Report on Patented Veterinary Drug Product - Pulmotil Premix

Brand Name: Pulmotil Premix

Generic Name: (tilmicosin)

DIN: 02240124 - 200000mg/kg
Patentee: Provel, Division of Eli Lilly Canada

Indication - as per product monograph:

Pulmotil Premix is indicated as an aid in reducing the severity of swine respiratory disease associated with Actinobacillus pleuropneumoniae (App) and Pasteurella multocida (Pm) when fed to pigs prior to anticipated disease outbreak.

Notice of compliance: June 17, 1999

Date of first sale: November 1, 1999

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

Scientific Review:

Tilmicosin is a semi-synthetic macrolide antibiotic. It is sold in 10 kg bags with a concentration of 200g tilmicosin (tilmicosin phosphate) per kg.

Pulmotil Premix (1.0 kg) is thoroughly mixed into 999 kg of non-medicated swine feed (to provide 200 g tilmicosin activity per tonne in complete feed). The recommended dosage is to feed to pigs at 1 kg Pulmotil Premix per tonne (1000 kg) for a 21-day period, beginning approximately 7 days before an anticipated outbreak; it is fed continuously as the sole ration.

The following factors were taken into consideration in the PMPRB's review of Pulmotil Premix:

• Tilmicosin was first marketed as Micotil Injection for bovine respiratory disease and later, for lamb pateurellosis. Pulmotil Premix is the first formulation of tilmicosin approved for swine and the first and currently the only in-feed product approved in Canada for prevention and treatment of swine respiratory disease associated with App with or without Pm. Injectable tilmicosin cannot be used in swine because of its narrow safety margin when administered to this species.
• Two available alternatives for controlling outbreaks are generally considered for herds infected with App. The first option is eradication or culling program which if economically sound, will eliminate the pathogen from the herd. The second option is antimicrobial therapy. When antimicrobial therapy is elected, it is used during the initial phase of an App outbreak when it can reduce mortality. It is generally believed that a combination of parenteral and pre-oral medication yields the best results.
• For parenteral treatment, several products are available including Excenel Sterile Powder and Excenel RTU Sterile Suspension (ceftiofur), Trivetrin and Borgal (trimethoprim sulfa).
• For oral, in-water or in-feed medication, numerous single entity and fixed combination products are available and used in Canada although none are specifically indicated for App. The choice of treatment is always determined by sensitivities, clinical familiarity (and/or preference), availability of appropriate feed and/or water medications at any given farm, and economics.
• Some of the in-feed medications used include Aureomycin (chlortetracycline) and Denagard (tiamulin); in-water medications used include Oxysol-250 (oxytetracyline) and Sulfamit (sulfamethiazine/sulfathiazole).
• Under the PMPRB's Guidelines, comparable medicines for the conduct of a therapeutic class comparison (TCC) are normally selected from among those that are of a comparable dosage form. The oral antibiotic products currently used in Canada to treat swine respiratory disease associated with App, particularly the in-feed formulations, would therefore be considered potential TCC comparators for Pulmotil Premix. It is, however, difficult to establish comparable dosage regimens for these agents that would provide a clinically equivalent effect for the purposes of conducting a reliable TCC test in the absence of extensive comparative clinical data and given the differences in the mixing and administration directions for each agent.

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. The Guidelines provide for use of the median International Price Comparison (IPC) test when a TCC test is inappropriate or impossible.

As shown in the table below, the introductory price of Pulmotil Premix was lower than the price in the only other country in which it was being sold and therefore was within the Guidelines.