Voluntary Compliance Undertaking of Novartis Pharmaceuticals Canada Inc. to the Patented Medicine Prices Review Board
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1.0 Product Summary
1.1 Ciprodex® (ciprofloxacin/dexamethasone) is indicated for the treatment of infections caused by most strains of gram-positive and gram-negative microorganisms in the specific conditions including in part acute otitis media with otorrhea and acute otitis externa.
1.2 Health Canada issued a Notice of Compliance for Ciprodex® to Alcon Canada Inc. (“Alcon”) on May 10, 2004. Ciprodex® was first sold in Canada on June 1, 2004.
1.3 The marketing authorization for Ciprodex® was transferred from Alcon to Novartis Pharmaceuticals Canada Inc. (“Novartis”) on February 17, 2017.
1.4 The last reported patent pertaining to Ciprodex®, Canadian Patent No. 2459930, expires on September 13, 2022. Novartis is the patentee for the purposes of the Patent Act and the Patented Medicine Prices Review Board (PMPRB).
1.5 Vigamox® (moxifloxacin hydrochloride)is indicated for the treatment of patients one year of age and older with bacterial conjunctivitis caused by susceptible aerobic gram-positive and gram-negative bacterial strains.
1.6 Health Canada issued a Notice of Compliance for Vigamox® to Alcon on May 11, 2004. Vigamox® was first sold in Canada on June 29, 2004.
1.7 The marketing authorization for Vigamox® was transferred from Alcon to Novartis on March 24, 2017.
1.8 The last reported patent pertaining to Vigamox®, Canadian Patent No. 2342211, expires on September 29, 2019. Novartis is the patentee for the purposes of the Patent Act and the PMPRB.
2.0 Application of the Price Guidelines
2.1 The Human Drug Advisory Panel identified Ciprodex® as a Category 3 level of therapeutic improvement. The introductory National Average Transaction Prices (N-ATP) for Ciprodex® was within the thresholds set out in the Guidelines.
2.2 The N-ATP of Ciprodex® first exceeded its National Non-Excessive Average Price (N-NEAP) during the January to December 2017 reporting period. As of December 31, 2018, cumulative excess revenues for Ciprodex® were calculated to be $78,536.03.
2.3 Board Scientific Staff identified Vigamox® as a Category 3 level of therapeutic improvement. The introductory N-ATP for Vigamox® was also within the thresholds set out in the Guidelines.
2.4 The N-ATP of Vigamox® exceeded its N-NEAP during the January to December 2013 reporting period and again during the January to December 2017 reporting period. As of December 31, 2018, cumulative excess revenues for Vigamox® were calculated to be $62,623.38.
3.0 Positions of the Patentee and Board Staff
3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Novartis that the prices of Ciprodex® and Vigamox® are now, or were at any time since the date of first sale, excessive for the purposes of the Patent Act, nor is this VCU binding upon any panel of the Board for the purposes of the Patent Act.
4.0Terms of the Voluntary Compliance Undertaking
4.1 Pursuant to this VCU, Novartis undertakes:
4.1.1 To agree that the 2017, 2018 and 2019 N-NEAPs for Ciprodex® and Vigamox® are as follows:
4.1.2 To ensure that the 2019 N-ATPs for Ciprodex® and Vigamox® do not exceed their 2019 N-NEAPs and that the prices of Ciprodex® and Vigamox® are within the thresholds set out in the Guidelines in each market in which they are sold;
4.1.3 To offset the combined cumulative excess revenues accrued by Novartis in respect of Ciprodex® and Vigamox® by making a payment of $141,159.41 to Her Majesty in right of Canada within 30 days of acceptance of this VCU; and
4.1.4 To make a further payment to Her Majesty in right of Canada within 30 days of receiving Board Staff’s notification of any remaining cumulative excess revenues in respect of Ciprodex® and Vigamox® as of December 31, 2019, as calculated based on the semi-annual price and sales data filed by Novartis; and
4.1.5 To ensure that the prices of Ciprodex® and Vigamox® remain within the PMPRB’s Guidelines in all future periods in which they are under the PMPRB's jurisdiction.
Name: Lison Prévost
Position: Vice-President, Health Policy and Patient Access
Patentee: Novartis Pharmaceuticals Canada Inc.
Date: June 10, 2019