Other PMPRB Services

PDCI Market Access can assist you in preparing new medicine submissions using our expertise on the PMPRB’s Guidelines, Procedures and Policies. Expertise gained through extensive experience navigating new drugs through the Board’s price review process.

A new medicine submission should speak to the Board in its own terms, following the process used by the staff of the Board to review new medicines. The staff’s review is a methodical application of the scientific review procedures, excessive price guidelines and, as needed, provisions of the compliance and enforcement policies.

The scientific review process involves, among other things, categorization of the new medicine and the selection of comparable medicines and dosage regimens. The process involves the Board's own scientific staff, drug information centres and independent drug advisory panels. The latter are responsible for making official recommendations to the Board on scientific issues.

From the scientific review, flows the price review. A staff compliance officer reviews the price of each new drug product with reference to the Guidelines as they apply to the category assigned by the scientific staff. On this basis, one or more price comparisons will be conducted. In all cases, the price is reviewed against the range of international prices. Ideally, this process can be conducted before the new medicine is launched (and thereby avoid enforcement actions).

Submissions for new medicines are not required by the PMPRB. However, without a submission, the staff of the Board will not have an opportunity to consider the company’s position nor important information that may be relevant to the scientific and price reviews.

Some companies wait until the Board staff has conducted its review and formed an opinion regarding scientific and pricing questions. This "wait and see" approach can be a mistake. It is far less difficult to convince the Board of the company’s position in the first instance than it is to alter an opinion once it has been formed. For many of these issues (e.g., primary indication and dosage regimens) there may be more than one appropriate interpretation or a range of acceptable values. However, application of the Guidelines requires precise answers and values. The staff of the Board often seek recommendations from independent sources. Without a submission, these sources are not in a position to see the issues from the company’s perspective.

For further information on PDCI Market Access's consulting services for PMPRB new medicine submissions please contact Janice D’Angelo or Neil Palmer.