Posted on May 13, 2019
The European Alliance for Personalised Medicine, at a conference in Berlin, has heard of the need for more pro-active action in tackling prostate cancer.
The gathering in Germany plays host to representatives from the EAU, UoA, Bayer, KCL, Jansen and others, as well as EAPM’s executive director Denis Horgan, and covers aspects from a prostate cancer irrespective that involve dissemination and communication, as well as legal, ethical and governance matters, and much more.
PIONEER project official James N’Dow said in Berlin: “There is a clear need for action now on prostate cancer.
“It is evident that policymakers, legislators, regulators and all stakeholders including patients and payers need to work together and reduce the burden of this disease.” “Apart from anything else, much more research is absolutely needed into prostate cancer,” he added.
N’Dow explained that, despite the best efforts of scientists, no specific gene has so far been identified with a direct link to prostate cancer, although research has flagged up that faulty genes linked to a higher risk of breast cancer could also increase the risk of getting the disease. He said: “Nothing is certain right now and, as I said, much more research is needed into a disease that not only will not go away, but will actually increase as our population ages.”
The PIONEER project is looking to develop and validate a framework for the value assessment of innovative technologies in prostate cancer using real-world evidence, or RWE.
This all comes against a backdrop that shows that regulators are increasingly recognising the value of real-world evidence when making decisions on the safety and efficacy of new medicines.
New regulatory pathways open the door to launching ‘breakthrough’ medicines based on relatively immature clinical trial data, provisional on collection of real-world evidence.
Meanwhile, HTA bodies and payer groups recognise the potential of RWE, but alignment on how to collect, analyse, interpret and to use the output in healthcare decision-making is still necessary.
PIONEER exists to establish minimum evidence requirements while identifying, at an early stage, potential uncertainties requiring extra data. At the same time aims to ensure that policy keeps up with emerging and fast-moving science.
With the EAPM involvement, PIONEER Work Package 6 (WP6) has committed to developing a prostate-cancer-specific framework for evidence requirements to support the efficient and targeted use of current treatment options in addition to the appropriate introduction and adoption of new technologies.
Moreover, WP6 will seek to develop reference models for use in economic evaluations and, as a key objective, will explore whether it can develop a core set of reference models for different stages of prostate cancer, or an overarching modelling framework.
Developing consensus amongst regulatory and HTA agencies and payers is an important feature of the work and this is one more reason for this week’s meeting in Berlin.
In prostate cancer, as elsewhere, Europe is faced with numerous new and valuable, but often costly, diagnostic and therapeutic options. So there is a concern over the level of certainty around the long-term value that balances benefits to the patient, delay to longer-term healthcare costs, and the opportunity cost to other areas of healthcare.
Innovators have their own view of the world: they are conscious of the potential merits of their innovations and of the efforts expended to achieve them; regulators bring their own approach, operating on the basis of standards of quality, safety and efficacy.
Meanwhile patients, and their carers, have a clear view about what is valuable to them - a complete cure, longer life, quality of life, the choice (sometimes) between one or the other - even helping others through sharing their personal health data. HTA, of course, plays a huge part. Its ultimate goal is to improve patients' access to effective medicines, whilst considering the alternative health trade-offs that might be forgone within a nation’s health budget.
With those European elections on the way, some current and would-be MEPs are promoting a feminist EU. Current deputy Terry Reintke, for example, will be playing a part in the Women Rule Summit on 27 June in Brussels.
The gathering will look to see what’s required for the EU to promote women’s empowerment.
Meanwhile, one woman who is also looking towards the elections, ex-chief of DG SANCO Paola Testori Coggi, is running for the EP on the list of Italy’s +Europe party, aligned with the Guy Verhofstadt-Emmanuel Macron liberal group in the hemicycle.
Coggi has of late been teaching EU affairs at the University of Parma and heading up the Italian government’s joint drug procurement efforts under the Valletta Declaration umbrella.
Said the candidate: “I’m making a case for health [as an area] where the European Union has achieved a lot of things.” She added: “Still we can do more.”
Coggi also has as a priority boosting the role of women, with her country behind only Greece when it comes the the proportion of women in the workforce. She is also big on investing in research and young people.
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