|
PMPRB July Newsletter released and Another Hearing Called
The PMPRB has released its July 2007 Newsletter. Highlights of the Newsletter are presented below:
1- Update on the Review of the Board's Excessive Price Guidelines:
- Next steps in the review of the Board's Excessive Price Guidelines are outlined in the Stakeholder Communiqué issued May 31, 2007
- Further meetings have been scheduled for September 10, 11, and 12
- Participants to make written submissions to the Board following the meeting outlining the key concerns and messages raised at the meeting
2- Upcoming hearing/pre-hearing dates:
Copaxone August 13 (closing arguments day 2)
Concerta August 29 (closing arguments)
Penlac Nail Lacquer (dates TBA)
Quadracel and Pentacel (October 31 pre-hearing; November 28-30 hearing)
Strattera (dates TBA)
Zemplar (November 13 pre-hearing; December 10 hearing)
3- HDAP meeting dates for 2008 and deadlines for submissions:
February 11; PM due November 12, 2007; Submission due December 11, 2007
May 15; PM due February 15; Submission due March 17
September 15; PM due June 16; Submission due July 15
November 24; PM due August 25; Submission due September 24
4- PMPRB approved 3 VCUs in the last 3 months:
Airomir: May 2007
Risperdal Consta: June 2007
Forteo: June 2007
Summaries provided in previous correspondence from Brogan Inc.
5- NPDUIS update:
Several new projects underway:
- A pharmaceutical expenditure forecasting methodology and guidelines to provide guidance for short-term forecasting of drug plan expenditures.
- Defined Daily Dose (DDD) analyses to better understand utilization trends and cost drivers for leading therapeutic groups.
- Costing analysis of Catastrophic Drug Coverage to be updated for the National Pharmaceuticals Strategy Task Group.
6- Gardasil new Category 2 drug:
- Breakthrough medicine; first drug product sold in Canada that addresses effectively both the prevention of infections with HPV types 6, 11, 16 and 18 and the associated precancerous cervical and external genital lesions.
- No comparable medicines selected: "There is no drug therapy or vaccine indicated or used for the prevention of HPV and its associated precancerous lesions."
- Price below median of the international prices identified in an IPC test
Public Hearing into the price of Zemplar (Abbott Laboratories)
Zemplar, 5µg/mL solution for injection, is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure.
Statements of Allegations by Board Staff indicate that the introductory price of Zemplar is excessive based on Subsection 85(1) of the Patent Act which lists the factors that the Board shall take into consideration in determining whether a medicine is being or has been sold at an excessive price in any market in Canada.
In relation to the application of Subsection 85(1)(c)", "the prices at which the medicine and other medicines in the same therapeutic class have been sold in countries other than Canada" and in particular, the application of what the Board referred to as "international TCC Test" (highlighted part of this factor); Board Staff submits that in conducting an international TCC Test the following criteria must be satisfied:
a) The comparators in an international TCC Test must be those identified in the domestic TCC Test; and
b) The price of the drug under review will be deemed excessive if it exceeds the median of the international TCC Test.
Note that one item for discussion during the upcoming consultations on Excessive Price Guidelines (as per the stakeholder communiqué) relates to the international TCC Test.
|
