Did you know that one million deaths per year in the WHO European Region are due to harmful use of alcohol? – and that these figures vary within and between countries in the region and by social group? Evidence also shows a clear relationship between alcohol consumption and life expectancy; if you decrease the former you can increase the latter. So why aren’t countries doing more to prevent this?

Well there are a number of challenges and barriers to implementation of alcohol relate policies, such as cultural resistance, strong lobbying, lack of political commitment, to name a few. Also, don’t forget about the commercial determinants of health – which relate to marketing, global money flows, trade agreements etc.

The session started with a number of setting-the-scene presentations by several expert panellists; participants were then asked to break up into groups to discuss the following challenges and to try to come up with ideas on how to address them:

• Challenge 1: How to overcome barriers for implementing WHO best buys – policies that have proven to be cost effective – reducing availably of alcohol, taxation, and marketing?
• Challenge 2: How to create a fora that will not end up being a ‘talk shop’ and ‘white-washing’ that avoids conflict of interest?
• Challenge 3: How do we mobilize public support and shift the social alcohol norms to create a transformative change for health and well-being?
• Challenge 4: How should we enforce, monitor and evaluate process in the implementation of alcohol policies and actions?

What came out of the session was the need for better understanding of the root causes and social drivers around harmful alcohol uses – to assist to establish alternative, effective interventions. Alongside that should be the implementation other interventions such as product replacement, taxation, the promotion of healthy-lifestyles, restrictions of opening hours in pubs, alcohol bans in sports centres and events, and reducing the size of alcohol bottles etc. Also, a coalition rather than a fora could be established. But whatever is done, it needs to be packaged in a clear, strong and unified message, and supported by strong collective leadership.

Written by Young Gasteiner Lucinda Cash-Gibson

Bullet points:

1. We do not measure what matters most to patients
2. There are economic disincentives for hospitals even if the drug is less invasive – this should not happen
3. In the 21^st century we are still trying to provide healthcare that is not working
4. We need to think big and globally when it comes to health data to provide better care for all
5. We need complete and robust data in order to work effectively
6. We need large amounts of data to give us real insights, the patient is a single outcome, but the input has to be much larger

Title: 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, 4^th October 2019, titled: Making real world data real – new methods for EU health technology assessments.

Amongst the experts, Dr Anja Schiel (Senior Adviser & Statistician, Unit for HTA and Reimbursement, Norwegian Medicines Agency (NoMA)) addressed the uncertainties faced during the conduction of clinical trials often resulted from incomplete and flawed patient data. She encouraged the audience to always pose questions such as (i) what data do we need to generate in order to answer the posed questions (ii) what does the data we have exactly tell us and (iii) is the data we gathered robust and complete to draw conclusions or allow further research.

The ‘Health Technology Assessment’ was introduced to the audience as the systematic evaluation of the properties, effects and/ or impacts of health technology and a health economics model to predict future scenarios based on existing available data. Dr Schiel stressed the importance of contextualising data in order to be useful and applicable in different national health care and its finance systems. This implies that treatment and economic-based decisions are reliant on robust evidence. Dr Schiel also posed the question why what was good enough for approval is often not acceptable for reimbursement anymore.

Audience and experts also discussed the crucial aspect of patient data safety initiated by a comment from one of the participants outlining the need to especially protect data of vulnerable groups such as migrants. Participants agreed that there is the danger of data falling into hands of those using it to commercialise needs and this has to be prevented. Patients have the right to share their information with whomever they want and it is the system’s responsibility to keep the data safe.

The healthcare sector needs robust data to advance and optimise treatment for patients. This means that public health professionals and those using data for research purposes need to communicate why and how data is used to increase the willingness of sharing.

This Blog was written by the Young Gasteiner Anna Stielke

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

NO DISRUPTIONS FOR CAR-Ts

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.