When considering commercial distribution, pharmaceutical manufacturers often have concerns about launch and life-cycle management. Specialty pharmacies—with access to prescribers, payers, and patients—are uniquely positioned to address these concerns with a direct-to-patient distribution solution.

With more than 100 drugs likely to be approved within the next 3 years, below are 7 essential things to know to position specialty pharmacies for therapies that may be limited-distribution opportunities:

1. Clinical Expertise
Clinical expertise is the most important factor when positioning limited-distribution agents. The care team at a specialty pharmacy can interact with the patient, caregiver, prescriber, and payer to support the patient in appropriate use. Care team engagement begins when a referral for a specialty agent is received by the specialty pharmacy.

The care team then verifies that all information needed to process the request has been provided by the prescriber, and reaches out for additional information if needed. The majority of specialty pharmaceuticals require a prior authorization from the payer before the patient is granted access. The specialty pharmacy care team works with the prescriber to follow the payer’s process to review the use of a new specialty agent.

When specialty agents are new to the market, payers might not have criteria in place to perform such a use review. In these instances, specialty pharmacy clinical teams can be a key resource to provide drug information to the payer community. If allowed by the payer, the care team will submit the prior authorization with supporting documentation on behalf of the prescriber, and monitor the request until a determination is made.

Supporting documentation can include chart notes, laboratory values, peer-reviewed journal articles, and compendia reference. Patient-access specialists on a care team might also support the prescriber and patient in appeals, where clinical expertise is leveraged for a deeper dive into individualized patient support of appropriate use. Once appropriate use has been determined, the care team engages with the patient and/or caregiver to provide drug and disease state education.

The more educated a patient is about their therapy, the better their chance for positive outcomes. The clinical support for the patient’s journey continues with reminder calls, and possibly, adherence support programs. Clinicians on the care team also notify the prescriber, when appropriate, in support of a comprehensive continuum of care. Some care teams even have prescriber portals that support bidirectional prescriber communication and patient-centered collaboration.

The care team will monitor adherence and persistency, and identify individual patient needs, and real-world specialty agent trends. Patient monitoring and documentation are important aspects of the care team’s capabilities. Ongoing clinical support and training are required to verify that the care team has the most up-to-date information on the specialty agent. When selecting a limited number of specialty pharmacy partners, pharmaceutical manufacturers should insist on clinical excellence in support of their specialty agent. 

2. National Accreditation
National accreditation for the specialty pharmacy has become the standard for access to limited-distribution specialty agents. Accredited specialty pharmacies have documented policies and procedures for the entire patient support and fulfillment support process.

They also have quality auditing and quality improvement programs as ongoing initiatives. In addition to national accreditation at the specialty pharmacy level, many specialty pharmacies require national certification of their technicians and pharmacists. This is available through the Pharmacy Technician Certification Board, and might be a state requirement. National certification of a specialty pharmacist is available through the National Association of Specialty Pharmacy.

Due to the individualized needs of the specialty agent patient population, these national accreditations help support a quality and consistent patient journey that is repeatable and auditable. An overwhelming majority of pharmaceutical manufacturers require national accreditation for their specialty pharmacy partners of limited-distribution agents.

3. Reporting Capabilities
Reporting capabilities of a specialty pharmacy to support limited-distribution agents should include actionable data delivered to the pharmaceutical manufacturer that is timely, accurate, and complete. Most pharmacies can report dispensing-level data through an adjudication system that is leveraged to submit claims to the payer. Clinical data needed to determine utilization trends are not captured in current adjudication transactions.

Examples of these data points include diagnosis codes, previous and concurrent therapies, and lab values. While some specialty pharmacies are leveraging simple spreadsheets, accuracy and efficiency is gained through technology-supported longitudinally through patient management systems. Having the capabilities to support patient-level clinical data over time is generally a necessity for access to limited-distribution specialty agents.

Accurate reporting of sales and inventory on hand is needed to assist the manufacturer’s financial and manufacturing teams. At the dispensing level, clinical and inventory data reporting of a limited-distribution agent is a key resource for pharmaceutical manufacturers. A specialty pharmacy’s ability to deliver these data is a deciding factor in access to limited-distribution specialty agents.

4. Managed Care Access
Proven managed care contracting is critical to support patient access to specialty medications. Most payers have a preferred or mandated specialty pharmacy under contract to meet the needs of their specialty patient population. Contracting with payers to support their specialty needs requires diligence to patient support, quality measures and outcomes, and accurate data reporting.

Documentation of patient support, activities, and success might be required of a specialty pharmacy through contractual obligations. Specialty pharmacies and payers might also collaborate such that the specialty pharmacy is supporting the payer’s quality measures, which could include adherence rates and laboratory values.

Payer reporting on specialty pharmaceuticals is generally at the disease or provider level, and could include total spend and cost avoidance calculations. Pharmaceutical manufacturers want to know the level of expertise a specialty pharmacy has working with the payer community and will generally work with those that have proven payer relationships when considering partners for limited-distribution specialty agents. 

5. Prescriber Support
A key area in positioning for limited-distribution specialty agent access is prescriber sales support. Specialty pharmacy sales teams sell the services of the specialty pharmacy, assisting the prescriber with payer use management requirements, assisting the patient with financial issues relative to product access, and continuing their follow-up in support of the continuum of care.

Specialty pharmacy sales team members have a deep understanding of the specialty space, and can serve as a valuable resource to the prescriber relative to specialty pharmaceuticals. Pharmaceutical manufacturers that successfully leverage the specialty pharmacy channel find value in the specialty pharmacy’s dedicated sales force, understanding that the specialty pharmacy sales team is selling the services of the specialty pharmacy to support the prescriber.

The sales capabilities of a specialty pharmacy are often a final determinate in access to limited-distribution specialty agents. 

6. 24/7 Patient Support
Patients and caregivers might have many questions and needs throughout their specialty pharmacy journey. Often, these needs are addressed after the patients’ daily or weekly obligations are concluded, and they have time to devote to themselves.

Because of this, calls from patients and caregivers can come to the specialty pharmacy late at night, early in the morning, and on weekends. Most specialty pharmacies offer 24/7 clinical support access for patients and caregivers, which is critical to support limited specialty agent access. It is also a requirement of a specialty pharmacy for access to a manufacturer’s specialty agent.

7. National Reach
Specialty pharmacies with access to a limited-distribution agent might be small, but they need to meet the demands of patients and prescribers in all 50 states and US territories. Each state and territory has its own unique requirements for drugs delivered or shipped within its jurisdiction.

Gaining access to distribute in these areas is a lengthy and costly process, requiring ongoing diligence to verify up-to-date obligations and requirements for each. The above essentials are generally the starting point when manufacturers are considering a limited-distribution panel for their specialty agent.

Specialty pharmacies can start with these essentials, and then craft their own messages to the market about their targeted expertise that meets the needs of specialty agent manufacturers. â—†



About the Author

CHERYL ALLEN, BSPHARM, MBA leads Diplomat’s Industry Relations team in finding partnerships and crafting health care solutions. Specifically, Cheryl leads Diplomat’s corporate efforts in identifying new opportunities within the pharmaceutical industry. She then collaborates with manufacturers to design services and distribution solutions that support their patients’ journey. Cheryl brings more than 25 years of industry experience, with work in independent, compounding, and specialty pharmacy, as well as in managed care consulting and health care IT.