Report on New Patented Drug - Revlimid

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.

Brand Name: Revlimid

Generic Name: lenalidomide

DIN: 02304899 (5 mg capsule)
02304902 (10 mg capsule)

Patentee: Celgene Corporation

Indication – as per product monograph:

For the treatment of patients with transfusion-dependent anemia due to low or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Date of Issuance of First Patent(s) Pertaining to the Medicine: August 16, 2005

Notice of Compliance: January 17, 2008

Date of First Sale: February 27, 2008

ATC Class: L04AX
Antineoplastic and Immunomodulating Agents; Immunosuppressive Agents; Immunosuppressive Agents; Other Immunosuppressive Agents

Application of the Guidelines

Summary

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

Scientific Review

Revlimid is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Revlimid be classified as a category 2 new medicine (a breakthrough or 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.

Revlimid 5 mg capsule Introductory Period (February – June 2008)

Sources:
Germany: Rote Liste, January 2008
Sweden: Prislista, June 2008
Switzerland: Medwin Web site, July – December 2008
United Kingdom: MIMS, April 2008
United States: Federal Supply Schedule (FSS), January – June 2008;
Thomson Micromedex Wholesale Acquisition Cost (WAC), April 2008

Revlimid 10 mg capsule Introductory Period (February – June 2008)

Sources:
Germany: Rote Liste, January 2008
Sweden: Prislista, June 2008
Switzerland: Medwin Web site, July – December 2008
United Kingdom: MIMS, April 2008
United States: Federal Supply Schedule (FSS), January – June 2008;
Thomson Micromedex Wholesale Acquisition Cost (WAC), April 2008

As no comparators were identified for the purposes of conducting a TCC test, the introductory prices of Revlimid were considered within the Guidelines as they did not exceed the median of the international prices identified in an IPC test – Revlimid was sold in six of the seven countries listed in the Regulations. For purposes of publication, the Tables above do not include prices for Canada and one of these countries (France) in which Revlimid was sold in the introductory period as there were no publicly available sources for the prices. The prices of Revlimid in Canada were also below the median price of the five comparator countries for which a public price was available.

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.