The Role of Independent Specialty Pharmacies in Product Commercialization

Pharmaceutical manufacturers are increasingly looking to independent specialty pharmacies to play a key role in the launch of new products, harnessing the power of the independents’ ability to devote time and resources to patient care.

The pharmaceutical industry is experiencing very exciting times with new technological breakthroughs and developments that offer hope for diseases that have historically been difficult to treat or have not had treatment options. The FDA has created opportunities to streamline the process of getting these new pharmaceuticals out of the research pipeline and into the hands of health care professionals and their patients. There are currently over 5000 agents in the pipeline offering ground-breaking technology that could meet the needs of patients and offer new possibilities for disease management.

This excitement also presents interesting challenges for the pharmaceutical manufacturers as they consider how to bring these technologies to patients who are so desperately in need. In many cases, the disease state that a pipeline drug may address is associated with a very small patient population, which could bring along with it a very large price point. Out of over 5000 agents in the pipeline, some 450 or so are for the treatment of orphan disease states. An orphan disease is by definition a disease affecting fewer than 200,000 patients annually in the United States. On average, the typical oral orphan agent has a price point in excess of $100,000 per patient annually. This presents a pharmaceutical manufacturer’s brand team with many questions to be considered as they seek the appropriate distribution channel for their orphan agent.

Recently, pharmaceutical manufacturers have leveraged the benefits of high-touch patient-focused independent pharmacies with no payer or pharmacy benefit manager (PBM) ownership to support the launch of their products. While this may stray from traditional routes of product launches, a deeper look into the needs of the stakeholders shows a strong rationale for this approach, as independent pharmacies have unique capabilities designed to meet stakeholder needs.

The attributes of a pharmaceutical product are key in determining stakeholder perspective. Product attributes such as route of administration; dosing and dosing challenges; likely patient, prescriber, and payer; and clinical and financial access issues are all area of consideration. Using the example of orphan oral oncolytics, the primary stakeholders are the patient, payer, prescriber, and manufacturer.

Patient Perspective

From the patient’s perspective, the primary concerns are quality of care and ease of working with the pharmacy. A well-thought out, high-touch patient care program designed to address these concerns is essential. Specialty pharmacy patient care coordinators are trained to be accessible, pleasant, and knowledgeable. Specialty medications, especially orphan agents, present challenges for patients above and beyond those found with other agents. Additional education is needed to ensure that the patient has the necessary information pertaining to side effects, dosing schedule, potential drug interactions, and behavioral modifications (if applicable).

Independent specialty pharmacies with resources available to dedicate to one-on-one patient care are equipped to handle these needs. Pharmaceutical manufacturers value the ability of independent specialty pharmacies to address access barriers. The most common barriers are payer utilization management measures and financial constraints. High-touch specialty pharmacies support appropriate utilization through prior authorization and appeals processes to ensure access.

Patients are also cognizant of their medications’ price point. Specialty pharmaceuticals come with a high price point, even more so when considering agents in the orphan category. A high-touch specialty pharmacy can provide assistance with locating supplemental funding through grants and other outside sources, along with expertise in navigating manufacturer copay programs that can be invaluable in facilitating a patient’s ability to begin and remain on their therapy.

Payer Perspective

Payers bring their own set of considerations to the table when working with specialty pharmaceuticals. These concerns are primarily financially driven, as the high costs associated with these drugs have a significant impact for payers. There are 3 primary areas of note for payers: appropriate utilization of therapy, patient therapy compliance, and overall therapy outcomes. When a specialty pharmacy is able to verify the accuracy of a prescription and ensure that patients are receiving the appropriate therapy for their diagnosis, the result is significant cost savings for the payer as well as avoidance of potential harm to the patient. Specialty pharmacies that have implemented a high-touch care model are uniquely positioned to address appropriate therapy utilization through internal system driven checkpoints of therapy validation. Through the relationships high-touch specialty pharmacies build with patients, these pharmacies are also well positioned to monitor compliance and report on therapy outcomes.

Prescribers have significant needs in relation to both their patients and the product. Not only are they seeking the correct product to address the patient’s disease state, they are also seeking a specialty pharmacy that can work as a partner in the therapy process. Communication is essential to providing value to a prescriber relationship. The high-touch independent specialty pharmacy offers frequent, personal outreach to both the patient and prescriber, functioning as part of the overall health care team. This directly benefits the patient in creating an environment that promotes adherence and offers additional benefits unique to the prescriber and their needs.

The independent specialty pharmacy has personnel dedicated to assisting with prior authorizations and appeals, taking much of the paperwork burden from the physician and making the process easier. Additional employees are trained to work in reimbursement support, which helps alleviate potential complications for both the physician and patient. Throughout these processes, the independent specialty pharmacy can keep open lines of communication with the prescribing physician, supporting the patient’s journey with clinical excellence and personal care.

Manufacturer Perspective

Manufacturers, while ultimately concerned with providing a product that can make a difference in the lives of patients, particularly when considering those living with an “orphan” disease, have to factor in a wide range of additional elements. With the considerably high price point of specialty medications in the orphan category, each dose must be accounted for—both to ensure that expensive medication is not wasted, and also to stay in tune with the level of success the patient is experiencing with the therapy. This is another area of concern that an independent specialty pharmacy has the expertise to address through well-thought-out medication therapy management programs. The high-touch care model again comes into play as independent specialty pharmacies are able to maintain a regular schedule of personal contact with the patients, which in turn yields information on the entire patient journey. Valuable information related to this journey can provide actionable data for the pharmaceutical manufacturer.

In fact, real-time reporting of actionable data is essential for evaluating the success of a product from both a therapeutic and financial standpoint. Additional metrics can be provided detailing the specialty pharmacy’s overall service performance. Reporting on turnaround time, funding support, follow-through, communications, and other touch points included in the therapy monitoring process provides vital information that the manufacturer uses to measure the efficacy of their specialty pharmacy provider(s) in addition to the overall efficacy of the product itself.

Ideally, a manufacturer seeks a specialty pharmacy partner who can provide a high level of support for the product and patient while maintaining a collaborative relationship marked by transparency. Partnering with an independent specialty pharmacy has proved to be a successful approach for pharmaceutical manufacturers. An independent specialty pharmacy can provide access to a high number of covered lives while still choosing to approach care from a patient-centric philosophy. This can be particularly critical at product launch, as all 4 aforementioned stakeholders have need of detailed information. The independent specialty pharmacy has the ability to be nimble and flexible along with maintaining strong lines of communication with their patients and caregivers. This type of collaboration between pharmaceutical manufacturer and independent specialty pharmacy is a true differentiator in delivering patient-centric solutions that meet the needs of all stakeholders and facilitate getting these breakthrough drugs into the hands of those who ultimately need them. SPT

Diplomat Specialty Pharmacy is the largest independent specialty pharmacy in the United States. Based in Flint, Michigan, the company has 8 locations in Michigan, Florida, and California, as well as American Homecare Federation in Connecticut. Diplomat serves patients throughout the country with disease-specific management programs. As of 2013, Diplomat Specialty Pharmacy has been ranked on the Inc 500|5000 list of fastest-growing US corporations for 5 consecutive years.

About the Author

Cheryl Allen, RPh, BSPharm, MBA, is vice president, business development and industry relations, at Diplomat Specialty Pharmacy. In her role, Cheryl is responsible for all facets of new business development and industry relations, where she leads the Diplomat team in finding partnerships and crafting health care solutions. Cheryl also leads corporate efforts in identifying new opportunities for Diplomat. For patients, she seeks ways to continually improve care. For external stakeholders, she strives to help keep producing financial results.

Cheryl brings more than 20 years of industry experience, with work in independent, compounding, and specialty pharmacy, as well as in managed care consulting and health care technology. Before joining Diplomat, Cheryl worked as the senior director of clinical services at Sanovia Corporation, where she managed new product development and sales support. Prior to her tenure at Sanovia, she held roles with Priority HealthCare as a pharmacist-in-charge for oncology and lead pharmacist for pain management and compounding. Cheryl also founded C. Allen & Associates, a firm focused on managed care consulting, and Eden Drug Company, an independent pharmacy with a compounding focus.

Cheryl earned her Bachelor of Science in pharmacy at Samford University and her Master of Business Administration at Saint Joseph’s University Erivan K. Haub School of Business with a focus in pharmaceutical and health care marketing.