Report on New Patented Drugs - Avastin

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.

Avastin

Brand Name: Avastin

Generic Name: (bevacizumab)

DIN: 02270994 25 mg/mL injectable solution

Patentee: Hoffmann-La Roche Canada Ltd.

Indication - as per product monograph:

In combination with fluropyrimidine-based chemotherapy is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.

Notice of Compliance: September 9, 2005

Date of First Sale: November 2, 2005

ATC Class: L01XC07

Antineoplastic and Immunomodulating; Antineoplastic Agents; Other Antineoplastic Agents; Monoclonal Antibodies.

Application of the Guidelines

Summary

The introductory price of Avastin was found to be within the Guidelines because the price in Canada did not exceed the median of the prices of the same drug in those countries listed in the Patented Medicines Regulations in which it was sold.

Scientific Review

Avastin is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Avastin be reviewed 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. See the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Guidelines and the policies on TCCs.

The HDAP did not recommend any comparators for Avastin (bevacizumab) given that, based on current published evidence, no other drug product appears to be indicated for, or have similar efficacy when used in combination with an irinotecan/fluoropyrimidine chemotherapy, in the first-line treatment of metastatic colorectal cancer (MCRC). Although Avastin provides a significant survival improvement when added to an irinotecan-based fluropyrimidine chemotherapy regimen, the HDAP could not determine whether Avastin provides a significant improvement over existing chemotherapy regimens used for first-line treatment of MCRC, as studies using other known efficacious regimens are not yet publicly available.

Price Review

Under the Guidelines, the introductory price of 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 Guidelines further state that when it is inappropriate or impossible to conduct a TCC test, Board Staff will give primary weight to the median of the international prices identified in an International Price Comparison (IPC) test. See the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Guidelines.

As no comparators were identified for the purposes of conducting a TCC test, the price of Avastin was considered within the Guidelines as it did not exceed the median of the international prices identified in an IPC test.

Introductory Period
Country Price for 25 mg/mL injectable solution
Canada $125.0000
France --
Germany $130.7149
Italy --
Sweden $132.7221
Switzerland $136.5705
U.K. $131.4463
U.S. $186.6446
Median $132.7221

Sources:

Canada - Hoffmann-La Roche Canada Ltd.

Germany - Rote Liste, July 2005

Italy - L'informatore farmaceutico, December 2005

Sweden - Prislista, September 2005

Switzerland - Medwin Web site, July-December 2005

U.K. - MIMS, December 2005

U.S. - Average of Thomson Micromedex Wholesale Acquisition Cost (WAC),
October 2005 and Federal Supply Schedule (FSS), July-December 2005.

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.

References

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21. Product monograph of Avastin (bevacizumab). Hoffman-La Roche Limited, Mississauga, ON.

22. US National Comprehensive Cancer Network. Practice Guidelines Colon Cancer v.3.2005. Chemotherapy for advanced or metastatic disease.

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