Report on New Patented Drugs - MultiHance

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

Brand Name: MultiHance

Generic Name: (gadobenate dimeglumine)

DIN: 02248302 529 mg/ml

Patentee: Bracco Diagnostic Canada

Indication - as per product monograph:

MultiHance is indicated for intravenous use in adults and children 2 years of age and older as an adjunct to magnetic resonance imaging (MRI) of the Central Nervous System (brain, spine, and surrounding structures).

Notice of Compliance: March 31, 2004

Date of First Sale: October 25, 2004

ATC Class: V08CA08
Various, Contrast Media, Magnetic Resonance Imaging Contrast Media, Paramagnetic Contrast Media

Application of the Guidelines:

Summary:

The introductory price of MultiHance was found to be within the Guidelines because the cost of therapy did not exceed the cost of therapy of existing drugs in the therapeutic class comparison (TCC) and the price did not exceed the prices in other comparator countries where MultiHance was sold.

Scientific Review:

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

The HDAP recommended Omniscan (gadodiamide), Magnevist (gadopentate dimeglumine), Gadovist (gadobutrol), ProHance (gadoteridol) and Optimark (gadoversetamide) as the most appropriate comparators for MultiHance. These products share the same fourth level ATC class and are all used as adjunct for magnetic resonance imaging.

The PMPRB's Guidelines provide that the dosage recommended for comparison purposes will normally not be higher than the maximum of the usual recommended dosage. The recommended dosage regimens for MultiHance and the comparators are based on their respective product monographs and supported by clinical literature.

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 price of MultiHance was within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicines.

1 Company price list dated July 29, 2005
2 Publicly available price as per the Patented Medicines Regulations
3 PPS Pharma

In 2004, MultiHance was being sold in France, Germany, Italy, Sweden, Switzerland and the United Kingdom. In compliance with the Guidelines, the price in Canada did not exceed the prices in those countries; the price of MultiHance in Canada was the lowest of those countries, below the median international price.

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.

References:

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