Prescribers and patients can no longer blindly rely on simple and straightforward drug delivery in specialty pharmacy.
Complex disease management: Beyond ‘Take two and call me in the morning’
The above idiom, describing drug therapy from a pre-specialty landscape, is wildly inapplicable to many of the newest marketed drug products. Prescribers and patients, the center of the medication paradigm, can no longer blindly rely on simple and straightforward drug delivery.
Although oral medications are still a cornerstone of chronic disease management, research and development from manufacturers has shifted towards injected and infused medications, used to manage conditions that were previously underserved. As pharmaceutical science continues to improve, so too does the need for education and monitoring to ensure intended outcomes.
Lacking a concrete definition, most specialty medications boast atypical dosing regimens, feverous monitoring for serious adverse reactions, a hefty price tag, or some combination of these factors. High development costs, measured in billions of dollars, create a high-stakes challenge to pharmaceutical companies. With so much invested, a manufacturer must select a distribution model that satisfies the unique needs of its product.
While traditional channels, retail outlets, and prescribers’ offices function as essential compliments, specialty pharmacies (SP) are able to more completely address the complexities created by these novel therapies. In selecting a specialty distributor, a manufacturer must ensure product accessibility, precise clinical management, compliance with government regulations, and adequate data collection.
Patient access: Balancing availability with safe and effective use
Using a specialty pharmacy, a subsection of the entire pharmaceutical distribution network, seems counterintuitive to achieving universal product access. However, the disease states and associated therapies that are primarily distributed through this channel necessitate accompanying services to ensure safe and effective use. Further complicating the situation, the sheer cost of these medications creates a two-pronged challenge: precise inventory control for manufacturers and the need for reimbursement assistance for patients.
As a growing number of therapies exceed of $100,000 per patient per year,1 inventory management is directly tied to a manufacturer’s overall financial statements. With product in stock at a few hundred, rather than tens of thousands of pharmacies, a company marketing a specialty product is able to produce medication closer to actual utilization levels.
In cases where products are ultra-costly, a manufacturer may elect to provide medication to a pharmacy on consignment.2 This arrangement, with the pharmaceutical company retaining title until a claim is adjudicated allows for optimal inventory control. This retained ownership, although an expense to the company, minimizes the potential for waste or misuse.
SPs can use their existing infrastructure to coordinate the spectrum of payers to alleviate the emotional distress and financial burden to the end patient. In response to rising costs, benefits managers are becoming increasingly reliant upon restricting access via red tape.3
Most specialty pharmacies have dedicated reimbursement teams that leverage their understanding of established billing procedures, including step therapies, prior authorizations, and manufacturer or foundation assistance. In this role, SPs increase the number of patients receiving appropriate therapy. Some of the rarest and most complex diseases require even more than the standard reimbursement counseling obtained from a specialty pharmacy. In these cases, manufacturers have the option to commission a product-specific hub.4
Acting as a single intermediary between prescribers and patients, hubs work closely with the manufacturer to facilitate therapy initiation, as well as continued safe and effective product use. Although an expense to the pharmaceutical company, hubs function as customized intermediaries that coordinate reimbursement, data collection, and clinical management.
Clinical management: high touch services for high touch populations
While product-specific hubs largely deal with the most clinically complex patient groups, specialty pharmacies execute a wide array of clinical management services. Monthly refill questionnaires, the most basic form of clinical service, are customized to investigate drug efficacy, and monitor for adverse reactions.
Leveraging the monthly touch point while coordinating prescription refills, SP representatives are able to discuss the effects of therapy with patients more frequently and consistently than their prescribers, who may only interact with the patient once or twice a year. In this way, specialty pharmacies serve as an educated intermediary between prescribers and patients.
Prescribers are able to write for specialty products with less of a burden, as the specialty provider assists with monitoring and patient education. Patients are provided access to knowledgeable nurses and pharmacists who assist in the management of their disease state, involving prescribers in appropriate situations.
As a result of this high level of service, SPs are positioned to collect valuable information and documentation that is essential to a product’s continued use in the marketplace.
Data collection: capturing the evidence in evidence-based medicine
Many specialty products require intense documentation and data collection for myriad reasons. REMS drugs approved by the FDA under the condition of continuous monitoring for safety possess additional requirements to remain eligible for marketing.
The strictest programs require monthly lab testing and patient-specific authorization for each dispense with subsequent documentation of fulfilling these requirements. Less stringent REMS programs require the communication and prevention of serious adverse effects, again with the recording of the required procedures. By restricting product to dozens of pharmacies, or less, a manufacturer can capture more consistent and reliable data.
Providing treatment for a rare disease that affects less than 200,000 people nationwide5 carries a unique set of challenges. As drugs to treat rare and ultra-rare orphan diseases continue to receive FDA approval, robust information on these patients has become increasingly important. In addition to addressing safety concerns, SPs are able to collect diverse sets of data.
This data enables insight into conditions that the medical community is striving to develop a more complete understanding. These data collection services are fully customizable, enabling a manufacturer to commission the collection of whatever information is desired.
Executing a tailored recording process is considerably more feasible across a finite number of specialty pharmacies, opposed to tens of thousands of retail pharmacies nationwide.
Manufacturers: making special choices for special products
Specialty drugs continue to be the target of manufacturer research and development, contributing to these products driving increases in health care spending. Critics of this trend, and the specialty pharmacies at its center, must understand the value added from a SP provider.
Championing expertise in multi-dimensional disciplines, including reimbursement, clinical monitoring, and data collection, specialty pharmacies are equipped to provide substantial value to all stakeholders in the management of specialty diseases. Without such services, the optimal delivery of a pharmaceutical company’s life-altering medication would be a daunting task.
Christopher Ogurchak earned his PharmD degree from the Duquesne University in 2011. Chris served as a pharmacy manager at an independent pharmacy in Southwestern Pennsylvania before transitioning to CVS Specialty Pharmacy as a clinical pharmacist. He is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) 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 the business of medicines.