Report on Patented Veterinary Drug Product - ProHeart 6

Brand Name: ProHeart 6

Generic Name: (moxidectin)

DIN: 02245422 - 100 mg/mL

Patentee: Ayerst Veterinary Laboratories

Indication - as per product monograph:

Proheart 6 is indicated in dogs six months of age and older, for the prevention of canine cardiovascular dirofilariosis (heartworm disease) caused by Dirofilaria immitis for six months after a single administration. It is also indicated for treatment of parasitic infections due to the adult and developing larval stages of hookworms in dogs.

Notice of Compliance: February 8, 2002

Date of First sale: March 5, 2002

Application of the Excessive Price Guidelines:

Special Provisions for Veterinary Patentees

The Special Provisions for Veterinary Patentees provide for an alternative means to review the price of patented veterinary medicines during the three-year trial complaints-driven process. In lieu of filing price and sales information, patentees must provide the proposed introductory price for any product that was not previously offered for sale in Canada. The Guidelines continue to be applied to the extent that they are appropriate. See the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Special Provisions for Veterinary Patentees.

Scientific Review:

The recommended dosage for dogs is 0.17 mg (0.05 ml)/kg of body weight every 6 months. The following information was taken into consideration in setting out the Therapeutic Class Comparison (TCC):

• Although other canine parasiticides are available in Canada, HeartGard-30 Plus and Interceptor Flavor Tabs are the most appropriate comparators as their indications include the prevention of heartworm disease and the treatment of hookworms in dogs.
• The administration of ProHeart 6, HeartGard -30 Plus and Interceptor Flavor Tabs varies depending on the size of the dog. An average size of 20 kg was used for the purpose of conducting the TCC. The dosage regimens are based on the respective products monographs.

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 the comparable drug products based on the TCC test, and if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicine Regulations. As a result of the Special Provisions for Veterinary Patentees, only the TCC test was carried out to review the price of ProHeart 6.

* Drug cost based on CDMV (formerly known as the Centre de distribution de médicaments vétérinaries) price list (May 2003)