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EAPM: How biomarker testing can pierce the fog of Alzheimer’s and related dementia

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Hello and welcome, health colleagues, to the second update of the week from the European Alliance for Personalised Medicine (EAPM). There is plenty of news today about a recent academic publication from EAPM, the evolution of the EU’s pharma strategy and updates on the ongoing COVID-19 crisis, writes EAPM Executive Director Denis Horgan.

A fundamental shift in Alzheimer's Disease (AD) health-care strategy

EAPM recently launched an academic publication with a multistakeholder perspective to tackle the issue of biomarkers entitled Piercing the Fog of Alzheimer’s and Related Dementia. This paper discusses the challenges, lists the achievements to date, and highlights the actions needed to allow biomarker testing to deliver more fully on their potential in AD. 

The paper is available here. Biomarker testing is improving the prospects for tackling Alzheimer Disease and other dementias, and holds the key to discovering new treatments. Early diagnosis and more personalised health care will have a central part to play in confronting this massive challenge to Europe’s citizens and its health-care systems. 

The EU is itself in constant evolution, both organically, as its competences are progressively refined, and in response to changes in the wider world. In health care, its evolution is marked not only by the emergency of the COVID-19 pandemic, which has largely monopolized the attention of all the major EU institutions throughout most of the  year, but also by the constant increase in morbidity, which now affects more than its ageing population.

With the initiation of a European Health Data Space and a new Pharmaceutical Strategy which will be discussed below, it is an appropriate moment also for it to review its approach to diagnostic testing as an intrinsic element in an integrated health strategy. 

In these straitened circumstances, a reappraisal of the significance and potential of biomarker testing in AD can provide the EU and its citizens with a much-needed immediate up-tick in quality and accuracy of care. 

The COVID-19 pandemic should also provide a warning of how vulnerable society is to inadequacies in healthcare preparation – and should serve to highlight the risk that dementia could, if unchecked, present a pandemic of similar or greater proportions within decades. Europe, with real foresight, can now make a change in policy that holds out the prospect of a radical transformation of care in the coming years as the full benefits of an optimum approach to the use of biomarkers begin to be felt.

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EAPM lung-cancer screening event 

On 10 December, the EAPM will be holding on online conference on lung cancer screening. The Alliance and its stakeholders realize that, among other elements, what is required in Europe is continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted. 

You can check out the agenda of the 10 December conference here, and register here.

Kyriakides presents pharma strategy in Parliament 

On Thursday (26 November), access to safe and affordable medicines and supporting EU pharmaceutical innovation were debated in Parliament. Health and Food Safety Commissioner Stella Kyriakides presented the new Pharmaceutical Strategy as an important component of the new EU Health Union. 

A new strategy was already expected before COVID-19, but in the light of the pandemic, a more ambitious proposal is essential. Most MEPs welcomed the new strategy, which puts into effect Parliament’s requests to step up efforts to tackle medicine shortages – a problem exacerbated by COVID-19 – and to move towards a more sensible use and disposal of pharmaceuticals in order to prevent risks to the environment and public health. Several MEPs highlighted the need for all EU citizens to have equal access to high-quality medicines. 

They emphasized the need to decrease the EU’s dependence on imports of active pharmaceutical ingredients from non-EU countries, namely by increasing their production in Europe and supporting innovation in the EU pharmaceutical industry. The Commission has said that it wants to “work with the European Parliament and the Council towards the adoption of the Regulation on health technology assessment”. 

EPP MEP Peter Liese, while supportive of the Pharmaceutical Strategy, said, in an emailed statement: “The core of the current debate is how we can be less dependent on China and India when it comes to lifesaving pharmaceuticals. The coronavirus crisis has shown that the problem that has existed before is getting bigger and bigger.”

Advance funds for COVID-19 – Parliament seals its approval

On Tuesday (24 November), Parliament approved €823 million in EU aid in response to the coronavirus crisis in seven EU countries. The aid from the European Union Solidarity Fund (EUSF) will be distributed in advance payments to Germany, Ireland, Greece, Spain, Croatia, Hungary, and Portugal in response to the major public health emergency caused by the COVID-19 pandemic in early 2020.

Medicine supply to be prioritized in Portuguese Council presidency 

A secure supply of medicines will be a key priority for the Portuguese Council presidency — set to begin in 2021 — said Rui Ivo Santos, the president of Portugal’s drug agency Infarmed. Speaking at a panel organized by the European Public Health Alliance on Wednesday (25 November), Santos said he fully supported the Pharma Strategy’s goal of ensuring adequate availability of drugs.

NICE launches consultation on its methods of drug evaluation 

The UK’s National Institute of Health and Care Excellence (NICE) is set to review its methods of evaluation for drugs, medical devices and diagnostics. The health technology assessment (HTA) agency launched a public consultation last week on a proposal for changes to the methods it uses to evaluate potential medical treatments. NICE uses the Quality-Adjusted Life Year (QALY) measure to determine whether or not a treatment is cost-effective, with the current threshold set at around £30,000 per QALY. 

This formula weighs the cost of a potential drug for a year against the extension of life and improvement in the quality of life. In addition, new cancer treatments can be approved via NICE’s Cancer Drugs Fund (CDF) which was introduced in 2016. 

Through the CDF, NICE can appraise drugs while providing interim funding for up to two years to give patients access to drugs that have either a draft recommendation for routine use on the NHS or a draft recommendation for use within the CDF. While NICE regularly undergoes reviews of its processes, many industry experts have called for fundamental changes to the way in which it evaluates new technologies and medicines in an effort to improve patient access to the latest medical innovations.

EU must ease COVID-19 curbs slowly to avoid new wave, von der Leyen says

The European Union must only lift coronavirus restrictions slowly and gradually to avoid another wave of infections, the head of the bloc’s executive said. Ursula von der Leyen spoke after the 27 national leaders discussed stepping up joint testing efforts in the bloc, doling out vaccines and coordinating easing lockdowns as a second wave of the pandemic weighs on Europe. 

She said: "We will make a proposal for a gradual and coordinated approach to lifting containment measures. This will be very important to avoid the risk of yet another wave.”

Europe has had about 11.3 million confirmed COVID-19 cases and nearly 280,000 people have died, according to data from the European Centre for Disease Prevention and Control. The pandemic has also thrust the EU into its deepest recession.

And that is everything from EAPM for this week, don’t forget to check out the agenda of our 10 December conference on lung-cancer screening here, and register here, and EAPM’s multistakeholder paper on biomarker testing for dementia is available here. Have an excellent, safe weekend, and see you on Monday (30 November) for EAPM’s monthly newsletter.

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