and guideline references Timeline: 30 days for insurer response

6. Request Ohio External Review (Patient)

Eligibility: After final internal denial Deadline: 180 days from final adverse determination Contact: Ohio Department of Insurance: 1-800-686-1526

7. Coordinate Pharmacy Benefits (Patient/Pharmacy)

Verify: Coverage details and copay assistance options Manufacturer support: Genentech Access Solutions may provide copay cards Specialty pharmacy: May be required for dispensing

Appeals Playbook for UnitedHealthcare in Ohio

Internal Appeals Process

Level Deadline How to File Required Documents
First Internal 180 days from denial Provider portal or written request Denial letter, medical necessity letter, clinical records
Second Internal 180 days from first denial Same process Additional clinical evidence, peer review notes
Expedited Review 72 hours if urgent Request with clinical urgency documentation Medical urgency attestation

Ohio External Review Process

Eligibility: Medical necessity denials after internal appeals exhausted
Timeline: 30 days for standard review, 72 hours for expedited
Cost: No charge to patient
Decision: Binding on UnitedHealthcare if overturned

How to file:

  1. Contact Ohio Department of Insurance at 1-800-686-1526
  2. Complete external review request form
  3. Submit all denial letters and clinical documentation
  4. Independent Review Organization (IRO) conducts medical review

Common Denial Reasons & Solutions

Denial Reason How to Address Required Documentation
Missing ALK test Submit complete pathology report FDA-approved ALK testing results (FISH/IHC/NGS)
Step therapy required Request exception with clinical justification Medical necessity letter citing contraindications to crizotinib
Insufficient clinical information Provide comprehensive treatment history Complete oncology notes, staging, prior therapies
Non-formulary status Appeal with medical necessity NCCN guideline references, clinical trial data
Adjuvant use without surgical proof Submit surgical documentation Operative reports, pathology confirming resection

FAQ

How long does UnitedHealthcare prior authorization take in Ohio?
Standard PA decisions typically take 3-5 business days. Expedited reviews for urgent cases can be completed within 72 hours if medical urgency is documented.

What if Alecensa is non-formulary on my plan?
Non-formulary drugs can still be covered through medical exception processes. Your oncologist must demonstrate medical necessity and provide clinical justification for why formulary alternatives are inappropriate.

Can I request an expedited appeal in Ohio?
Yes, if treatment delay would seriously jeopardize your health. Your oncologist must provide documentation supporting the urgency of treatment.

Does step therapy apply if I failed crizotinib outside Ohio?
Previous treatment failures should be documented and submitted with your PA request. UnitedHealthcare should consider prior therapy regardless of where it occurred.

What happens after Ohio external review?
If the Independent Review Organization overturns UnitedHealthcare's denial, the insurer must cover Alecensa. If the denial is upheld, you may still pursue other legal remedies.

How much does Alecensa cost without insurance?
The wholesale acquisition cost is approximately $19,466 per 240-count bottle. Genentech Access Solutions offers copay assistance programs that may significantly reduce out-of-pocket costs.

Getting help with complex insurance appeals: Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttal letters. Their platform helps patients, clinicians, and specialty pharmacies navigate the prior authorization process more effectively, particularly for complex specialty medications like Alecensa.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies and requirements may change. For questions about Ohio insurance regulations, contact the Ohio Department of Insurance at 1-800-686-1526.

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