Seven Essential Points to Position Specialty Pharmacies for Limited-Distribution Agents

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.



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