Market Access

In Canada, gaining access to pharmaceutical drug markets is subject to a number of milestones. The drug product must receive a federal approval for safety and efficacy by means of receiving a "Notice of Compliance (NOC)." The drug product with a patent must undergo pricing reviews by the "Patented Medicine Prices Review Board (PMPRB)." And finally, the drug product must be listed in the public and private formularies.

Although the latter step is not a requirement per se, it is a key step in successful marketing and viability of a drug product. Public and private drug plans pay for nearly 90% of prescription drug purchases. Consequently, drug manufacturers must secure the coverage of their drug by private and public drug plans to gain access to major markets in Canada.

For provincial and private drug plan coverage, pharmaceutical marketers need to obtain formulary listing in each of the ten provincial formularies, numerous private drug plans, and other government drug plans such as the Non-Insured Health Benefit (NIHB) program. Formulary listing maximizes market exposure and boosts sales, while listing delays may cost millions of dollars in lost revenues and loss of market share. Failure to meet certain economic criteria may eliminate access to these markets entirely.

Brogan Inc. offers market access assistance early in the process by providing strategic advice and assistance with PMPRB submissions for obtaining the optimal price and PMPRB categorization for your patented drug product ( see Pricing Strategy and Regulation ).

The process for putting a submission together for provincial or private drug plan coverage can be lengthy and challenging and requires access to accurate market information. With access to the largest claims database available in Canada and a pool of in-house talent, Brogan Inc. offers assistance with your submissions for drug plan coverage. Brogan Inc. team has the expertise and the experience to ensure that your submissions are complete and supported with sound, credible economic analysis (see CDR/Formulary and Health Economics).