The following was publishes by the Pharmacy Times (2020-06-16 12:36:00)
Author: Gannon Vanscoy, RareMed’s Director of Specialty Markets
Specialty pharmacy hubs have become increasingly popular in recent years, offering a wide variety of services to pharmaceutical manufacturers. Although many hubs offer similar services, no 2 specialty pharmacy hubs and no 2 hub programs are entirely alike.
Each program has unique needs based on a manufacturer’s desired network, relevant disease state, services required, and many other factors. Hub services may include case management, benefits investigation/verification (BI/BV), prior authorization assistance, co-pay, financial assistance program management, distribution support, nursing support, health care professional education, patient adherence and education, and noncommercial pharmacy dispensing.
In many cases, these services are offered as a “menu” for pharmaceutical manufacturers that may only need a subset of services from the list. Primary aspects of a program that define which services will be used include hub type (hub lite vs full service), hub necessity (mandatory vs non-mandatory), hub size (large/transactional vs small/dedicated), network composition, and therapeutic area/methods of administration.
“Hub Lite” vs Full-Service Solutions
A recent trend in hub services is the evolution of a “hub-lite” model vs the traditional/full-service hub. In a typical hub-lite model, the hub will perform data intake of all referral forms. In some cases, this will include a light patient benefit investigation.
For products categorized under the pharmacy benefit, this is achievable through a simple electronic BV/E1 eligibility check. Once a light benefit investigation is completed, the referral and all associated details are electronically submitted to a downstream network pharmacy based on the manufacturer’s business rules.
In most hub-lite models, the hub also manages a call center for health care provider and patient questions. Patient assistance program (PAP) qualification is also typically managed at the hub to ensure it is routed to the non-commercial pharmacy quickly and efficiently.
If the hub offers non-commercial pharmacy dispensing, the hub may also dispense PAP product and provide clinical support. In this hub-lite model, enhanced BI/BV, prior authorizations, nursing support, clinical support, and various other enhanced services are frequently managed at the specialty pharmacy or site of care.
Traditional or full-service models include many of the aforementioned enhanced services at the hub. When employing a limited network of pharmacies, this allows the manufacturer to provide a consistent experience for all patients, rather than allowing for varied experiences across their network of pharmacies.
In some networks, a specialty pharmacy within the network may not have a capability the manufacturer would like to implement, so the hub is able to take this responsibility for the entire network. In many cases, the hub manages reimbursement support and will provide a welcome call.
Nursing support services are also commonly managed at the hub. This requires close coordination with specialty pharmacies to ensure continuity of care; however, if executed properly, can provide a consistent patient experience. Nursing services can include psychosocial support, behavioral coaching, and adherence support programs.
Mandatory vs Non-Mandatory Networks
Another major program decision a manufacturer must make when designing their program is whether they would like a mandatory or non-mandatory hub. If the manufacturer allows prescriptions to be sent directly to a pharmacy (without going through a hub), this is considered a non-mandatory network. Some health care providers find this convenient if they have a preferred specialty pharmacy.
Non-mandatory models are also common in the oncology market, as some hospitals prefer a buy-and-bill model which can be considered a revenue source. These hospitals still in many cases rely on the HUB to assist them through the complex reimbursement landscape associated with specialty products.
Other hospitals choose to let the specialty pharmacy or hub process the enhanced reimbursement given their experience and expertise. Non-mandatory hubs require certain processes and data feeds to be put in place. If a hub does not have experience and a well-defined strategy, this will likely result in duplicate and lost records, miscommunication, and delayed overall time to fill.
Based on experience and approach, some hubs are able to monitor these data/activities, eliminate duplicate records in a timely manner, and ensure no referrals are lost. It is critical for a manufacturer and hub to think through every possible scenario throughout the patient journey so that these instances do not occur.
Mandatory hubs are also frequently used. If executed properly, this model can ensure appropriately distributed referrals among a specialty pharmacy network.
This can also ensure that a referral gets to a pharmacy that can fill the prescription fastest, rather than being sent to out of network pharmacies. Having each referral flow through the hub in a full-service reimbursement model allows the hub to capture extensive data on payer policies.
Specialty pharmacies may be able to capture this information, but they do not capture this in a uniform or centralized manner across the network. With mandatory hubs, these data can be captured at an aggregate level, allowing future reimbursement support to flow more efficiently and improving manufacturer visibility of aggregated payer data.
Patient Population and Volume
Another major factor to consider when designing a HUB program is the size. Larger non-rare programs frequently require hundreds to thousands of individuals employed at the hub. These services are commonly managed through shared (non-dedicated) employees in order to more efficiently manage the volume of work.
In non-dedicated support models, manufacturers will be charged by the hub on a transactional basis. This means that the manufacturer pays the hub for transactional occurrences such as BI/BV completion, prior authorizations acceptances, the number of patient calls completed, and the number of referrals triaged to specialty pharmacies. These types of hubs may also maintain relationships with temporary employment agencies to manage major fluctuations in staffing volumes.
Examples of larger providers that service these high-volume programs include Lash, Sonexus, and RxCrossroads manage. Programs with smaller patient populations commonly require a hub to build a highly customized program with dedicated support to meet the complex needs of rare disease populations.
Providers such as RareMed Solutions build teams dedicated to each specific product with specialized training for each disease state. All dedicated employees are able to become familiar with the full patient journey, the disease state, medication use needs, health care provider offices, and the patients themselves.
This allows for more consistent, high-touch care and increased likelihood of better patient outcomes. These types of hubs may not have the capability to fluctuate by hundreds of employees on-demand, as they spend significantly more time on the hiring process.
Rather than using a transactional model, this type of hub typically charges the manufacturer a monthly full-time employee (FTE) fee for each dedicated associate employed at hub. These smaller programs in many cases do not work well with larger providers, as they have low volumes relative to the hub’s larger clients.
Therefore, these smaller manufacturers cannot expect the same level of service that would be provided when using a dedicated model at a hub focused on small patient populations. Many larger programs also focus primarily on efficiency and do not offer as much customization that might be required for a smaller complex program.
Network composition can also greatly impact the hub’s role. In networks with a large number of specialty pharmacies, full-service hubs are frequently implemented so that patients have a consistent experience. With a highly limited network of highly capable specialty pharmacies, however, hub-lite models may be preferred because these pharmacies may have similar capabilities and the ability to provide a consistent experience.
In some cases, primarily in the oncology market, specialty pharmacies may not even be used. This situation generally occurs when there is a highly limited number of centers of excellence (COE) offering a complex treatment.
These commonly require significant patient support from a hub. These models generally require patients to travel to the COE for their procedure and hubs, in many cases, provide a single point of contact for logistical, reimbursement, and psychosocial support.
Hospitals may rely heavily on the hub to guide them through the reimbursement process. These hubs are also used in this case for specialty distributor and third-party logistics coordination.
Therapeutic area and methods of administration also play a major role when designing a hub model. The recent emergence of cell and gene therapy (CGT) provides new opportunities and challenges for manufacturers and hub providers.
With these high-touch patient populations, in many cases, fully dedicated support is paramount. However, patient volume can be extremely limited, which can create a challenge for hubs and manufacturers because a number of dedicated FTEs are generally needed in order to provide 8 am-8 pm support.
In many cases for CGT treatments, this support is required on weekends/holidays due to the time-sensitive nature and unpredictable timing of certain gene therapy cultivations. Unique to CGT, these programs usually do not offer a non-commercial pharmacy given the 1-time treatment, limited patient population, and high expense associated with the treatment. Without a patient assistance or bridge program, foundation assistance and effective commercial reimbursement support are absolutely critical.
Due to the high price and complex coordination, some gene therapy manufacturers are opting to utilize a hybrid hub model in which the manufacturer hires individuals in addition to contracting with the hub. Reimbursement and other backend support may be performed at the hub while all patient interaction may be managed through the manufacturer. Some manufacturers even opt to insource their hub services entirely.
Although this approach may give the manufacturer more control over their program, many of these manufacturers are launching their first product and do not have experience building and managing these types of teams, which can lead to difficulties if not planned appropriately. Insourcing hub services can lead to HIPAA violations if the information is not appropriately de-identified.
Selecting the Best Partner
Although there is a large number of hub providers in the market, choosing the right hub and service model may not be as simple as selecting a well-known or respected partner. Each manufacturer must consider which type of hub model they want to implement, hub necessity, the size of the program, network composition, and the therapeutic area.
Some hubs have more experience or may be better suited for a specific patient population based on these factors. Most manufacturers work with an experienced consultant to make this decision.
Specialized consultants that frequently guide manufacturers through this process include the Blue Fin Group, Protean, and TwoLabs. Hub selection is a critical process with many variables to consider. For emerging biopharma manufacturers, the success of their product and company’s future can be reliant on a successful launch with an effective hub model and distribution network.
About the Author
Gannon Vanscoy is the Director of Specialty Markets at RareMed Solutions, the nation’s first rare disease focused specialty pharmacy HUB. Gannon leads RareMed’s overall business development efforts and manages strategic partnerships across the company’s portfolio. Gannon began cultivating his expertise in rare and orphan disease states at PANTHERx Rare Pharmacy, where he participated in a rotational development program focused on hub services. Prior to working at PANTHERx Rare, Gannon served as a leader at a number of large multi-national banks, both in internal and client-facing roles.
Gannon earned his Bachelor of Business Administration degree from the University of Miami and is currently pursuing a Master of Pharmacy Business Administration (MPBA) from the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines.