Therapeutic value of new medicines not submitted to Health Canada 2014-2021: Cross-sectional study.

OBJECTIVES: To examine whether there has been a change in the number of therapeutically important new medicines not being introduced into the Canadian market in light of the December 2017 announcement of regulatory changes to lower Canadian prices.

METHODS: A list was compiled of medicines approved by the Food and Drug Administration (FDA) between 2014-2021 but not submitted to Health Canada. The therapeutic value of these medicines was assessed based on evaluations by two independent sources. If no evaluation was available, potential therapeutic value was determined based on the presence of one or more of three medicine characteristics. Interrupted time series was used to determine if there were changes in overall new medicine introductions and therapeutically important new medicines.

RESULTS: The FDA approved 364 new medicines of which 116 (31.9%) were not submitted to Health Canada. There was a decrease in overall annual number of submissions but that was not related to the announcement at the end of 2017. There was no change in the introduction of therapeutically important new medicines as a percent of all medicines not marketed in Canada but there was a decrease in the absolute number.

CONCLUSIONS: The number of therapeutically important medicines not being introduced into Canada is increasing but that is not related to the proposed price reforms.