As the specialty pharmaceuticals market continues to expand, the demand for specialized patient support services grows in tandem. Just in the past few years, 86 percent of medical practice leaders reported an increase in prior authorization requirements denoting a larger trend of growing challenges in accessing necessary therapies. While patient hubs and specialty pharmacies are sometimes viewed as competitors, they can, and often do, work together to support patients on behalf of biopharmaceutical manufacturers. With all parties working toward a common goal - to help patients access and maintain their medical therapy while improving their experience - it’s beneficial for the patient hub team and specialty pharmacy (SP) to establish a collaborative partnership to deliver comprehensive support to patients. This article outlines how the roles of patient hubs and specialty pharmacies may differ and a few considerations for how biopharmaceutical manufacturers can coordinate programs with support from both a hub and a specialty pharmacy to ensure patients’ needs are being met.

Although patient hubs and SPs have some overlap in services offered, their function and purpose are distinctly different, which is why it is important for pharma manufacturers to clearly establish roles and protocols at the onset of these relationships. While the specialty drugs market has seen rapid growth, so have SPs as they’re expected to play a key part in providing comprehensive care for chronic patients.

While SPs are primarily focused on the dispensing, and sometimes even prior-authorization, of specialty drugs, hubs work as a central point for all stakeholders involved in the specialty pharmaceuticals process, including manufacturers, patients, payers and providers. SPs can be an excellent source of information for patients regarding their medication and tools to ensure ongoing adherence; but when it comes to comprehensive patient education and engagement services, today’s chronic patient requires significantly more support than what an SP can typically provide on their own. Biopharma companies are turning towards patient hubs more than ever before for resources and tools to help patients address issues with cost, access and medication use.

When engaging both a patient hub and an SP to support a single product, it’s important to establish a collaborative structure at the onset of the relationship to ensure that both groups can communicate effectively and efficiently. With both teams working toward a common goal, an open line of communication will ensure that issues or challenges are addressed quickly to ensure that patients are getting the support they need.

From a regulatory standpoint, it can be beneficial for biopharmaceutical companies to have their patient assistance programs (also known as free drug programs) (PAP) managed by a non-commercial SP that is separate from their commercial SP. The Office of Inspector General (OIG) confirms^[1] that using a non-commercial SP to support a PAP adds a deeper layer of protection against inducement. A non-commercial SP offers a more effective, risk-mitigating approach to structuring and distributing a PAP to those in need than a traditional free drug program. Commercial SPs can still help to manage the PAP by helping to identify and enroll patients and gather important data for eligibility requirements. Cardinal Health Sonexus™ Access & Patient Support was one of the first hubs in the specialty healthcare industry to establish a non-commercial SP with the goal of ensuring that pharma manufacturers could deliver compliant PAPs.

Another best practice is to have a dedicated team of legal and compliance experts in your hub and SP to ensure all aspects of the program are meeting compliance standards. At Sonexus™, we routinely kick-off new programs by bringing together the hub team and the SP team to align on the rules associated with the aspects of the program. By making sure that both parties know what data they should be collecting and sharing, biopharma companies can optimize their patient programs and ensure adherence to HIPAA guidelines and pharmacovigilance requirements.

Pharmaceutical manufacturers that engage with a patient hub early on are able to collect valuable data on patients via the hub before they begin their treatment. While both patient hubs and SPs collect important patient information, patient hubs can play an integral role in data analysis, providing valuable insights back to manufacturers to inform and enhance ongoing patient engagement strategies. By bringing together SP and program data at the patient hub, biopharma sponsors can get a more complete picture of the patient journey. A patient hub may also be able to marry together patient segmentation and other data sources to paint a more insightful and actionable picture of the patient.

With a patient hub and SP working as partners, patients are able to experience end-to-end support throughout their treatment journey.  In order for achieve optimal support levels and reduce operational inefficiencies, bi-directional data contracts should be established at the beginning of the relationship. This ensures the patient hub and SP have the latest information and can deliver aligned support when communicating with the patient.

Successfully bridging the gap between a patient hub and the SP will benefit the patients and the manufacturer alike. Biopharmaceutical companies have an opportunity to expand their services to patients by bringing SPs and their patient hub team to the table for integrated solutions. With the combined educational, data and support resources, an SP and patient hub collaboration on behalf of biopharmaceutical companies can help to set patients on the path to the best outcomes. Aggregating data and sharing valuable insights into each patient’s journey enables both parties to better serve and support patients, and ultimately helps to inform manufacturers on their patient population.

Author:
Jon Kwiatkowski, Director of Pharmacy Service, Sonexus™ Access & Patient Support, Cardinal Health

References: ^[1] Op. OIG 15-11 (2015);