Report on New Patented Drugs - Cancidas
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: Cancidas
Generic Name: caspofungin acetate
DIN: 02244265 50 mg/vial, 02244266 70 mg/vial
Patentee: Merck Frosst Canada
Indication - as per product monograph: For the treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
Notice of Compliance: July 19, 2001
Date of First Sale: August 1, 2001
In most cases, patents are issued before the drugs come to market. In this case, the first patent pertaining to Cancidas was issued in May 2002 and it came under the PMPRB's jurisdiction at that time.
ATC Class: J02AX04
Antiinfectives for Systemic Use; Antimycotics for systemic use; Other antimycotics for systemic use.
Application of the Guidelines:
The introductory prices of Cancidas at the date of first sale were found to be within the Guidelines because the cost of therapy did not exceed the cost of therapy of existing drugs in the therapeutic class comparison and the prices did not exceed the range of prices in other comparator countries where Cancidas was sold. These prices continued to be within the Guidelines when Cancidas came under the PMPRB's jurisdiction.
Cancidas is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) reviewed it as a category 3 new medicine (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 provide that it may, however, be appropriate to include products from other ATC classes if they are clinically equivalent for the appropriate indication to the drug product under review. See the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Guidelines and the policies on TCCs.
There were no other medicines in the same 4th level ATC class. The HDAP recommended Abelcet (amphotericin B liquid complex), AmBisome (liposomal amphotericin B) and Fungizone (amphotericin B) as comparators for Cancidas as they are clinically equivalent at addressing the approved indication of Cancidas.
The Guidelines provide that the dosage recommended for comparison purposes will normally not be higher than the maximum of the usual recommended dosage. The recommended comparable dosage regimens for Cancidas and the comparators are based on product monographs and clinical literature.
Under the Guidelines, the introductory price for a new category 3 drug product will be presumed to be excessive if it exceeds the price of all of the comparable drug products in the TCC test, or if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicines Regulations.
The prices of Cancidas were within the Guidelines as the cost per day did not exceed the cost of therapy of the comparator medicines.
||Cost of therapy
||50 mg daily for 83 days
||350 mg daily for 83 days
||350 mg daily for 83 days
||105 mg daily for 83 days
||70 mg for day 1 treatment
||350 mg for day 1 treatment
||350 mg for day 1 treatment
||105 mg for day 1 treatment
1 Publicly available price as per the Patented Medicines Regulations
2 PPS Pharma, 2001
3 Ontario Drug Benefit Formulary, 2001
In 2002, Cancidas was also being sold in Sweden and the United States. In compliance with the Guidelines, the prices in Canada did not exceed the range of prices in those countries; the prices of Cancidas were second lowest below the median of international prices.
Where comparators and dosage regimens are referred to in the Summary Reports, they have been selected by the PMPRB Staff and the HDAP for the purpose of carrying out the PMPRB's regulatory mandate, which is to review the prices of patented medicines sold in Canada to ensure that such prices are not excessive. The publication of these reports is also part of the PMPRB's commitment to make its price review process more transparent.
The information contained in the PMPRB's Summary Reports should not be relied upon for any purpose other than its stated purpose and is not to be interpreted as an endorsement, recommendation or approval of any drug nor is it intended to be relied upon as a substitute for seeking appropriate advice from a qualified health care practitioner.
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4. Product monograph of Cancidas (Caspofungin acetate). Merck Frosst Canada & Co., Kirkland, Quebec. July 2001.
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