Any pharmacist who works in the world of specialty pharmacy knows that the specialty process is simultaneously complex and expensive. Manufacturers are producing drugs for rare and serious conditions, often requiring limited distribution networks.  

Pharmacy benefits managers (PBMs) are working with employers to cover these medications through prior authorization models. Prescribers are treating these serious conditions, prescribing drugs with complex distribution channels and prior authorizations. 

Specialty pharmacy providers (SPPs) are working to gain access to limited distribution medications and service patients to the best of their ability, but it is patients who can end up as victims to all of these complexities. 

To address this challenge, hub services act to simplify the complexity and perform as an intermediary between involved parties.

Defining the Hub

Like the service they provide, hubs can be complex and difficult to define. Historically hubs largely provided reimbursement services, helping patients and providers navigate the process to obtain reimbursement for expensive specialty medications.

Today, hubs provide a more complete suite of services.

Boiled down to the basics, a hub is a service that allows a manufacturer to have a singular point of contact with patients who utilize their therapies. A hub is meant to provide better and more comprehensive patient services. 

These services range from benefits investigation, prior authorization processing, drug delivery and administration support, financial and co-pay assistance, patient education, compliance with risk evaluation and mitigation strategies (REMS), data reporting, and bridge supplies or prescription triaging.

Hub services are offered through a variety of vendors with affiliations to pharmacy benefit managers, SPPs, manufacturers, and distributors, as well as through unaffiliated freestanding vendors. Regardless of relationship, all hub providers operate under HIPAA with substantial security and privacy requirements. 

Furthermore, internal manufacturer hubs are subject to strict firewall parameters in order to completely separate patient information from sales and marketing divisions.

Examining the Services

The aforementioned hub services allow the manufacturer to positively affect the patient journey by ensuring efficient distribution of medication and improving patient compliance. Knowledge of these services helps one better understand the importance of hubs and the important role they play in specialty pharmacy.

Patient Support Programs

One of the principal purposes of the hub is to ensure patient compliance and prevent therapy abandonment. This is accomplished by setting up programs that connect patients and practitioners to the product.

These programs help to establish a patient on therapy, maintain patient engagement with therapy, and, in turn, drive patient compliance to therapy. This is accomplished through various means, such as online web portals, social media integration, telephone outreach, etc. 

Some hubs also employ nurses or professional personnel to travel to homes and teach patients and caregivers how to properly mix, administer, and store their medications.

Benefit and Reimbursement Services

As previously alluded, hubs were created in the 1990s mainly to assist with benefit and reimbursement services for patients and providers. Among other services, this offering continues today and is a cornerstone service of many hubs.

When prescribing a specialty medication that has available hub services, a prescriber can send referrals directly to the hub. This breaks down barriers to the patient receiving medication therapy. 

The hub can complete benefits investigation, review formulary requirements, explore co-pay assistance offerings, and identify prior authorizations or step therapy requirements. The hub vendor specifically services this patient set and works diligently to resolve problems, thereby boosting compliance and preventing abandonment.

Because specialty medications are complex, third-party payers often require extensive paper work and clinical information for review before approving a drug. Hub services work closely with companies who are able to automate this process and can expedite the prior authorization process from weeks to days.

Furthermore, many hubs may administrate quick start programs that are designed to provide patients with therapy while the benefits investigation is being resolved. Additionally, some hubs are capable of filling full prescriptions. 

This can occur when benefits investigation is ongoing or when a servicing pharmacy is no longer in network. The hub will then take over filling the prescription while the benefits are verified and then triage the script to the correct pharmacy.

Finally, hub services exist to provide patients, providers, and pharmacies with visibility to co-pay assistance programs. When a hub is operated by a pharmaceutical company, the hub can work with the pharmacy to provide patients with manufacturer co-pay assistance.

Regulatory and REMS Requirements

Another hurdle that SPPs and manufacturers must clear is cumbersome REMS reporting requirements. Many new medications are earning approval with the caveat that REMS must be implemented and followed for safe patient use. 

These REMS requirements may contain any of the following elements:
  • A medication guide to be distributed.
  • A communication plan to disseminate accurate information to appropriate stakeholders.
  • Elements to ensure safe use (ETASU), such as physician, patient, and pharmacy certifications.
  • ETASU implementation plan.
  • Timetable for submission of assessments for evaluation by the FDA.
A hub service can be a custodian over this information and a data repository for reporting requirements. For example, a specialty pharmacy is required to comply with REMS requirements when dispensing medications. Therefore, depending on the REMS elements present, the SPP may need to engage with the hub to record certifications, inform on the need for parties to register with the hub, or generate authorizations to dispense. 

Then, the SPP will need to keep records of complying with these requirements, and report back to manufacturers or accreditors. Staying compliant with REMS is a matter of law and it helps to ensure that pharmacies can continue to have access to the medications.

On the other hand, a hub can act as a data repository for manufacturer reporting to the FDA. The FDA will periodically evaluate the REMS program and determine if modifications need to be made. 
A hub that operates to maintain REMS reporting requirements can provide valuable information for these reevaluations.

Distribution Services

In addition to patient services, benefits investigation, and REMS reporting, a hub must understand and consider the manufacturer’s drug distribution strategy. Specialty medications are often expensive products with limited distribution models that service smaller patient populations and have cold chain storage requirements. 

With these complexities, the hub can function as a liaison between the distribution channel partners and the patient. A manufacturer that develops a medication with characteristics such as limited distribution, REMS requirements, or orphan drug patient populations can greatly benefit from the services of a hub. 

The hub provides access to the maximum number of covered lives, while maintaining tight control over medication distribution. The ability to offer patient services, provide visibility for funding and co-pay assistance, funnel patients through a shared service, and maintain some control over drug distribution, helps to promote medication compliance and ensure ideal storage and handling of medications.

It is becoming more common for medications to have strict storage and shipment requirements, especially for costly specialty medications. Thus, dispensing hubs have working knowledge of the supply chain requirements for medications and the hub can also triage prescriptions to SPP partners that are participating in limited distribution networks. 

In relation to this idea, manufacturers are using hubs to shorten the supply chain, using logistics organizations to manage inventory and supply to appropriate pharmacies. This management can be in the form of a partner pharmacy that works explicitly with the manufacturer or a network of pharmacies that are contracted to dispense the manufacturer’s medication.

Therefore, because of the advantage that the pharmaceutical manufacturer receives for the distribution of medication, they will periodically elect to operate a hub in-house. Nevertheless, this does pose challenges and it is imperative to keep patient information away from the operations of the business.

Final Thoughts

Hopefully, this has helped to illuminate some of the mystery behind hubs and show how they work to ease the specialty process for some patients. Hub services are most often created for medications that have a complicated path into the patient’s hands. 

While performing many duties, the hub functions to simplify the path from manufacturer to patient. As understanding of them improves, it is easy to see how they can benefit all stakeholders, including manufacturers, wholesalers, distributors, doctors, pharmacies, and patients. 

However, the pharmacist is concerned the most with one stakeholder in particular—the patient. Through their numerous services, the hub acts to assist the patient in their health care journey. 

The hub may be there for patient education and support, co-pay assistance, pharmacy triage, or a series of other reasons. Therefore, as a partner to the patient, the hub is tasked to improve patient care and outcomes, which is something every pharmacist can get behind.

About the Author
Alex Toman attended Duquesne University, earning his Doctor of Pharmacy degree in 2011. Alex worked as a retail pharmacist until 2015, at which time he transitioned into a clinical pharmacist role within the specialty pharmacy industry. In 2017, he received his Masters of Science in Pharmacy Business Administration degree at 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.