Digital disease management in rheumatoid arthritis

Executive Summary

Approximately 20 million people live with rheumatoid arthritis worldwide, and about a million new patients are diagnosed each year.¹ As the population ages the prevalence of rheumatoid arthritis is expected to rise, and women are disproportionately affected.²

Early detection, treatment and proper disease management are crucial to slowing joint damage and avoiding complications like loss of movement and joint replacement, as well as other related outcomes like lost employment and premature heart disease.³ While it’s impossible to know how a specific patient's disease will progress, data collected by digital allows providers to be proactive and track trends over time to more accurately project disease progression.

Leading biopharma companies recognize the opportunity for digital to augment medications and manage disease progression for many conditions, including rheumatoid arthritis. In a recent survey conducted by BrightInsight and HealthXL, 61% of respondents said that disease management is the most promising use case for Software as a Medical Device (SaMD), and rheumatoid arthritis was named as a top 10 indication for SaMD. It’s no surprise as several biopharma companies have invested in R&D for rheumatoid arthritis and have drug candidates in the late clinical-stage of development.

[Rheumatoid arthritis] is still unclear to healthcare providers. They have 10 to 12 DMARDS and 6 different mechanisms of action, so which patient will respond better to which therapy? Yes—an algorithm in a disease management solution would be incredibly helpful."

- VP, Therapy Lead, Top 20 Biopharma company

Digital disease management solutions can directly drive therapy value in a multitude of ways: impacting physician prescribing patterns, improving patient access, increasing adherence or persistence and optimizing dose delivery, among others.

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

1  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7436952/
2  https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html
3  https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis

Challenges in rheumatoid arthritis

Digital solutions can help solve some of the challenges that have long impacted care for patients with rheumatoid arthritis. Here are some of the key obstacles:

Poor adherence and persistence: Biologic treatments require significant education, training and lifestyle adjustments. It can take weeks to know if a drug is working as intended, and patients may need to cycle through multiple drugs before they find one that’s truly effective. Medications may be administered by injection, infusion or orally. Some biologics need to be refrigerated and some follow a very specific dosing timeline. The complexity of administration can make adherence more difficult than it already is. Research shows that overall, 50% to 60% of patients report poor adherence or stop taking medications 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. They cost 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.
Insurance requirements: There are about a dozen disease-modifying antirheumatic drugs (DMARDS), including biologics and synthetics, and there are several different mechanisms of action among them. Add to that JAK inhibitors, TNFs and other classes that play a role in treatment of rheumatoid arthritis, and you can see how formulary placement can be competitive. To find the drug that works best, patients typically have to undergo a lengthy trial and error process.
Complicated and competitive landscape: In 2021 the Food and Drug Administration issued a black box warning for JAK inhibitors, due to an increased risk of serious heart-related events. Providers struggle to weigh risks against the potential benefits for patients for whom other drugs haven’t worked. There are also a lot of biologics on the market. Yet with the standby tumor necrosis factor inhibitors (TNFs) being prioritized on formularies, and patents protecting the existing monopoly drugs against approved biosimilars, it can be hard for new classes and modalities of drugs to gain traction—even if they're a more appropriate match for a patient's clinical or financial needs.

Data limitations due to lack of consistency and context: Healthcare providers who treat rheumatoid arthritis will tell you that another major barrier to finding the right treatment is that these chronic conditions depend on accurate self-reporting by patients. Rheumatoid arthritis care requires frequent monitoring to track disease progression and response to therapy. Providers must rely on patients’ self-defined assessments of feeling good, better, or at their best when they take a specific drug, and many providers are stuck relying on antiquated, paper-based symptom tracking that only captures a moment in time and doesn’t give any insights into quality-of-life metrics.

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 only periodically.

Things don't change in a day for my patients, so [with a digital solution] I could plot what’s happening between visits, to see what’s happening over time."

- Immunologist

Siloed care providers: Because rheumatoid arthritis is so common, doctors are familiar with treatment options and standards of care. But that doesn’t always ensure a smooth path to treatment. Many patients with RA also have other autoimmune indications or comorbidities that make treatment planning and sequencing difficult. Multiple providers are often 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. Without a clear method of information sharing it can easily become a game of telephone, with the burden of communicating their overall care plan falling to the patient and relying too heavily on their subjective understanding of their various symptoms and their relationship to each other.

Opportunities for digital in rheumatoid arthritis care

These challenges frustrate providers and patients alike, and bleed value from the healthcare system. Well-designed digital solutions can address these shortcomings by connecting healthcare stakeholders and giving them tools to excel. Successful digital solutions restore value in three important ways:

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. Keeping patients engaged improves adherence and persistence—one study found a 44% greater adherence for patients enrolled in a digital support program.⁴

Biologics are a clear fit for digital solutions that can help ease the burden and differentiate the drug. Medication reminders and companion solutions to assist patients with a challenging therapy administration can provide comprehensive support between appointments. Connected digital devices, such as autoinjectors, companion apps and wearable tech give patients the real-time insights they need to better manage their condition. Dose adjustment algorithms or provider-set dosing guidance can help patients more accurately adjust their dosing when necessary. And patients can receive environmental updates based on geolocation when environmental factors might impact their condition.
Improve patient-provider communication
Providing clinicians with tools that enable them to have more informed discussions with their patients—and other providers—through access to longitudinal and real-time health data can create more therapy "stickiness" with providers.

Regular quality-of-life assessments and electronic Patient Reported Outcomes (ePRO), via user-friendly patient apps, can transform sporadic symptom tracking into real-time data, creating continuity between appointments and enabling more accurate clinical decision making. These tools make it easy for providers to incorporate valuable clinical questionnaires that are currently so cumbersome that most HCPs don't even bother using them after the first appointment. And 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. Notifications, pre-treatment checklists, and e-records can help keep patients up to date with immunizations and recommended preventive care. A digital platform that integrates Electronic Health Records (EHRs), real-time patient data and the latest news on clinical trials can optimize patient care.

Generate invaluable real-world data
Biopharma increasingly relies on insights from real-world data to optimize both R&D and commercialization. Real-world data can inform clinical development strategies, improve access and enable outcomes-based contracts with payers, enhance sales and marketing strategies and substantiate the value proposition of your therapy.

But it can be challenging and expensive to acquire high-quality, longitudinal RWD. Common data sources, like claims data, often lack the level of detail needed for clinical and commercial use cases. When useful data sets do exist, they can often cost upwards of $1M per year. The best digital health solutions in disease management generate and utilize a wealth of data at both the individual patient and population levels.

In rheumatoid arthritis care, powerful algorithms can instantly synthesize data from multiple sources and provide personalized treatment recommendations based on each individual patient’s condition. As patients inevitably change treatments over time, these algorithms can help providers plan care pathways. When providers can access population-level data and trends, they can better predict which treatment may work best for each individual patient. Best of all, when all this data is available in one streamlined dashboard, it frees up time that can be spent face to face with patients. And over time, the real-world data collected can help build a case for reimbursement.

We should be growing faster, acquiring more patients. Marketing budget is not enough to solve upstream challenges. Relying on TV ads is a brute force approach, but what is required is a surgical approach: How do we get patients paired with the right doctor, healthcare system and drug? It takes time and resources, but the brand lifecycle is finite. How do you get more patients on your brand? Digital."

– Data Science & Artificial Intelligence lead at a top 10 biopharma company

4 https://finance.yahoo.com/news/boehringer-ingelheim-healthprize-announce-study-130000796.html

BrightInsight’s 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 are some of the benefits our Disease Management Solution can deliver:

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.

HEALTHCARE PROVIDER INTERFACES

Our Healthcare Provider Interfaces enable clinicians to facilitate improved communication with patients, and to see trend data directly within the EHR workflow to track how patients are responding to therapy.

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.

CLINICAL RHEUMATOID ARTHRITIS ASSESSMENTS

Rheumatoid arthritis clinical assessments

The Patient App connects patients to tools like clinical assessments, such as the DAS28 to assess RA disease activity level severity.

MEDICATION REMINDERS

The BrightInsight Disease Management Solution imports a patient's RA therapy prescription directly from the EHR into their Patient App and medication reminders can be configured to support treatment persistence and adherence.

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.

It’s a game changer if it creates less time for me to spend in the office. The common thread is patient engagement and participation in their treatment and journey. It's important to put the patient first and make them feel like they are useful in the process. That powerful sense of engagement says it all for them to participate. To objectively show them numbers, results—follow the disease progression through the journey. As a clinician, I welcome it—it's not easy to help them understand why we’re doing what we’re doing."

– Rheumatologist

ANALYTICS DASHBOARDS

Commercial and brand leaders leverage our Analytics Dashboards to harness unique data to drive product strategy and marketing tactics.

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.

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The BrightInsight Disease Management Solution (DMS) is not a cleared or approved medical device. The use cases presented within this article are hypothetical use cases and do not make reference to a specific product, product claims, or product branding. The Rheumagrin interface that is illustrated is for example purposes only and does not represent a real product or product branding.

How digital solutions resolve challenges and deliver value

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