Report on New Patented Drugs - Xolair

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 Excessive Price Guidelines (Guidelines), for all new active substances introduced after January 1, 2002.

Brand Name: Xolair

Generic Name: (omalizumab)

DIN: 02260565 150 mg/vial

Patentee: Novartis Pharmaceuticals Canada

Indication - as per product monograph:

For adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

Date of Issuance of First Patent(s) Pertaining to the Medicine: December 15, 1998

Notice of Compliance: November 18, 2004

Date of First Sale: February 3, 2005

ATC Class: R03DX05 Respiratory System, Drugs for Obstructive Airway Diseases, Other Systemic Drugs for Obstructive Airway Diseases, Other Systemic Drugs for Obstructive Airway Diseases

APPLICATION OF THE GUIDELINES

Summary

The introductory price of Xolair 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

Xolair is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Xolair be reviewed as a category 3 new medicine (provides moderate, little or no therapeutic advantage over comparable medicines).

The HDAP did not recommend any comparators for the conduct of a Therapeutic Class Comparison (TCC) test. Xolair is indicated as an adjunct to inhaled corticosteroids in a very specific population: those who have persistent asthma due to aeroallergens despite optimal therapy with anti-asthma medications.

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 comparable drug products could be identified for the purposes of conducting a TCC test, the price of Xolair was considered within the Guidelines as it did not exceed the median of the international prices identified in an IPC test.

Introductory Period (February to June 2005)

Country Price for 150 mg/vial
Canada

$600.0000
France --
Germany --
Italy --
Sweden --
Switzerland --
U.K. --
U.S. $ 647.7163
Median $ 647.7163

Sources

Canada
Publicly available price as per Patented Medicines Regulations.

U.S.
Average of Thomson Micromedex Wholesale Acquisition Cost (WAC), April 2005 and Federal Supply Schedule (FSS), January-June 2005.

The Guidelines provide that when a medicine is sold in fewer than five countries at the time of its introduction, the introductory price will be treated as the interim benchmark price. The interim benchmark price may be reviewed at the end of three years or when the medicine is sold in at least five countries, whichever comes first.

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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