Lunch Session: Making real world data real – new methods for EU health technology assessments (L7)

Health data – a matter of safety, robustness and advancement

In healthcare we constantly need to make accurate decisions based on efficient and correct assessments of not just the short- but also long-term value and performance of new therapies and drugs for patients. We need robust and especially complete data from patients. This however poses challenges in terms of data protection, regulatory approvals to meet comparative effectiveness and value in terms of health outcomes. Experts and advocates discussed the above matters during the lunch session on Friday, 4th October 2019, titled: Making real world data real – new methods for EU health technology assessments.

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Obesity in Europe – time for a new approach? (F8)

We have all heard the words chronic diseases and non-communicable diseases before. But have we ever considered defining obesity as one? In this afternoon’s session, Jacqueline Bowman-Busato, the policy lead of the European Association for the Study of Obesity, asked a controversial question: What would happen if Europe approached obesity like other chronic disease epidemic and focused on addressing the biological causes in approaches to policy along the obesity continuum?  

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Nobody Left Outside:

Improving Healthcare access for marginalised people (B1)

It was just after sunrise when I walked past these two containers with the beautiful sign: “Nobody Left Outside”. It was 7 am and I was on my way to one of the most inspiring and innovative workshop that I have attended in a long time.

Already over 70 years ago, in the 1946 Constitution of the World health Organization (WHO) it was articulated the right to Health as a fundamental part of human rights:

“The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”

Unfortunately, in the year 2019, in the European region there are still large population groups that are left outside of the healthcare system. Groups such as homeless, sex workers, migrants, LGBTI people, people who use drugs, prisoners are often stigmatised and marginalised and are disconnected from the society. Thus, the event organized today by Merck & Co. (MSD) and by Nobody Left Outside (NLO) was an unique opportunity to bring to light this huge public health challenge and highlight the need for improving access and equity.

“The event comprised a breakfast workshop and an incredibly inspiring exhibition. The workshop was a refreshing and stimulating event. It started with a focus on the opinion of some of the most underserved communities. Dinah Bons, Director of Transgender Europe and representing the International Committee on the rights of sex workers in Europe (ICRSE), highlighted that the groups “left behind” are often groups living in Poverty that we may not encounter in our day-to-day life. They usually have different needs and they are often more affected by complex health issues such as HIV or Hepatitis.  “

Dinah Bons (from Transgender Europe) discussing during the Nobody Left Behind Workshop.

Her intervention was followed by Mario Cascio from European AIDS Treatment Group (EATG) who emphasised the importance of community programmes for prisoners as they are often marginalised from the healthcare system and at higher risk of suffering from infectious diseases.

One of the most marginalised communities across Europe are migrants. As an epidemiologist working in Malta, I often witness how asylum seekers and migrants tend to struggle to access the healthcare system. Thus, hearing the work of Denis Onyango from the Africa Advocacy Foundation (AAF) was refreshing and encouraging. It was particularly inspirational to hear Elena Val (from the International Organization for Migration, IOM) who recognised that entering a new health system is challenging for all migrants, but refugees and asylum seekers often face additional difficulties, such as stigma, fears of deportation, changes in legislation and limited rights to health access.

The NLO initiative has issued a Service Design Checklist intended to be used by service providers and policy makers to design and deliver targeted health and social services accessible to people in marginalized communities ant risk of vulnerability. They have also recently issued a call to action statement and further information can be found here.

The second part of this event was a beautiful art exhibition located just in front of the main conference center. In these containers, photographs and audio recordings with stories from different individuals are shown highlighting their struggles.

The NLO Exhibition

Vytenis Andriukaitis, EU Commisionair for Health and Food Safety visiting the Exhibition.

This type of innovative events are a great opportunity to strengthen the collaborations between all  the groups involved in providing health for undeserved communities  and for raising awareness among health professionals while creating positive relationships and reducing stigma. There is still a large challenge ahead; Nevertheless, we ought to continue our efforts to reduce these barriers. We ought to continue working together and innovative initiatives such as Nobody Left Outside (NLO) which are an inspiring projects that are giving a voice to this communities and contributing significantly to make Europe a better place for all.

This Blog was written by the Young Gasteiner Raquel Medialdea-Carrera

EHFG Session ‘CAR-T: The evolution of a revolution?’ (F9)


Day 2 of the #EHFG2019 concluded with a session about the current hype in cell therapy – CAR-Ts! Many aspects were discussed from R&D, manufacturing, logistics, infrastructure, delivery, patient access and reimbursement schemes. While all speakers, ranging from oncologists, patients, industry and payers agreed how fantastic this hope-bringing innovation is, one important aspect of the debate was not given the attention it deserves – fair pricing of such innovative cancer treatments. 

There is no doubt CAR T-cells provide hope to the hopeless with no alternative options. However, the current list price for Novartis’ Kymriah is €320,000 (excl. VAT) per patient. Kymriah has been on the European market for about a year and it seems to be about 50% successful in the short-term. German payers recently noted they are paying 5% of their drug budget for 0.007% of the population. This excludes the investments that need to be made to ensure quality of the medical facilities, properly trained work force and addressing serious side-effects caused by the drug’s toxicity.

So, why are CAR-Ts so expensive? Everyone knows prices are not always based on the spending for research and development. After all, CAR-T research was heavily funded by public investment. Is it the cost of manufacturing? Hardly, academics can now cook their own CAR-Ts in the labs. Is it value? Perhaps. No one can argue with that, especially when we do not know what is the value of life, especially for paediatric patients. The problem with current pricing models is that they are based on speculations of how much is the system willing to pay.

So, what would be a fair price for CAR-Ts? There is no universal definition of a fair price understood by all stakeholders, but everyone agrees that fair price might not necessarily be the cheapest price as it needs to generate enough revenue to stimulate research. Currently, the average return on investment for cancer medicines is over 14 USD on each invested buck. Maybe this fair price equation should contain an ethical aspect too.

This Blog was written by the Young Gasteiner Anna Prokupková

Interested in reading more about CAR-Ts? Click here.


The human touch in a digital world (P2)

Digitalising health services:  are we ensuring equity and the human touch?

The plenary started off with the opening remarks from Dr. Hans Kluge (nominee Regional Director-elect for the WHO European Region) sharing his thoughts and views on digitalisation. His remarks were echoed by the panel in the discussion that followed.

Digital technologies are redefining public health and health services. Dr. Hans Kluge is committed to working toward accessible and affordable digital health services across all 53 member states within the European Region. However, he highlighted the importance of accessible and affordable digital services for all. Are we so enthusiastic in digitalising our health services that we fail to oversee if services are accessible and affordable to all, thus risking to push more people into poverty? Are we ensuring that digital health services are accessible to all? Are we engaging civil societies and the public and are we including their views and thoughts in the design of digital health services? Digital health tools present new opportunities to current challenges. Nevertheless, we should be careful that we do not get blinded by this digital transformation and forget about the human touch. 

We need ethically and morally responsible policies to ensure that no one is left behind!  This requires a good governance framework across all European member states, which is built in partnership with patient groups, health professionals, and the general public. We need more evidence on the safety and efficacy of digital interventions, most notably for artificial intelligence – so that we ensure that we don’t lose the human touch. 

Think about the last time you introduced a new intervention or service, based on digital health. Did you get your patients’ views about this? Did you check whether it would be accessible to all your patients? Did you ascertain that it would not undermine their safety, privacy, security and trust? Did you make sure that your patients are not being deprived from the human touch? If not, think again. It doesn’t mean that digital health is not the solution, but rather that an alternative is required.

Technology can bring us together or break us apart. It all depends on why we choose to implement new technology (is the decision based on our needs, our patients’ needs or both?) and the way we design the service (ensuring an element of human touch and making sure that the service is accessible and affordable to all).

Technology should not steer us away from the human touch in patient/provider interactions, but free up time and facilitate better and increased human to human interaction in healthcare.  “We must make conscious changes for a human touch in the digital world and make sure that no one is left behind” Dr. Hans Kluge

This Blog was written by the Young Gasteiner Joseph Grech