June 19, 2021

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
Options in the Supply Chain

Once the product leaves the manufacturing line, decisions must be made regarding which product flow option will best suit its individual needs. Given the criteria above and the market size of the product, the real “art of the story” comes into play. The flow options are visualized in Figure 2.

Order to Cash: The Third-Party Logistics Solution

In today’s market, few manufacturers have an in-house order-to-cash solution. Once a product leaves the manufacturing line, it must be stored per the package insert in the FDA’s Current Good Manufacturing Practice environment. The customer—whom we define as the entity who orders and pays for the product—must have an effective process to place a purchase order and have that order fulfilled, including picked, packed, and shipped. Once the product is shipped, the customer must be invoiced, and in turn, the manufacturer must assure that payment is received for the product. 

Figure 3 details the major deliverables offered by a third-party logistics (3PL) firm.

With distributors and other intermediaries, challenges of contracts, charge-backs, and data reporting arise. Building this level of infrastructure can be quite costly, must be constantly updated, and typically lands outside the core competency of a manufacturer. Serving these needs are the main services provided by a 3PL organization. 

The 3PL model has matured over the past 25 years and, as I have previously written, is the best deal in the industry. As such, there is no need to build out this functionality. Like the selection of a specialty pharmacy network, a manufacturer should start the selection process of a 3PL at least 2 years from the potential commercialization date. Pricing is competitive, so be sure to include a request for proposal (RFP) in your process, analyze the offerings of the 3PL vendors, and most important, visit these potential partners in person. In my experience, and as a former general manager of one of the leading 3PL enterprises, your decision will not be largely based on price or capabilities, but rather on a cultural fit. The 3PL will manage your baby!

Is Specialty Pharmacy the Right Channel for Your Product?
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, therefore, is a service that endeavors to provide 2 key deliverables:

  1. A mechanism to manage the cost of specialty pharmaceuticals for the patient.
  2. An opportunity to save money for the benefit sponsor compared with traditional models in which products are delivered through less efficient means, primarily via the hospital or physician office. Specialty pharmacy is more focused on specialty disease states. On its website, an accredited specialty pharmacy will often describe its focused services, highlighting their expertise on these disease states. If your products fall within the following disease states, chances are good that specialty pharmacy is in your future.
  • Hemophilia/von Willebrand disease
  • Gaucher disease
  • Growth hormone deficiencies
  • Multiple sclerosis
  • Hepatitis (types A, B, C)
  • Pulmonary hypertension
  • Cystic fibrosis
  • Fertility/hormone therapies
  • Immune disorders (eg, intravenous immune globulin treatment)
  • Respiratory syncytial virus
  • Hematopoietic colony-stimulating factors
  • Rheumatoid arthritis/osteoarthritis
  • Transplant
  • Oncology
  • Dermatology/psoriasis
  • Devices/testing

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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