Product Details

Caprelsa

Vandetanib
100 mg
Tablet


DIN/PIN/NPN

02378582

Manufacturer

Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc.

Formulary Listing Date

2018-09-13  

Unit Price

99.1573

Amount MOH Pays

99.1573

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EX04

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Vandetanib

  • Brand(s): Caprelsa
  • Dosage Form/Strength: 100 mg, 300mg tablet
  • Effective date: September 13, 2018

Caprelsa (Vandetanib) is funded for the treatment of symptomatic and/or progressive1 medullary thyroid cancer (MTC) in patients who meet the following criteria:

  1. Patient has unresectable locally advanced or metastatic disease; AND

  1. Vandetanib is being used as monotherapy for MTC; AND

  1. ECOG less than or equal to 22; AND

  1. Prescribed by or in consultation with an oncologist or internist experienced with the treatment of MTC.

Exclusion Criteria:

  1. Patients with QT interval prolongation/abnormalities (e.g., QTc that is unmeasurable or greater than or the same as 480ms) or who are taking medications that prolong QT interval prolongation.

  1. Patients with indolent, asymptomatic, or slowly progressive disease.

  1. Vandetanib is not funded as combination therapy

Renewal Criteria:
Renewal of funding will be provided until disease progression or development of unacceptable toxicity3. 

1As confirmed by radiological reports.

2Patients with an ECOG greater than 2 will be considered case-by-case upon submission of information regarding the risk of toxicity.

3At the time of renewal, prescriber should address whether there have been any significant cardiac events or concerns regarding cardiovascular toxicities.

Duration of approval for initial and renewal criteria: 1 year

Note: Prescribers and dispensing pharmacies are presumed to be in compliance with the requirements of the Caprelsa Restricted Distribution Program which is administered through the manufacturer.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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