Hub Background
Hub service organizations provide a variety of different services that enable prescribing specialists and patients to seamlessly obtain specialty medications and prevent treatment delays.

Originally, hubs provided manufacturers with a central point of contact for their therapies to ensure efficient medication distribution. With the evolution and growth of specialty pharmacies, so too did services provided by hubs and the places where they were situated. For instance, some hub services now can be found embedded in specialty pharmacies.

Today, the hub acts as a conduit among patients, payers, distributers, physicians, and specialty pharmacies.

Why Are Hubs Needed?
Specialty medications, as defined by the National Association of Specialty Pharmacy (NASP), are more complex than most prescription medications and are used to treat patients with serious and often life-threatening conditions. These medications may be taken orally, but often, they must be injected or infused and may have special administration, storage, and delivery requirements.1

The complexity of these medications may be due to the drug itself, the way it’s administered, the management of its adverse effect profile, the disease or condition it’s treating, special access conditions required by the manufacturer, payer authorization or benefit requirements, patient financial hardship, or any combination of these.1

Specialty prescription medications cannot be routinely dispensed at a typical retail community pharmacy because the therapy typically requires special handling as well as significant patient education regarding appropriate utilization. Additionally, typical retail pharmacies are not designed to provide the high-touch patient care or other services that specialty medications require.

Therefore, by their nature, specialty medications are made available following a series of checks and balances verifying appropriate guidelines and indications to prevent overutilization and off-label use. In addition to the work that goes into managing the illness and determining treatment options, patients and physicians are not always able to navigate and understand this multi-step process required to obtain these drugs. Meanwhile, hubs can provide coordination of these comprehensive services.

Hub Services Provided
Services provided by the hub include coordination of benefits, such as co-pay and coinsurance management, contracted or preferred pharmacy requirements, formulary coverage, step therapy policies, medical necessity requirements, and prior authorizations.

Hub agents work to resolve access challenges to ensure appropriate prescription fulfillment and other follow-up services, such as patient assistance programs. As patient-centric service needs have increased, there has been complementary growth in product support options and medication adherence programs.

Who Finances Hubs: Conflict of Interest?
The question remains whether the interest of the manufacturer or specialty pharmacy is being represented by hub agents. If the best interest of the prescriber/patient relationship is central to the process, then this model would seem to be a win for the patient/prescriber/payer and manufacturer.

However, since it’s in the best interest of the manufacturer to have their drugs covered—even in instances in which another drug may offer better value and/or outcomes—this calls to question whether they should be directly involved in obtaining authorization or coverage for their own drug.

For this reason, the specialty pharmacy is ethically better positioned to perform the hub service. A specialty pharmacy may be reimbursed by manufacturing companies to provide hub services. However, they are removed from the conflict in the process because the patient will receive the drug with the best value and following the guidelines of the payer.

Due to contractual language, payers (insurers) are not allowed to deal directly with third-party agencies (hubs) facilitating access to specialty medications. This is set up to avoid sharing confidential information with a third party who is not authorized to have protected information. 

Even if confidentiality agreements are provided by the third-party, it would not be in the best interest of the payer to open a dialogue with a hub service unless the service was unbiased and did not have an agenda to push a particular product.

According to hub services at PANTHERx Rare Pharmacy, they perform all aspects of data collection and completing forms on behalf of prescribers. Then, the completed documents are returned to prescribers to verify and submit to payers for approval. 

This process seems reasonable because the pharmacists collecting data from prescribers also are performing services for which they are knowledgeable about criteria and guidelines to authorize the drugs.

This is in sharp contrast to third-party hubs that I have dealt with as a reviewer for a payer, that automate the prior authorization process with pre-completed forms containing identical background information for each patient for whom they are seeking authorization. This process indicated to me that a thorough clinical review was not performed and the main purpose for the submission was to provide necessary documentation to approve the medication, whether it was substantiated or not.

It isn’t to say that all hub services directly run by and funded by manufacturers have acted this way. However, without oversight or regulations this type of aggressive behavior would go unchecked. 

Also, providers who rely on these services should be made aware that the process for providing quality, cost-effective care by payers is being circumvented by the hub service and, in the best interest of their patients and health care spending, they should think twice about rubber stamping their names onto forms provided to them. 

Third-party accreditation of hub services would indicate sound standardized protocols are being followed by a hub service and would lend credibility between prescribers, payers, and hub services. Unfortunately, accreditation is not currently available for hub services.

Hub Services Are Valuable
The desired outcome is for patients to receive the best possible treatment at the best price and have access to care without barriers that prevent treatment. In addition, clinicians providing treatment should be able to access the best options and not spend an inordinate amount of time coordinating care, because this is not the best use of their time.

For these reasons, hub services are valuable and important to bridge gaps among health plans, patients and prescribers. The issues as I outlined of who provides and pays for the services should be factored into existing hub services models. 

If regulations can be established regarding the affiliation of employees to manufacturers, and if they can provide high-quality services that improve compliance to treatment and overcome barriers to access, then working together for the greater good of patients is possible.

If these conflicts could be resolved, it might be possible to remove contractual language prohibiting third-party advocates for patients based on the common ground to help the patient stay adherent and healthy. Successful drug therapy will decrease further disease, adverse effects and reactions.

Reference
1. NASP Definitions of Specialty Pharmacy and Specialty Medications. February 24, 2016, http://naspnet.org/wp-content/uploads/2016/06/633570_864cb572b8b042909a3f207eaf764d7a.pdf

About the Author
Nivedita Kohli earned her Bachelor of Pharmacy degree from the Bouvé College of Health Sciences at Northeastern University and is currently enrolled in the Master of Pharmacy Business Administration (MPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in pharmacy business. She spent the past 20 years developing and implementing drug safety initiatives for a health plan and pharmacy benefit management provider serving Western New York. Over the past decade, she spearheaded educational programs for healthcare practitioners around appropriate opioid prescribing in addition to supporting the Erie County Opioid Epidemic Task Force with multi-faceted programs to improve the outcomes and reduce the impact of the opioid epidemic in Western New York. More recently, she is focusing on opportunities to provide high quality, sustainable healthcare in the current US market, employing her skillset in managed care and business.