Most healthcare supply chain professionals have experience with value analysis — the process healthcare organizations often use to decide which products it should consider for purchase. The goal of most value analysis efforts is to ensure that good decisions are being made regarding the cost, quality, and outcomes (CQO)* associated with the use of the product being evaluated.
What Should My Value Analysis Committee Understand About Biologics?
There are many excellent resources that can help you determine an appropriate design and process flow for your organization’s value analysis program and teams. Because of this, I assume that you have accessed those resources and have a broad understanding of the purpose, principles, and best practices of an effective value analysis program. Therefore, this article is focused on the specific considerations for effective value analysis of biologics.
The biologics used in spine surgery are varied and complex. They are often obtained from many vendors, with different technologies, at wildly varying price points. This makes it very difficult to unravel all the information regarding these products, particularly for non-clinicians. Biologics are also typically considered “physician preference items,” which can add greatly to the complexity of value analysis efforts. This makes preparation critical for value analysis efforts, and can make or break savings or vendor consolidation goals.
Defining the current problem can be a challenge unto itself, particularly if your organization does not have a solid process to evaluate the business case for a product. Make sure the project addresses quality and safety issues, unjustified variation, and reimbursement. It is particularly helpful for your team to agree on the level and type of clinical evidence that is acceptable before starting the project.
There are varying and often conflicting sources of information that make classifying and categorizing biologics a challenge. Get all stakeholders aligned on how products should be grouped to avoid roadblocks. This critical step can determine the success of all other efforts. You can find a Supply Chain Guide to Biologics to help with the conversation here.
This is among the most critical phases in the value analysis process, and where many organizations create or experience roadblocks to success. Before starting the analysis part of the process, make sure that you select champions to evaluate/validate products, coordinate with suppliers, and arrange for trials. Avoid using free products for evaluations, as this can unduly influence the participants in the evaluation process. The value analysis process can be shortened when there is a clear difference in cost or clinical outcomes, the products are already in use at the facility, or the conversion process will be easy. No need to follow a long, formal VAC process — simply validate that the product is acceptable and quickly approve to capture savings. Choose to evaluate when there is not a large gap between suppliers on costs or outcomes, or product conversions will be difficult. Spinal biologics are complex products, therefore it is highly likely that you need to evaluate rather than merely validate.
The implementation phase will require close coordination with suppliers. Effectively implementing new products or those new to some users requires well executed planning, communication, and education. Suppliers can help drive the process by providing resources, developing a systematic plan for education, and providing materials and communication in the facility and across the integrated delivery network.
Many value analysis efforts end at the implementation phase, when the project is considered finished by most stakeholders. Review progress of the project quarterly against the goals of the project with your suppliers and internal stakeholders. Evaluate quality, cost and outcome metrics and identify roadblocks that have presented themselves and work ztogether to quickly resolve them.
Please see Instructions for Use for a complete list of indications, contraindications, warnings, and precautions on the product label, by calling 1-800-637-4391 or at www.BioventusSurgical.com.
OSTEOAMP is a minimally manipulated allograft which is compliant to 21 CFR 1271 and is regulated as a 361 HCT/P (ie, human cells, tissues, and cellular and tissue-based products regulated solely under Section 361 of PHS Act). OSTEOAMP is not combined with a drug, medical device, or carrier. As a 361 HCT/P, OSTEOAMP does not require prior FDA approval for commercial distribution (ie, no premarket clearance/approval by FDA is required).
OSTEOAMP may be used in situations where an autograft is appropriate. It should be restricted to homologous use for the repair, replacement, or reconstruction of musculoskeletal defects.
Bioventus, the Bioventus logo and OSTEOAMP are registered trademarks of Bioventus LLC.
INFUSE is a registered trademark of Medtronic.
*In vitro performance may not be predictive of performance in humans.
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