What began as patient call centers for select complex medicines has expanded to a full suite of support services, ranging from financial assistance to patient education: so-called hub services have become ubiquitous in the pharmaceutical marketplace. With the growth of the specialty drug market, in particular, hub services have become a necessity. As manufacturers look to develop increasingly complex drug products, including gene and cell therapies, so too will hubs require a higher degree of specialization and flexibility.
In the mid-90s, the pharmaceutical industry shifted from launching simple, small-molecule drug products to more complex, large-molecule therapies. These treatments required more complicated administration and also came at a significantly higher cost. New businesses began to emerge, offering support to manufacturers and their patients in the form of call centers, predominately focused on financial assistance.1 Each independent service provider played a specific role and offerings were customized as new needs became evident.
Over time, these support services expanded, in part owing to a series of blockbuster drug approvals that would benefit from assistance beyond finances, such as coordinating and scheduling product distribution, clinical support programs, and persistency and compliance monitoring.
External providers morphed to meet the market needs of the time; instead of simply operating a patient call center, these companies began to offer a set of comprehensive services to support their clients.1 These external vendors have come to be known as hub service providers, as their offerings are centered around a particular drug product and supporting patients to help them start and stay on treatment.
Even after the boom of blockbuster drugs dissipated, hubs have remained a key component of manufacturers’ specialty drug strategy. Once reserved for select therapies, hub services have essentially become ubiquitous in the specialty marketplace. As manufacturers look to develop increasingly complex drug products, including gene and cell therapies, so too will hubs require a higher degree of specialization and flexibility.
External vs Internal Hubs
Despite their ubiquity, hub models can vary considerably from manufacturer to manufacturer. As hubs became more commonplace, some manufacturers sought to internalize such services rather than fully outsourcing their hub. Today, some manufacturers internally manage some or all of their patient support programs; others have taken a blended approach, using external organizations for certain services and managing others in-house. The rationale for internal and external hubs is variable, but some common determinants of insourcing vs outsourcing services include the following.
Legality. In the digital age, privacy of patient health information is a key concern across the health care system, and hub services are no exception. Maintaining patient confidentiality, especially in an internal hub, and ensuring compliance with separating patient information from other functions (eg, marketing) can be particularly challenging when support services are in-house. External hub providers, which all operate in accordance with the Health Insurance Portability and Accountability Act,2 can be particularly useful to overcome such challenges, as they offer an automatic firewall between patients’ health information and the manufacturer
Visibility and Control. Some manufacturers may require greater control over their patient support programs. Internalizing services that involve direct contact with patients, in particular, can be attractive for such manufacturers, as it increases oversight and transparency of patient interactions with their organization.
Ownership. Internalization of support services, particularly high-touch offerings like patient case management, may reflect the manufacturer’s desire to own the patient experience and have a higher degree of control over the “face” of their company.
Although there are pros and cons to insourcing and outsourcing hub services, hub providers continue to be engaged with manufacturers and are frequently contracted for a host of services. In particular, manufacturers can benefit from hub providers’ customer relationship management systems, which provide the necessary infrastructure to collect data.
Hub Service Models
Manufacturers that opt to continue outsourcing hub services may engage external vendors that offer services ranging from basic and transactional to customizable and high-touch. The different types of services can be categorized into three levels based on their degree of involvement with patients and patient information (Figure 1). Level 1 services include offerings that are purely transactional and typically involve financial assistance and reimbursement support. Services that are more patient-facing, but do not involve disease management are classified as Level 2. Finally, Level 3 services encompass direct patient management and tracking (eg, case management).
Manufacturers that take on a blended approach frequently manage patient education, patient assistance programs, and copay assistance internally.3 Hub providers are most often engaged for Level 1 services but may provide some or all of Level 2 and Level 3 services, depending on the manufacturer’s hub strategy.
Specialty Pharmacy vs Hub Providers
The growth of specialty drugs in the market has also given rise to specialty pharmacy providers. Specialty pharmacy providers may offer services that are seemingly duplicative to those of traditional hubs, namely benefits verification and prior authorization support.2 While specialty pharmacies are equipped to carry out these tasks, having a hub provider as a central point of contact may offer some additional benefits for the patient and, in turn, the manufacturer.4
Hub providers have dedicated resources for their clients’ products, which allows them to carry out benefits investigation and verification in a timely and comprehensive fashion. As such, hub providers can provide patients with a more seamless and consistent prescription fill process, which may include prior authorization or fulfillment of other utilization management criteria. Hub providers are able to assist in acquiring the necessary documentation to complete these processes.4,5 Further, some hubs may also be able to coordinate getting a small supply of the drug to patients so that they can start therapy while awaiting payer authorization.5
The Future of Hub Services
Hub Service Specialization
As demonstrated by the history of hubs, changes in the pharmaceutical landscape have dictated changes in patient support needs, and hub service providers have evolved accordingly. Where hub services are headed may be reminiscent of the past: where providers played specific and distinct roles in supporting manufacturers’ products. This trend toward specialization has been reflected in an increasing degree of niche services and specific capabilities offered by some hub service vendors (eg, TrialCard specializing in copay cards, the focus of CareMedx on rare disease).
Going beyond the specificity of services, it seems that a new era of hub services could be on the horizon, as a new wave of orphan drugs, targeted immunotherapies, and gene and cell therapies come to market. These treatments are costlier and more complex than ever and have brought several challenges to the marketplace, most notably in terms of access.
The intricacies of the drug products themselves as well as the reimbursement and access landscape will require hub providers to once again transform, as traditional offerings are not designed to support drug products as complex as gene therapies and the like. Additionally, there is potential for hub providers’ capabilities to be leveraged to address unique changes in the marketplace, such as data collection and coordination for outcomes-based agreements and real-world evidence generation.
Connecting Value-Based Payment Methods to the Hub
While the concept of value-based agreements is not new, implementation of true outcomes-based agreements has been sparse. As gene and cell therapies come to market, however, there is more focus than ever on actualizing these types of contracts on a broader scale. Outcomes-based agreements will require more frequent follow-up with patients in addition to data collection and synthesis.6 Hub service providers can position themselves to assist manufacturers as such contracts are executed in several ways:
These types of arrangements require a higher degree of patient management and tracking outcomes throughout the treatment course. Developing robust data management systems that can aggregate clinical outcomes, patient-reported outcomes, compliance data, and even lab results can help to substantiate fulfillment of the terms of each agreement.6
The particulars of an outcomes-based contract for one product will vary based on who the manufacturer has contracted with. Hub providers will need to offer the flexibility to produce unique data sets that align with each contract.
Given the complexity and high cost of these therapies, patient education and engagement will be more important than ever for products that require multiple treatments.6 Hub providers may opt to focus on strategies to engage these patients and ensure that they are well-resourced to provide case management services.
Although these treatments typically have small patient populations, each case may require a higher degree of resources and specialization, especially in instances where outcomes are directly linked to reimbursement. Offering a comprehensive set of services to support outcomes-based contracts will require significant investment on the part of both the manufacturer and any hub providers that they engage to assist in such endeavors.
Evidence Generation Through the Hub
Certain gene therapies present additional challenges in that they are one-time treatments with potentially curative effects. It is well recognized that such products come with a high price tag and that the current system is not set up to accommodate such expensive, one-off therapies. All health care stakeholders have grappled with how to address these issues, ie, not only how these drugs will be paid for, but also who will pay for them. Further, there are questions about how payers—and patients—can be assured that they will get value for their money, given that clinical trials do not offer proof of a cure or even durability of effect exceeding 5 to 10 years.
With these concerns, post-launch evidence generation will be paramount to the success of these innovative therapies. Hubs may very well become centralized conduits for collecting these data; data collected by hub providers can be leveraged as real-world evidence to support efficacy and safety outcomes and may be funneled to internal health economics and outcomes research teams to feed into key evidence-generation activities. Much like data collected for outcomes-based contracts, information-gathering will likely need to be specialized in a way that meets each manufacturer’s specific needs.
Further, collecting patient data in a hub may be a means to mitigate payer concerns about patient turnover. Although who pays, and how treatments will be paid for as patients move from plan to plan, will need to be addressed through contracts, hubs can facilitate these transitions by housing claims data as well as patient information in a central database.
Conclusion
The growing complexity and cost of innovative therapies coincide with a stronger focus on patient-centered care. Patients who receive appropriate therapy and support and are compliant with their treatment regimen are more likely to succeed and achieve improvements in health outcomes. In turn, payers and health systems can realize greater economic value. Overall, successful and comprehensive patient support can benefit all stakeholders in the health care system.
Although manufacturers may continue to manage certain components of a hub, the need for services designed specifically for these products is likely to carry over into hub providers’ offerings. Ultimately, the role of hubs in the future will be dictated by manufacturer objectives, which, much like their pipelines, appear to be increasingly specialized.
References
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2016/. Updated April 16, 2016. Accessed June 6, 2019.
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3. Basta N. Patient support / hub services continue to evolve. Pharmaceutical Commerce. March 4, 2019. https://pharmaceuticalcommerce.com/brand-marketing-communications/patient-support-hub-services-continue-to-evolve/. Updated April 4, 2019. Accessed June 6, 2019.
4. DePinto J. External partners + integrated services = added value, efficiency for specialty drug manufacturers. Specialty Pharmacy Times. July 26, 2017. https://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2017/july-2017/external-partners-integrated-services-added-value-efficiency-for-specialty-drug-manufacturers. Accessed June 6, 2019.
5. Meyer L. Differentiating specialty pharmacies from hub services. Specialty Pharmacy Times. November 5, 2018. https://www.specialtypharmacytimes.com/news/differentiating-specialty-pharmacies-from-hub-services. Accessed June 6, 2019.
6. Herington T. The outcomes-based reimbursement environment. Pharmaceutical Commerce. March 16, 2019. https://pharmaceuticalcommerce.com/brand-marketing-communications/the-outcomes-based-reimbursement-environment/. Accessed June 6, 2019.
