Mental health in an unequal world. World Mental Health Day 2021

Mental health in an unequal world. World Mental Health Day 2021

Mental illness, why bother if all goes well? Because the day it hits you or your loved ones, you may be faced with the harsh reality of “Mental Health in an unequal world”. Close to 1 billion people globally are living with a mental disorder. Yet, countries spend on avg. 2% of their national health budgets on mental health leaving a disproportionate gap between demand for mental health services and supply. Each year, October 10th marks the “World Mental Health Day”. This year the theme is “Mental Health in an Unequal World”. 

Originally chosen by the World Federation for Mental Health, the theme Mental Health in an Unequal World” refers to the inequality in access to health services in low- and middle-income countries, where between 75% and 95% of patients with mental disorders have no access to mental health services at all. Despite the universal nature and the magnitude of mental illness, the gap between demand for mental health services and supply remains substantial.

The global pandemic along with the climate crisis and social disarrangement lead the world to a difficult place. To date, the pandemic is impacting people of all ages and backgrounds: Illness, economic impact, job insecurity, and most importantly, physical distancing leading to social isolation and millions of people facing mental health issues.

  • Close to one billion people have a mental disorder and anyone can be affected.
  • Depression is a leading cause of disability worldwide and a major contributor to the global burden of disease. Globally, an estimated 5% of adults suffer from depression.
  • Globally, one in seven 10-19-year-olds suffers from a mental disorder. Half of all such disorders begin by the age of 14, but most go undiagnosed and untreated.
  • People with severe mental disorders like schizophrenia typically die 10-20 years earlier than the general population.
  • One in 100 deaths is by suicide. It is the fourth leading cause of death among young people aged 15-29.
  • The COVID -19 pandemic has had a significant impact on people’s mental health.

The World Federation for Mental Health also addresses the disparity between mental health investment and overall health. On average, countries spend only 2% of their national health budgets on mental health. This has changed little in recent years. Despite the scale of mental illness, the gap between demand for mental health services and supply remains substantial. Unaddressed mental health issues are now a leading global cause of disability and suffering. Yet only 10% receive “adequate” treatment – 75% receive no treatment at all.

The limited global availability of effective mental health treatments and a lack of objective measures of response to treatment, are some of the barriers in advancing patient outcomes. To reduce burden, it is critical to diagnose and monitor mood disorders using widely accessible, less costly, and scalable methods, which can enable a higher degree of specificity in mental health diagnoses and timely detection of clinical deterioration.

Building on the widespread adoption of smartphones, mobile health (mhealth) has gained significant interest as a means for capturing continuous, objectively observable and measurable data of patients’ behaviour and mental state. The data collected on smartphones and sensors represent a new approach aimed at measuring human behaviour and mental health, and thus an opportunity of detecting, assessing, and monitoring psychiatric disorders in a less costly and less burdensome way for the clinician.

The data collected on the smartphone are also referred to as digital biomarkers. These can be collected both passively through inbuilt sensors on the smartphone (physical activity and geolocation, social activity, text messages usage, phone usage, voice and speech pattern or wearables (sleep and activity), and actively via user engagement through self-monitored data/self-assessment data (mood, sleep, stress, medicine adherence).

By collecting this data between physician visits, clinicians can see fluctuations in patients’ mental states, providing a more holistic representation of the patient’s functioning over time. The data hereby offer the opportunity for clinicians to predict relevant outcomes in mood disorders and can thus serve as a tool of triage enabling to provide timely and preventative support to the individuals in critical need.

This approach, also known as digital-enabled psychiatry, has gained considerable interest and been extensively researched over the past decade to offer more people access to high-quality health and social care.

To learn more, visit our Research section here or watch a video on the opportunity of digital-enabled psychiatry from the Week of Health and Innovation conference 2021 in Denmark.

References:

https://wfmh.global/2021-world-mental-health-global-awareness-campaign-world-mental-health-day-theme/

https://www.who.int/publications/i/item/9789240031029

https://www.who.int/campaigns/world-mental-health-day/2021

https://www.who.int/key-messages

[1] https://www.who.int/gho/publications/world_health_statistics/EN_WHS2012_Full.pdf

[2] The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011

[3] OECD – 2015

[4] Economist Intelligence Unit – 2015

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

With the rise of patient-centered medicine and accelerated approvals, health technology assessment (HTA) bodies and payers are looking to real-world evidence (RWE) to strengthen evidence packages and reduce uncertainties at the time of launch.

Increasingly, stakeholders are recognizing the importance of RWE that incorporates patients’ real-world experiences in understanding what treatments work, and for whom, in clinical practice.

Real-world evidence is generated through applying data science to real-world data (RWD), or data “relating to patient health status or the delivery of healthcare routinely collected from EHRs, claims, registries, patient-reported outcomes, devices/applications, etc.” Decision-makers are exploring how this evidence can supplement clinical trials and provide additional context on the effectiveness of therapies.

There is some overlap between patient experience data, which provides information about a patient’s experience with a disease or condition, and real-world data (RWD), however, they are not one and the same. For example, patient-reported outcomes (PROs) collected in an electronic health record (EHR) would be considered both RWD and patient experience data, however, lab test results in the medical record would be considered only RWD. As personalized medicine continues to gain traction, decision-makers like ICER, FDA, NPC, EMA, EUNetHTA, and EHDEN are calling for patients’ voices to be included in the drug development and assessment process. Such information – direct input from patients on how they feel and function is often lacking from RWD sources, and FDA and EMA identified such missing data as problematic for interpretation.

We spoke with Ashley Jaksa MPH, Scientific Partnerships Lead, Aetion and Chung Yen Looi, DPhil Partnerships Director, Monsenso, about the evolving landscape of patient experience data and how biopharma organizations can incorporate the patient voice into their RWD and RWE programs.

Q: Ashley, can you tell our readers a little more about what Aetion does? 

AJ: Aetion is a healthcare technology company that uses routinely collected health care data to generate RWE on the safety and effectiveness of medical treatments and technologies. We were founded by Harvard epidemiologists to develop a way to conduct scalable and transparent RWD analyses at the highest level of scientific rigour. Our RWE analytics platform helps biopharma organizations, regulators, HTAs, payers, and other researchers generate RWE to inform decisions on the safety, effectiveness, and value of medical interventions across the product lifecycle. Our platform is data fluent, meaning it can analyze almost any type of RWD, and we often work with our customers and partners to identify the most fit-for-purpose data set for their research question.

Q: Why is the patient experience important for biopharma to understand, and where in the drug development lifecycle is it most important to integrate patients’ voices? 

CL: I think we can all agree that pharma and its stakeholders want to develop safe and effective drugs and bring them to market, to improve patients’ lives. As such, asking patients directly about how a drug impacts their lives is critical. Without the patient voice, we will never know how patients experience therapies in the real world, and how medical interventions could make a meaningful difference to their lives. Capturing and incorporating the patient voice across the product lifecycle can help biopharma companies to better understand the real-world impact of their drug, treatment responders, and meaningful endpoints based on a wider, representative population, in a quick and cost-effective way. 

AJ: Similar to RWE, patient experience data is important in almost all stages of the product lifecycle—not just as a post-marketing exercise. For example, understanding the treatment pathways and patient experiences on first-line therapies can help shape what comparators and outcomes should be captured in future randomized controlled trials to differentiate the drug in the market.

Q: How can incorporating the patient voice improve market access?

CL: Patient voice is a powerful way to demonstrate the impact of a drug on patients’ quality of life to payers and HTA bodies, particularly for cost-effectiveness evaluations. Some biopharma organizations have used PRO measures on daily functioning and health-related quality of life as their primary and secondary endpoints in clinical and real-world studies, while others have directly linked PROs to their drug reimbursement contracts. Patient voice contributions can help biopharma companies differentiate their product from similar drugs for coverage, especially for payers who are tying reimbursement to the value to patients based on outcomes and have longer-term responsibilities for their populations.  Some of the common myths are that “payers don’t care about PRO evidence, PROs only matter if they make it to the label, and that PROs should only be collected in Phase IV.” The facts are that not all payers are alike. Some pay a lot of attention to PRO evidence. Payers will consider all data from pivotal trials, whether or not it is on the package insert, and coverage decisions will be made on pivotal trials, so waiting until Phase IV to collect PROs would be too late.

Q: What are the common barriers in generating high-quality, patient-centric RWE?

AJ: I think the common barriers to generating RWE and patient-centric RWE are very similar; researchers must ensure that the data exists, that the data is capturing the relevant underlying medical concept, and that it is generated in a way that limits bias and confounding. Traditional RWD sources, like claims and EHRs, often have limited patient-centric data. This is a challenge for researchers attempting to incorporate this information into their studies. However, groups like Friends of Cancer Research and data providers like Monsenso are working to ensure this information is being collected. Once it is collected, it is essential to validate that these data and algorithms are actually measuring what we are intending to measure. Finally, researchers must be cognizant of bias and confounding and control for this as much as possible through study design and analytic methods. 

CL: Adding to Ashley’s points, I think data privacy and security, patients’ burden of contributing to research, and standardized methodology to analysis and interpretation are common barriers. It may seem like a no-brainer to ensure that patient data is managed in a secure way, but a recent study showed that almost a third of health apps out there collect patient data without privacy policy, and about one in five data transmissions occurred on insecure communication protocols. Furthermore, as patients are already suffering from their disease or conditions, contributing to research could add to their burden, which is why data capture platforms should be designed in a way that is easy-to-use and that provides valuable insights to patients. Finally, there is a lack of standardization in analysis and interpretation—which is why companies like Aetion are important to ensure that critical questions are answered, data sets are relevant, and standards are followed to derive and present meaningful insights that will inform decision-making.

Q: How can biopharma generate high-quality, patient-centric RWE for decision-makers? 

AJ: In addition to addressing the common barriers mentioned above, we think it is important to follow a principled approach to study design and execution. The main reasons why decision-makers like regulators and HTAs/payers dismiss RWE are due to deficient data selection and insufficient methodology. Following principled epidemiologic methods of selecting fit-for-purpose data, avoiding common methodological mistakes, and ensuring the protocol and results are clearly communicated are essential to ensuring the decision-makers trust the evidence. This planning and execution of RWE studies is not easy; it takes forethought. Biopharma manufacturers should be considering RWE at every stage of the product lifecycle, and proactively planning for how RWE studies will be incorporated into each product’s launch. 

Q. What is the cost-benefit for biopharma of generating patient-centric RWE? 

CL: Relative to the costs of bringing a new drug to market – which could go up to billions of dollars and take over a decade, with limited success ratesthe costs associated with collecting patient-centric RWE is insignificant. In return, patient-centric evidence could provide significant savings and valuable insights as early as possible to ensure that new drugs are truly driven by patients’ unmet needs, that they impact outcomes that matter to patients, and, ultimately, that they have the greatest chance of reaching the market and making a meaningful difference to patients. 

AJ: RWE can provide value for biopharma organizations across the product lifecycle—from eliminating costs typically incurred during clinical trials to accelerating time to market. Using a validated RWE platform can take this a step further, allowing companies to run more efficient, credible studies and reach insights faster than they could with traditional line programming. By ensuring patient-centric outcomes are collected in clinical data sources, then incorporating patient-centric RWE across drug development and commercialization programs, biopharma organizations can unlock insights that deliver value not only for their company but for patients as well. 

Q: Lastly, for our readers who are not familiar with Monsenso, Looi can you kindly tell a little more about what Monsenso does? 

CL: of course, Monsenso is a digital health company that enables patient-centric care and research. We’re a spinout from the IT University of Copenhagen based on the groundbreaking research of Professor Lars Kessing and Dr. Mads Frost on bipolar disorder and depression. We were founded in 2013 and have been listed on Nasdaq First North in Denmark since 2020. Our solution enables pharma companies to collect self-reported and device-generated data directly from patients in a simple, scalable, secure, and cost-effective way. Our cloud-based platform connects patients and investigators via an app and a web portal, respectively, to collect data in real-time across clinical development, post-market studies, and clinical practice to inform decision-making. Our platform can integrate with wearable devices and sensors, and combine with other RWD sources to provide a more holistic view of the impact of a drug on patients’ lives.

Monsenso signs a new contract with Empano

Monsenso signs a new contract with Empano

Monsenso expands collaboration with Empano, a private provider of psychology and psychiatry services, signing a new contract to help citizens with stress return to work in the municipality of Slagelse.

Monsenso and Empano partnered up last year to help unemployed people get back to work faster. Together, Monsenso and Empano offer a solution for Danish municipalities to help unemployed people suffering from stress and depression return to work.
Following the successful implementation in the municipality of Guldborgssund, the services are now offered to more municipalities, starting in the municipality of Slagelse, Denmark.

Empano offers individual courses and group sessions to the employment sector in the municipalities and uses Monsenso’s digital health solution to collect self-reported data from service users to validate and demonstrate the program’s effectiveness.

The courses have a duration of 6-8 weeks each, after which new citizens are enrolled.

It is a preventative course that teaches strategies to reduce stress and promote mental health. Citizens are introduced to techniques that enable them to better cope with symptoms and challenges in everyday life and the job market, based on cognitive therapy, metacognitive therapy, and mindfulness.

“We are excited to expand our collaboration with Empano to help more people get back to work faster,” says CEO Thomas Lethenborg. “Mental health and unemployment are closely linked. While unemployment can cause stress which may have other negative consequences on people’s mental health, including depression, anxiety and lower self-esteem, a good mental health has shown to have a positive impact on employability, finding a job and staying in that job.”

Monsenso signs a contract with the Elite Sports Academy Aarhus (ESAA)

Monsenso signs a contract with the Elite Sports Academy Aarhus (ESAA)

Monsenso signs a contract with the Elite Sports Academy Aarhus (ESAA). The Monsenso digital health solution will be used to promote mental wellbeing among ESAA’s students.

Strong mental health is a prerequisite for top athletes to perform at their best. Yet, top athletes are more vulnerable to psychological distress due to the top performance culture. In response, many clubs have over the recent years taken initiatives to promote mental health among their elite athletes and today sports psychology is as much about mental health, as it is about athletic performance.

ESAA, an Elite Sports Academy located in Aarhus (Denmark), is no exception. With mental health as part of the academy’s core values (Mind, Body, Culture, Team), ESAA seeks to provide their young athletes with self-insight and tools to learn how to master the mental aspects of being an elite athlete.

From August 2021, 75 young elite athletes will be offered the Monsenso mhealth app as part of ESAA’s talent program to track their mental wellbeing daily, while giving them access to “Tools” and “Challenges” to boost their mental health and wellbeing. ‘Tools’ provides the young athletes with coping strategies and ‘Challenges’ helps to learn new skills, like how to gain insight into their emotions, how to develop a positive mindset or improve their confidence.

At the same time, the daily tracking offers ESAA the opportunity to identify and act proactively upon signs and symptoms of mental distress, and hereby to provide preventive support to their young athletes.

 “We are pleased to collaborate with ESAA in this project,” says Thomas Lethenborg, CEO of Monsenso. “The importance of mental health in elite sport, in particular among young athletes, can not be underestimated and we are happy that the Monsenso solution can contribute to that. 

For additional information contact:
Bettina van Wylich-Muxoll
Chief Marketing Officer
marketing@monsenso.com
Monsenso

 

 

 

Monsenso announces new chairman of the Board

Monsenso announces new chairman of the Board

Copenhagen, (April 14, 2021): Monsenso, a leading provider of digital mental health solutions, today announced the appointment of Maria Hjorth as Chairman of the Board, as replacement of Jukka Pekka Pertola, who had decided to resign to reduce his number of board seats. 

The company’s Annual General Meeting was held today, in which Maria Hjorth was elected to join the board. Immediately after the Annual General Meeting, the Board of Directors held its constituent meeting and elected Maria Hjorth as Chairman and re-elected Jakob Eyvind Bardram as Deputy Chairman.

The appointment of Maria Hjorth as chairman follows changes in January where Peter Høngaard Andensen and Jacob Hahn Michelsen were elected to the Board with the aim to further strengthen the competences and the diversity of the board.

 “Maria brings extensive experience and accomplishments from the financial sector, lately from a position as CEO at VP Securities A/S, in addition to her board experience from Trifork, May Invest Holding A/S and Asetek” says CEO Thomas Lethenborg. “Her experiences from top management, financial businesses, investor relations and M&A is a great supplement to the rest of the board”. 

The Board and the management of Monsenso would like to thank Jukka Pertola for his great efforts in supporting the management, the company in general and particularly the listing on Nasdaq First North Growth Market in 2020.

“It has been a great pleasure to have served as Chairman of the Monsenso Board of Directors,” said Jukka Pertola. “I am very proud of our accomplishments over the past years, and I am confident that with Maria’s leadership, and the changes made in January, Monsenso will continue to grow and expand it’s positive impact in driving better mental health for more people at lower cost.”

The Board of Directors now consists of Maria Hjorth (Chairman), Jakob E. Bardram (Deputy Chairman), Jeppe Ø. Øvlesen, Peter Høngaard Andersen and Jacob Hahn Michelsen. 

To read the Danish version, click here.

For additional information contact:

Bettina van Wylich-Muxoll
Chief Marketing Officer
marketing@monsenso.com
Monsenso