EAPM update: Moving access and diagnostics forward as lung-cancer screening round table lands 

Greetings, colleagues, and here’s the latest European Alliance for Personalised Medicine (EAMP) update as we approach what we would normally call ‘Christmas’. It’s all just a bit different this year, of course, and not for the better. Some countries are winding-back their lockdown processes slowly but surely, it remains to be seen how many of us decide on how to celebrate Christmas - amid continuing fears in respect of COVID-19. In the meantime, don’t forget that EAPM has a virtual conference coming up on Thursday, 10 December entitled 'Lung Cancer & Early Diagnosis: The Evidence Exists for Lung Screening Guidelines in the EU'. Alongside our many great speakers, attendees will be drawn from leading experts in the lung cancer arena - including patients, payers, health-care professionals, plus industry, science, academia and the research field. You can check out the agenda here, and register here, writes EAPM Executive Director Denis Horgan.

Numbers game

We are all aware that by far the best way to reduce numbers of lung cancer patients is to persuade smokers to stop. Although not all sufferers are, or have ever been, smokers.  High-risk groups exist, of course, and early diagnosis is vital. Currently, five-year survival rates stand at a mere 13% in Europe and 16% over in America.

It is the most commonly found cancer in men and lung cancer in women is being represented by a “worrying rise” according to the World Health Organization.

Some one billion people on the planet are regular smokers. And figures show that lung cancer causes almost 1.6 million deaths each year worldwide, representing almost one-fifth of all cancer deaths.

Within the EU, meanwhile, lung cancer is also the biggest killer of all cancers, responsible for almost 270,000 annual deaths (some 21%).

The European Respiratory Society and the European Society of Radiology (also a supporter of the event, as is the European Cancer Patient Coalition  - ECPC), have recommended screening for lung cancer under the following circumstances: “In comprehensive, quality-assured, longitudinal programmes within a clinical trial or in routine clinical practice at certified multidisciplinary medical centres.”

Meanwhile, the International Association for the Study of Lung Cancer (IASLC) Strategic Screening Advisory committee (SSAC) developed a consensus statement after the publication of the NLST trial identifying issues which required further research. These include effective risk assessment, and integrating screening with anti-smoking information.   The SSAC experts indicated that, while we wait, there is a good case for “immediate implementation of carefully designed and well targeted demonstration programmes”.

Of course, cost-effectiveness questions arise whenever population-wide screening is considered, especially in relation to frequency and duration.  The UK lung cancer screening trial (UKLS) has demonstrated that screening is cost effective by NICE criteria, in the modelling of their pilot screening trial.

The potential benefit of low-dose CT lung cancer screening would almost certainly see an improvement in the lung cancer mortality rate in Europe.

What next?

For screening to be cost effective, it has to be applied to the population at risk. For lung cancer, this is not simply based on age and sex, as it is in the majority of breast or colon cancer screening.

Europe needs to involve all key groups in developing recommendations and guidelines for implementation, adapted according to the healthcare landscape of individual countries.

Various member states have already shown a willingness to move forward in lung-cancer screening, and several countries’ health attachés will take part in the event.

The Alliance and its stakeholders realise 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.

All this will be discussed in our upcoming event on 10 December, you can check out the agenda here, and register here.

First patient in world receives Pfizer-BioNTech coronavirus vaccine

Margaret Keenan, a 90-year-old woman from Northern Ireland, on Tuesday morning (8 December) became the first patient in the world to receive the coronavirus vaccine developed by Pfizer and BioNTech. However, Emer Cooke, a Dublin native who has just been appointed as the new head of the European Medicines Agency (EMA), urged caution: “We have to make sure that we are the oracle on scientific information about vaccines,” she said. “I’m a bit worried that the debate on whether the COVID-19 vaccines work or not is happening in the media before the data is in and they can be evaluated. Drug manufacturers always issue press releases before trials end but there has never been such media attention on it before.”

Council greenlights temporary VAT relief on COVID-19 vaccines and test kits

 The EU is taking steps to ensure affordable access to COVID-19 vaccines and testing kits. The Council today adopted amendments to the directive on the common system of value added tax (VAT) to allow member states to temporarily exempt COVID-19 vaccines and testing kits, as well as closely related services, from VAT. Member states may also apply a reduced VAT rate to testing kits and closely related services, if they choose to do so. This possibility is already available for vaccines. The measures decided today only concern COVID-19 vaccines authorised by the Commission or by the member states and COVID-19 test kits that comply with the applicable EU legislation. They will apply until 31 December 2022.

Italy facing ‘nightmare’

 Walter Ricciardi, health advisor to the Italian government and chair of the Horizon Europe Cancer Mission board, warned that the country is facing a “nightmare” December and January. According to newspaper La Stampa, Ricciardi blamed strained public services, as well as the wide divergence between the health situation in different regions, for the difficulties ahead.

European politicians call for more transparency and tackling access

Jytte Guteland, Swedish S&D MEP, said: “We must be certain that there are strong safeguards in favor of the public, ensuring the affordability and accessibility of any vaccine that is placed on the European market — as well as indisputable liability clauses in case there would be any adverse effects resulting from a COVID-19 vaccine.”

Tilly Metz, Luxembourgish Green MEP, wants more clarity about what parts of the contracts the Commission would show MEPs: “It’s a shame that the Commission does not see the importance of ensuring full transparency on certain key aspects of these contracts. It comes down to the trust of citizens.”

And that is all for now – don’t forget, EAPM’s round table on lung-cancer screening, ‘Lung Cancer & Early Diagnosis: The Evidence Exists for Lung Screening Guidelines in the EU’, takes place in just two days time on 10 December – the agenda is available here, and you can still register here. Until next time, have a safe, happy week.

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