The Hub Model: A Centralized
and Comprehensive Approach to
Maximize Patient Access.
WHITE PAPER
NOW YOU CAN SPEND LESS TIME
WORRYING ABOUT PATIENT DROP OFF.
SPRING 2011
Table of Contents
Specialty Pharma — The State of the Industry................................................................3
The Hub Model............................................................................................................................4
Centralized and Personalized Patient Support...............................................................5
Customized Data Capture, Management and Delivery.................................................6
Overcome REMS Challenges....................................................................................................6
Differentiate Your Drug Launch Program.......................................................................7
A Logical Approach to Specialty Distribution
and Coordinated Patient Care..............................................................................................7
The Hub Model: A Centralized
and Comprehensive Approach to
Maximize Patient Access.
WHITE PAPER
Specialty Pharma — The State of the Industry
Today, specialty pharmaceuticals are the fastest growing healthcare drug segment in the United States.
Comprised of more than 90 companies marketing more than 550 prescription pharmaceutical products,
the U.S. specialty pharmaceuticals market had an approximate value of $21 billion in 2009. And, generating
revenues of $10.6 billion in 2009, specialty pharmaceutical products are key contributors to the U.S.
pharmaceutical market.1
Specialty pharmacy growth is expected to continue climbing as more products are approved. Over the next
three years, the pipeline is replete with new specialty drugs in the areas of oncology, rheumatoid arthritis,
multiple sclerosis, and lupus, comprising upwards of 30-40% of the pipeline by some estimates. To help
illustrate the growth of the specialty market, today there are 339 companies plus partners developing 456
drugs targeting breast cancer2, 244 companies plus partners developing 265 drugs targeting pancreatic
cancer3, and 675 companies plus partners developing 1,185 biological drugs in 2,288 developmental projects
in cancer.4
Specialty drugs typically come with a high cost and are designed to address the most complex and life
threatening diseases such as cancer, rheumatoid arthritis, multiple sclerosis and hepatitis C, representing a
relatively small population of patients when compared to prescriptions dispensed through the traditional retail
channel. However, the higher costs of specialty drugs tend to present many different challenges to physicians,
patients, payers, pharmacies, and pharmaceutical manufacturers. These biologic products are complex and,
therefore, expensive to manufacture, have high acquisition costs, and present significant reimbursement
challenges. Moreover, they often necessitate a high level of patient support, have special data and handling
requirements, and can require strict inventory controls.
High drug costs have also heightened the need for manufacturers to understand the reimbursement landscape
and work effectively with payers to ensure needed therapies are accessible and out-of-pocket costs for patients
are managed. For these biotech manufacturers, developing effective patient and provider support strategies
has become as important as identifying the appropriate distribution channel.
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There is no question that specialty pharmaceuticals pose a myriad of challenges to all stakeholders involved.
For patients, it is cost and access. For pharmacies, there’s inventory, product knowledge and administration
tools. For physicians, the hurdles are inventory and slow reimbursement. For managed care, it can be unusual
administrative challenges related to claims submission and tracking. And for manufacturers, product access,
data gathering, patient/provider experience, cost-effective drug delivery, and messaging are all important
challenges that must be overcome to get the patient started on the product and maximize the treatment’s
performance in the marketplace.
All these challenges require an approach that looks beyond the specialty drug to a comprehensive and
integrated program of coordinated care that streamlines the drug-distribution, delivery, and management
processes in ways that engage patients in their care, help payers to understand their return on investment, and
assist manufacturers in creating a direct link with patients and providers.
The Hub Model
A hub model approach can address and overcome these complex challenges by serving as a single point of
contact for patients and providers to access specialty drugs, as well as providing comprehensive healthcare
management services that ensure continued access and adherence to prescribed therapies.
A centralized approach not only connects patients directly with specialty pharmaceuticals, but offers a
comprehensive set of services and programs that can be customized and delivered in both a bundled or
unbundled format to meet specific product, disease, patient population or manufacturer needs, including
elements such as:
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Distribution services
Inbound call handling
Intake and insurance verification
Reimbursement and co-pay services
Patient education and assistance programs
Adherence services and relationship marketing
Case management
REMS management
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Centralized registry
Data management
Virtual reporting and analytics packages
Clinical support from registered nurses
Patient loyalty and retention programs
Consistent product messaging and education
Medical information and pharmacovigilance
Web-based portal solutions
For manufacturers facing significant service provider fees from multiple organizations, the hub model’s
centralized approach helps streamline services and maximize budgets by preventing potentially redundant
resources. The hub model also provides an opportunity for the manufacturer to demonstrate its value to the
patients, physicians, and payers by controlling costs, building relationships, and creating an environment that
promotes patient compliance and overall health management.
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Enrollment
(fax/portal)
Co-pay Foundation
Referral
Reimbursement
Support
Support Program Hub
Co-pay
CopayBranded
Foundation
Referral
Assistance
• Case management
• Site coordination
• Customer service
• Educational materials
Adherence
Support
Patient
Assistance
Specialty Pharmacy
Network
Manufacturer
Enrollment Data
Centralized and Personalized Patient Support
One of the primary goals of the hub model is to partner with patients, physicians, pharmacies and
manufacturers in managing specialty drug access from decision-to-treat to product delivery, including
adherence support to help patients remain on therapy longer and provide consistent patient experiences that
drive better outcomes.
This patient support begins with an up-front assessment of the patient benefits and directs the prescription to the
appropriate access point (e.g. specialty pharmacy), helping the patient to optimize their benefit. This has a positive
impact initially on the patient’s ability to afford their prescription, and beyond that when it comes to building the
relationship between the pharmacy and the patient for that long-term care and access.
The hub is also well suited to police the prescription process, from confirming the first fill, to ensuring subsequent
refills are processed at the most appropriate pharmacy based on the patient benefit. Without the hub, a provider
may send the patient home with a prescription, allowing them to choose a pharmacy that may or may not
be the best dispenser from an affordability or benefits perspective. Alternatively, the physician could send the
prescription to a preferred provider or pharmacy without knowing what is the best benefit for the patient.
Once therapy has begun, the hub acts as the single point of patient and provider contact for ongoing support
with symptom management, therapy questions, education, encouragement and coordination for follow-up
appointments, as well as support for ongoing compliance and adherence to their prescribed regimen. Patient
calls into the hub are triaged by a live person and directed to the appropriate resource. They may be put in
contact with a specialist for help with a reimbursement issue or connected to a registered nurse trained in their
specific disease state. Whatever their need, patients always have access to an advocate focused on providing
them with the support they need.
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The hub also enables manufacturers to present a very supportive and professional front line to their customers.
Whatever the size of the manufacturer, the hub provides an ideal environment for improving the patient
experience with consistent messaging, information and advice for every patient engagement. Ideally, all patient
touch points are logged and entered into a single database, providing manufacturers with an even greater
range of valuable patient-specific data upon which business decisions and future strategies can be based.
Customized Data Capture, Management and Delivery
One of the greatest challenges facing specialty drug manufacturers is the capture, management, and sharing
of patient and product data. For most manufacturers, real time access to various data types is critical to
monitoring and understanding product performance. Because the hub model connects with, and allows
electronic data collection to and from the specialty pharmacy networks, all the data lives within one system
and serves as an actionable data warehouse for the manufacturers.
With patient data being captured upon initial referral, the hub model is able to gather data related to program
enrollment, coverage trends, activity related to patient experience, refill data from the pharmacy, and nurse
input on adherence. The hub model can also capture indirect data from other third parties, like specialty
distributors or pharmacies, who are performing fulfillment and reporting on patients who bypassed the hub
and came to them directly. This data is extremely useful when trying to capture and present the entire patient
population back to the manufacturer.
Depending on the data needs of the manufacturer, the hub model can produce full-scale analytics, provide
executive reports, and/or provide raw data to be analyzed and packaged by the drug manufacturer.
Overcome REMS Challenges
The advent of Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) has
significantly affected not only the way many new drugs are launched but also how safety risks are monitored
post launch. Specialty manufacturers now require distribution strategies that not only meet their market
penetration goals, but that also drive physician/patient education while improving therapy adherence and
meeting FDA requirements.
The hub model is designed to partner with the manufacturer and ease the burden on physicians by providing
the processes, milestones and data necessary to navigate and meet regulatory requirements like REMS
management, patient access, and specialty drug therapy reimbursement. The hub model also provides the
flexibility to serve exclusive, limited, managed, and non-exclusive distribution models that drive success
and continuity of service levels to patients and other stakeholders throughout the product life cycle. These
capabilities improve the chances of increasing product adoption and a greater overall product performance.
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Differentiate Your Drug Launch Program
Specialty pharmaceutical manufacturers rarely get a second chance to make a significant impact with a
new product. Increased competition in a more crowded marketplace has put tremendous pressure on
manufacturers to grow awareness, address the different needs among providers, patients, and payers, and
enhance coordination across multiple business functions and groups.
How specialty pharmaceutical manufacturers drive product uptake and share successful therapy outcomes
and data increasingly defines early and long-term product success.
For manufacturers with a new product and a distribution and patient support strategy that includes specialty
pharmacies, or a network of providers for whom patient services will be important, the hub model provides
a single point of access to a comprehensive set of services designed to support the unique needs of the
patient and physician. This can be a clear differentiator versus other manufacturers whose products may have
comparable service offerings, but are not similarly integrated.
The hub model also provides a streamlined way to talk about the services and the level of support
manufacturers are providing with the product, which is compelling when delivering messages to patients
and providers. The capability to deliver those services in a very integrated and comprehensive way that is
oriented towards patients and providers drives greater success in terms of initial referral and ongoing access
to the therapy. For a new product in an existing market, this helps you establish closer relationships with your
customers and gain a competitive foothold in the marketplace. The hub model simplifies and coordinates
functions in a way that lets prescribers focus on the clinical merits of the product and the associated efficacy,
without worrying about the increasingly complex logistics around product access and affordability.
A Logical Approach to Specialty Distribution and Coordinated Patient Care
Utilization of a hub model provides manufacturers with the most comprehensive and customized platform for
addressing the unique and complex needs of the specialty pharmaceutical industry. As more pharmaceutical
manufacturers continue to adopt this approach, they will find it unmatched in its ability to create an ideal
environment that demonstrates product value to stakeholders, maximizes patient access, improves patient
adherence, maintains compliance in a changing regulatory environment, and increases product revenues.
1
Guide to U.S. Specialty Pharmaceutical Market: Companies, Products and Market Data. MCD Group LLC, January 2011
2
Breast Cancer Drug Pipeline Update 2011, BioSeeker Group, February 2011
3
Pancreatic Cancer Drug Pipeline Update 2011, BioSeeker Group, February 2011
4
Biologicals in Oncology Drug Pipeline Update 2011, BioSeeker Group, February 2011
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Lash Group has expanded its range of offerings to include patient education, case
management and adherence services. With registered nurses certified in your disease states,
we provide personalized and scalable support services that help your brand experience
greater success. Partner with Lash Group to enhance speed-to-therapy, promote increased
adherence, and deliver actionable data. For more than 20 years, manufacturers have relied
on Lash Group as the leader in the innovative design, development and implementation of
unique patient and provider support programs. Our solutions help patients start therapy in
a more timely manner while maximizing their ongoing continuity of care. Partner with us to
take your brand to the next level with comprehensive services including:
>>Reimbursement Support
>>REMS Management
>>Patient Education
>>Medical Information &
Pharmacovigilance
>>Co-pay Assistance
>>Adherence Programs
>>Patient Assistance
>>Case Management
>>Strategic Consulting
>>Web-based Portal Solutions
>>Reporting and Analytics