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

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