#EAPM – Prioritizing prostate cancer in Europe (via Berlin) – HTA/Payer Alignment

| May 13, 2019

The European Alliance for Personalised Medicine (EAPM) is currently in Berlin taking part in a meeting on PIONEER (13-14 May), alongside leading Working Package 6, relating to HTA regulation and payer integration, writes EAPM Executive Director Denis Horgan.

The Berlin meeting hopes to get matters moving a lot faster than anything currently going on in Brexitland (or Never Never Land, if you prefer), as the UK gropes its way towards European elections that nobody, except the ubiquitous Nigel Farage, really wants.

Of course, EAPM will be keeping a close watch on any further Brexit developments, including the possibility that British Prime Minister Theresa May will set her own departure date (also something of a moveable feast, thus far).

The Alliance will meanwhile be keeping tabs on the run-in those important European Parliament polls taking place towards the end of the month, and will specifically be eyeing developments in the areas of access, regulatory alignment and bringing innovation into healthcare systems.

The gathering in Germany plays host to representatives from the EAU, UoA, Bayer, KCL, Jansen and others, as well as 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 prime mover 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.”

Prostate cancer, PIONEER, HTA and payers

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 recognize the potential of RWE, but alignment on how to collect, analyse, interpret and to use the output in health-care 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 aforementioned 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 health care.

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.

First foot forward for feminism 

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 womens 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. 

Paola 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: “Im 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.”

Paola 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. 

Elsewhere in personalised medicine Europe…

Health attachés are discussing whether the view of EU legal eagles that joint clinical assessments under proposed EU-wide HTA will be legally binding on national governments is correct. This in the face of Germany, France, Spain and some other member states pooh-poohing the idea of mandatory action.

Romania currently holds the rotating EU Presidency (until 30 June) and its health minister, Sorina Pintea is aiming for a ‘progress report, due to be delivered by the Health Council next month.

Over in Finland, Helsinki has called for comments for a second time on how best to handle genomic data, based on draft plans to create a genomic centre to centrally store and manage genomic information generated by biobanks and service providers. 

Finland’s powers-that-be seem to be listening to the feedback, as the first call resulted in significant changes to its draft proposals

And in Berlin again, the German Ethics Council has decided there should be a moratorium on human germline interventions, which corresponds with the views of lots of other academics and researchers across the globe. 

The council said that such research would be “ethically irresponsible at the present time because of the associated incalculable risks”. 

Heading back to Bucharest, now, and the European Commission has warned Romania it will “trigger the rule of law framework without delay” over “major concerns” about the state of the rule of law in the member state, it has been reported by Politico.

The step will apparently be taken if the countrys government, president and parliament fail to make “the necessary improvements,” and make them quickly, “or if further negative steps are taken”.

The Commission has major concerns on judicial independence, corruption, reducing the punishment for abuse of office, governmental methods, and emergency ordinances.

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