Report on Patented Veterinary Drug Product - Revolution

Brand Name: Revolution

Generic Name: selamectin

DIN:

02242045 – 240 mg/tube
02242046 – 120 mg/tube
02242047 – 30 mg/tube
02242048 – 45 mg/tube
02242049 – 60 mg/tube
02242050 – 15 mg/tube

Patentee: Pfizer Canada Inc., Animal Health Group

Indication - as per product monograph:

Revolution is indicated in the treatment and control of flea infestations, for the prevention of heartworm disease and for the treatment and control of ear mite infestations in dogs and cats; it is also indicated for the treatment and control of sarcoptic mange mite infestations in dogs and intestinal hookworm and roundworm infections in cats.

Notice of Compliance: April 6, 2000

Date of First sale: September 5, 2000

Application of the Excessive Price Guidelines:

Special Provions 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 PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Special Provisions for Veterinary Patentees.

Scientific Review:

Selamectin is a semi-synthetic parasiticide of the avermectin class. Revolution is applied topically to the skin at the recommended minimum dose of 6 mg of selamectin per kg of body weight, once a month. It is supplied in packages of six single-dose tube sizes for cats and dogs of different weights.

Selamectin is a new chemical entity which is structurally related to milbemycin and ivermectin, two other parasiticides used in veterinary medicine. Revolution is therefore the first DIN of a new chemical entity to be sold in the veterinary market in Canada.

The following information was taken into consideration in setting out the TCC:

• Many veterinary parasiticide products are available in Canada in various dosage forms (oral tablets, topical solutions, sprays, dips, etc.) with various indications. None of these other products is approved for all of the same five indications for Revolution. To achieve the same spectrum of coverage provided by Revolution, it would be necessary to use different combinations of products; however, since all of the parasites do not afflict the same animal at the same time, the primary use of Revolution will vary with each situation. For this reason, products which share one or more of the same approved indications of Revolution were considered as potential TCC comparators.
  
• Although Revolution is topically administered, the selamectin is absorbed through the skin into the bloodstream to act systemically. It is therefore appropriate to include both topical and oral dosage form products in the TCC. The drug products that are most chemically similar to Revolution, Heartgard (ivermectin) and Interceptor (milbemycin), are sold as oral tablets. The comparators selected for the TCC are those that appear to be most commonly used and include the products identified in Table 1.
  
• In establishing the comparable dosage regimens for the TCC, it was assumed that the 15 mg (mauve) and 45 mg (blue) tubes will be used to treat cats of the weight specified and that the 30 mg (purple), 60 mg (brown), 120 mg (red) and 240 mg (teal) tubes will be used to treat dogs of the corresponding weights, based on information provided in the approved product insert for Revolution.
  
• The comparable dosage regimens for the comparator products were based on the animal species and body weight assumed for each tube size of Revolution. In most cases, the comparable medicines are administered on the same dosage schedule as Revolution i.e. once monthly schedule. For other products, a single treatment is used. Program injection (lufenuron) is administered once every six months to control fleas; in this case, 6 months of treatment with Revolution would be compared to a single injection of Program.

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 for each strength of Revolution.

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