Report on Patented Veterinary Drug Product - Ingelvac

Brand Name: Ingelvac PRRS MLV

Generic Name: (porcine reproductive and respiratory syndrome vaccine)

DIN: N/A

Patentee: Boehringer Ingelheim

Indication - as per product monograph:

Ingelvac PRRS MLV is a modified live virus vaccine for the vaccination of healthy, susceptible swine as an aid in the reduction of disease associated with Porcine Reproductive and Respiratory Syndrome (PRRS) virus, reproductive and respiratory forms.

Notice of Compliance: October 28, 1997

Date of First sale: June 27, 2000

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:

PRRS is a relatively new disease which emerged in the 1980's in swine industries around the world. It is characterized by outbreaks of late term abortions, stillbirths, mummified or weak newborn piglets, and respiratory disease in young suckling and weaned pigs. PRRS appears to have a complex etiology; much remains unknown, controversial and hotly debated about this disease.

The current trend is not to vaccinate but to maintain/develop PRRS negative herds through complex management. The impact of vaccinating varies from herd to herd. In some herds immunity has been successful; in others, disease outbreaks have been disastrous, even in vaccinated animals. Ingelvac PRRS MLV is considered to be a tool which, used strategically, can help to develop herd immunity in selected cases. A single 2 mL dose is given by intramuscular injection; the duration of immunity is at least 4 months.

Ingelvac is the only vaccine available in Canada to be used for this purpose. As a result no comparators were identified for a Therapeutic Class Comparison (TCC) Test.

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. Since it is the only vaccine to be sold in Canada for this indication, a Therapeutic Class Comparison (TCC) test cannot be conducted. 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 price of Ingelvac passed the median IPC test.

1 Publicly available prices as per the Patented Medicines Regulations.