December 10, 2018

Launching a New Specialty Product? Finding the Ideal Patient Path to Optimal Outcomes

By Dan Steiber, RPh, Specialty Pharmacy Times Editor-in-Chief & Executive Vice President

One of several key decisions a manufacturer must make when launching a new product is centered on its distribution strategy. As the market has shifted from traditional community-based products to specialty medications, expanded solutions to better serve these products have evolved. High-touch, focused pharmacy solutions have emerged that are targeted toward maximizing patient outcomes for specialty products. Specialty pharmacy offers a greater level of patient care but also brings more complexity and the need for greater understanding to home in on the right solution. 
 

Timing
Typically, a manufacturer that is contemplating a distribution strategy for the launch of a new product should be in the planning phase no later than 24 months from its launch date. Several critical variables need to be weighed when selecting a strategy; often led by the supply chain team, the selection team should strategically evaluate its options. If a manufacturer does not have a team, a handful of experienced consultants are available who can drive the process of strategy, selection, and implementation. 

Figure 1 is a sample flow chart delineating the process, accompanied by a list of significant milestones.


 

Is Your Product Specialty? Selecting a Distribution Model
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. Specialty pharmaceuticals 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 than traditional drugs
  • Special storage, handling, and/or administration
  • Narrow therapeutic range
  • Periodic laboratory or diagnostic testing
  • Higher costs than traditional products ($10,000-$100,000 annually)
  • 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, 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 need for specialty pharmacy have also emerged, such as:

  • Enhanced data
  • Risk evaluation and mitigation strategies (REMS) management
  • Inventory management
  • Coordination of care
  • Testing management
  • Reimbursement handling and patient assistance
  • White- and brown-bagging needs




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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