Despite advances in tumour biology research, few tumour biomarker tests have been adopted as standard clinical practice. This lack of reliable biomarker tests stems from undervaluation, inconsistent regulatory standards and reimbursement, as well as insufficient investment in research and development, scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility wrote USA researchers in a commentary published in the Science Translational Medicine.
Dr Daniel Hayes, clinical director of the breast oncology program at the University of Michigan Comprehensive Cancer Center led a panel of experts from USA universities, corporations, insurance and advocacy organizations to outline the issues presented. In their article they offer recommendations designed to serve as a roadmap to personalised cancer care and call for a dialogue, as changes in regulation, reimbursement, investment, peer review, and guidelines development require the participation of all stakeholders.
Unlike drugs or other therapies, cancer biomarker tests are undervalued
The authors wrote in their article that inconsistent regulatory rules, inadequate payment and underfunded tumour biomarker research has made a vicious cycle that prevents development and testing of reliable biomarker tests that could be used to personalize clinical care of patients with cancer.
According to Dr Hayes if a tumour biomarker test is being used to decide whether a patient should receive a certain treatment, then it is as critical for patient care at the extent as a therapeutic agent.
Tumour biomarker tests result in in personalized medicine, which means patients get treatments that benefit them specifically and they avoid treatments – including their costs and side effects – that are not likely to make a difference for them.
The regulatory process, the research funding, the reimbursement, even the standards for journal publications for tumour biomarker tests are all meager compared to the robust support for drug development, according to the authors.
This creates a vicious cycle in which researchers and drug companies don't invest in tumour biomarker research, tests are not fully evaluated in clinical trials, and tests with uncertain value in terms of predicting the success of treatment are published. This in turn means that few of these tests are included in evidence-based care guidelines, leaving health care professionals unsure of whether or how to use the test, and third-party payers unsure of how much to pay for them.
The authors outline five recommendations and suggest that all five must be addressed to break the vicious cycle:
- Reform regulatory review of tumour biomarker tests
- Increase reimbursement for tumour biomarker tests that are proven to help determine which therapies will or are working
- Increase investment for tumour biomarker research so it's comparable to new drug research
- Increase the rigor for peer review of tumour biomarker publications
- Include only proven biomarker tests in evidence-based care guidelines.
According to Dr Hayes, these recommendations are not about creating more regulation. The authors wish to stimulate innovation yet hold investigators and clinicians to the highest scientific standards.
DrHayes is a consultant for Oncimmune LLC, Inbiomotion, and Biomarker Strategies and has received research funding from Novartis, Veridex (Johnson & Johnson), and Janssen R&D, LLC (Johnson & Johnson). He is a co-inventor on a patent for a method for predicting progression-free and overall survival in metastatic breast cancer patients using circulating tumour cells; and has applied for patents for a test for diagnosis and treatment of breast cancer and for circulating tumour cell capturing techniques and devices.