January 18, 2021

Developing a Distribution Plan for Your Specialty Product

By Dan Steiber, RPh, Specialty Pharmacy Times
Published Online: Monday, Jan 07, 2019

Specialty pharmaceuticals are generally defined as products used to treat chronic, high-cost, or rare diseases. They can be injectable, infusible, oral, or inhaled medications, and they tend to be more complex to maintain, administer, and monitor than traditional drugs. Therefore, they require closer supervision in their production and closer monitoring of a patient’s overall therapy. Key characteristics include:
  • Frequent dosage adjustments
  • Dosage administration of injectable and infusible drugs
  • Potentially more severe adverse effects (AEs) than traditional drugs
  • Special storage, handling, and/or administration
  • Narrow therapeutic range
  • Periodic laboratory or diagnostic testing
  • Higher annual costs than traditional products ($10,000-$100,000)
  • Target small numbers of patients (5000-100,000)
  • Patient registration
  • Patient training and clinical call center
  • Compliance management
  • Clinical data reporting and analysis
Often, specialty pharmaceuticals can be subcategorized into 4 distinct areas that are defined by the method of administration. These often drive a plan around the use of specialty pharmacy:
  • Office-administered injectable products
  • Self-administered injectable products
  • Clinic- or office-administered infusible products
  • Select oral agents
Newer criteria around the responsibilities of specialty pharmacies have also emerged, such as:
  • Enhanced data collection and sharing
  • Risk evaluation and mitigation strategy (REMS) management
  • Inventory management 
  • Coordination of care
  • Testing management
  • Reimbursement handling and patient assistance
  • White- and brown-bagging needs

Specialty pharmacy is defined as the service created to manage the handling and service requirements of specialty pharmaceuticals, including dispensing, distribution, reimbursement, case management, and other services specific to patients who have rare and/or chronic diseases. Specialty pharmacy is a service that endeavors to provide 2 key deliverables:

1. A mechanism to manage the cost of specialty pharmaceuticals for the patient.

About the Specialty Pharmacy Times Industry Guide

The Specialty Pharmacy Times Industry Guide includes comprehensive editorial content relative to all specialty pharmacy stakeholders. Content includes information relative to market trends, commercialization, distribution, order to cash, HUB Services, managed care strategies and DIR fees. The guide also includes profiles, and a complete list of stakeholders along the patient journey: specialty pharmacies, wholesaler distributors, manufacturers, support services, group purchasing, and trade associations.

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