Osimertinib (Tagrisso®)

ORAL ADMINISTRATION

Indications for Prior Authorization:

  • 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
  • Treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy

All of the following must be met as a condition for coverage:

  • Prescribed by or in consultation with an oncologist, AND
  • Chart note documentation confirming one of the following:
    • Metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, OR
    • Metastatic EGFR T790M mutation-positive NSCLC, whose disease has progressed on or after EGFR TKI therapy

This Medication is Not Approvable for the following condition(s):

  • Any condition not listed above as an approved indication

Dosing:

  • 80 mg once daily until disease progression or unacceptable toxicity
  • Avoid co-administration of strong CYP3A4 inducers
  • If concurrent use with strong CYP3A4 inducers is unavoidable:
    • 160mg daily when co-administering with a strong CYP3A inducer
    • Resume Tagrisso at 80mg 3 weeks after discontinuation of strong CYP3A4 inducer

Approval:

  • One year

 

Last review date: April 16, 2019

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