Pharmaceutical companies, biotech firms, and anyone in the business of developing new therapeutics knows there is significant pressure to reduce the cost of research and development (R&D) while delivering treatments and devices that safely and effectively alleviate symptoms, deliver medications or cure medical conditions—all while maintaining billing compliance. Luckily, utilizing a Protocol Cost Savings Analysis (PCSA) eases some of that pressure, allowing your organization to focus on creating innovative therapeutics that lead to positive patient outcomes.
What is a Protocol Cost Savings Analysis?
What exactly is a Protocol Cost Savings Analysis? Simply put, a PCSA is a comprehensive review of clinical procedures and other protocol items with a focus on determining billable items under the Medicare Clinical Trial Policy (National Coverage Determination 310.1). The PSCA is typically performed during the final stage of protocol development.
Throughout the PCSA process, PharmaSeek:
- Assists in aligning the study procedure schedule and objectives with routine care via participation in protocol development discussions
- Analyzes draft protocol to a.) determine if your study is a qualifying clinical trial per Medicare guidelines, and b.) identify any additional cost savings
- Develops study-specific, inclusive, detailed activity grids and completes a coverage analysis of all procedures and tests outlined in the protocol by documenting routine care and research items with supporting Medicare rationale for each determination
- Reviews institution-specific justification of routine care to assist sponsor negotiations
- Performs a thorough review of the clinical trial agreement, budget and sponsor informed consent documents to ensure synchronization and reduce the need for amendments
If pharmaceutical companies are unfamiliar with the intricacies of coverage regulations, such information tends to be left out of protocol design, study budgeting, and other start-up activities. Completing a PCSA provides a clear understanding of how to maintain billing compliance in each specific study, which can lead to reduced costs and streamlined budget negotiations. The PCSA grants the ability to align protocol procedures with routine care. This provides an offset of R&D expenses since these items are reimbursed by governmental (i.e., Medicare) or private third-party payors. Reducing overall R&D costs is a benefit all around, with positive financial impacts for sponsors and researchers, ultimately leading to more treatment options for patients.
Utilizing a PCSA can:
- Reduce per patient costs leading to a decrease in R&D expenses
- Enhance internal operational efficiencies resulting in cost savings
- Support routine care determinations with Medicare guidelines
- Harmonize key study documents to reduce the need for amendments
- Accelerate study start-up timelines due to improved processes
Want to learn more about PCSA?
For a more detailed look at the process and benefits of utilizing a Protocol Cost Savings Analysis—including a case study example—check out our latest white paper. If you have questions, don’t hesitate to contact us!