In the ‘Dialogue’-section we bring together different points of view in order to explore topics of interest to the Oncode community. For the first edition of our revamped stakeholder newsletter Stefan Gijssels talks to Emile Voest about the advances in drug research, development, registration, pricing and access.
Former VP Communications & Public Affairs at Janssen, currently Executive Director at Digestive Cancers Europe/EuropaColon and Founder/Consultant at SEBOIO
Oncode Investigator, Medical Director and Medical Oncologist at the Netherlands Cancer Institute
Cancer drug development should be as fast as possible
Oncology R & D levels are at an all time high. To what extent can cancer patients benefit from this?
Stefan: “Significantly, I think. Over the past decades we have already seen how great the effects of new cancer medicines can be with many more patients surviving cancer. Take colon cancer, the type of cancer I know most about, both as a former patient and as the head of Digestive Cancers Europe. Around 800,000 people in the EU are diagnosed with digestive cancers each year, of which 500,000 will die. On the positive side, since 2000 new cancer drugs have been approved for 175 indications. And this number is increasing, just like overall survival. Also, new advances in cell genome therapy seem promising, in spite of remaining challenges.”
Emile: “I agree. These are productive and exciting times. Discoveries in the field of immunotherapy and genomics-guided therapy are particularly on the rise and could make a big difference. And innovations in the area of oncology are quicker and faster than in any other medical field. Having said that, there are still way too many patients that I cannot help. So it is imperative that the sense of urgency regarding the development of effective cancer medicines is kept up- or felt even more.”
In the meantime, there are growing societal fears that the high pricing of oncological medicines by pharmaceuticals will ultimately make cancer care unaffordable to governments. What’s your take on this?
Stefan: “This is a much-heard concern, but when you look at the actual costs I think we are doing ok. The costs of oncology medicines are 40-50 euros per capita per year in the EU. That’s 200 euros a year for a family of four. Projections are that with the rise of immunotherapy, more personalised medicine and the expected rise in cancer patients, costs will amount to 100 euros per capita by 2022. I would say that’s still acceptable. Moreover, let’s not forget that the relatively high prices for oncological medicines are a main incentive for pharmaceuticals to continue to invest heavily in cancer drug discovery.”
Emile: “I am slightly more pessimistic. Pharmaceutical companies, like all companies, are forced to satisfy their stakeholders’ demands for high profits. This can lead them to ask overly high prices, just because they can. It is striking that nearly every new cancer medicine is more costly than its predecessors. Pharmaceuticals blame this on higher production costs, but not all new medicines appear to be that expensive to make. To ensure that pricing remains within reasonable bounds, governments could ask pharmaceuticals to disclose their R & D costs more. Or opt for value-based pricing, whereby prices reflect how much a drug really helps.”
“Innovations in the area of oncology are quicker and faster than in any other medical field, but there are still too many patients I cannot help.”
What are ways to further improve cancer health care by the stakeholders involved?
Emile: “I am a firm believer in learning health care systems. When scientists and clinicians continuously analyse health data from patients, medical treatments can be refined and improved. Health insurance companies can play an active role in this, including by co-investing in clinical trials. That does not just open up more funds for research, it would also boost their involvement in bringing new treatments to patients and offer them more opportunities to evaluate the outcomes of trials. Which in turn creates more transparency on the potential value of a proposed drug treatment and can speed up patient access to new drugs.”
“In the meantime, the ability to track patients’ responses to a given medicine on a wide scale is crucial for scientists to determine its working. When a patient receives very expensive, recently released medication, you can perhaps wonder if in return he or she should be obliged to give permission for his or her data to be shared in the scientific realm – rather than this being optional. But as a former cancer patient and campaigner, Stefan is far better equipped to reflect on the ethics of this issue.”
Stefan: “As long as a patient remains anonymous, I don’t see any problem with such schemes. The more Big Data scientists can access on the effects of cancer treatments, the better they are positioned to find cancer cures. For that reason, Digestive Cancers Europe already encourages patients to share their data. In fact, I would go a step further and encourage the tracking of patients’ data beyond medical treatment alone, for instance by stimulating people to use tracking apps on their phone. When patients share as much information as possible on their illness and personal characteristics, scientists could gain more insight into factors that can help patients respond positively to medical treatments. From the level of physical fitness to the effects of nutrition.”
“However, we should also look beyond the realm of pharma and medicines when it comes to improving cancer survival rates. The earlier cancer is diagnosed, the easier it can be cured. So governments should invest in nation-wide cancer screening programmes for groups at risk whenever this is technically possible. Right now, much more can be done to detect colorectal cancer, the second deadliest cancer in the EU. While a growing number of European countries have screening in place, programmes are not always comprehensive or reach insufficient citizens due to limited public awareness campaigns. That is a great pity. Because in countries that do have screening programmes with a large reach, such as the Netherlands, we see a steep decline in the number of people dying from colorectal cancer. If, thanks to better screening, 50% of colorectal cancer patients would be diagnosed in stage I, instead of the current 15%, more than 3 billion euros could be saved on healthcare each year. While the costs are just 2 euro per screened citizen. More importantly, an estimated 100,000 lives would be saved yearly.”
“In countries with a nation-wide screening programme for groups at risk, we see a steep decline in the number of people dying from colorectal cancer.”
Inventions in cancer medicine all start in the lab. What should scientists work on to create an even bigger impact with their work?
Emile: “Right now we have amazing technologies to treat patients, but patients’ responses to these can greatly differ. So, I am pretty thrilled with the current wave of research activity on individual tumour profiling. This may be done at the level of DNA, RNA, proteins, but imaging and histology are important research areas as well. Once we know for each patient what drives their tumour growth, we might be able to prevent cancer or fight tumours more effectively.”
Stefan: “There is a lack of research on creating medicines for relatively rare, but nearly incurable cancers like oesophageal, stomach and pancreatic cancer. The biological mechanisms of these cancers remain unclear. This makes it for pharmaceuticals relatively risky to invest in early phase drug discovery programmes in these areas. To tackle these unmet medical needs, governments could invest more in research into these areas at academic health centres.”
The American Federal Drugs Agency approves more drugs, at a faster rate, than the European Medicines Agency. Should EMA be more flexible in its procedures?
Emile: “Overall, I am happy with the medicines that are approved. But, EMA could be more visionary and try and find new models to approve medication for cancer patients that suffer from relatively rare cancers or have a rather particular tumour profile. For instance, more medicines against lung cancer have been introduced in the past years, leading to better survival rates. The large randomised clinical trials that are a prerequisite for EMA to approve a new medicine are in such cases more difficult to come by. And given that personalised cancer drugs are the future, this problem is likely to occur more frequently. So we need to be innovative. The American FDA is more active in this sense.”
Stefan: “I am on board with this. We should give patients access to new medicines as quickly as possible, once major safety concerns have been cleared. After all, the patients waiting for the outcomes of these trials are those that could not be helped with conventional treatments and their potential gains seem therefore bigger than possible health risks. And given that the clock is ticking, cancer drug development processes should be as fast as possible.”