Epidemiology Information in Branded Patient Materials

[Jennifer Carroll]

Happy Friday @Manufacturer and @Agency

We hope to start your weekend off with some good news. We have updated the Guidance on Branded Patient Information to include a new section (details below).

Section 2.9 - Epidemiological information in branded patient material
Due to the changing landscape and the new therapeutics coming to the forefront, we are adjusting the way we review epidemiological information in branded patient materials in order to improve patient access to high quality information. An increasing number of products are receiving indications for highly specific subtypes of a condition. We acknowledge that it is difficult to find information specific for the indicated subtype. However, general epidemiological information for a condition may still be useful to a patient. Moving forward, PAAB will consider epidemiological data for the general condition in patient material, provided that it is clear that the subtype the product is indicated for makes up only a portion of the general condition.

Example: A product is indicated for advanced BRCA mutated high-grade epithelial ovarian cancer. A message similar to “Around 3,100 Canadian women were diagnosed with ovarian cancer in 2023, a portion of which is comprised of advanced BRCA mutated high-grade epithelial ovarian cancer” may be acceptable in branded patient material.