Product Details

Nexavar

Sorafenib
200 mg
Tablet


DIN/PIN/NPN

02284227

Manufacturer

Bayer Inc., Health Care Division

Formulary Listing Date

2014-01-30  

Unit Price

46.4689

Amount MOH Pays

46.4689

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EX02

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Sorafenib

  • Brand(s): Nexavar
  • Dosage Form/Strength: 200 mg tablet

For the treatment of metastatic renal cell carcinoma (MRCC) as second-line treatment for patients who have:

  1. Histologically confirmed metastatic clear-cell renal-cell carcinoma; AND

  1. Experienced disease progression after prior cytokine therapy within the previous 8 months; AND

  1. A performance status of 0 or 1 on the basis of the Eastern Cooperative Oncology Group criteria; AND

  1. Intermediate-risk or low-risk status, according to the Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic score.

Duration of Approval: 1 year

Renewals will be considered with confirmation from the physician that the patient has benefited from therapy and is expected to continue to do so.

For the treatment of advanced hepatocellular carcinoma (HCC) in patients who have: 

  1. Child-Pugh Class A disease; and 

  2. ECOG* status 0, 1 or 2; and 

  3. Either progressed on transarterial chemoembolization (TACE) or are not suitable for the TACE procedure (where detailed rationale is provided). 

Duration of Approval: 3 months 

*ECOG = Eastern Cooperative Oncology Group Performance Status 

Renewal will be considered for patients with documentation of radiography and/or scan results indicating no diseases progression.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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