Launching a drug isn’t easy. All manufacturers, no matter the classification of product they create, face challenges on the journey to bring their drug to market.

However, due to the nature of their dose form, complex storage needs, stability requirements, and costs, manufacturers launching specialty drugs must often navigate more hurdles than those dealing with a traditional retail product. Not appropriately planning for or inaccurately handling these hurdles could lead to serious consequences.

The most common challenges specialty pharmacy manufacturers face includes:

Dose form or packaging issues: Specialty drugs frequently have unique dosing needs or packaging requirements. Missteps at this stage could lead to difficulty dispensing appropriate quantities of medication to meet the supply approved by the patient’s insurance plan. It may also cause waste and loss of product, which could then elicit a payer audit of the specialty pharmacy and loss of revenue.

Storage or utilization issues: With products requiring unique storage needs (refrigeration, freezing, etc.), there is a need to ensure product stability from the 3PL to the specialty distributor and/or specialty pharmacy. The specialty pharmacies must have a solution to ensure the product reaches the patient in usable condition. If medications are short-date expiration, manufacturers must understand the utilization of product from the specialty pharmacy all the way back to the batch production cycle where the product is made.  Inattentive monitoring could result in expired product returns and loss of revenue.

Insurance issues:The high costs associated with specialty medications may cause issues with insurance plans covering product. They’ll likely require prior authorizations and appeals.

Contracting challenges: The administrative burden of working through multiple agreements between a 3PL, specialty distributors, and specialty pharmacies can be time consuming and often confusing. These documents are the foundation of a product launch and the driving force behind partner performance. They manage the distribution of the product to the patients as well as services performed.

Often, specialty drug manufacturers don’t know about an issue until a complaint comes from a patient or physician. At that time, they are playing catch-up to understand the issue and find solutions to mitigate recurrence.

Methods to prevent or quickly overcome these issues frequently start with data that the manufacturer can provide, however many specialty drug manufacturers are unaware of pharmacy processes, systems, or even laws.

That’s where Specialty Trade Management comes in

Two Lab’s Specialty Trade Management experts understand the entire specialty drug launch journey from 3PL to the patient. They provide manufacturers with in-depth insights on pharmacy operations and are able to interpret the data that manufacturers receive.

Though most specialty drug manufacturers will benefit from Specialty Trade Management, the most common signs a manufacturer would benefit from this expert team include:

  • The manufacturer does not have the staff resources available to manage and monitor specialty pharmacy
  • The manufacturer does not have a comprehensive understanding of pharmacy operations in order to monitor the success of a product launch and to prevent issue escalation.
  • The manufacturer has an existing specialty pharmacy network solution that seems to be struggling, resulting in patient/provider complaints or a network that is not meeting the sales objectives expected.

Through proper planning, data reporting and analysis, and understanding of specialty pharmacy procedures, the Specialty Trade Management team helps create solutions to the unique challenges these manufacturers face and often find ways to streamline the process.

While some issues may still arise as is the nature of bringing a specialty drug to market, trade management can identify them early with solutions to mitigate delays, prevent negative patient outcomes and avoid potential loss of revenue.

Want a partner that can help you successfully navigate the complex specialty drug launch journey and provide comprehensive insights? Fill out the form below to get in touch with our Specialty Trade Management expert team!