Tag: Health systems

The right to breathe: how policymakers can tackle severe asthma

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Asthma impacts over 330 million people worldwide. While severe asthma makes up only 5-10 percent of cases, it is accountable for over half of asthma-related costs globally.[1] It profoundly affects patients’ lives, undermining their physical, mental and economic well-being, and increasing the risk of preventable deaths. Despite its significance, severe asthma is often overshadowed by other health priorities, leading to inadequate resource allocation and substandard care, further straining already pressured health systems.

Severe asthma outcomes, like many other chronic diseases, are deeply entangled with a wide range of environmental and socio-economic factors. Therefore, addressing it is not merely about medical intervention, but about creating and implementing comprehensive, holistic strategies.

The challenges presented by severe asthma are not beyond our capabilities. Around the globe, there is a wide range of best practices, treatments, and approaches to asthma management. Yet, the path to transformation demands a unified commitment from a broad set of stakeholders, from policymakers to medical professionals, industry, patients and beyond. While the blueprint for a future unburdened by severe asthma exists, it is up to decision-makers to realize it together.

While the blueprint for a future unburdened by severe asthma exists, it is up to decision-makers to realize it together.

And the good news is that progress is already underway. Since autumn 2022, we have collaborated as an international expert group to support the development of the Copenhagen Institute for Futures Studies’ (CIFS) Severe Asthma Index. This tool assesses how 29 OECD countries manage severe asthma across various indicators, such as national strategies, treatment access, hospitalizations, societal costs and air quality, among others.

While the Severe Asthma Index is an important stride in tackling severe asthma, the true test lies in how its insights are applied in practice. Among the many actions needed to be taken to improve severe asthma care, the most pressing concern is policy change.

We have identified three actions, derived from the work we have conducted to date, for policymakers to kickstart strengthening health systems’ approaches to and management of severe asthma:

  1. Development and implementation of national asthma plans and strategies

The Severe Asthma Index has found that less than half of the countries analyzed have a national strategy for asthma, prevention, and management. There is, therefore, a need to formulate and actively implement dedicated national asthma programs, tailored to the unique challenges of individual health systems. These programs should not only emphasize prevention, early detection and diagnosis but also adapt best practices to specific national and local contexts.

Importantly, plans should be situated in the context of long-term strategies for improving population health outcomes.

“In England, work around respiratory illness is gaining traction,” notes Sir David Behan, chair of Health Education England, NHS, and expert group member. “Part of the initiative being developed [is] to ease pressure on the emergency care pathways and hospitals.”  

All approaches should promote awareness on respiratory diseases, support personalized care plans, empower patients and improve training and opportunities for training health care professionals working in respiratory care.

2. Coordination and harmonization of policies and care guidelines

There is a patchwork of country approaches to severe asthma, illustrated by the observation that more than two-thirds of the country guidelines assessed in the Severe Asthma Index do not fully align with the Global Initiative for Asthma’s (GINA) guide for Difficult-to-treat and Severe Asthma in Adolescence And Adult Patients. Policymakers must strive to coordinate their approaches to severe asthma by harmonizing policies and guidelines for asthma care to the greatest possible extent, with the aim of reducing outcome disparities, bolstering equity and promoting health system sustainability.

In doing so, there should be an emphasis on identifying and scaling best practices, promoting cross-border collaboration, and championing holistic solutions informed by the widely-acclaimed Health in All Policies approach.

The Australian National Asthma Council’s Australian Asthma Handbook is a strong example of a best practice in this area that policymakers could draw inspiration from in acting on this point.

3. Supporting improved data collection and the development of a more robust evidence base for severe asthma

Policymakers should incentivize and ultimately mandate improved production, recording and utilization of asthma- and severe asthma-specific data, as well as identifier data such as prescription data, adherence to treatment regimes, lung function analysis and demographic and socioeconomic indicators, following a set of common standards.

Currently, despite the existence of clinical codes for severe asthma, the condition remains significantly underreported in clinical settings due in large part to inconsistent coding practices, leading to an increased probability of patients receiving inadequate care and suboptimal allocation of health system resources. The dearth of severe asthma data and barriers to accessing the few datasets that do exist render it difficult to develop a comprehensive and consistent understanding of the full impact of severe asthma.

National policymakers need to prioritize financial and logistical support for country-level asthma research. Research activities should aim to produce a solid evidence base that will offer a nuanced understanding of each country’s needs, challenges and opportunities regarding asthma care. Support for research activities granted over the long term will enable longitudinal studies so that national trends and progress can be accurately tracked.

Only 3 percent of the European Union’s budget for health [is] spent on lung health, although 13 percent of Europeans have lung disease.

“Only 3 percent of the European Union’s budget for health [is] spent on lung health, although 13 percent of Europeans have lung disease,” says Susanna Palkonen, director of the European Federation of Allergy & Airways Diseases Patients’ Associations (EFA) and expert group member.

The International Severe Asthma Registry (ISAR) initiative provides a strong basis for continued work in this area.

The path ahead requires that these actions evolve in tandem with the latest advancements in respiratory care and approaches to the management and prevention of noncommunicable diseases. This is not simply about updating and developing new policies — it’s about crafting robust and well-rounded solutions that proactively address a health challenge that is both global and local and supporting a much-needed vision for improved respiratory health outcomes.

As we look forward, we cannot just treat asthma. We must transform our approach to ensure that every patient’s right to breathe becomes a global reality.

Author(s):
Patrick Henry Gallen, senior advisor and futurist at Copenhagen Institute for Futures Studies

Bogi Eliasen, director of health at Copenhagen Institute for Futures Studies

Professor Dr. Vibeke Backer, MD, DMSci, chief respiratory physician at Department of ENT and Centre for Physical Activity Research (CFAS), Rigshospitalet, Copenhagen, Denmark

Sir David Behan, chair Health Education England, National Health System (NHS), U.K.​

Dr. Mark Levy, board member, Global Initiative for Asthma (GINA), U.K.​

Mikaela Odemyr, chair European Lung Foundation (ELF) Patient Advisory Committee; chair Swedish Asthma and Allergy Association, Sweden

Susanna Palkonen, director, European Federation of Allergy and Airways Diseases Patients’ Associations (EFA)  

Professor Dr. Arzu Yorgancıoğlu, chair European Respiratory Society (ERS) Advocacy Council; member of Global Initiative on Asthma (GINA) Board; chair of GINA Dissemination and Implementation Committee; chair of the WHO GARD Executive Committee Turkey 

References:
[1] Al Efraij K, FitzGerald JM. Current and emerging treatments for severe asthma. J Thorac Dis 2015;7(11):E522-E525



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Speed is everything for patients: together we can bring medicines faster

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Working in our industry brings huge responsibility. We deal with people’s lives, and our  medicines give people an opportunity to improve their health, often at the most overwhelming time for them. I had a strong reminder of that recently.

Last month, I met with a colleague, Heiko, who lives in Germany. His young daughter has central nervous system (CNS) neuroblastoma — a type of cancer that tends to affect children under the age of five.

Heiko and his family have been navigating the health system for months, including an overload of information in the form of complex ‘oncological-speak’, treatment guidelines and health insurance claims. They have also been dealing with constant travel to specialist centers — all while juggling the emotional burden of caring for a sick child and the daily challenges of home and work life.

He shared something that stuck in my mind the night I spoke with him, which serves as an important reminder for all of us working in health care.

“Trust must be bigger than fear.”

When their health is at stake, friends, families and colleagues put their trust in their local health care system — every part of it, including industry — in the hope of protecting the future for them and their loved ones.

As Heiko put it to me, “Speed is everything. If you gain enough speed, you gain enough time. And if you have time, you have the hope of more options that can help you.”

Faster, more equitable access to new, life-saving medicines for people living in Europe is a goal that I believe we all share. There are challenges in achieving this, but we at Roche are committed to addressing these, together with everyone involved.

It is the inequality in access to medicines that is untenable.

Teresa Graham, CEO, Roche Pharmaceuticals, and chair EFPIA’s Patient Access Committee | via EFPIA

The average time that patients in the EU wait to get access to a new medicine is around 517 days. Uptake of new technologies can be low and slow, but it is the inequality in access to medicines that is untenable. If you have cancer in Germany, you may need to wait, on average, 128 days to access a new medicine, but if you are a patient in Romania it will take you 918 days to receive the same treatment.

I am concerned that Europe’s policymakers believe this can be fixed with legislation alone. And, even if it could, families like Heiko’s do not have the luxury of waiting four to five years for the ongoing revision to the EU pharmaceutical legislation to attempt to resolve these issues.

Improving access to medicines requires solutions that are developed in partnership with everyone who has a stake in their delivery: industry, member states, health regulators, payers, patients and health care providers. With the right ambition and desire for collaboration, we can act now.

The crucial first step is for governments and policymakers to treat spending on health care and innovation as an investment in economic growth and societal advancement. Improving health care and expanding access to innovation are vital for reducing pressure on health care systems, maintaining a healthy and productive society, and driving future economic growth.

Governments and policymakers have a pivotal role in enabling and encouraging this cycle of improved health and economic benefit. We must take a strategic view of investing in innovation, acknowledging the wider societal value it provides, and find sustainable ways to manage immediate fiscal challenges that do not limit or delay access to new medicines and technologies.

The industry is also driving changes. One concrete commitment pharmaceutical companies have made is to file new medicines for pricing and reimbursement in all member states within two years of EU approval of a new medicine. This will improve timely access to the latest innovations.

The industry has also established a portal for tracking access delays and ensuring companies are held accountable in meeting the two-year filing commitment.

With the right ambition and desire for collaboration, we can act now.

With multiple ongoing legislative changes currently taking place in Europe — from the revision of the EU’s Pharmaceutical Legislation, to the EU’s reform of Health Technology Assessment (HTA) and the introduction of the European Health Data Space (EHDS) — we have a unique opportunity to build a stronger and better European environment for life sciences and health care that serves patients’ best interests. One major opportunity for collaboration is the implementation of the EU’s HTA regulation. This aims to address access delays by streamlining and accelerating highly fragmented HTA processes across Europe. There is only one year to go before this either becomes a meaningful contributor to faster access decisions for patients or — if not adequately in focus during 2024 — risks becoming an additional hurdle for patient access to essential treatments. In order to avoid this scenario, industry involvement in the implementation of EU HTA is crucial to leverage expertise, co-design relevant processes, and ultimately ensure a workable system.

Such actions can reduce some of the delays in accessing new medicines, but they will not solve everything. The majority of delays come from the variation and delays in individual countries’ reimbursement and health care systems. That is why it is critical that member states, payers and health systems collaborate with industry to develop tailored access solutions. 

However, there are also proposals on the table today that are concerning and at face value will not lead to improved access for patients. For instance, the EU Commission is proposing to reduce a company’s intellectual property rights — specifically regulatory data protection (RDP) — if a medicine is not available in all member states within two years of receiving marketing authorisation. This would only hinder innovation, without delivering faster, more equitable access to new medicines.

If this were to go ahead as proposed, Europe would become a less attractive place for research. A recently-published study on the impact of the European Commission’s proposal estimated that it would reduce Europe’s share of global R&D investment by one-third by 2040.

I firmly believe this proposal must be reconsidered and focused on policy solutions that ensure patients in Europe continue to benefit from innovation.

As Heiko says, speed, time and hope are all people have. Often, patients are waiting for the next innovation, during which time, their disease progresses or their condition deteriorates. This makes the next clinical trial, the next regulatory approval, the next standard of care, the next reimbursement decision absolutely vital for those who simply cannot wait.

Across industry, there are more than 8,000 new medicines in the global pipeline today. This is the hope Heiko needs, and families like his are trusting us all to deliver.

Speaking with Heiko reminded me that the most effective treatment is the one that makes it to the patient when they need it. It is now our collective responsibility to find the path to making this happen for patients everywhere in Europe.



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Transforming HIV prevention in Europe

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This article is part of POLITICO Telescope: The New AIDS Epidemic, an ongoing exploration of the disease today.

The world’s battle to end the HIV epidemic is being fought on two fronts. The first involves getting as many people as possible who are living with the virus diagnosed and rapidly onto antiretroviral medication. This reduces the virus inside their bodies to such a low level that it is undetectable and therefore cannot be passed to others. The approach is known as “undetectable = untransmittable” or “U=U*.”

The second front is focused on protecting people from contracting the virus in the first place, even if they have been exposed to it — an approach known as pre-exposure prophylaxis, or PrEP. Taken as prescribed, PrEP makes a person’s body almost entirely resistant to HIV infection.

There is a critical need to bring forward new PrEP options that are informed by and designed for the communities that could benefit from PrEP in Europe.

Jared Baeten MD, PhD, vice president for HIV clinical development at Gilead Sciences

PrEP comprises antiretroviral drugs that can be taken intermittently, around the time someone expects to be sexually active. They protect against the virus in two ways: by increasing the production of antibodies in the cells in the rectal or vaginal lining, making them less receptive to HIV in the first place, and by interfering with the ability of HIV to replicate in the body.

Nearly 5 million people around the world have taken PrEP at least once — including about 2.8 million in Europe — and it has been shown to reduce the incidence of HIV infection during sex by 99 percent. In the European Union, new HIV infections have fallen by about 45 percent since PrEP was licensed in 2016, although this decline is also partly due to U=U.

PrEP as part of combination prevention strategies

Missing doses or running out of PrEP can mean becoming susceptible to HIV again. I via Shutterstock

Today, PrEP comes primarily in the form of an oral tablet, which has the advantage of being cheap to produce and easy to store. But it is not a universal solution. Because it needs to be taken regularly while someone is sexually active, missing doses or running out can mean becoming susceptible to HIV again. What’s more, in the same way that some bacteria are developing resistance to antibiotics, the HIV that does enter the bodies of people who have paused or discontinued their use of PrEP has a greater chance of being resistant to subsequent antiretroviral medications they may then need.

PrEP taken in tablet form is also an issue for people who need to keep their use of PrEP private, perhaps from family members or partners. Having to take a pill once a day or two or three times a week is something that may be hard to hide from others. And some people, such as migrants, who may not be fully integrated with a country’s health care system, may find it hard to access regular supplies of daily medication. Limitations such as these have prompted the development of alternative, innovative ways for people to protect themselves that are more tailored to their needs and life situations. These include longer-acting drugs that can be injected.

Like existing oral medications, injectable PrEP works by preventing HIV from replicating in a person’s body, but its effect lasts much longer. In September, the EU approved the use of the first intramuscular injectable that can be given every two months. Gilead is, until 2027, running trials of another injectable option, which, once the required efficacy and safety have been demonstrated, could be administered subcutaneously just once every six months. This would be more convenient for many people and more adapted to the circumstances of certain populations, such as migrants, and may therefore lead to better adherence and health outcomes.

HIV continues to be a public health threat across Europe, where in 2022 more than 100,000 people were newly diagnosed with HIV.

Jared Baeten MD, PhD, vice president for HIV Clinical Development at Gilead Sciences

Further ahead — but still in the early stages of development and testing — are patches and implants, which would provide a continuous supply of antiretroviral drugs, and immunotherapies. Immunotherapies would comprise a broad spectrum of naturally produced or manufactured antibodies against HIV, which, in theory, would pre-arm their bodies to resist infection.

As more types of PrEP become available, we will see a greater awareness of its benefits, as more people are able to find the version of PrEP that best suits their living conditions and personal requirements. This is a fundamental principle of “combination prevention,” or innovative interventions that reflect the specific needs of the people they are trying to reach.

Preparing for the future

Despite clear scientific evidence of the benefits of PrEP, there are still some hurdles we need to overcome to make it a powerful tool to end HIV altogether. These include investments and funding in prevention and availability, and programs to combat stigma.

Although the EU licensed PrEP in 2016, availability varies across the bloc. In France, the U.K., Spain, Germany and, more recently, Italy, oral PrEP is available at no cost to those who would benefit from it. In Romania, although PrEP is included in the country’s new HIV National Strategy, it is not yet funded, and it is only available via non-governmental organizations that rely on external funding sources. And in Poland, Hungary and Bulgaria, PrEP is not state funded and there are no current plans to make it so. In many member states, even though PrEP is technically licensed, in practice it can be hard to get hold of, in particular for specific communities, such as women, migrants or trans people. Potential users may find it hard, for example, to access testing or even doctors who are willing to prescribe it.

Jared Baeten MD, PhD, vice president for HIV clinical development at Gilead Sciences

Another key challenge that health systems and providers face is communicating the importance of PrEP to those who would most benefit, and thereby increase uptake. Many respondents in multiple studies have indicated that they don’t feel HIV is something that affects them, or they have indicated that there is a general stigma in their communities associated with sexual health matters. And some groups that are already discriminated against, such as sex workers, people who inject drugs, and migrants, may be hesitant to engage with health care systems for fear of reprisals. Again, injectable PrEP could help reach such key populations as it will offer a more discreet way of accessing the preventive treatment.

“There is a critical need to bring forward new PrEP options that are informed by and designed for the communities that could benefit from PrEP in Europe,” says Jared Baeten MD, PhD, vice president for HIV clinical development at Gilead Sciences. “At Gilead, we are excited to engage with communities and broader stakeholders to inform our trials efforts and partner with them in our goal to develop person-centered innovations that can help end the HIV epidemic in Europe.”

Europe is leading the world’s efforts toward ending HIV, but, even in the bloc, PrEP usage and availability varies from country to country and demographic to demographic. If the region is to become the first to end the HIV epidemic entirely, the European Commission, the European Parliament and the governments of member states will need to lead the way in fighting stigma, promoting and prioritizing HIV prevention in all its aspects including innovation in therapeutics strengthening the financing and funding of healthcare systems, and establishing effective pathways to zero transmission to end HIV entirely.

“HIV continues to be a public health threat across Europe, where in 2022 more than 100,000 people were newly diagnosed with HIV,” says Baeten. “HIV prevention is critical and has the potential to change the trajectory of the epidemic, but stigma and other barriers limit the impact that PrEP medications can have on reducing HIV infections in Europe. We all have a responsibility to collaboratively partner to make this work.”

*U=U is true on two premises: taking HIV medicines as prescribed and getting to and staying undetectable for at least six months prevents transmitting HIV to partners through sex. Undetectable means that the virus cannot be measured by a viral load test (viral load <200 copies/mL)



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Beyond forgetfulness: Why we must act on Alzheimer’s disease now

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In the face of an increasingly aging population, today’s reality reveals a harsh truth: health systems in the EU and beyond are ill-equipped to provide early and timely diagnosis of Alzheimer’s disease and embrace innovative treatments that could help to preserve memory and, with it, independence.  

Recent advances suggest that timely intervention may hold the promise to slow the memory decline in Alzheimer’s disease, making early diagnosis more critical than ever before. Yet without the necessary health care infrastructure in place to diagnose and provide treatment, we risk missing the crucial early window and the opportunity to delay — and hopefully in the near future prevent — distressing symptoms for patients and heartbreaking experiences for families.  

The EU and its member countries have the opportunity to be remembered for leading in this space by increasing funding for research, improving health care infrastructure to support accurate diagnosis and timely intervention, and enhancing support services at a national and regional level. The forthcoming European Parliament elections in June 2024 are the ideal moments to make that pledge. For individuals, families and health care systems, Alzheimer’s disease is a ticking time bomb unless we invest in our future health today.  

The EU is not prepared for Alzheimer’s disease  

In Europe, approximately 7 million people are affected by Alzheimer’s disease, a number set to double to 14 million by 2050.1 On top of the physical and emotional distress this will cause, there are direct financial and social implications on families and communities, with Alzheimer’s costs expected to reach a staggering €250 billion by 20302 — bigger than the GDP of Portugal3 — placing an additional and substantial weight on global health care systems that are already struggling under cost and capacity burdens.4 

Timely diagnosis stands as a cornerstone in determining the appropriate treatment for patients.

That’s why MEP Deirdre Clune is leading the call for a European Parliament hearing to discuss a focused EU strategy on dementia and Alzheimer’s disease. “Timely diagnosis stands as a cornerstone in determining the appropriate treatment for patients,” argues Clune. “Therefore, the EU must create a strategic framework which lays out clear recommendations for national governments and recognises the toll of dementia and Alzheimer’s disease on societies across Europe, encourage innovation and take on board best practices to develop effective and efficient approaches. Together, with a unified approach and firm commitment, the EU can pave the way for better Alzheimer’s care.”

In the next EU political mandate, policymakers must answer the call by developing a comprehensive EU Beating Dementia Plan that specifically addresses the unique challenges posed by Alzheimer’s disease and building on established coordinated action plans for other significant health burdens, such as the EU Beating Cancer Plan. The European Brain Council and EFPIA’s, RETHINKING Alzheimer’s disease White Paper is a useful resource, calling for policymakers to rethink Alzheimer’s and offering policy recommendations to make tangible changes to improve the lives of people living with the disease.  

EU member countries must commit to investing in diagnostic infrastructure, technology and integrated care that can help to detect Alzheimer’s disease at an early stage and ensure timely intervention resulting in the preservation of memory and, thereof, independent living and normal social functioning.  

Laying the foundations at national level  

While action is certainly needed at the EU level, huge opportunity lies at the national and regional levels. Each member country has the chance to apply well-funded national dementia plans that tailor their strategies and responses to address the distinct needs of their populations, making a real and meaningful impact on the people and health systems in their country.  

Inspiration stems from Italy, which recently launched its Parliamentary Intergroup for Neuroscience and Alzheimer’s, dedicating its efforts to raising awareness, fostering discussions among national and regional institutions, promoting clinician and patient involvement, supporting novel research, implementing new diagnostic models, and strengthening patient access to care. 

Italian MP Annarita Patriarca, co-host of the Parliamentary Intergroup, affirms: “Primary responsibility of a member state is to ensure to all citizens the greatest standards of diagnosis and access to treatment and care. Thus, it is necessary to put in place a strong collaboration between the public and private sector to strengthen investments in neurological diseases. Improving patients’ diagnostic and care pathways, especially in a disease area like AD with such a high unmet medical need and societal impact will be the core focus of the intergroup.” 

Additionally, during the Alzheimer’s and Neuroscience Conference: a priority for the country in July, members of the Italian Parliament importantly put forward legislative and regulatory solutions to ensure an early and accurate diagnosis. 

Leading the conversation on the international stage   

Amid the growing burden of Alzheimer’s disease globally, this is a moment for policymakers to hold each other accountable. Member countries are uniquely placed to do this within the EU but also across the wider health care ecosystem, calling on countries and leaders to honor prior commitments that prioritized investment in relieving major health burdens, including Alzheimer’s.  

Encouragingly, the May G7 Hiroshima Leaders’ Communiqué specifically recognized and supported dementia as a freestanding issue, breaking away from the typical categorization with NCDs. Moreover, the G7 health ministers published a joint Communiqué spotlighting the priority to “enhance early detection, diagnosis and interventions, including developing care pathways and capability and capacity building of health and primary care providers by strengthening primary health care (PHC)”.  

These promising steps mean that Alzheimer’s disease is beginning to gain the recognition it deserves but also acts as a line in the sand to ensure complacency doesn’t creep in. Collectively, EU countries must assume a leading voice within the international fora, ensuring that Alzheimer’s disease remains a global health care priority and receives the investment it warrants. 

Time to commit to action in Alzheimer’s disease  

September marks World Alzheimer’s Month, and its theme Never Too Early, Never Too Late, reiterates the importance of early diagnosis. It presents a valuable foundation to initiate discussions on country- and regional-level strategies to drive and strengthen diagnostic infrastructure and services for the prevention, diagnosis, case management, monitoring and treatment of Alzheimer’s disease. 

Unless we act now, a generation of people will be forgotten as they begin to lose their memories.

“Unless we act now, a generation of people will be forgotten as they begin to lose their memories,” shares Frédéric Destrebecq, executive director of The European Brain Council. “By recognizing the urgency of the situation and making concerted investments, we can forge a path toward a more compassionate, empowered future for individuals, families and communities impacted by Alzheimer’s, and remember all those who’ve been lost to this devastating disease.”

It is never too early, never too late, to be remembered for taking action against this debilitating disease.  

References:  

1 – Jones RW, Mackell J, Berthet K, Knox S. Assessing attitudes and behaviours surrounding Alzheimer’s disease in Europe: key findings of the Important Perspectives on Alzheimer’s Care and Treatment (IMPACT) survey. The journal of nutrition, health & aging. 2010 Aug;14:525-30.  

2 – Cimler R, Maresova P, Kuhnova J, Kuca K. Predictions of Alzheimer’s disease treatment and care costs in European countries. PLoS One. 2019;14(1):e0210958. Published 2019 Jan 25. doi:10.1371/journal.pone.0210958 

3 – Published by Statista Research Department, 20 J. GDP of European countries 2022. Statista. June 20, 2023. Accessed August 1, 2023. https://www.statista.com/statistics/685925/gdp-of-european-countries/. 

4 – The Economist. Why health-care services are in chaos everywhere. Available at:  https://www.economist.com/finance-and-economics/2023/01/15/why-health-care-services-are-in-chaos-everywhere. Accessed: July 2023.  



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Labs: the (overlooked) building block of Universal Health Coverage

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Hepatitis C (HCV) — a potentially life-threatening virus that infects 1.5 million new people around the world every year — is highly treatable if diagnosed early.[1]

Unfortunately,  access to quality screening is far from universal. Countries like Egypt — one of the countries with the highest prevalence of HCV in the world — demonstrate the impact screening can have. In 2015, HCV was prevalent in an estimated 7 percent of the country’s population and accounted for 7.6 percent of the country’s mortality, presenting a significant health care and societal burden.[2]

But since then, Egypt has turned a corner. In 2018, the Egyptian Ministry of Health and Population launched a massive nationwide HCV screening and treatment campaign as part of its 2014-2018 HCV action plan.[3] The campaign’s results were inspiring: by July 2020, Egypt had screened more than 60 million people[3] and treated 4 million residents.[2] Today, Egypt is set to be the world’s first country to eliminate HCV within its borders.[2]

The results of Egypt’s HCV screening program speak to diagnostics’ power in contributing to improved health outcomes around the world. Among the essential components of any health system is the capacity for prevention, which includes timely screening and detection. But a preventive approach based on timely diagnosis won’t work without the right infrastructure in place.

Strong laboratories as a cornerstone of building better health care

Matt Sause, CEO Roche Diagnostics | via Roche

The World Health Organization (WHO) highlights the critical role well-functioning laboratory services play in health systems with good reason.[4] Around the world, clinicians increasingly rely on  laboratory tests for diagnostic and treatment decisions. These tests help them make more informed decisions that result in better care and potentially improved outcomes for patients.

The challenges facing labs today — and tomorrow

Two key challenges facing laboratory systems today are underfunding and insufficient resources. Despite their central importance, laboratories struggle to garner the political and financial support they need to be as effective as possible. For example, it’s estimated that while lab results drive approximately 70 percent of clinical decision making, laboratories make up only 5 percent of hospital costs.[5]

After all, it’s the health care systems with strong, resilient labs that will be best placed to manage future pandemics and ever-growing health threats like heart disease and dementia.

What’s needed is a political commitment to provide everyone with access to accurate and timely diagnosis that paves the way to effective treatment and health. And putting this commitment into practice can only be achieved and sustained through coordinated multistakeholder efforts and public—private partnerships. This is not just a worthwhile investment for patients, but also the wider health care system in the long run. After all, it’s the health care systems with strong, resilient labs that will be best placed to manage future pandemics and ever-growing health threats like heart disease and dementia.

Another challenge is the health care workforce. Effective use of diagnostics requires qualified people to drive it, with expertise in pathology and laboratory medicine. Yet the world currently faces a laboratory staffing shortage. For diagnostics in particular, baccalaureate degree programs in laboratory science have previously been on the ‘endangered list’ of allied health professions.[6] In the end, inadequately trained staff, frequent turnover and scheduling problems all make quality lab results more difficult to guarantee.

This UHC ambition is only possible when backed by a network of strong laboratories that help ensure individuals can access high-quality diagnostics services without financial burden in all health care systems.

And that’s not all: inadequate infrastructure and staffing shortages are more present in low-income, rural communities, which exacerbate the broader diagnostics gap troubling global health care today. Many low-income countries lack an integrated laboratory network that can fully provide high-quality, accessible and efficient laboratory testing services for the entire population. In fact, a commission convened by The Lancet concluded that 81 percent of these populations have little or no access to diagnostics.[7]

The path to Universal Health Coverage

Put simply, innovative diagnostics are only meaningful if they reach people where and when they’re needed. Advancing this equity is at the heart of the WHO’s vision for Universal Health Coverage (UHC) by 2030. The goal? To guarantee all people have access to high-quality services for their health and the health of their families and communities, without facing financial hardship.

This UHC ambition is only possible when backed by a network of strong laboratories that help ensure individuals can access high-quality diagnostics services without financial burden in all health care systems. To do this, UHC should explicitly include diagnostics services. Financially, it’s savings from screening, early diagnosis and targeted treatment that make UHC feasible. Health care systems will have to undergo a systemic shift from focusing on treatment to focusing on prevention. And that’s just not possible when clinicians don’t have access to fast, accurate and cost-efficient lab results to inform their clinical decision-making. Policies and regulations that safeguard UHC goals of access and health equity are essential to make progress toward UHC.[8] The Saving Access to Laboratory Services Act (SALSA), in the United States, is an example of how national policies can help to ensure sustainable laboratory networks and contribute to equitable access to essential healthcare.

Stronger labs can not only help health care systems make savings in the routine management of population health; investing in them also helps to reduce costs and prepare in advance for any future public health crises.

This year has already seen encouraging progress toward achieving UHC through enhanced diagnostics capacity. The adoption of the resolution on strengthening diagnostics capacity at the World Health Assembly in May was an important signal of growing international political support for diagnostics. It was also a call to action. The next step for this month’s United Nations General Assembly and Sustainable Development Goals (SDG) Summit is channeling political support for diagnostics into the development of an action-oriented declaration.

To put us closer to UHC, this declaration should commit to ensuring that national health plans include access to timely detection and prevention. That starts with supporting laboratory systems and establishing National Essential Diagnostics Lists that identify the most critical diagnostic tests to help diagnose patients quickly and accurately so that they can receive needed treatment. At Roche, we’re advocating that governments, industry, civil society and other policy stakeholders will come together around concrete plans and shared resources that strengthen diagnostics and the lab infrastructure that makes them effective. In line with our commitment to increase patient access to important diagnostic solutions by 2030, we plan to do our part.

[1] Hepatitis C. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c (Accessed 22.08.2023)

[2] Egypt’s Ambitious Strategy to Eliminate Hepatitis C Virus: A Case Study. Hassanin, A. et al. Available at:   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8087425/ (Accessed 22.08.2023)

[3] Hepatitis C in Egypt – Past, Present, and Future. Roche Diagnostics. Available at: https://diagnostics.roche.com/global/en/article-listing/egypt-s-road-to-eliminating-hepatitis-c-virus-infection—a-stor.html (Accessed 22.08.2023)

[4] Monitoring the Building Blocks of Health Systems. World Health Organization. Available at: https://apps.who.int/iris/bitstream/handle/10665/258734/9789241564052-eng.pdf (Accessed 14.07.2023)

[5] The Cost-effective Laboratory: Implementation of Economic Evaluation of Laboratory Testing. Bogavac-Stanojevic N. & Jelic-Ivanovic Z. J Med Biochem. Volume 36, Issue 3, 238 – 242. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6287218/

[6] Ensuring Quality Cancer Care through the Oncology Workforce: Sustaining Care in the 21st Century: Workshop Summary. National Academy of Sciences. Available at: https://www.ncbi.nlm.nih.gov/books/NBK215247/ (Accessed 14.07.2023)

[7] Essential diagnostics: mind the gap. The Lancet Global Health. Available at: https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00467-8/fulltext (Accessed 14.07.2023)

[8] Private Sector Commitments To Universal Health Coverage. UHC Private Sector Constituency 2023 Statement. https://www.uhc2030.org/fileadmin/uploads/UHC2030_Private_Sector_Commitments_Statement_April2023.pdf (Accessed 29.08.2023)



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Putting health back in health care

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Advances in medical science and technology are rapidly changing and as we saw with the pandemic, diagnostic tests play a pivotal role in health care decision making. They inform treatment decisions, save costs and, most importantly, deliver better outcomes for patients. Unfortunately, these life-changing innovations are all too often not available to many of the people who need them most. Currently, 47 percent of the global population and 81 percent of people in low and lower-middle income countries have little or no access to life-saving diagnostics.

If you’re following the policy trend at large — or even if you’re not — this is where we inevitably turn to discussions of the role of Universal Health Coverage (UHC) in the pursuit of better access to screening and diagnosis. Population health is not only in the best interest of individual countries, but as evidenced by a global pandemic, it is important to global health as well. UHC — ensuring people can access the health care they need, when they need it, without financial hardship — is foundational to improving world health care.  

Currently, 47 percent of the global population and 81 percent of people in low and lower-middle income countries have little or no access to life-saving diagnostics.

So, where do we start? With better access to diagnostics.

After the world faced a global pandemic and pulled together, we all learned vital lessons which must not be forgotten. First and foremost, we saw that by working together and sharing information early, we could develop diagnostics and vaccines faster. This learning must extend beyond times of crisis.

We also saw that health systems with well-developed diagnostics infrastructure were more effective at containing and controlling the pandemic. And they were better able to continue providing essential diagnostic tests and treatment monitoring for patients with other diseases such as cancer.        

Normally, it would take years to bring a new test to market. Here — through focus and collaboration — we managed to do so in months.

As the world responded to urgent calls for better access to COVID-19 tests, hopes were also expressed that this would spark innovation leading to widespread testing, vaccines and treatments, which ultimately would reduce the spread of the pandemic.

After the World Health Organization (WHO) declared COVID-19 as a public health concern, the urgency galvanized companies to work at full speed. The first Polymerase Chain Reaction (PCR) tests for SARS-CoV-2 were available for limited laboratory use within eight days. Only 64 days later PCR tests were authorized for use and available for scaled-up testing in major health centers.[1]

Normally, it would take years to bring a new test to market. Here — through focus and collaboration — we managed to do so in months.

As reported by the Lancet Commission, investing in diagnostic capabilities has been shown to lead to fewer misdiagnoses, better use of resources, and better patient care.

Driven by necessity, countries invested in diagnostics capabilities to fight the virus and, as reported by The Lancet, real change was seen at a pace that would previously have seemed impossible.

Why stop there? 

Ann Costello, Global Head of Roche Diagnostics Solutions | via Roche

The recommended WHO Resolution on strengthening diagnostics capacity represents an important step toward recognizing access to diagnostics as a policy priority as well as establishing concrete policy measures, to ensure equitable and timely access. It would pave the way for a considerable shift in strengthening our health care systems, driving progress toward global health equity and global health security.

As reported by the Lancet Commission[2], investing in diagnostic capabilities has been shown to lead to fewer misdiagnoses, better use of resources, and better patient care.

Early diagnosis is the cornerstone of sustainable, efficient and resilient health care systems. This in turn would reduce late-stage health care expenditures, including long-term costs of chronic disease management and disability, and better manage costs for patients, payors and governments. 

Increasing access to diagnostics is crucial to controlling and potentially even eradicating certain diseases like cervical cancer, HIV, tuberculosis, viral hepatitis and malaria.

Laboratories are an essential component of a sustainable, efficient and resilient health system. But only if there’s enough of them and trained staff to run them. 

The crux of the matter is that staff shortages in both high-income countries and low- and middle-income countries continue to create a barrier to diagnostic services. 

How short-staffed are we? Well, to put a number on it, an estimated shortage in diagnostic workforce capacity saw a need for an additional 480,000-576,000 staff to support diagnostic testing.[2] And who loses when we don’t have enough skilled laboratory professionals? Patients.

Investment in diagnostics such as improving laboratory infrastructure and workforce development must also be supported by smart local regulatory approaches. This will ensure that patients, regardless of where they live, have timely access to innovation and safe, effective diagnostics.

Health care could enter a new golden age, shifting our focus from primarily treating disease to preserving health through prevention and by helping people live longer, more healthy lives.

This can be through adherence to international best practices, such as those created by International Medical Device Regulators Forum and implementation of regulatory reliance models — where one regulatory body (or the WHO) relies on the decisions, such as marketing authorizations, inspections and product changes, already made by trusted authorities and recognized institutions.

Governments should prioritize expansion of professionals with expertise in pathology and laboratory medicine[3] and introduce laboratory personnel as a key component of workforce initiatives to address the needs of currently over-burdened health care systems. 

A new golden age for health care?

Roche is building partnerships to increase access to diagnostic solutions in low- and middle-income countries and to strengthen targeted laboratory systems through workforce training classes. In May 2022, Roche entered a partnership with the Global Fund to support low- and middle-income countries in strengthening critical diagnostics infrastructure. The aim is building local capacity to tackle infrastructure challenges to improve diagnostic results and manage health care waste. This is in line with Roche’s ambition to double patient access to innovative, high-medical-value diagnostics for people around the world.

Health care could enter a new golden age, shifting our focus from primarily treating disease to preserving health through prevention and by helping people live longer, more healthy lives.

To achieve the golden age we need to learn from the past. All public and private stakeholders have a duty to work together to ensure diagnostics continue to improve health outcomes around the world by bringing this important resolution to life. 

Where a person lives should no longer be the key determining factor in their health. We have a tremendous opportunity here, let’s take it. 

[1] Accelerating diagnostic tests to prevent a future pandemic. Bill Rodriguez. Cepi. Available at: https://100days.cepi.net/100-days-mission-diagnostic-test-future-pandemic/ (Accessed 04.04.2023)

[2] The Lancet Commission on diagnostics: transforming access to diagnostics. Fleming, Kenneth A et al.The Lancet, Volume 398, Issue 10315, 1997 – 2050. https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(21)00673-5.pdf

[3] https://www.ihe.net/ihe_domains/ihe_pathology_and_laboratory_medicine/ (Accessed: 04.04.2023)



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