Environmental Scan on Pharmaceuticals Requiring Companion Diagnostics

Objectives: Companion diagnostic tests (CDx) are used to measure an individual's protein or gene expression (biomarkers) to inform choice of therapy. The increasing number of drugs requiring CDx poses challenges for regulatory and reimbursement policies. To better understand this issue, an environmental scan was conducted by the Canadian Agency for Drugs and Technologies in Health (CADTH).Methods: The environmental scan was based on a focused literature search and feedback solicited from targeted stakeholders.Results: The global market for CDx is expected to grow considerably until the end of this decade, with compound annual growth rate around 20 percent. Several factors may impact the adoption of CDx, including the potential cost-savings associated with reduced treatment failures and adverse reactions. Anticipating an expansion in drugs with CDx, some countries have updated their regulatory frameworks, including the United States where the FDA released new guidance in 2014. With respect to reimbursement, both the United Kingdom and Australia updated their evaluation frameworks to inform reimbursement decisions; however, several countries, including Canada, have not published policies for co-dependent technology.Conclusion: The market size for CDx is expected to considerably expand in the future. The drive in uptake may be influenced by many factors including an increased knowledge of biomarkers and molecular drivers of disease and the potential cost-savings associated with fewer treatment failures and adverse reactions. Assessing whether such benefits materialize is important. Health technology assessment will play an important role in informing policies regarding the clinical use and funding of pharmaceuticals with CDx.