The fragmentation of the health care system has posed challenges for decades. In 2009, Alain C. Enthoven proposed integrated delivery systems could solve many of the problems posed by fragmentation in both the drug development and patient treatment processes.
Today, attempts at integrating those delivery systems remain ongoing. They have taken several forms, including Hub services and the rise of Patient Services teams.
Hubs and Patient Services teams do import work before the launch of a pharmaceutical product, given the clinical trial support that’s needed. A product launch can be complex, especially when a treatment is still in its late clinical trial phases or is awaiting FDA approval.
A Patient Services team can coordinate these complexities and ease the way toward a successful product launch.
The Role of Patient Services in Product Launches
Patient Services teams focus on the patient’s perspective and needs. They assist patients with accessing medication, securing financial support, connecting with in-home patient care, and finding patient community and support groups.
By making these connections, Patient Services teams add value both for patients and for specialty pharmacies. To help patients get what they need, a team member may collaborate across several departments, including brand teams, marketing staff, access and reimbursement personnel, and patient support/engagement teams.
Making these connections helps “to establish a patient on therapy, maintain patient engagement with therapy, and, in turn, drive patient compliance to therapy,” writes clinical pharmacist Alex Toman.
As chronic diseases and comorbidities rise, the patient population continues to age, and digital technologies continue to transform care, Patient Services teams play an increasingly important role in keeping patients engaged in the process of care and ensuring any issues during first fill get resolved.
Today, integrated models that use Patient Services teams and Hub technologies to leverage the specific skill sets of various professionals within the rare disease sphere offer opportunities to generate new best practices in patient care. An integrated collaborative approach offers one such best practices model, write Autumn Bagwell and fellow researchers in a 2017 article in the Journal of Managed Care and Specialty Pharmacy.
How Patient Services Integrate Into Late Stage Trials or Pending Approvals
“In the world of specialty where there are complex disease states, there are unique financial, operational, and clinical pieces to providing services to patients,” says Stacy Ward-Charlerie, director of scientific data strategy at Parexel. One unique challenge is building a successful product launch while a potential product is completing its late-stage clinical trials or awaiting FDA approval.
Where Is Your Team?
This challenge can be compounded by the location and perspective of a Patient Services team within a particular life science organization. While many life sciences companies see the value of Patient Services teams and have built such teams in-house, some companies locate their teams in different areas.
For example, in a 2020 report, nearly 30 percent of responding organizations said their Patient Services team was located with its brand/commercial team. Nearly the same percentage said their Patient Services team was its own dedicated group. In other companies, Patient Services fell under market access or medical affairs, spanned multiple departments, or simply did not exist, writes Nicholas Basta in Pharmaceutical Commerce.
Where a Patient Services team is located can easily change its perspective on its purpose and function — as well as its understanding of what is and is not possible. For example, a Patient Services team steeped in brand and commercial efforts is more likely to see itself as an extension of the brand, while teams that work independently of other groups may have a broader perspective but less deep knowledge of any given area.
These perspectives, in turn, may affect how a Patient Services team sees its contributions to a complex product launch.
Bringing the Patient Services Team Together
For some product launches, utilizing Patient Services’ ability to span several internal functions may serve as a powerful tool for improving product launches. Patient Services’ ability to gather data and insights from several departments — like marketing, sales, and Medical Affairs — may create a natural information center within the organization.
Using Patient Services as an information center during a complex launch has its benefits. Yet it can also pose challenges — including the risk of violating one or more laws or regulations.
As Patient Services and other integration methods have grown haphazardly to address issues with fragmented care, rules governing their behavior have lagged behind. “People expect black-and-white rules for these patient support activities, but they find that there are instead many gray areas,” writes Manny Tzavlakis, managing partner at Helio Health Group.
Currently, areas of risk for Patient Services teams include adverse events reporting, False Claims Act violations, HIPAA and other privacy violations, off-label/FDCA violations, and violating anti-kickback statutes, says Tzaviakis. Working with a partner that is HIPAA-, HITECH-, and SOC2-compliant is therefore important.
Until bright-line rules exist governing the work of Patient Services teams, the best practice for any life sciences organization is to address potential issues through clear internal policies. Such policies also clarify the role of the Patient Services team before, during and after product launch.
Coordinating Patient Services and Hub Efforts
Patient hubs and Patient Services teams share some functions, but their focus differs. When they coordinate their efforts, a Patient Services team, a patient hub and the right partner, like ClaritasRx, can do much to support product launch and patient access to specialty medications.
Patient Services teams typically focus on one patient at a time. They work on each patient’s access to specialty drugs, handling pre-authorizations and other tasks as necessary.
Hubs, by contrast, serve as a central meeting point for all stakeholders in the specialty pharmaceutical journey. This central contact point allows for more efficient distribution of medications, writes Lauren Meyer in Pharmacy Times. It also serves as a valuable single source for data collection. Consequently, Hubs offer a more comprehensive look at the entire process and more complete information for patients on their medication and ways to stay current with treatment.
Hubs can also perform “a number of key functions, including reimbursement services, distribution services, adherence or clinical monitoring, and outcomes reporting,” writes Meyer. These tools can benefit Patient Services teams by providing access to more comprehensive data and thus to better-founded insights.
Measuring the impact of Patient Services teams can prove challenging. Using effective data collection methods can simplify the process, writes Reshma Bennur, who led the customer experience team at PeopleMetrics for six years. Hubs offer one way to make data collection and analysis easier. Integrating partner, specialty pharma and manufacturing data are critical, as well, to have one view.
Access to more comprehensive data, in turn, allows Patient Services team members to focus on each patient’s needs in the moment. “We work with our staff to properly train them in active listening. You need to listen to the patient, listen to their responses. For example, focusing on any hesitation, any language barriers, or any confusion,” says Rick Miller, VP of clinical and professional services at AllianceRx Walgreens Prime.
Patient Services team members provide essential human contact, which “is needed to facilitate best practices in specialty care, particularly in the growing number of health-system specialty pharmacies,” write Autumn D. Zuckerman and fellow researchers. For many Patient Services teams, this person-to-person work is enhanced when it is supported by the insights and connections created by effective Hub access.
Efforts to address the fragmentation of healthcare in the United States have led to a number of potential solutions, including both Patient Services teams and Hub tools. Using these tools together can better integrate care for patients with rare diseases — ensuring these patients receive the treatment they need when they need it.
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