The MedTech Europe blog

With its Contract for a Healthy Future, the medical technology industry acknowledges its role and responsibility in maintaining high-quality, affordable healthcare in Europe despite an ageing population and constrained budgets. This industry commitment offers the much needed solutions to prove that innovation is not a cost driver but a facilitator for driving healthcare quality and efficiency in the future.  From personalized medicine to disease monitoring, the role of the diagnostics industry will be crucial in managing healthcare spending. 

A companion diagnostic test that provides vital information necessary for personalised medicine to occur is no longer a new concept. HER2/Herceptin for treating breast cancer is no longer the only successful example of personalised medicine. More and more companion diagnostic tests are being launched and the R&D pipelines of drug and diagnostics manufacturers are well filled.

Two more recent examples are KRAS/Erbitux/Vectibix for treating metastatic colorectal cancer and BRAF/Zelboraf for treating multiple melanomas.

Diagnostic innovation takes place not only in companion diagnostics but also in other areas, including disease monitoring. Asthma monitoring based on exhaled nitric oxide is expected to improve steroid therapy, resulting in fewer exacerbations and fewer ER visits and hospitalizations.

Glaucoma monitoring based on continuous IOP measurements can potentially improve therapy choice and management to the extent that expensive surgical interventions can be significantly reduced or avoided altogether.

Oncotype DX is a diagnostic test that quantifies the likelihood of disease recurrence in women with early-stage breast cancer and assesses the likely benefit of costly and burdensome chemotherapy.

Triple-rule-out computed tomographic angiography can provide a cost-effective evaluation of the coronary arteries, aorta, pulmonary arteries, and adjacent intrathoracic structures for patients with acute chest pain, helping to optimize therapy choice and preventing unnecessary cardiac interventions.

Examples are plentiful of the diagnostics industry meeting its obligations under the Contract for a Healthy Future in terms of driving value-based innovation to better serve stakeholders’ clinical and economic needs. Diagnostic R&D particularly focuses on improving the quality and cost of treating chronic diseases. As such, it plays an important role in dealing with the healthcare challenges of an ageing population in Europe. In this sense, the diagnostics sector may even be ahead of the therapeutic device industry despite its underexposure.

And yet, from my point of view, it seems that policymakers and payers do not yet fully acknowledge the positive impact that effective diagnostics can have. Companion diagnostics are in some cases not reimbursed at all, with the argument that the manufacturers of the related drug therapies already earn enough money – although the test may be marketed by a different manufacturer. The reimbursement of other advanced diagnostics, such as continuous glucose monitoring in diabetes management, is heavily restricted to small subpopulations despite their potential to reduce hypoglycemic events and/or improve HbA1c levels in larger patient groups. An insufficient clinical evidence base is very often the key reason for policymakers’ and payers’ limited support of new diagnostics. At the same time their expectations of clinical data are unrealistic to the extent that they are unfeasible or too costly for manufacturers in view of expected reimbursement restrictions. I would compare it to a chicken-and-egg situation where budget holders have to effectively balance and assess short-term costs against sustainable long-term healthcare cost savings.

It cannot be disputed that diagnostics for preventing diseases and managing therapy quality and cost play an essential role in European healthcare systems, and will continue to do so. The diagnostics industry is certainly committed to playing its part in shaping a better future. But in order to meet this obligation and to bear the necessary R&D investments and risks, I believe policymakers and payers in Europe will need to increase their involvement in transparent and constructive market access and funding decision-making for diagnostic innovations.  

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