Table of Contents

Executive Summary

Executive Summary

There are few opportunities for the digital transformation of healthcare as big as improving disease management. More than half of American adults (52%) suffer from at least one chronic disease, and globally, one in three of all adults suffer from multiple chronic conditions.

Digital health leaders recognize the opportunity that lies in digitizing disease management: In a recent survey conducted by BrightInsight and HealthXL and HealthXL, 61% of respondents said that disease management is the most promising use case for Software as a Medical Device (SaMD).

For biopharma companies, there’s a compelling business case for doubling down on digital health solutions. The industry has experienced unreliable returns in recent years and is facing significant challenges due to increased competition from “me too” drugs and biosimilars, downward pressure on drug prices from governments and payers, and increasing drug development costs, among other challenges. Meanwhile, new groundbreaking therapies are struggling to gain market access due to high prices and sparse Real-World Evidence.

In an increasingly competitive industry, it all comes down to meeting patient demands—and patients are asking for intuitive digital experiences in all facets of life, including healthcare. Eighty percent of patients prefer digital communication with healthcare providers at least some of the time, and 60% say they expect a seamless digital healthcare experience, akin to retail.

The need is there, the business case exists, patients are asking for digital, and biopharma companies are answering the call: The top five biopharma companies invested $270 million in SaMD between 2019 and 2021, and the global market opportunity for digital therapeutics is forecasted at $56 billion by 2025. The time for a comprehensive patient-centric digital disease management solution is now.

White paper Sa MD most promising use cases in Sa MD resource version v24

"Digital enables more engaging patient experiences by increasing therapy compliance, improving disease and medical tracking and as importantly, building connections among patients and with healthcare providers. The data collected with digital can be used to deliver more personalized therapies, increase reimbursement and potentially increase revenues through extended patent life."

– Brad Gescheider, Global Head, Digital Innovation and Patient Services, Immunology at Sanofi

Challenges in Disease Management

Part of the challenge in designing digital disease management solutions lies in the complexity of disease management itself. Here are some of the key hurdles:

  • Poor adherence and persistence: It can be overwhelming for patients to manage an ongoing condition (or multiple conditions), especially when myriads of treatments, drugs, behavior modifications and lifestyle adjustments are involved. Even simply taking medications consistently can be a struggle—research shows that 50% to 60% of patients report poor adherence or stop taking medications altogether after one year.


    Drug-related morbidity and mortality from non-optimized medication therapy cost the U.S. healthcare system more than $500 billion in 2016. It costs pharma companies even more—over $600 billion a year is estimated to be lost to poor adherence worldwide. Research shows that a 10% increase in adherence would translate to a $124 billion pharmaceutical revenue opportunity, globally.

  • Unequal access to specialty care: It can take a lot of time and trial and error to match an individual patient with the right treatment for their chronic condition. Specialists in rare diseases, autoimmune conditions, oncology and other treatment areas may have more knowledge about treatment options than a patient’s primary care provider, but building a relationship with a specialist and sharing health information can be difficult, especially for patients who live far from a major health system.
  • Disparate data sources: In an effort to improve care, patients are often given multiple devices for capturing biometric data—including scales, blood pressure cuffs and heart monitors. These disparate data points, viewed without context, can make it difficult for providers to extract meaningful insights to make informed care decisions, especially when they are reviewed sporadically.
  • Siloed care providers: Chronic conditions are often tricky to manage, and multiple providers are involved in a patient’s care. Yet, they often operate independently from each other, with a limited purview of the patient’s holistic care journey and a reliance on the patient’s recall of other providers’ care recommendations.
  • Limited data visibility between visits: A patient may see their provider only once every few months (or less), yet chronic conditions require ongoing monitoring. Clinicians need real-time symptom and quality-of-life data in order to provide comprehensive care, and patients need insights that allow them to better track their disease, understand triggers and see the cause and effect of lifestyle modifications on a regular basis—not just when they are in the doctor’s office.

7  Hichborn J, Kaganoff S, Subramanian N, Yaar Z. Improving Patient Adherence Through Data-Driven Insights. McKinsey & Company. December 14, 2018. 
8 Watanabe JH, McInnis T,  Hirsch JD. Cost of Prescription Drug-Related Morbidity and Mortality. Annals of Pharmacotherapy. Sept. 2018.
9  HealthPrize, Medication Adherence: Pharma’s $637 Billion Opportunity. Accessed June 2022.
10 Capgemeni Consulting, HealthPrize. Estimated Annual Pharmaceutical Revenue Loss Due to Medication Non-Adherence. 2012. 

Opportunities for Digital

When digital health leaders invest in digital innovation, they’re often asked: How does this solution provide value? In other words, will this solution provide a solid return on investment? The most successful digital health solutions in disease management will check three major boxes:

  1. Keep patients engaged
    Successful disease management depends on patient adherence. Multiple factors contribute to poor adherence and persistence, including forgetfulness, complex dosing regimens, difficulty refilling prescriptions, administration challenges, concerns over side effects, perceived lack of efficacy and high out-of-pocket costs.

    Whether it’s a patient app with a personalized drug dosing algorithm, medication reminders, a companion solution that assists patients with a challenging therapy administration, or symptom tracking that can be done anytime, anywhere, digital solutions can provide comprehensive support between appointments. Connected digital devices, companion apps and wearable tech give patients the real-time insights they need to better manage their condition. And keeping patients engaged translates to increased adherence and persistence.
  2. Improve patient-provider communication
    Providing clinicians with tools that enable them to have more informed discussions with their patients through access to longitudinal and real-time health data can create more therapy “stickiness” with providers.

    Secure, compliant communication tools can connect providers to both patients and other care team members, improving collaboration and streamlining care decisions. Well-designed digital health solutions can enable patient outreach, educational opportunities, telehealth, remote patient monitoring and more.
  1. Generate invaluable Real-World Data
    The best digital health solutions in disease management generate and utilize a wealth of data at both the individual patient and population levels. Patient-level data and insights support clinical decision-making and improve the standard of care. On a population level, this powerful data can inform research and development, commercial sales, and pricing and market access (including outcome-based pricing models).

    This type of unique, longitudinal, patient-level data has been historically impossible or costly for biopharma companies to acquire. This data not only provides insights to improve patient engagement, but can potentially enable biopharma companies to identify new indications, produce cost-effectiveness analyses, enhance clinical decision support and so much more.

Our ability to provide a sustainable competitive advantage with our products won't be based on developing our own cloud-based solutions—that’s not our expertise. Where we can generate new competitive advantages is in how we analyze and use the new data being generated by all of these digital health solutions."

– Paul Upham, Head of Smart Devices, Roche / Genentech

Therapy Areas Primed for Disease Management Solutions

We’ve analyzed and identified some specific therapy areas that offer the most potential for disease management solutions. Each has its own challenges and opportunities:

 

Addressing the growing diabetes epidemic takes more than best-in-class medicines alone. We need to engage with people on their level and integrate with the solutions they are already using to manage their diabetes. Medical-grade digital health platforms like BrightInsight are key to helping us improve the conversation between people with diabetes and their caregivers."

– Anders Dyhr Toft, former Corporate Vice President of Commercial Innovation at Novo Nordisk

CARDIOVASCULAR

For diseases like heart failure, hypertension and arrhythmias, poor adherence can turn patient care from proactive to reactive, increasing morbidity, increasing care costs and negatively affecting quality of life. Digital solutions can link up data collected from devices like smart blood pressure cuffs, scales and ECG monitors with self-reported patient symptoms and lab work to give providers a more complete picture of a patient’s disease management—with proactive alerts to head off complications.

DIABETES

Diabetes is a costly and complicated condition to manage. While connected devices like insulin pens, insulin pumps and continuous glucose monitors are important disease management tools, they are often siloed and fail to provide comprehensive support. Nearly half of diabetes patients do not achieve adequate glycemic control. Disease management solutions can include drug dosing support, patient apps, data integration and clinical portals for real-time data sharing and collaboration.

IMMUNOLOGY

Innovation is everywhere in the field of immunology. As a variety of new and groundbreaking biologics become available, patients and providers need digital health solutions that help them work through adherence and self-reporting challenges. A robust patient app can help autoimmune patients track and improve quality-of-life metrics. Biopharma companies, meanwhile, can benefit from the capture of Real-World Data to demonstrate a compelling value story.

NEUROLOGY

There is an opportunity for digital health to make an impact on people living with neurological conditions such as Alzheimer’s and Parkinson’s, as well as those rehabilitating from stroke and other mental health conditions. In a treatment landscape where it’s difficult to access consistent appointments with specialists, digital health solutions like patient apps can provide day-to-day support with features like symptom tracking, dosing reminders and behavior modification support.

ONCOLOGY

There are a myriad of treatments for various types of cancer, with hundreds more in the pipeline. This presents so many options for patients, from new combinations of drugs to participation in clinical trials. Yet understanding and managing symptoms and side effects from therapies can be overwhelming to patients and lead to confusion. Patient apps that track symptoms through patient diaries and quality-of-life surveys can help patients better understand their therapy and improve patient-provider communication to bolster treatment adherence.

RARE DISEASES

Over 300 million people globally are affected by over 6,000 rare diseases. Because they’re so uncommon, it’s challenging for the providers tasked with diagnosing, treating and managing these conditions. These conditions may also have complex dosing regimens or administration. Digital health solutions that include dosing algorithms, patient apps and robust healthcare provider interfaces can give both patients and providers the tools and insights they need to better manage rare diseases.

RESPIRATORY

Respiratory diseases like chronic obstructive pulmonary disease (COPD) and asthma are common, but they’re not always easy to treat. Providers rely heavily on patient reporting, while patients attempt to juggle a combination of preventive and emergency treatments. Digital health solutions in this space can unlock remote patient monitoring, symptom tracking, and apps that use third-party data, like personalized air quality reporting, to empower patients to control for environmental triggers.

11 Centers for Disease Control and Prevention. World Diabetes Day. Infographic. Last reviewed January 2, 2020.

What to Look for in a Digital Disease Management Solution

In order to solve these disease management challenges and take advantage of the wide range of opportunities, it’s important to take a strategic approach. Here’s what you should look for in a solution:

  1. Configurable, flexible functionality
    Applications that are configurable to meet your unique needs are core to both accelerating speed-to-market and expanding your product portfolio over time. Ensure that your platform of choice supports:
    • Connected devices
    • Custom clinical surveys to capture electronic Patient Reported Outcomes (ePRO) and Quality of Life (QoL) tracking
    • Configurable notifications, reminders and alerts to prompt health interventions
    • Configurable care plans and educational resources to personalize the patient experience
    • Configurable user and administration controls and alerts to meet data privacy requirements
    • Robust clinician interfaces that integrate with the EHR 
    It’s also important to build on a platform that’s compliant with even the most highly regulated digital health SaMD classifications. This allows you to maintain compliance across geographies and over time, even as the product scales and evolves.
  1. Comprehensive, patient-centered tools
    A patient app with tools that support patients throughout their disease management journey is a key differentiator. A great patient app solution helps patients recognize the impact of their actions through features like symptom tracking, patient-care team communication, automated medication and refill reminders and integration with connected devices.

    The best patient tools include personalized drug dosing algorithms to drive adherence and persistence, plus personalized education tools designed to empower patients.
  2. A Real-World Data engine with actionable insights
    The most powerful digital health solutions allow for the secure, compliant capture and use of patient- and population-level data. On an individual level, analytics dashboards with usage and usability metrics, combined with algorithm hosting, aid clinical decision-making, increasing patient adoption and engagement. On a broader level, data powers reimbursement management tools, demonstrating therapy value to payers and increasing therapy access.

Deliver Better Disease Management with BrightInsight

Go with the proven partner that top biopharma companies trust. When you team up with BrightInsight, you can accelerate time to market while future-proofing your disease management solutions for regulatory, security and privacy compliance.

By building their disease management solutions on top of the BrightInsight® Platform, top biopharma companies can address patient and provider pain points and unlock a better path to adherence and persistence across a wide range of therapy areas and treatments.

This is a holistic one-stop-shop so we’re all on the same page with what’s going on with my health. This gives me the power to advocate for myself."

– Tanya, Breast Cancer Patient

Case Studies

CSL Behring’s Hizentra App

CSL Behring chose the BrightInsight Platform® to build and operate their current and future digital health offerings aimed at improving treatment experiences for patients with rare and serious diseases. To better support remote care and enhance treatment experiences for adult patients taking Hizentra for Primary Immune Deficiency (PID) or for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), CSL Behring and BrightInsight partnered on the Hizentra app. CSL Behring wanted to improve the experience for patients taking Hizentra, who administer multiple daily subcutaneous infusions that require close tracking of timing and location of infusion sites.

The Hizentra app elevates the lives of patients by enabling them to manage their condition with independence, confidence and control. The app enables patients to easily track infusions, get reminders, and record and share their infusion journal with their doctor. The solution solved the pain points for CSL Behring and achieved rapid uptake of over 3,000 users—representing a wide cross section of Hizentra patients—and has earned a rating of 4.5 stars on the Apple App Store.

Novo Nordisk

Novo Nordisk is leveraging the BrightInsight® Platform to build and operate many of their digital health solutions and the corresponding data from these smart devices within a regulatory-compliant environment.

The solution will capture data from Novo Nordisk’s next-generation connected insulin pens and integrate data from leading third-party diabetes solutions, including the Abbott Freestyle Libre system, the Glooko Diasend platform, the Dexcom continuous blood glucose meters, as well as diabetes solutions from Roche. Novo’s non-exclusive partnership strategy is incredibly unique in an industry where data is historically very siloed.

By safely and securely enabling data integration across Novo Nordisk’s partner ecosystem, the BrightInsight Platform supports Novo Nordisk’s goal of helping more people realize the full benefit of their innovative medicines to ease the burden of diabetes management for those individuals.

Contact our team to learn how BrightInsight can accelerate digital initiatives and help deliver a digital disease management solution that serves your specific needs.

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