Biomarker discovery is one of the fastest-growing areas of clinical research. However, translating the science into the realities of clinical practice is a major barrier preventing the promise of personalized medicine from being realized. Our medical and market access experts offer their insights into the interconnected journey needed to drive biomarker testing in the community setting and the optimal stakeholder engagement strategies biopharmaceutical companies can employ to better support the uptake of testing in this setting.
Biomarker testing is essential to the realization of precision medicine, in which treatments are targeted to each individual patient’s genetic profile and the molecular characteristics of their tumor.
These tests analyze biological samples such as blood or tumor tissue to detect proteins or genetic mutations in cancer cells, and the results help to inform estimates of prognosis as well as decisions on treatment strategies for targeted therapies or immunotherapies. The demonstrated value of biomarker testing to direct treatment strategies and improve patient outcomes has generated much excitement and optimism within the oncology community. However, there are still many barriers to implementing the tests and translating these benefits into clinical care, particularly in community oncology settings.
The National Cancer Institute in the USA has identified more than 75 oncology biomarkers in common use for a range of different cancers. With the global biomarker market expected to grow at a compound annual growth rate of 13.3% by 2030, this list will continue to expand. This growth is driven by an increasing understanding of the molecular science behind the causes of cancer and treatment resistance, along with the rising prevalence of cancer, greater investment in companion diagnostics, and an increase in the use of novel technology such as artificial intelligence to identify new biomarkers.
“It’s important to remember that approximately 80% of cancer patients in the US are treated by community oncologists, who typically do not have a specialism in one particular type of cancer, so they have to stay abreast of the latest data across a broad range of indications,” says Andree Rose, Senior Director, Scientific Strategy.
“With the pace and volume of new trials in oncology, practicing clinicians may struggle to stay up to date with the data—how new data may impact current treatment algorithms, clinical implications of test results, and the next steps to take for patients who test positively or negatively for a specific biomarker. The sheer volume of all this information can be overwhelming.”
“From a US access perspective,” Jessica Holzhauer, Director, Scientific Strategy, adds, “patients and providers usually have to deal with health insurance companies and plans, which have pre-specified healthcare expenses that they will and will not cover. Healthcare providers also have to consider which labs and facilities near them offer testing and may be in-network for their patients with commercial insurance. So in reality, a lot of validation is needed prior to biomarker testing, and community settings aren’t necessarily well set up for it.”
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