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 is Cyber Essentials certified

Monsenso is Cyber Essentials certified

Copenhagen, Denmark – 8th of April 2021.

Monsenso A/S, a technology leader in digital health solutions for mental health is now Cyber Essentials certified.
The Monsenso digital health solution that connects individuals and clinicians to provide optimal care received a Cyber Essentials certification demonstrating the company’s commitment to security and data protection.

Cyber Essentials is the UK Government’s answer to a safer internet space for organisations of all sizes, across all sectors. Developed and operated by the National Cyber Security Centre (NCSC), the Cyber Essentials certificate assures that essential cyber security measures are in place to protect data against cyber-attacks.

“Monsenso is committed to adhere to the highest security standards. Beyond the Cyber Essentials certification, Monsenso holds the ISO 13485 and ISO 27001 certifications, a TGA certification, class 1 CE mark and is HIPAA compliant. The Cyber Essentials certification demonstrates our continuous commitment to keep the data of our customers secure” says Thomas Lethenborg, CEO at Monsenso.

To read more about our data protection, download our Data management & Security fact sheet.

About Monsenso

Monsenso is an innovative technology company offering a 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.

For additional information contact:

Bettina van Wylich-Muxoll
Chief Marketing Officer
Monsenso
+45 22 70 47 24
marketing@monsenso.com

New partership to help unemployed people get back into the labor force faster.

New partership to help unemployed people get back into the labor force faster.

New partership to help unemployed people get back into the labor force faster. Monsenso enters a partnership with Empano, a private player in psychology and psychiatry services. Together, Monsenso and Empano offer a solution for the Danish municipalities to support unemployed people suffering with stress and depression in their return to work process. Initially, the solution will be implemented in Guldborgssund Municipality, Denmark, in September 2020.

“In a situation with historically high unemployment, we are pleased to offer a solution that can help get more Danes back into the labor force faster. It’s always difficult to be outside the labor force, and even more so if you suffer from stress and depression. “Therefore, we are pleased to offer a solution to municipalities that can help unemployed people suffering with stress and depression get back to work” says CEO Thomas Lethenborg.

“The municipalities are facing a major task due to the increased unemployment we are seeing in the wake of Covid-19. The combination of our services in the psychology and psychiatry services, and Monsenso’s platform to support follow-up and data collection is unique in the market and we are convinced that the service can help municipalities to proactively help the larger group of unemployed ” says Director Camilla Stokholm Bjørkman from Empano. 

To read the Danish version, click here.

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

Monsenso signs agreement to support global pharmaceutical across Europe

Monsenso signs agreement to support global pharmaceutical across Europe

Following a year-long collaboration, Monsenso signs a three-year +10 mio DKK agreement with a global pharmaceutical company.

Monsenso’s mobile health solution will be used for real-world data collection across two studies in connection with the launch of a new drug for depression treatment. The studies are expected to start in the first half of 2021 and will run over a three-year period, covering up to 2250 patients and 120 clinicians across Belgium, the Netherlands, the United Kingdom, Switzerland, Italy, Spain, Denmark, Sweden and France.

In connection with the two studies, Monsenso’s solution will be used to collect data from patients and their relatives through clinical questionnaires, daily self-assessments and behavioral data from smartphones and wearables.

In addition, the patients will be offered in-app study information and can receive reminders about medication and consultations with their clinician. Monsenso’s unique mobile health solution will in this way help increase the quality of clinical studies with real-time data collection while also facilitating better communication between patients, caregivers and clinicians.

“We are very pleased to expand our collaboration with this global pharmaceutical company and to participate in these projects. Depression is a leading burden of disease for society, and it has severe consequences for patients and their family caregivers, so we are proud to contribute to solving this problem” says Thomas Lethenborg, CEO of Monsenso. “In addition, the project will support our European expansion and our focus on partnering with pharmaceuticals, which is in line with our strategy”. 

The project will not affect Monsenso’s previously communicated plans and guidance for the 2020 financial year.

To read the Danish version, click here.

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

Monsenso partners with the Black Dog Institute in Australia

Monsenso partners with the Black Dog Institute in Australia

Copenhagen, Denmark – 30 August 2016.  Monsenso, the Copenhagen-based technology company developing mHealth solutions for mental illnesses, today announced a partnership with The Black Dog Institute in Australia.

Black Dog Institute is a pioneer in the identification, prevention and treatment of mental illness and the promotion of well-being. The Institute will conduct feasibility studies to determine if the Monsenso mHealth solution can be used to collect much needed data for a number of large-scale mental health trials.

“The mission of Monsenso and that of Black Dog are highly aligned. We both aim to enable better mental health care through innovation and science, therefore this is an exciting moment for both parties” said Thomas Lethenborg, CEO at Monsenso. “Monsenso is looking to build sustainable, long-term partnerships, with the ultimate goal of delivering better care, to more people, and at lower cost.”

As part of the on-going collaboration between Monsenso and the Black Dog Institute, Mads Frost, Chief Product Officer of Monsenso, has been invited to participate as a guest-speaker at the conference “Humans and Machines: A Quest for Better Mental Health” organised by Black Dog.

Helen Christensen, Director of the Black Dog Institute, said the trial would allow them to collect real-time information using a device that most people carry at all times – their Smartphone. “Our focus will be on collecting self-reported daily mood ratings and activity data that may be used to predict changes in mental health conditions over time. Ultimately these sorts of tools can be used to deliver real time assistance to those in distress at the time they most need help. However, like all good research and development projects, our aim is to test the validity of these approaches; their feasibility and the extent that they can provide better health care services.  Ultimately, we hope to use these sorts of tools in our national programmes involving youth mental health and suicide prevention.”

The Monsenso mHealth solution for mental illnesses holds a CE mark and a TGA certification and it has been technically and clinically validated in clinical evaluation studies and randomised clinical trials. Furthermore, Monsenso is in the process of obtaining the ISO 13485 and ISO 27001.

For additional information contact:
Jennifer Highland
Marketing and Communications Manager
Monsenso
+45 81 71 7713
highland@monsenso.com

Gayle McNaught
Head of Public Affairs
The Black Dog Institute
g.mcnaught@blackdog.org.au

About The Black Dog Institute
The Black Dog Institute is a not-for-profit organisation which is internationally recognised as a pioneer in the identification, prevention and treatment of mental illnesses, and the promotion of well-being. We are dedicated to improving the lives of people affected by mental illness through the rapid translation of high quality research into improved clinical treatments, increased accessibility to mental health services and delivery of long-term public health solutions. Our unique approach incorporates clinical services with our cutting-edge research, our health professional training and community education programs. We combine expertise in clinical management with innovative research to develop new, and more effective, strategies for people living with mental disorders. For more information visit www.blackdoginstitute.org.au

 

You can download this article as PDF in English and Danish