Monsenso enters partnership with psychiatric clinic in Greece

Monsenso enters partnership with psychiatric clinic in Greece

Monsenso has entered into a partnership agreement with the Greek psychiatric clinic Tzeranis Psychis Omma to deploy the solution in their clinic from Q2 2022 and drive market expansion of the Monsenso solution on the Greek market.

In 2019, 18% of the Greek population was living with a mental illness [1] – since then, the Covid-19 pandemic has led to a significant rise in mental health problems [2]. At the “Meeting of Minds on Quality of Care” conference hosted by WHO/Europe in Athens in December 2021, the necessity to “improve the quality of mental health care for children and adolescents” was emphasised, particularly in light of the Covid 19 pandemic [3]. Greek officials have further highlighted the significance of patient-centricity in mental health services in particular [2].

Psychis Omma has supported individuals with psychological and psychiatric illnesses for over 50 years, aiming at “offering a better life for people suffering from mental disorders, both to themselves and their families” [4]. The clinic provides both inpatient hospitalisation in their facilities in Nea Penteli, close to Athens, as well as (online) psychological support services and external observation [4]. 

The Monsenso Digital Health Solution will be implemented in Psychis Omma’s clinical practice as a tool to support patients in their treatment pathway and to facilitate early intervention and crisis reduction. Moreover, Psychis Omma Mental Health Solutions will act as a partner of Monsenso in Greece, advocating for the benefits of using digital support tools in mental health settings and actively marketing the Monsenso solution on the Greek market.

The Monsenso app for individuals helps patients to keep track of their well-being, symptoms, and medication intake through self-reported data, as well as their behaviour through sensor data collected on mobile phones. The historical data is visualised and helps individuals remember how they have been doing, e.g. between support sessions. It also helps them gain better insight into the behaviours that trigger their symptoms, empowering them to better manage their condition. Healthcare providers access the user data via a web portal for professionals, enabling them to see fluctuations in the mental state of the patients. This can help to predict relevant outcomes and reduce potential relapses and readmissions.

We are excited to bring the Monsenso Solution to Greece and work with Psychis Omma as a partner who values enabling people with mental illnesses to live better, more independent lives as highly as we do.”, says Thomas Lethenborg, CEO of Monsenso.

We are looking forward to working with Monsenso as a partner in Greece and to using their digital health solution to offer improved treatment support to more patients. Remote patient monitoring will open new doors to us in terms of our capabilities to actively support individuals outside of treatment sessions.”, says Spyros Tzeranis, Scientific Director of Tzeranis Psychis Omma.

About Tzeranis Psychis Omma 
Tzeranis Psychis Omma is a Greek Neuropsychiatric Clinic founded in 1971, providing specialist health services and supporting individuals with various psychological and psychiatric illnesses. Working with highly experienced and trained nursing and medical staff, the clinic offering both inpatient care and external psychological support aims at enabling more individuals suffering from mental illness to live better lifes.
To learn more visit tzeranis.gr.

About Monsenso
Monsenso is an innovative technology company offering a medical grade digital health solution. Our mission is to help provide better mental health to more people at lower costs. Our solution helps optimise the treatment of mental disorders and gives a detailed overview of an individual’s mental health through the collection of outcome, adherence, and behavioural data. It connects individuals, carers, and health care providers to enable personalised treatment, remote care, and early intervention. Based on continuous research and development, our team is committed to developing solutions that fit seamlessly into the lives of individuals, increase their quality of life and improve the efficacy of mental health treatment. To learn more, visit www.monsenso.com

[1] Stewart, C. (2021). Europe: mental disorders among adolescents in 2019, by country. Statista. https://www-statista-com.esc-web.lib.cbs.dk:8443/statistics/1273254/mental-disorders-among-adolescents-in-europe-by-country/

[2] WHO (2021). Athens Mental Health Summit – Ministers and representatives renew commitment to prioritize mental health in the WHO European Region.
https://www.euro.who.int/en/countries/greece/news/news/2021/8/athens-mental-health-summit-ministers-and-representatives-renew-commitment-to-prioritize-mental-health-in-the-who-european-region

[3] WHO (2021). WHO/Europe and Greece put quality of care at the top of the health agenda. https://www.euro.who.int/en/countries/greece/news/news/2021/12/whoeurope-and-greece-put-quality-of-care-at-the-top-of-the-health-agenda

[4] Psychis Omma Tzeranis Clinic (n.d.). Our Clinic. https://tzeranis.gr/en/our-clinic/

Norddjurs municipality in Denmark joins a successful back-to-work program supported by the Monsenso digital health solution

Norddjurs municipality in Denmark joins a successful back-to-work program supported by the Monsenso digital health solution

Norddjurs Municipality in the Central Jutland region joins the successful Return-to-Work program, facilitated by several partners including Empano, Sundinvest, Den Sociale Kapitalfond, AS3, PWC and supported by Monsenso’s digital health solution. From February 2022, Monsenso’s digital health solution will be deployed in Norddjurs Municipality to support individuals during their return-to-work process, while collecting real-world insights on outcomes.

The impact of COVID -19 on social care.
The disruption or shutdown of critical mental health services during the COVID -19 pandemic has led to the rapid adoption of technology-enabled care (TEC) in both health care and adult social care (ASC). Today, there is no doubt that digital technologies offer the potential to improve social care, from targeting resources where they are most needed to promote independence in the community through remote care and treatment support.

Commissioning beyond COVID -19
The adoption of technology-enabled care (TEC) also provides an opportunity to move towards a more person-centered and evidence-based model of commissioning that focuses on service delivery outcomes.

Three forward-thinking municipalities in Denmark implement an outcome-based back-to-work service provided by Empano and Monsenso

To date, two forward-thinking municipalities in Denmark (Guldborgsund and Slagelse) have implemented an outcome-based back-to-work service provided by Empano and Monsenso.

The back-to-work services are designed to help citizens with mental illness return to the labour market faster and consist of coping and motivational courses provided by Empano, offered in conjunction with the Monsenso digital health solution for remote treatment support and real wold data collection on outcomes to validate and demonstrate program effectiveness. 

Since February 2022, Norddjurs municipality in the Central Jutland region has also joined the successful program and more municipalities are expected to follow during the year.

About Monsenso
Monsenso is an innovative technology company offering a medical grade digital health solution. Our mission is to help provide better mental health to more people at lower costs. Our solution helps optimise the treatment of mental disorders and gives a detailed overview of an individual’s mental health through the collection of outcome, adherence, and behavioural data. It connects individuals, carers, and health care providers to enable personalised treatment, remote care, and early intervention. Based on continuous research and development, our team is committed to developing solutions that fit seamlessly into the lives of individuals, increase their quality of life and improve the efficacy of mental health treatment.

To learn more, visit www.monsenso.com

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.