Pharmacy Purchasing & Products Magazine

Tips for Biosimilar Implementation

September 2022 : Generic Drugs 2022 - Vol.19 No. 9 - Page #2

Category: Generics Manufacturers

Now more than ever, payors require the addition of biosimilars to a health system’s formulary. These products are an asset to many stakeholders, helping to ensure that patients have access to safe and effective medications at lower cost. In light of these benefits, it is important to maintain a well-defined process so that these drugs can be introduced to a facility as seamlessly as possible. Consider the following when determining the process for biosimilar implementation:

TIP #1

Formulary Considerations

Biosimilars under consideration may undergo a full evaluation, an abbreviated evaluation, or a different process conducted by either a formulary or P&T Committee. This includes a review of a comprehensive drug monograph and the following factors:

Efficacy
Safety
Drug Storage
Preparation Steps
Operational Requirements
Manufacturer

Data is key to this process, and patient safety should always take priority. All factors should be weighed against patient, payor, and facility needs. Timing of the review will vary based on a facility’s existing process and frequency of committee meetings, which must be accounted for when determining a review schedule.

For more information, see
Key Considerations for Biosimilar Formulary Adoption

TIP #2

Financial Impacts

Following efficacy and safety determinations is a financial review. Many considerations factor into the cost of a biosimilar, and beyond acquisition costs are the often overlooked downstream costs due to a product change. Technologies such as the EHR, smart pumps, and ADCs will need to be updated following any product changes to ensure correct use and documentation. Interconnected systems will need to be synced, and decisions will need to be made about order set builds. While such costs will not accrue at the outset of implementation, these steps do require significant time and resources that will need to be accounted for to ensure a comprehensive financial analysis.

For more information, see
Considerations for Adding Biosimilars to Formulary

TIP #3

Monitor Biosimilar Availability

Frequently monitor what biosimilars are in the pipeline, approved, and available to ensure the facility is prepared to accommodate implementations as needed. The FDA hosts a list of approved biosimilars (available at http://tinyurl.com/y2c9w6f5); however, approved drugs may not always be immediately available. Because of this, it is important to determine at what point in the biosimilar approval and availability process formulary review will begin.

For more information, see Considerations for Adding Biosimilars to Formulary<

TIP #4

Efficient Workflows

Key to overcoming operational hurdles when implementing biosimilars is a streamlined workflow. Crafting a thorough, step-by-step process that prioritizes input from each department and includes education ensures that each stakeholder is empowered to take the necessary steps for the efficient implementation and deployment of biosimilars. Some disciplines to include are pharmacy, finance, informatics, formulary management, and hematology oncology administration. This workgroup can determine factors that will affect the workflow, including:

How the preferred products will be listed in treatment plans
By whom and how are interchanges to be made
How a change will be documented

Responsibilities for each discipline should be clearly delineated. Streamlining biosimilar processes not only ensures efficiency, but helps to maximize financial benefits as well (see the FIGURE).

For more information, see
Operationalizing Biosimilar Adoptions at Mayo Clinic

Click here to view a larger version of this FIGURE.

TIP #5

Prioritize Education

Quelling safety concerns, elaborating on benefits, and explaining basic biosimilar concepts can help an institution work toward smooth integration of biosimilar medications. Thorough education about the topic is one way to achieve these goals. When creating an education toolkit, consider outside resources to supplement your internal materials. The FDA provides several items to aid in education development, including: