Pharmacy Prior Authorization Criteria

Ensacove (ensartinib)

Indications for Prior Authorization

Ensacove (ensartinib)

• For diagnosis of Non-Small Cell Lung Cancer (NSCLC)
  Indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor.

Criteria

Ensacove

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of non-small cell lung cancer (NSCLC)
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
AND
• Disease is anaplastic lymphoma kinase (ALK) rearrangement-positive as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient has not previously received an ALK-inhibitor [e.g., Alecensa (alectinib), Alunbrig (brigatinib), Lorbrena (lorlatinib), Xalkori (crizotinib), Zykadia (ceritinib)]

Ensacove

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2026-07-08, 2025-07-09

References

1. Ensacove Prescribing Information. Xcovery Holdings, Inc. Miami, FL. February 2026.

---

Revision History

• 2026-07-08: Annual Review 2026 - No criteria changes. Background updates
• 2025-07-09: New program.

---