January 18, 2021

Developing a Distribution Plan for Your Specialty Product

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

As the field gets is winnowed, the team should be reviewing contracts and other service agreements. The pharma industry is in a highly regulated environment, so there is typically a good amount of back-and-forth until the legal teams can align on appropriate contractual language. Critical elements of the contracting process include:
  • The contract must accurately include the entire business relationship.
  • The contract should contain manufacturer representation that there is a legitimate business and clinical need for the services.
  • The contract should contain a representation, by each party, that it will not violate the Anti-Kickback Statue.
  • There should be measurable key performance indicators (KPIs) associated with each service provided, and compensation should require meeting certain KPI metrics.
  • Each material stakeholder should certify that the written agreement reflects all the material terms of the arrangement and annually recertify these terms.
  • Each contract should be vetted through the formal contracting review process.
The reality is, however, that despite all of the tedious efforts to develop well-measured parameters around your decision, the gut feeling of which entities can best manage your product will likely prevail. The development of standard operating procedures and implementation are the next and final steps, which we will cover in a future article in Specialty Pharmacy Times ®.

Specialty pharmacies that win agreements offer comprehensive clinical services, therapeutic expertise, and access to patients and have strong data reporting capabilities. Typically, the specialty pharmacies that have access to preferred payer relationships have broader lines of products. Establishing relationships with manufacturers has cost and access advantages. Many manufacturers choose to have a network of specialty pharmacies that provide broader access to patients and lower the resistance from payers who may own these pharmacies. Health professionals often have a degree of influence over the specialty pharmacy that patients choose and are best aware of which providers offer comprehensive support services, therapeutic expertise, and access to products. More recently, we have seen smaller regional specialty pharmacies become more successful, in part because of strong relationships with local physicians and payers. Most specialty pharmacies do not market directly to individual patients.


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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