Product Details

Giotrif

Afatinib
30 mg
Tablet


DIN/PIN/NPN

02415674

Manufacturer

Boehringer-Ingelheim (Canada) Ltd./Ltee

Formulary Listing Date

2022-04-29  

Unit Price

77.4784

Amount MOH Pays

77.4784

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EB03

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Afatinib

  • Brand(s): Giotrif
  • Dosage Form/Strength: 20 mg, 30 mg, 40 mg tablet

Initial requests:

For the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) who meet the following criteria:

  1. Afatanib is being used as first line therapy; AND

  2. Afatanib is being used as monotherapy; AND

  3. Patient’s cancer is EGFR positive

Dose: 40 mg orally once daily

Exclusion Criteria:

  • Patients with EGFR wild-type, negative, or unknown mutation.
  • Afatinib will not be considered for funding in patients who have progressed on a prior EGFR TKI targeted therapy.
  • Not funded for 2nd or 3rd line or maintenance NSCLC.

Notes:

  1. Patients should be assessed for disease status at least every two months. Afatinib may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of afatinib.
  2. Patients who receive afatinib 1st line are NOT eligible for erlotinib in the 2nd or 3rd line or maintenance NSCLC setting.
  3. Requests for afatinib for patients who have initiated another EGFR TKI therapy (i.e., Iressa [gefitinib]) in the first line setting and who have not had disease progression will be considered on a case-by-case basis.

Renewal requests will be considered based on the following:

Afatinib 40 mg once daily may be continued until evidence of disease progression or development of unacceptable toxicity at which point the drug should be discontinued. Patients should have their disease status assessed at least every two months.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph