Product Details

Apo-Erlotinib

Erlotinib
100 mg
Tablet


DIN/PIN/NPN

02461870

Manufacturer

Apotex Inc.

Formulary Listing Date

2017-10-30  

Unit Price

47.4667

Amount MOH Pays

47.4667

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EB02

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02377705 Teva-Erlotinib 47.4666 47.4666
02269015 Tarceva NA NA
02454386 PMS-Erlotinib 47.4667 47.4667
02483920 Nat-Erlotinib 47.4667 47.4667
02461870 Apo-Erlotinib 47.4667 47.4667
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Erlotinib

  • Brand(s): Tarceva and generics (see formulary for a funded list of generics)
  • Dosage Form/Strength: 25 mg,100 mg, 150 mg tablet

For the treatment of clinically documented incurable progressive non-small cell lung cancer (NSCLC) where:

  1. Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior chemotherapy (any regimen) in patients 70 years of age or older.

  2. Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with clinically documented incurable progressive non-small cell lung cancer (NSCLC) despite prior chemotherapy including both docetaxel and a platinum-based treatment (i.e. cisplatin or carboplatin).

  3. Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically documented incurable progressive non-small cell lung cancer (NSCLC) despite prior chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin) AND either pemetrexed or topotecan.

  4. Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line platinum-based therapy, where no other chemotherapy will be given and erlotinib is used as the last treatment for the patient

Patients should be assessed for disease status at least every two months. Erlotinib should be discontinued if there is evidence of disease progression.

Note that erlotinib is not indicated and therefore, is not considered for reimbursement as 1st line therapy in treatment of NSCLC.

Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and have not received treatment with either platinum-based combinations will be considered on a case-by-case basis.

Approved dosage: 150 mg/day

Duration of Approval: 6 Months

Renewal will be considered for patients who respond to therapy with no evidence of disease progression. Patients should be assessed for disease status at least every two months. Erlotinib should be discontinued if there is evidence of disease progression.

Duration of Approval: 6 Months

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph