Prediction of therapeutic value of new drugs approved by health Canada from 2011−2020: A cross-sectional study

OBJECTIVES: To examine whether a combination of three characteristics of new drugs – review type, outcome of premarket trials (surrogate or clinical) and first-in-class is associated with significant therapeutic value. DESIGN: Cross-sectional analysis of new drugs approved by Health Canada from January 1, 2011 to December 31, 2020. SETTING: Canada. PARTICIPANTS: New drugs approved by Health Canada for which therapeutic evaluations, trial outcomes and first-in-class status was available. MAIN OUTCOME MEASURES: Distribution of therapeutic value (major, moderate, little to no) depending on how many of the three characteristics were present for each drug. RESULTS: Health Canada approved 340 drugs of which 243 had data available for analysis. If all three characteristics were present 10 out of the 20 drugs had a major therapeutic rating. Conversely if none were present only 2 drugs out of 37 had a major therapeutic rating. CONCLUSION: This study introduces a new evaluation method for determining whether new drugs will have major therapeutic value that appears to be more successful than relying only on the type of review that drugs receive.