The Precision Medicine (PM) market is growing rapidly, with approximately 1000 treatments currently in development. Many of those treatments require identifying an appropriate patient population to ensure optimal health outcomes—meaning optimal patient reach depends on providing the right diagnostic test at the right time to the right patient.
Unfortunately, conditions in the clinical diagnostic testing landscape are far from optimal. Multiple challenges continue to impede the delivery of PM treatments to patients, including pervasive lack of reimbursement. Chronic underinvestment in diagnostic cost-effectiveness studies has resulted in an imperfect market for diagnostic coverage across the globe—from the US, where a coding system has been tasked to provide sufficient reimbursement to laboratories for high-volume, multi-component testing procedures, to Europe where coverage of novel diagnostics ranges from full reimbursement (Spain) to little or no reimbursement (Italy), to China where the patient predominantly pays. At the same time, the trend continues for pharmaceutical companies having to pay for companion diagnostic (CDx) testing in the absence of a reimbursement program. The lack of a reimbursement infrastructure continues to inhibit CDx test launches across leading health care markets.
Access to diagnostic tests and the subsequent reimbursement is an issue affecting all stakeholders in the fast-evolving PM space, including patients, drug companies, payers, insurance companies, laboratories, and national health organizations. The complexity of CDx reimbursement can be explained by the following factors:
- All reimbursement systems have evolved to be local to the health care and cost management infrastructure. Europe and the US do not reimburse diagnostics at the same rate or speed.
- Payer management of new CDx test costs is still in flux, with some countries seeking streamlined decisions and clarity over health technology assessment (HTA) requirements and others operating without guidelines.
- Some pharmaceutical companies have stepped in to subsidize CDx testing costs to “accelerate” access to their targeted therapies in certain markets. However, there are long-term financing implications for such market subsidies.
And the landscape is never static as adjustments are continually made alongside new considerations on pricing for each diagnostic test and associated therapy. Negotiating the system is crucial for stakeholders as access to the right diagnostics is closely linked to efficient reimbursement.
The suboptimal PD-L1 testing landscape
A close look at the current PD-L1 testing landscape will help discern common challenges in the delivery of PM treatment today, including reimbursement issues and confusion over testing options, and the interpretation and reporting of results. For example, current pricing and reimbursement systems for these diagnostics are not efficient and provide poor incentives for new diagnostic approaches. Additionally, the rapid expansion observed in PD-L1/PD-1 PM in the last few years has resulted in confusion regarding how optimal PD-L1 testing should be performed, with:
- 4 commercially available assays existing in the market alongside numerous standalone antibodies, and
- Various recommendations regarding scoring algorithms and clinical cut-offs, each depending on the assay-indication combination.
The effects of these challenges were clearly seen in a recent analysis by Diaceutics of 8800 US oncologists comprising the main segment of health care professionals treating patients with non‒small cell lung cancer (NSCLC) characterized by PD-L1 testing.1 According to the analysis, 50% or more of those in oncology/hematology, medical oncology, and internal medicine tested at least one of their patients for PD-L1 expression.1 On the surface, that statistic may appear promising, with more than half of patients with NSCLC receiving PD-L1 testing. However, it also reveals the suboptimal testing landscape lying beneath: one in which PD-L1 testing is not being conducted on all eligible patients—meaning approximately 50% of patients who could benefit from life-saving anti-PD-L1 treatments are not being reached.1
Further challenges in the PD-L1 testing landscape are evident in the continued prescribing of precision treatments to patients with NSCLC who have not yet undergone a relevant test.2-4 For example, one study revealed that only 11.3% of patients with metastatic NSCLC were tested for PD-L1 expression prior to receiving nivolumab or pembrolizumab.4,5
Collaborating to solve problems in the PD-L1 testing landscape
Diaceutics believes these challenges in the PD-L1 testing landscape can be solved via collaborative dialogue between pharma, payers, and labs. Diaceutics’ new global network platform DXRX - The Diagnostic Network® has been carefully designed to accommodate such collaborations. The world’s first diagnostic network for PM, DXRX is an end-to-end solution for the development and commercialization of PM diagnostics, from biomarker discovery to in-market test availability. DXRX enables a vibrant marketplace where all stakeholders in PM come to find trusted partners for collaboration on PM diagnostics in a secure, standardized way.
What is a DXRX collaboration?
A DXRX collaboration is an opportunity for multiple stakeholders to solve real-world testing challenges ensuring all patients get the treatment they deserve. In a DXRX collaboration, partners can work end-to-end on any aspect of diagnostic development and commercialization either by joining sponsored collaborations or creating their own on the marketplace.
An organic entity, DXRX features collaborations sponsored by Diaceutics as well as those strategically seeded by users of the Network. The collaborative nature of the DXRX network enables a more democratic playing field within the clinical diagnostic testing ecosystem. (Find out more at http://www.diaceutics.com/dxrx-network.)
The “PD-L1 Reimbursement Collaboration” is a currently live DXRX collaboration focused on addressing reimbursement challenges in particular in the United States (US). The question at hand is if test affordability may result in the incorrect test being performed and the patient receiving a result that is incorrectly matched to the therapy being considered.
Additionally, multiple collaborations involving PD-L1 testing review in specific countries also are underway currently, including the US, Spain, Turkey, Italy, France, the UK, Germany, Portugal, and Canada. For this collaboration, Diaceutics will work with labs to identify barriers for optimal and consistent use of PD-L1 testing across multiple indications, clones, and platforms. The valuable real-world data uncovered will be used to write a peer-reviewed article helping to educate the stakeholder community and help address some of the challenges in the PD-L1 testing landscape.
Other currently live and upcoming collaborations on DXRX can be found here.
- Diaceutics Data on File: Diaceutics’ proprietary Global Diagnostic Index (GDI) unpublished data, 2020.
- Hardtstock F, Myers D, Li T, et al. Real-world treatment and survival of patients with advanced non-small cell lung cancer: a German retrospective data analysis. BMC Cancer. 2020;20:260. doi: 10.1186/s12885-020-06738-z. Accessed September 17, 2020.
- Spicer J, Tischer B, Peters M. EGFR mutation testing and oncologist treatment choice in advanced NSCLC: global trends and differences. Ann Oncol. 2015;26(Suppl 1):i57–i61. doi: 10.1093/annonc/mdv128.04. Accessed September 17, 2020.
- Khozin S, Abernethy A, Nussbaum N, et al. Rates of PD-L1 expression testing in U.S. community-based oncology practices (USCPs) for patients with metastatic non-small cell lung cancer (mNSCLC) receiving nivolumab (N) or pembrolizumab (P). J Clin Oncol. 2017;35(suppl 15):11596. doi: 10.1200/JCO.2017.35.15_suppl.11596. Accessed September 17, 2020.
- Mason C, Ellis PG, Lokay K, et al. Patterns of biomarker testing rates and appropriate use of targeted therapy in the first-line, metastatic non-small cell lung cancer treatment setting. J Clin Pathw. 2018;4(1):49-54. doi: 10.25270/jcp.2018.02.00001. Accessed September 17, 2020.