Voluntary Compliance Undertaking of Sanofi-Synthélabo Canada
Inc. to the Patented Medicine Prices Review Board
1.0 Product Summary
1.1 Fasturtec (rasburicase) is a patented medicine sold in Canada by Sanofi-Synthélabo Canada Inc. (Sanofi).
1.2 Fasturtec is indicated for the treatment and prophylaxis of hyperuricemia in pediatric and adult cancer patients. It is a new active substance (also referred to as a new chemical entity) and its ATC classification is V03AF07.
1.3 Canadian Patent Nos. 2,035,900 and 2,148,537 were granted to Sanofi on January 11, 2000 and July 16, 2002 and will expire on July 13, 2010 and May 3, 2015 respectively.
1.4 Sanofi began selling Fasturtec (previously known as Elitek) to hospitals in Canada under Health Canada's Special Access Program (“SAP”) on May 21, 2002 at a price of $200.00 per vial. The price was increased to $295.00 per vial in July 2002.
1.5 Health Canada issued a Notice of Compliance to Sanofi for Fasturtec 1.5 mg vial (DIN 02248416) on October 29, 2003.
2.0 Application of the Excessive Price Guidelines
2.1 The PMPRB's Human Drug Advisory Panel (HDAP) recommended that Fasturtec be classified as a category 3 new medicine. The HDAP also recommended that there are no appropriate comparators for purposes of conducting a Therapeutic Class Comparison (TCC) under the Guidelines.
2.2 Board Staff conducted its review of the price of Fasturtec in accordance with the PMPRB's Excessive Price Guidelines. The Guidelines state that when it is inappropriate or impossible to conduct a TCC, the PMPRB will give primary weight to the median of the international prices identified in an International Price Comparison Test.
2.3 Based on the results of this test, Board Staff concluded that the introductory price of $200 per vial exceeded the maximum non-excessive (MNE) price of $119.1838 by 67.8%. In the second half of 2002, the $295 price per vial exceeded the MNE by 147.5%. In 2003, the price of Fasturtec continued to exceed the CPI-adjusted MNE price of $122.5209 per vial by 140.8%. Board Staff has calculated that Sanofi has received excess revenues of $374,343 fromMay 21, 2002 to December 31, 2003.
3.0 Terms of the Voluntary Compliance Undertaking
3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Sanofi that the price of Fasturtec is or was excessive for purposes of the Patent Act.
3.2 In order to comply with the Excessive Price Guidelines and policies of the PMPRB, Sanofi undertakes as follows:
3.2.1. To agree, for purposes of the Guidelines, that the MNE price of Fasturtec in 2002 at the time of its introduction in Canada was $119.1838 per vial and that the MNE price in 2004 is $124.7854 per vial.
3.2.2. To reduce the price of Fasturtec, within 30 days of acceptance of this VCU, so that the average transaction price for 2004 does not exceed the MNE price of $124.7854 per vial.
3.2.3. To offset excess revenues received by Sanofi from May 21, 2002 to December 31, 2003 by making payments to each of the customers that purchased Fasturtec over this period. Each payment shall be calculated by taking the difference between the actual price paid and the MNE price at the time of purchase times the number of vials purchased over the period. All payments shall be made within 30 days of acceptance of this VCU.
3.2.4. Within 30 days of acceptance of this VCU, to advise each customer that purchased Fasturtec of the price reduction and the repayment specific to their hospital and to further advise that these actions are the result of an undertaking to the PMPRB and to provide a reference to the PMPRB website for the complete text of the VCU, and to further provide copies of such notifications to the PMPRB forthwith.
3.2.5. To provide, within 30 days of making the payments provided for in paragraph 3.2.3 above, copies to the PMPRB of the cheques made to each of the customers that purchased Fasturtec and the documentation to support the calculation of the said payments.
3.2.6. To provide, in addition to the price and sales data to be filed pursuant to the Patented Medicines Regulations by January 30, 2005, the PMPRB with customer specific price and sales information as evidence of Sanofi's compliance with paragraph 3.2.2 above.
3.2.7. To ensure that the average transaction price of Fasturtec remains within the Guidelines in all future periods in which it remains under the Board's jurisdiction, and that no customer in Canada shall pay a price higher than the MNE price.
Signature: Original signed by
Company Officer: Yvon Bastien
Date: June 21, 04