Pharmacy Prior Authorization Criteria

Tagrisso (osimertinib)

Indications for Prior Authorization

Tagrisso (osimertinib)

• For diagnosis of First-line Treatment of EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)
  Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

• For diagnosis of Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC
  Indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

• For diagnosis of Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC)
  Indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

• For diagnosis of First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC
  Indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 or exon 21 L858R mutations, as detected by an FDA-approved test.

• For diagnosis of Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC
  Indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

Criteria

Tagrisso

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of First-line Treatment of EGFR Mutation-Positive NSCLC

• One of the following:
• Both of the following:
• Diagnosis of metastatic non-small cell lung cancer (NSCLC)
AND
• Patient has known active epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations as detected by an U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
OR
• All of the following:
• Diagnosis of locally advanced NSCLC
AND
• Patient has known active epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations as detected by an U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Used in combination with both of the following:
• Pemetrexed
• Platinum-based chemotherapy (e.g., cisplatin, carboplatin)

Tagrisso

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC

• Diagnosis of metastatic non-small cell lung cancer (NSCLC)
AND
• Patient has a known active epidermal growth factor receptor (EGFR) T790M mutation as detected by a U.S. Food and Drug Administration (FDA) -approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient has experienced disease progression on or after one of the following EGFR Tyrosine Kinase Inhibitors (TKIs): [1-3]
• Gilotrif (afatinib)*
• Iressa (gefitinib)*
• Tarceva (erlotinib)*
• Vizimpro (dacomitinib)*

Tagrisso

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC)

• Diagnosis of non-small cell lung cancer (NSCLC)
AND
• Patient has known active epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations as detected by an U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Both of the following:
• Patient is receiving as adjuvant therapy
• Patient has had a complete surgical resection of the primary non-small cell lung cancer (NSCLC) tumor

Tagrisso

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC

• Diagnosis of non-small cell lung cancer (NSCLC)
AND
• Disease is one of the following:
• Locally advanced
• Unresectable (Stage III)
AND
• Presence of known active epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations as detected by an U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy

Tagrisso

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-11-05, 2024-10-18, 2024-05-01, 2024-04-03, 2023-06-21, 2023-04-10, 2022-04-07, 2021-06-07, 2021-04-13, 2021-02-01, 2020-03-13

References

1. Tagrisso prescribing information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. September 2024.
2. National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium [internet database]. National Comprehensive Cancer Network, Inc.; 2014. Updated periodically. Available by subscription at: www.nccn.org. Accessed March 27, 2023.
3. National comprehensive cancer network (NCCN). Clinical practice guidelines in oncology. Non-small cell lung cancer. v.3.2022. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed March 27, 2023.

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End Notes

1. Tagrisso (osimertinib) may be continued as a single agent therapy in patients with NSCLC and known sensitizing EGFR mutation following disease progression (Category 2A). [2, 3]

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Revision History

• 2024-11-05: Addition of new criteria for locally advanced, unresectable NSCLC
• 2024-10-18: Adjusted effective date
• 2024-05-01: updated criteria
• 2024-04-03: 2024 annual review - Addition of new NSCLC indication.
• 2023-06-21: Removed Oncology specialist requirement
• 2023-04-10: 2023 Annual Review
• 2022-04-07: 2022 Annual Review- No changes
• 2021-06-07: addition of EHB formulary. no changes to criteria
• 2021-04-13: Updated GPIs
• 2021-02-01: updated to add criteria for new indication
• 2020-03-13: Annual Review: updated background & references

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