By Counterforce Health Team in Tagrisso (osimertinib) —

Aetna (CVS Health) Coverage Criteria for Tagrisso (Osimertinib) in Pennsylvania: What Counts as "Medically Necessary"?

Answer Box: Getting Tagrisso (Osimertinib) Covered by Aetna (CVS Health) in Pennsylvania

Aetna (CVS Health) requires prior authorization for Tagrisso with documented EGFR mutation testing (exon 19 deletion or L858R) and FDA-approved indication. Submit through CVS Caremark Specialty (1-866-814-5506) with complete clinical documentation. If denied, you have 180 days for internal appeals, then four months for Pennsylvania's external review with a 50%+ overturn rate. Start today: confirm EGFR test results and contact CVS Specialty.

Table of Contents

  1. Policy Overview: Plan Types and Coverage Rules
  2. FDA Indication Requirements
  3. Step Therapy and Medical Exceptions
  4. Quantity and Frequency Limits
  5. Required Diagnostics and Documentation
  6. CVS Specialty Pharmacy Requirements
  7. Evidence for Medical Necessity
  8. Appeals Process in Pennsylvania
  9. Common Denial Reasons and Solutions
  10. Cost Assistance Programs
  11. FAQ

Policy Overview: Plan Types and Coverage Rules

Aetna (CVS Health) covers Tagrisso (osimertinib) across most plan types in Pennsylvania, but coverage requirements vary by product:

  • Commercial Plans (HMO/PPO): Prior authorization always required through CVS Caremark
  • Medicare Advantage: Similar PA requirements with Medicare-specific timelines
  • Medicaid Managed Care: Follows state Medicaid guidelines with Aetna-specific processes

All Tagrisso prescriptions must be dispensed through CVS Specialty Pharmacy, as it's classified as a specialty tier medication. You cannot fill this prescription at regular retail pharmacies.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Always required CVS Caremark Specialty portal Aetna Policy
EGFR Testing Exon 19 deletion or L858R mutation Pathology/molecular testing report FDA Label
Specialty Tier High copay/coinsurance Plan formulary CVS Specialty
Step Therapy May vary by plan Individual plan documents Aetna Formulary

FDA Indication Requirements

Tagrisso must be prescribed for FDA-approved indications to meet Aetna's medical necessity criteria:

Approved Uses

  1. Metastatic NSCLC: First-line treatment with EGFR exon 19 deletions or L858R mutations
  2. Metastatic NSCLC with T790M: After progression on prior EGFR TKI therapy
  3. Adjuvant NSCLC: After complete resection with EGFR exon 19 deletions or L858R mutations

Documentation Requirements

  • Histologically confirmed non-small cell lung cancer
  • FDA-approved EGFR mutation test results
  • Appropriate staging (metastatic vs. resected)
  • ICD-10 codes matching the clinical scenario
Note: Off-label uses are typically not covered and require extensive documentation and appeals.

Step Therapy and Medical Exceptions

Aetna's step therapy requirements for Tagrisso vary by clinical setting and plan type:

Metastatic First-Line Setting

Recent policy updates suggest step therapy may not be required for first-line metastatic EGFR-mutant NSCLC, as osimertinib has become the standard of care. However, individual plans may still enforce step therapy.

Medical Exception Pathways

If step therapy is required, you can request a medical exception based on:

  • Contraindications to first-generation TKIs (erlotinib, gefitinib)
  • Previous intolerance with documented adverse effects
  • Clinical urgency requiring immediate optimal therapy
  • Physician attestation that step therapy would be detrimental

Documenting Medical Exceptions

Include in your prior authorization request:

  • Detailed clinical rationale
  • Specific contraindications or prior adverse reactions
  • Supporting literature references
  • Physician statement of medical necessity

Quantity and Frequency Limits

Tagrisso quantity limits are typically based on FDA-approved dosing:

  • Standard dose: 80mg once daily (30-day supply = 30 tablets)
  • Reduced dose: 40mg once daily for toxicity management
  • Initial approval: Usually 3-6 months
  • Reauthorization: Required with evidence of continued benefit and tolerability

Dose reductions for adverse effects are generally covered when clinically documented.

Required Diagnostics and Documentation

Essential EGFR Testing Requirements

EGFR mutation testing must be performed using FDA-approved methods and documented with:

  • Tissue sample: Minimum 0.4 cm tumor size with ≥50% tumor cells
  • Testing method: Next-generation sequencing (NGS) preferred
  • Timing: Before first-line treatment initiation
  • Results: Clear documentation of exon 19 deletion, L858R, or T790M mutations

Clinical Documentation Checklist

  • Pathology report confirming NSCLC
  • EGFR mutation test results
  • Staging studies (CT, PET, brain MRI as appropriate)
  • Performance status assessment
  • Prior therapy history (if applicable)
  • Treatment goals and monitoring plan

CVS Specialty Pharmacy Requirements

All Tagrisso prescriptions must go through CVS Specialty Pharmacy:

Enrollment Process

  1. Prescriber submits PA through CVS Caremark portal
  2. Patient receives enrollment packet from CVS Specialty
  3. Clinical review by CVS pharmacists
  4. Insurance verification and copay determination
  5. Delivery coordination (typically 7-10 days)

Contact Information

  • CVS Specialty Customer Service: 1-800-237-2767
  • Provider Prior Authorization: 1-866-814-5506
  • Online portal: Available through CVS Caremark provider login

Evidence for Medical Necessity

Clinical Guidelines Supporting Coverage

  • NCCN Guidelines: Recommend osimertinib as preferred first-line therapy for EGFR-mutant NSCLC
  • ASCO Guidelines: Support comprehensive biomarker testing including EGFR
  • FDA Labeling: Provides specific indication criteria

Key Studies to Reference

  • FLAURA Trial: Demonstrated superiority of osimertinib over first-generation TKIs
  • ADAURA Trial: Established adjuvant benefit after complete resection
  • Real-world evidence: Supporting effectiveness in clinical practice

Appeals Process in Pennsylvania

Pennsylvania offers robust appeal rights with high success rates:

Internal Appeals (Aetna)

  • Timeline: 180 days from denial letter
  • Standard review: 30-45 days for decision
  • Expedited review: 72 hours for urgent cases
  • Submit to: CVS Caremark appeals department

External Review (Pennsylvania)

Pennsylvania's Independent External Review Program offers significant advantages:

  • Success rate: Over 50% of appeals overturned
  • Timeline: 4 months from final denial to file; 45 days for decision
  • Cost: Free to patients
  • Binding decision: Insurers must comply with favorable rulings

Step-by-Step Appeals Process

  1. Receive denial letter from Aetna/CVS Caremark
  2. File internal appeal within 180 days
  3. Gather supporting evidence: medical records, peer-reviewed studies, guidelines
  4. Await internal decision (30-45 days standard)
  5. If denied: File external review with Pennsylvania Insurance Department within 4 months
  6. Submit additional evidence within 15 days of IRO assignment
  7. Receive binding decision within 45 days
From Our Advocates: "We've seen Pennsylvania's external review process work particularly well for cancer medications like Tagrisso. The independent medical reviewers often have oncology expertise and understand the urgency of treatment decisions. Success often comes down to having complete EGFR testing documentation and clear clinical rationale from the oncologist."

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
No EGFR mutation documented Submit complete molecular testing FDA-approved EGFR test results
Wrong clinical setting Clarify metastatic vs. adjuvant use Staging studies, surgical reports
Step therapy not completed Request medical exception Contraindications, prior intolerance
"Experimental/investigational" Provide FDA approval evidence FDA label, NCCN guidelines
Quantity exceeded Justify dosing rationale Clinical notes, toxicity management

Cost Assistance Programs

Manufacturer Support

  • AstraZeneca Access 360: Patient assistance program
  • Copay assistance: May reduce out-of-pocket costs
  • Eligibility: Varies by insurance type and income

Additional Resources

  • Pennsylvania Patient Advocate Foundation: Free assistance with appeals
  • Cancer Financial Assistance Coalition: Directory of support programs
  • Hospital financial counselors: Often available at cancer centers

Clinician Corner: Medical Necessity Letter

When submitting prior authorization requests, include:

Problem Statement: "Patient has metastatic NSCLC with confirmed EGFR exon 19 deletion mutation requiring targeted therapy per NCCN guidelines."

Prior Treatments: Document any previous therapies, responses, and reasons for discontinuation.

Clinical Rationale: Reference FDA approval, NCCN recommendations, and published evidence supporting osimertinib use.

Monitoring Plan: Describe follow-up schedule, imaging, and safety monitoring protocols.

At Counterforce Health, we help patients and clinicians navigate these complex prior authorization requirements by turning insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each payer's own rules.

FAQ

How long does Aetna prior authorization take for Tagrisso in Pennsylvania? Standard reviews take 30-45 days, but expedited reviews for urgent cases can be completed within 72 hours.

What if Tagrisso is non-formulary on my Aetna plan? You can request a formulary exception with clinical documentation supporting medical necessity and lack of suitable alternatives.

Can I request an expedited appeal if my treatment is urgent? Yes, both Aetna internal appeals and Pennsylvania external reviews offer expedited processes for urgent medical situations.

Does step therapy apply if I've failed other EGFR inhibitors outside Pennsylvania? Prior therapy history from other states should be documented and typically satisfies step therapy requirements.

What happens if I'm denied coverage for adjuvant Tagrisso? Adjuvant use has strong FDA approval and NCCN support. Appeals often succeed with proper documentation of surgical resection and EGFR mutation status.

How much does Tagrisso cost without insurance in Pennsylvania? List prices typically exceed $15,000 per 30-day supply, making insurance coverage or patient assistance programs essential.

Sources & Further Reading

For complex appeals or when facing repeated denials, Counterforce Health provides specialized support in transforming insurance denials into successful appeals through evidence-based advocacy and payer-specific workflows.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Appeal deadlines and requirements may vary by plan type and individual circumstances.

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