TM

White Paper

Digital + REMS = A Delightful User Experience

Improving patient safety, access and engagement

SPECIALTY PHARMACY

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 This white paper describes how one global life sciences company
successfully implemented what may be the world’s first fully digital and
patient-centric drug safety program.

By tying multiple stakeholders into a single ecosystem, physicians can now more
seamlessly guide patients through the required REMS (Risk Evaluation and Mitigation
Strategy)1 process with an almost real-time dashboard. Keep reading to learn how to:

• Create a breakthrough patient-centric digital REMS program

• Navigate the necessary cross-functional collaboration to ensure success
• Effectively implement and execute a digital patient support program

The Why
Patient support programs attempt to provide wraparound services for patients and providers to
enhance the customer experience, improve outcomes and drive differentiation. While pharmaceutical
manufacturers must continue to focus on research and development, the services they provide
together with their commercialized therapies are often a key factor in their success.

The rationale for such programs varies by product. Sometimes, the driver is to support the patient and
provider through the benefit verification, coverage, management and billing requirements, as well as
out-of-pocket costs. In other instances, patient safety is key in order to appropriately onboard and
monitor patients for the possibility of severe side effects. Other times, the focus is on better disease
management, especially for chronic and complex conditions. And in other situations, the need is for
improved treatment efficacy to assist providers in slowing disease progression by earlier interventions.

Regardless, in each of these instances, the patient and provider benefit whether it be through training
on effective self-medication, improved speed to treatment, increased adherence, enhanced patient-
specific education and/or improved efficiency through better workflow.

Safety First
For certain drugs that might otherwise not be approvable based upon their benefit-risk profile, the
REMS pathway offers a practical solution by instituting additional safeguards to mitigate risk. And while
the FDA considers other factors - such as the potential increased burden the REMS could place on
patients and/or healthcare providers, given things like patient access limitations, the characteristics,
experience, and size of the prescriber pool, and how the drug will be distributed and dispensed –the
REMS process can be cumbersome for all stakeholders.

1 https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

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Navigating REMS
This was the case for one mid-size, global life sciences company. Their highly effective specialty drug
was approved with a REMS requirement mandating ongoing lab testing for all patients continuing
on therapy. The patient, provider and dispensing pharmacy are required to join a safety program to
monitor the patient’s blood values, as the product can cause serious and potentially life-threatening
side effects in a small percentage of patients.

To become REMS-certified for the product, the provider must:

1. Complete the one-time certification process

2. Counsel and evaluate baseline liver testing prior to enrolling the patient into the REMS, and
complete the prescription
3. Perform ongoing patient monitoring
4. Complete a Patient Status Form for each patient on a prescribed basis

To dispense the product, the pharmacy must:

1. Designate an authorized representative, become certified, and recertify if there is a change in

the authorized representative
2. Train staff and comply with REMS requirements
3. Obtain authorization to dispense each prescription by contacting the REMS online or by phone
to verify prescriber is certified, and the patient is enrolled and authorized to receive the drug,
and dispense a limited supply

Patients receiving the product must:

1. Understand the risks associated with taking the product

2. Enroll in the REMS by completing the Patient Enrollment Form with their healthcare provider
3. Complete baseline testing before their first dose and on a regular basis thereafter

While the process appears to be straight forward, the administrative work, lab testing and coordination
between all stakeholders is complex and requires synchronization between all parties.

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The Birth of the Digital REMS Patient Support Program
The original program configuration, which involved a third-party data aggregator and REMS portal
provider, was largely based on communication via phone and fax. Quickly, that process became overly
burdensome and began to wear on both the patients and the prescribing nephrologists. Although
they felt the drug was highly effective, providers were struggling to efficiently satisfy the REMS
requirements. It became painfully apparent that a different, more connected and transparent approach
was needed to keep all stakeholders apprised with timely and accurate information.

The company discussed moving to a digitized process

but needed to conceptualize how it could work. Given
the importance of creating a new solution that would From Day 1, the
correct the process issues to help patients to access this management team
needed therapy, almost 100 participants assembled at the completely supported
first organizing meeting for the project. From Day 1, the digitizing the process and
management team completely supported digitizing the continued to be engaged.
process and continued to be engaged. Shortly thereafter,
a cross-functional team was created, including participants
from the Company’s in-house digital organization,
commercial business, regulatory and medical affairs. The current vendors were challenged to think
openly and holistically about the process flow, which involved integrating data from multiple sources
into a single actionable view. The engagement was harder than anticipated, as some stakeholders/
vendors had to obtain approvals from their own management teams, as sharing data and information
with third parties is not necessarily embraced equally in all organizations, and proprietary attitudes
often persist.

However, together, the entire flow was mapped from the time the prescription is written through
the duration of a patient’s therapy, identifying all the break points in the entire end-to-end process.
This required true intellectual honesty from all
participants including the various stakeholders,
vendors and partners, as understanding the where
This required true intellectual and how of each potential bottleneck was key to
honesty from all participants creating a successful solution.
including the various
stakeholders, vendors and Once the map was created, it showed exactly
partners, as understanding the what was needed: an integration engine that could
where and how of each potential help unite all stakeholders into one seamlessly
aligned ecosystem. The fundamental objective
bottleneck was key to creating a was to provide as close to a real-time solution, so
successful solution. prescribers could effectively oversee the entire flow
from a single dashboard.

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Finding a vendor that would not have to build the entire system from scratch, which would have taken
too long and been too costly, was essential. After a great deal of searching, Medocity was identified as
having a very comprehensive and flexible platform that could be readily custom fit for the program’s
specific needs and requirements. Utilizing the Medocity platform, the company was able to address
the product’s administrative challenges by improving the patient and provider experience and
workflow providing a holistic, interoperable and timely view of the REMS status, prescriptions, and on-
going lab requirements.

The solution was tested using a sandbox

version that was shared with a small panel
of patients and prescribers. Their feedback
Utilizing the Medocity platform, the
provided the necessary insights and company was able to address the
encouragement to move full speed ahead with product’s administrative challenges
implementation. In addition, disciplined project by improving the patient and provider
management and consistent support from experience and workflow providing a
company management helped to ensure the holistic, interoperable and timely view
project stayed on course and budget.
of the REMS status, prescriptions, and
The result is a connected care platform on-going lab requirements.
designed to support patients who have been
prescribed this product by establishing one
location for healthcare provider offices to
monitor and manage their progress. Through the platform, the patient, REMS-certified providers and
pharmacies, the REMS administrator, labs, and the data aggregator can share and see the user-specific
data necessary to support the patient in continuously accessing the medication.

Seamless, efficient workflow improvements

Patients Providers

Data integration with multiple entities

REMS Administrator Specialty Pharmacies Data Aggregator Labs

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The First Digital & Interoperable REMS Solution is Born
The implementation of Medocity’s cloud-based enterprise platform combined with multiple integrated
digital care capabilities transformed the management of this REMS program, enabling the delivery of
a patient-centered, end-to-end ecosystem improving patient experience and outcomes, while also
reducing provider burden.

The solution provides the following features:

• Single Sign-On Shared login information with the product’s REMS Portal
• Access to REMS Enrollment & Patient Status Forms Displays the current REMS status and
Patient Status Form due dates
• Prescription & Shipment Status Provides the prescription status and specialty pharmacy
shipment status
• Lab Results Offers At-a-glance charted lab values to enable monitoring of lab tests over time
• Tasks & Alerts Outlines tasks (eg Complete REMS Patient Status Form) or alerts (eg, New lab
results available)
• A Resource Library & Messaging Allows for publishing of resources for patient, as well as
secure messaging with patients

A central dashboard displays a roster of patients under a healthcare provider’s care who have been
prescribed the product and is designed to facilitate a timely review of key clinical and patient access
information.

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 Two distinct mobile apps are available on the App Store and Google
Play: one for patients and one for providers. Each was designed
with the user’s needs in mind. The patients’ app has (1) a calendar
to track upcoming appointments (2) the ability to message with
their care team (3) a virtual pillbox to track medications and report
missed doses and (4) resources and relevant patient education
materials. The providers’ mobile app complements the web-based
platform and facilitates responding to patient messages.

Success in the Midst of the Pandemic

The program’s launch was originally intended to be rolled out at a national sales meeting late in the
spring of 2020, which ended up being extremely challenging given the prevailing pandemic. Instead,
the company nimbly switched gears and targeted a small group of 30 practices and academic
institutions for a soft launch during the second half of the year. Once the administrative burden of
the REMS process was digitized, consolidated and more transparent, providers could more easily
prescribe and start their patients on this valuable drug. As such, adoption was remarkably fast, and by
the end of the year, all 30 sites were routinely utilizing the platform.

The feedback from providers has been exceedingly

positive, as they value the patient-specific, at-a-glance
information and alerts that allow them to take immediate
action if something is problematic. While the platform
“I am able to quickly see
still requires some administrative work, it is vastly what the tasks are and what
more efficient than the previous process of phone, fax, needs to be done next.”
voice mails, missing data and delayed treatments. By
— Healthcare provider regarding
collaborating with physicians on the design, the solution the Connect Rx Platform
really addressed and integrated within their workflows.
Consequently, with minimal training, the providers have
been able to derive immediate, tangible value, both in
terms of patient satisfaction and more productive staff time.

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What's Next
In less than a year from the initial discussion, the first ever digital REMS program was envisioned,
created, launched and is now in use nationally. Phase 2 from the original roadmap includes the
addition of a digital patient support program enhancement to the platform to enable patients to
manage their underlying conditions in conjunction with their physicians, which is currently underway.
Because Medocity’s platform offers a full range of patient-facing digital support, the new integrated
functionality can effectively be turned on with the flip of a switch.

In Conclusion
Digital solutions provide life science companies with innovative opportunities to create and deliver
timely and interoperable patient support via a connected ecosystem. Through journey mapping, a clear
understanding of each stakeholder’s processes and obstacles can be uncovered to identify points
to improve communication, data sharing, duplicative efforts and ultimately, the patient journey. Early
buy-in, transparency, continuous collaboration, and clear communication with internal stakeholders (eg,
upper management, medical, legal, marketing, etc.) and all external vendors involved are essential for
success. When patients and providers are connected, more timely, efficient, and collaborative care can
occur, and in the end, improve outcomes.

Contact Medocity to learn more about how utilizing holistic, patient-centric

digital care solutions can enhance your patients’ journey.

Loreen Brown

􀒥 +1 (203) 530-6797

􀍗 lbrown@medocity.com

􀥆 medocity.com