Report on New Patented Drugs – Fasturtec
Under its transparency initiative, the PMPRB publishes the results of the reviews of new patented drugs by Board Staff, for purposes of applying the PMPRB's Price Guidelines, for all new active substances introduced after January 1, 2002.
Brand Name: Fasturtec
Generic Name: rasburicase
DIN: 02248416 - 1.5 mg vial
Patentee: Sanofi-Synthelabo Canada Inc.
Indication – as per product monograph:
For the treatment and prophylaxis of hyperuricemia in paediatric and adult cancer patients.
Notice of Compliance: October 29, 2003
Date of First Sale: May 21, 2002
Fasturtec is being sold under Health Canada's Special Access Program (SAP)
ATC Class: V03AF07
Various, All OtherTherapeutic Products, Detoxifying Agents for Antineoplastic Treatment.
Application of the Guidelines
As a result of a price reduction in July 2004, further to a Voluntary Compliance Undertaking (VCU) by Sanofi-Synthelabo Canada Inc. (Sanofi), the price of Fasturtec is now within the Guidelines as it is based on the median of the prices for the same drug in the seven countries listed in the Patented Medicines Regulations, 1994 (Regulations) at the time of introduction.
Fasturtec was introduced by Sanofi in Canada in May 2002 at a price of $200 per vial. The price was subsequently adjusted upward to $295 per vial.
Following an investigation by Board Staff and allegations that the price of Fasturtec exceeded the Guidelines, the Board issued a Notice of Hearing on May 20, 2004 to consider whether, under sections 83 and 85 of the Patent Act, Fasturtec had been, or was being, sold by Sanofi at an excessive price. On June 28, 2004, the Board approved a VCU by Sanofi, negotiated with Board Staff, to resolve the issues raised by the Notice of Hearing and to reduce the price of the medicine Fasturtec to comply with the Guidelines. The acceptance of the VCU concluded the proceeding commenced by the issuance of the Notice of Hearing.
The PMPRB's Human Drug Advisory Panel (HDAP) recommended that Fasturtec be reviewed as a category 3 new drug product (provides moderate, little or no therapeutic advantage over comparable medicines).
The Therapeutic Class Comparison (TCC) test of the Guidelines provides that the price of a category 3 new drug product cannot exceed the prices of other drugs that treat the same disease or condition. Comparators are generally selected from among existing drug products in the same 4th level of the Anatomical, Therapeutic, Chemical (ATC) System that are clinically equivalent in addressing the approved indication. The Guidelines also provide that when it is inappropriate or impossible to conduct a TCC, the primary weight will be given to the median of the international prices. The price will be presumed excessive if it exceeds the median of the prices of the same drug in the seven countries listed in the Regulations. See the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Guidelines and the policies on TCCs and international price comparisons.
The other medicines within the same 4th level ATC as Fasturtec do not share the same indication, nor does there appear to be any evidence supporting their use in the treatment or prophylaxis of hyperuricemia. Zyloprim (allopurinol), a medicine from another ATC class, is indicated for the prophylaxis of hyperuricemia.
Based on its review of clinical trials and clinical literature, the HDAP concluded that Zyloprim does not appear to be a suitable comparator to Elitek (former name of Fasturtec), and therefore recommended no comparators for the conduct of a TCC.
As a result of the VCU, Sanofi agreed that the maximum non-excessive (MNE) price of Fasturtec for purposes of the Guidelines in 2002 was $119.1838 per vial, the median of the prices for the same drug sold in the seven countries listed in the Regulations. In the year of introduction, Fasturtec was sold in all of the seven comparator countries.
||$CDN price per 1.5 mg vial, 2002
Source: Sanofi-Synthelabo Canada Inc.
Taking into account the CPI Guideline, the MNE price in 2004 is $124.7854 per vial. Under the VCU, Sanofi agreed to lower the price in July 2004 so that no customer pays more than the MNE price.
The Fasturtec VCU is available on the PMPRB website under Publications; Voluntary Compliance Undertakings; Fasturtec.
Evidence/References considered by the HDAP
1. Easton J, Noble S, Jarvis B. Rasburicase. Paediatr Drugs 2001;3(6):433-7.
2. Ezzone SA. Tumor lysis syndrome. Sem Oncol Nurs 1999;202-8.
3. Goldman SC, Holcenberg JS, Finklestein JZ, et al. A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Blood 2001;97:2998-3003.
4. Jeha S. Tumor lysis syndrome. Sem Hematol 2001;38(4 Suppl 10):4-8.
5. Patte C, Sakiroglu O, Sommelet D. European exerience in the treatment of hyperuricemia. Semin Hematol 2001;38(suppl 10):9-12.
6. Pho KH, ed. Hyperuricemia. In: Cancer Care Handbook. 7th ed. The Kingston Regional Cancer Centre. 2001. P. 359.
7. Pui CH, Mahmoud HH, Wiley JM, et al. Recombinant urate oxidase for the prophylaxis or treatment of hyperuricemia in patients with leukemia or lymphoma. J Clin Oncol 2001;19:697-704.
8. Pui CH. Urate oxidase in the prophylaxis or treatment of hyperuricemia: The United States experience. Sem Hematol 2001;38(4 Suppl 10):1-3.
9. The Children's Oncology Group. Internet address: http://www.childrensoncologygroup.org/, accessed September 16th, 2002.
10. Welbanks L, editor. Compendium of Pharmaceuticals and Specialties, 37th Edition. Canadian Pharmacists Association, 2002, Ottawa.