DIALOGUE WITH STAKEHOLDERS - Dialogue with stakeholders
Industry Perspective - Daniel Schneider
Evidence-based test in vanguard of march towards personalised medicine
Switzerland-based Daniel Schneider is the Director of International Marketing at Genomic Health, responsible for marketing Oncotype DX tests across Europe.
The Oncotype DX assay personalises early-stage breast cancer treatment by identifying which patients are likely to benefit from chemotherapy and which can avoid the toxicities and costs associated with that treatment.
Essentially, it examines a breast cancer patient’s tumor tissue at a molecular level to help personalise treatment planning and identify options. Genomic Health say that the Oncotype DX test is the only multigene expression test commercially available that has clinical evidence to validate its ability to predict the likelihood of chemotherapy benefit, as well as recurrence in early-stage breast cancer. The test is incorporated into major international clinical practice guidelines such as ESMO, St. Gallen and ASCO.
Genomic Health’s general role is to conduct sophisticated genomic studies and research to develop clinically validated molecular diagnostic tests, which provide individualised information. These tests determine which sets of genes and gene interactions can be reliably used to predict an individual patients’ likely response to therapy or the likelihood of disease recurrence.
The upshot is that healthcare providers and patients can better understand what treatments are most likely to work for that patient or how likely a cancer is to spread or return.
So, while it has been proven that the Oncotype DX test can be of great value, who is taking it up and is reimbursement a key issue, especially in tough financial times?
Says Daniel: ‘The growing inequity in access to molecular diagnostics varies across countries and cost and reimbursement are issues. In our case, the first countries to reimburse in the EU were Ireland, Greece, and regions in Spain and now NICE in the UK has recommended Oncotype DX.
‘But every country, and often regions, have their own reimbursement pathways and budget silos and people can question the value (of such tests). By providing additional information to help physicians personalise treatment decisions for women with early breast cancer, Oncotype DX has consistently been shown to help save medical costs across multiple healthcare systems in various settings, including 12 studies which have shown that physicians change one-in-three decisions on treatment after using the test.’
The test is clearly a perfect example of what personalised medicine (PM) can offer but, regarding the specific hurdles to be overcome on the road to more-broadly available PM, Daniel says: ‘In PM there are many challenges – one of which is ‘who will benefit?’ There are so many unknowns. Everything needs to be evidence based.’
The Oncotype DX test certainly has its evidence, but Daniel flags other challenges, such as data collection and protection – ‘privacy is of utmost importance,’ he says. Genomic Health takes major steps to secure patient data with experience established from more than 400,000 tests performed in the past decade.
And Daniel echoes many others in the healthcare field when it comes to a need for various stakeholders to work more together. ‘Collaboration needs to be improved. The health sector needs to do a better job,’ is his view.
It seems, at least, that unlike certain technologies coming forward in healthcare there are few if any interoperability or training issues with the processing of the patient samples, although pathologists need to send the most representative sample to Genomic Health’s centralised lab.
Says Daniel: ‘Of course, we inform our physicians about what would be optimal when using our test, as a different fixative could impact results if not controlled by our proprietary quality control systems. These were built to address issues of heterogeneity across different practices.
‘Unlike other tests,’ he adds, ‘Oncotype DX is conducted in a single, centralised laboratory, enabling reliable results through conducting the test in the same standard environment, ensuring a great degree of precision, consistency and accuracy.
‘Leading Pharma companies are successful,’ continues Daniel, ‘because of their strong focus on research when developing targeted therapies and, while we produce a molecular diagnostic test, we apply the same rigour as pharma in developing tests.’
Again and again it seems that research is one of the cornerstones when it comes to PM. But research costs big money and the companies need to get it back. Having an evidence-based product is, it appears, key when it comes to reimbursement. Clearly, tests such as the Oncotype DX assay are in the vanguard of the inevitable cost-benefit debate – a debate ‘to be continued…’
Daniel Schneider was talking to Brussels-based freelance journalist Tony MallettAuthor: Tony Mallett