CSL Behring, a leader in global biotherapeutics, and BrightInsight, the leader in biopharma and medtech regulated digital health solutions, partnered on an app for adult patients taking Hizentra for primary immunodeficiency disease (PI) or for chronic inflammatory demyelinating polyneuropathy (CIDP). The Hizentra app quickly gained users—and high app store ratings. After nearly two years on the market, CSL Behring reports that the app has generated high patient adoption and retention rates, while enhancing the patient experience and providing valuable insights.

The Hizentra app was the first digital product to come from BrightInsight’s partnership with CSL Behring. In May of 2020, CSL Behring announced it selected BrightInsight for its unified platform that enables the company to develop and host digital health devices, apps, algorithms and Software as a Medical Device (SaMD) at scale while maintaining global compliance with privacy, security, quality and regulatory requirements. The goal of the partnership was to build and operate current and future digital health offerings to improve treatment experiences for patients with rare and serious diseases. The Hizentra app was launched in less than six months and updated with a major release in July 2021.

The Hizentra app has succeeded in solving pain points for patients using Hizentra, while providing valuable data to CSL Behring to continue innovating for these patients. After a successful launch in the U.S., CSL Behring expanded the Hizentra app to Japan, Canada and Latin America.

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The Facts

  • About 250,000 Americans have been diagnosed with PI, a rare genetic disorder that impairs the immune system. There are more than 300 types of PI.
  • Roughly 30,000 Americans have been diagnosed with CIDP, a rare neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms.
  • Patients using Hizentra self-administer subcutaneous infusions sometimes more than once a week. This requires close tracking of timing and location of infusion sites.

The Challenge

Hizentra enables patients to self-administer their infusions at home. This has many benefits for Hizentra patients. During the pandemic it has allowed patients with PI and CIPD, who are high-risk for serious complications of COVID-19, to lower their risk of exposure by alleviating the need for an in-person nurse visit. The transition from a nurse-infused therapy to a self-infused therapy can seem complex for patients.

CSL Behring’s challenge was to enhance and improve the treatment experiences for PI and CIPD patients, through digital, in a way that complies with privacy, security and regulatory requirements. CSL Behring also needed to update its underlying digital infrastructure to support scalability beyond the U.S. and to support app data capture and insight generation to enable CSL Behring to further optimize the app for patients.

There are two main patient pain points we want to improve: One is that we improve the process for patients transitioning from another therapy to Hizentra. We want to improve that process. And two, once they’re on Hizentra, we want to maximize their overall satisfaction. The app enables us to identify challenges in those two pain points, then address those challenges that we otherwise may not have."

– Brian Johnson, Senior Director, Customer Engagement Management, CSL Behring

The Solution

BrightInsight provides the leading global platform for biopharma and medtech regulated digital health solutions. Our pre-built and proven cloud-based platform serves as a compliant foundation for apps, healthcare provider interfaces, analytics dashboards, algorithms, medical devices, connected combination products, diagnostics and Software as a Medical Device (SaMD).

To better support remote care and enhance treatment experiences for adult patients using Hizentra for PI and CIDP, CSL Behring developed the Hizentra app, built on the compliant BrightInsight Platform®.

In conjunction with Hizentra therapy, the Hizentra app provides a holistic and integrated therapeutic solution that elevates the lives of patients by enabling them to manage their condition with independence, confidence and control. Specifically, the app enables patients to easily track infusions, get reminders, and record and share their infusion journal with their doctor.

After the swift and successful U.S. release CSL Behring began to launch the app in additional global markets, including Japan, Canada and Latin America.

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After conducting a rigorous evaluation, we selected BrightInsight because it was the only regulated solution with a robust Quality Management System and comprehensive privacy and security certifications. BrightInsight’s Platform allows us to focus on therapeutic innovation, rather than the underlying digital technology. CSL Behring is committed to delivering on our promise to support and empower our patients through digital engagement, and the Hizentra app is a step towards providing more holistic treatment experiences."

– Brian Johnson, Senior Director, Customer Engagement Management, CSL Behring

The Results

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The Hizentra app has an adoption rate of 25% of the brand’s patient population—without dedicated marketing support for the app. Moreover, of the patients who started using the app within the 1st month, we saw 79% retention on therapy and the app at 3 months and over 70% retention at 12 months, compared to an industry average of 45%. And, most importantly, the app is helping patients administer Hizentra: 75% of patients recorded at least one administration in three out of four weeks.

The app is also producing valuable data for CSL Behring. “This app enables you to add one more layer of insight into how the patient journey is occurring,” says Brian Johnson, Senior Director of Customer Engagement Management.” The company has captured over 250K self-administrations of the drug in a patient’s home.

These data are powering important insights to improve care. For example, CSL Behring found that patients who selected a schedule to complete an infusion on a specific day of the week had significantly higher adherence (80%) than patients who scheduled their infusions based on an interval between days (64%). “Perhaps there’s an insight here that says, maybe we should have them pick a specific day, rather than every seven days, and that might drive adherence,” says Brian Johnson, Senior Director, Customer Engagement Management, CSL Behring. “There are insights that we’re able to uncover that I wouldn’t ask in market research,” he says.

Compliant Solution to Minimize Risk

BrightInsight enables CSL Behring to develop and host digital health devices, apps, algorithms and SaMD at scale while maintaining compliance with privacy, security, quality and regulatory requirements across the globe.

The BrightInsight team proactively identifies and takes transparent action to potential risks. In one instance, BrightInsight implemented a critical operating system patch within 48 hours to mitigate CSL Behring’s risk and eliminate downtime for our patients."

– Brian Johnson, Senior Director, Customer Engagement Management, CSL Behring

Proven Platform to Accelerate Time to Market

Instead of building a custom platform from the ground up, CSL Behring leverages our proven BrightInsight Platform as its enterprise-wide digital health infrastructure. CSL Behring made the decision to focus on developing applications, like the Hizentra app, on top of the BrightInsight Platform which has led to cost and time efficiencies.

The successful launch of the Hizentra app is a fantastic proof point of BrightInsight’s proven track record of speeding time to market for transformational digital health products on behalf of our customers."

– Kal Patel, MD, CEO & Co-Founder, BrightInsight

We partnered with BrightInsight to develop standardized app modules that we can pull off the shelf and put a new brand coat of paint on it. And it saves us a ton of time and money in development. The app modules include features like an ePRO, calendar support, patient login, etc., all components that we need for every single app. Instead of starting from scratch for each app, we can leverage BrightInsight’s pre-built app modules. Then our development time is focused just on the new and unique features. This approach is more efficient for us from a cost and time perspective."

– Brian Johnson, Senior Director, Customer Engagement Management at CSL Behring

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, the company discovers, develops and delivers innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. CSL Behring uses three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Its parent company, CSL Limited (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 25,000 people, and delivers its life saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSLBehring.

About BrightInsight

BrightInsight provides the leading global platform for biopharma and medtech regulated digital health solutions. When speed matters, we help companies accelerate time to market for regulated digital health offerings across therapeutic areas, including apps, healthcare provider interfaces, analytics dashboards, algorithms, medical devices, connected combination products, diagnostics and Software as a Medical Device (SaMD).

BrightInsight replaces the need for lengthy and complex “build from scratch” implementations by offering configurable applications and a proven platform built under a Quality Management System to support global security, privacy and regulatory requirements. When building digital health products on the BrightInsight Platform, compliance is future-proofed as intended use changes scale across geographies.