Report on New Patented Drug - Lucentis

Under its transparency initiative, the PMPRB publishes the results of the reviews of new patented drug products by Board Staff, for purposes of applying the Board's Excessive Price Guidelines (Guidelines) for all new active substances introduced in Canada after January 1, 2002.

Generic Name: ranibizumab

DIN: 02296810 (10 mg/mL)

Patentee: Novartis Pharmaceuticals Canada Inc.

Indication – as per product monograph: For the treatment of neovascular (wet) age-related macular degeneration (AMD).

Date of Issuance of First Patent Pertaining to the Medicine: June 10, 2008

Notice of Compliance: June 26, 2007

Date of First Sale: July 26, 2007

Sensory Organs; Ophthalmologicals; Ocular Vascular Disorder Agents; Antineovascularisation Agents

Application of the Guidelines

Summary

The introductory price of Lucentis was found to be within the Guidelines because the price in Canada did not exceed the median of the prices of the same drug product in the comparator countries listed in the Patented Medicines Regulations (Regulations) in which Lucentis was sold.

Scientific Review

Lucentis is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Lucentis be classified as a category 2 new medicine (a breakthrough or provides a substantial improvement over comparable existing medicines). The HDAP did not recommend any comparators for the conduct of a Therapeutic Class Comparison (TCC) test.

Price Review

Under the Guidelines, the introductory price of a category 2 new drug product will be presumed to be excessive if it exceeds the higher of the prices of all the comparable drug products based on the TCC test and 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 introductory price of Lucentis was considered within the Guidelines as it did not exceed the median of the international prices identified in an IPC test. Lucentis was sold in the seven countries listed in the Regulations.

Sources:

Canada: Ontario Formulary Online Edition Version 1.4, August 2007

France: Sempex, August 2007

Germany: Rote Liste, July 2007

Italy: L'informatore farmaceutico, December 2007

Sweden: Prislista, December 2007

Switzerland: Medwin website, Jul-Dec07

UK: MIMS, December 2007

US: Federal Supply Schedule (FSS), Jul-Dec07;

Thomson Micromedex Wholesale Acquisition Cost (WAC), October 2007

The publication of the Summary Reports is part of the PMPRB's commitment to make its price review more transparent.

Where comparators and dosage regimens are referred to in the Summary Reports, they have been selected by 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 PMPRB reserves the right to exclude from the therapeutic class comparison list any drug product if it has reason to believe it is being sold at an excessive price.

In its Summary Reports, the PMPRB will also refer to the publicly available prices of comparators provided such prices are not more than 10% above a non-excessive price in which case no price will be made available. As a result, the publication of these prices is for information purposes only and should not be relied upon as indicating the public prices are considered within the Guidelines.

The information contained in the PMPRB's Summary Reports should not be relied upon for any purpose other than that stated 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.