In this issue, we return to a topic we’ve covered annually since 2013: hub services.
A definition: hub services are usually third-party providers, funded by manufacturers themselves, delivering the range of services necessary to get patients onto specialized (and usually expensive) therapies, and keep them adherent. For a business sector that is experiencing “explosive” growth, according to one of its participants, it is remarkably underpublicized. Part of this is because other parts of the healthcare ecosystem, notably specialty pharmacies and patient-support call centers and even, in some instances, health systems themselves, are angling to offer the same services. Some manufacturers run their own hubs internally.
Another part is the players themselves, who offer slightly differing sets of services (expediting “prior authorizations” in some cases, arranging in-home nursing services in others, etc.) and don’t want to be looked on as “just like” a competitor. We’ve been writing about this lack of coherence since the beginning; now, several years on, it doesn’t look as if the activity is going to form a strong self-identity any time soon.
Be that as it may, we remain strong proponents of the concept, and the logic of organizing patient services this way. Here’s our rationale: it is widely recognized that specialty pharmaceuticals represent the growth of the biopharma industry in the developed world; they will represent 50% of revenue for the US industry in 2020 (if not sooner). Specialty pharmaceuticals, because of the complexity of their administration and their expense, require more follow-up and more medical attention than conventional oral solids (some of which themselves are specialties).
Despite their value, abandonment or non-adherence of therapies is an ever-present problem; add to that the problems inherent in therapy areas such as rare diseases (where it can take years before a patient is correctly diagnosed); and therapies based on genomics and the still-nascent field of “precision” medicine.
To a high degree, the successful commercialization of a specialty pharmaceutical depends on the quality of patient services introduced along with it. It’s time to think of a prescription for a specialty pharmaceutical not as a piece of paper, but as a commitment to a bundle of services including the medicine. Moreover, if you eyeball the overall system from a certain direction, you realize that the biopharma industry is funding a part of healthcare delivery—the services that keep patients on therapy, which improves outcomes, and which helps health systems looking for favorable performance ratings. Sure, keeping patients on therapy means more sales and more revenues for the drugmakers themselves; but the manner in which reimbursement is set up these days, with higher copays and deductibles and those prior-auth hurdles, the healthcare system creates barriers to better care.
An equally intriguing development is “hub lite”: providing a scaled-down (and lower-cost) version of the full-bore hub service for drug products in lower price ranges, but which again serves to keep patients on therapy and to improve outcomes. Hub service providers are becoming adept at locating gaps in care or inefficiencies in healthcare delivery, and reinforcing those gaps with needed services. Another gap being filled is the enrollment and support of patients in clinical trials—once a hub provider is experienced in supporting a patient journey in the commercial realm, that expertise is proving valuable in the clinical research arena. Success in keeping enrolled patients engaged in the trial, and the ability to gather meaningful outcomes data are some of the benefits. A final validation of the activity is that it is being exported—some hub providers are making forays into international markets, addressing similar needs in other countries. We’re going to be tracking these developments and rooting for the success of these innovative organizations.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.
Operating Without a Commercial Blueprint: Empowering the Field for Niche Therapy Launches
October 24th 2024How emerging biotech companies can create fruitful partnerships between home office commercial teams and the field force to enable this intelligence gathering, while driving commercial success.