Tagrisso

Osimertinib

1. Brand(s): Tagrisso
2. Dosage Form/Strength: 80 mg tablets (40 mg on case-by-case)
3. Updated: January 10, 2020

Initiation criteria:

For the treatment of locally advanced (not amenable to curative therapies) or metastatic non-small cell lung cancer (NSCLC) in individuals meeting the following criteria:

1. Previously untreated¹ NSCLC in a patient with tumours that are documented to have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions (exon 19 del) or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations)
   OR
   Previously treated NSCLC in a patient who has experienced disease progression on one EGFR tyrosine kinase inhibitor (TKI) therapy (i.e., afatinib, gefitinib or erlotinib) with tumours that are documented to have EGFR T790M resistance mutations²;

   AND

2. Has a good performance status; AND

3. Osimertinib is being used as monotherapy.

Exclusion Criteria:

• Patients with EGFR wild-type mutations

• Patients with EGFR unknown mutations

• Osimertinib will not be funded as a third-line TKI

• Patients with EGFR exon 19 deletions (exon 19 del) or exon 21 (L858R) substitution mutations who receive afatinib or gefitinib in first line are not eligible for osimertinib in the 2nd line NSCLC setting.^3,4

Note:

¹Eligible patients should be previously untreated in the locally advanced or metastatic setting.

²Patients with de novo EGFR 790M mutations may be considered case-by-case.

³Time-limited consideration will be provided for patients meeting all the above criteria who are currently on a first-, or second-generation EGFR TKI (i.e., gefitinib, afatinib, erlotinib) who have not experienced disease progression or patients who are currently on chemotherapy and are found to harbour a sensitizing or resistance mutation who wish to switch to osimertinib therapy.

⁴Patients who progress on osimertinib in the first line will not be considered for another targeted TKI therapy (i.e., gefitinib or afatinib) for NSCLC

Renewal of funding of osimertinib will be considered in patients who continue to derive benefit from treatment. (i.e., until clinically meaningful progression occurs or development of unacceptable toxicities.)

Recommended dose: 80 mg per day orally
(Note that 40mg tablets are approved on a case-by-case basis to ensure cost-effectiveness of the funded strength.)

Duration of Approval for Initial and Renewal requests: 6 months

Osimertinib

• Brand(s): Tagrisso
• Dosage Form/Strength: 80 mg tablets (40mg on case-by-case)
• Effective Date: November 15, 2022 (Adjuvant setting)

Initiation Criteria:

For use as adjuvant therapy in patients with completely resected, EGFR mutated, non-small cell lung cancer (NSCLC) meeting ALL the following criteria:

1. Patient is 18 years of age or older; AND

2. Has completely resected NSCLC confirmed post-operatively as being stage IB-IIIA (AJCC 7th edition, or equivalent) NSCLC; AND

3. NSCLC tumour tissue confirmed to be EGFR (exon 19 deletion and/or exon 21 L858R substitution) mutation positive; AND

4. Patients has a good performance status (e.g., Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2); AND

5. Osimertinib is being initiated within 10 weeks of complete surgical resection if adjuvant chemotherapy was not used OR within 26 weeks of surgical resection if adjuvant chemotherapy (e.g., platinum-based doublet chemotherapy, maximum of 4 cycles) was administered.

6. Prescribed by a clinician experienced in the treatment and management of NSCLC.

Exclusion Criteria:

• Patients with EGFR wild-type mutations

• Patients with EGFR unknown mutations

Renewal Criteria:
Renewal of funding of osimertinib in this adjuvant setting will be continued until disease recurrence¹, or development of unacceptable toxicity, or until a maximum of treatment duration of 3 years is reached regardless of dose reduction and dose interruption.

¹Patient does not have evidence of disease recurrence, based on the absence of recurrence on CT or MRI scan, pathological disease on biopsy, or both.

Recommended dose: 80 mg per day orally

Approval duration: 1 year
(Total duration of funding up to 3 years)

EAP Drug Request Form:

Standard Form for EAP Drug Requests