Voluntary Compliance Undertaking of Eisai Limited to the Patented Medicine Prices Review Board
1. Product Summary
1.1 Halaven (eribulin mesylate) 0.5 mg/mL is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.
1.2 Canadian Patents No. 2,335,300 and No. 2,632,433 pertaining to Halaven were issued on October 7, 2008 and February 7, 2012, respectively, to Eisai R&D Management Co. Ltd. of Japan. The last patent will expire on June 16, 2019. Eisai Limited is the patentee for purposes of the Patented Medicine Prices Review Board (PMPRB).
1.3 A Notice of Compliance was granted to Eisai Limited for Halaven 0.5 mg/mL (DIN 02377438) on December 14, 2011. Halaven was first sold in Canada on June 29, 2011.
2. Application of the Guidelines
2.1 The Board's Human Drug Advisory Panel (HDAP) recommended that Halaven be classified as a drug product offering a moderate level of therapeutic improvement. At introduction, the national average transaction price (N-ATP) of $305.3747 per mL exceeded the maximum average potential price (MAPP) of $239.0815 per mL by 27.7%.
2.2 As of December 31, 2011, there were cumulative excess revenues of $7,159.67.
3. Position of Patentee
3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Eisai Limited that the price of Halaven is or was excessive for purposes of the Patent Act.
4. Terms of the Voluntary Compliance Undertaking
In order to comply with the Guidelines, Eisai Limited undertakes as follows:
4.1.1 To agree that the 2011 through 2013 national non-excessive average prices (N-NEAPs) of Halaven 0.5 mg/mL are as follows:
4.1.2 To ensure the 2012 N-ATP of Halaven does not exceed the 2012 N-NEAP price of $244.1022;
4.1.3 To offset the cumulative excess revenues received from June 29, 2011 to December 31, 2011 by making a payment of $7,159.67 to Her Majesty in right of Canada, within 30 days of the acceptance of this VCU;
4.1.4 To offset any excess revenues remaining as of December 31, 2012 as a result of selling Halaven 0.5 mg/mL at a N-ATP in excess of the N-NEAP set out in 4.1.1 by making a payment to Her Majesty in right of Canada not later than March 1, 2013;
4.1.5 To ensure that the price of Halaven remains within the Guidelines in all future periods in which Halaven is under the PMPRB's jurisdiction.
Original signed by:
||Mr. Takihiro Hirasawa
||December 11, 2012