June 19, 2019

Developing a Distribution Plan for Your Specialty Product

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

When selecting a specialty pharmacy network, it is critical that the RFP process includes rigorous documentation and full regimentation. This will ensure fair market value, vendor validation, and credentialing. In the absence of solid documentation, many states and other government payers—under the Physician Payments Sunshine Act, Any Willing Provider statutes, and other legislation—may challenge your selection. Should your product require a REMS, the RFP process will validate that your selection process has been fully vetted, and it can often be used for submission purposes on new product approvals that require such an assessment. The FDA may require manufacturers to disclose which pharmacies will be in the network, along with validation and documentation of their capabilities.

THE RFP PROCESS ​​​​​​​

Pharma companies should always use the RFP process for documentation of company viability, education, documentation of internal capabilities, departmental inquiries, focus areas, documentation for FDA/REMS submissions, verification of pricing methodology, and pricing for services and benchmarking. These processes establish demonstrated best practices should there be a need for a future reference at the manufacturer level.

Establishing a solid timeline will assure completion of a project within the scope of the deliverables. This can vary depending on several factors that may rate limit the timing, such as FDA review, REMS, manufacturing, etc.

THE FINAL SELECTION PROCESS

After a thorough analysis and review with the selection team, typical next steps include narrowing the field, inviting bidders to present to the team, or a combination of site visits. The use of RFP metrics-driven assessment tools can make this element as objective as possible and drive the decision. Here again, the use of highly qualified consultants with deep experience in the specialty space is crucial to making the right selection. It’s important that your organization ask all the right questions through every stage of the process.

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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