Last updated: January 1, 2025
Introduction to National Drug Codes (NDCs)
The National Drug Code (NDC) is a unique identifier assigned to each drug product by the FDA, consisting of a three-segment number that helps in tracking and managing pharmaceuticals. For the NDC 75788-0115, understanding the broader market trends and specific price projections is crucial for healthcare providers, pharmacies, and other stakeholders.
Understanding the NDC Directory
The FDA's NDC Directory is a comprehensive resource that contains information on all finished, unfinished, and compounded drug products submitted by labelers. This directory includes details such as the marketing start and end dates, which are essential for tracking the commercial distribution of drugs[4].
Current Market Trends in Pharmaceuticals
Drug Price Inflation
According to Vizient's summer 2024 Pharmacy Market Outlook, the overall drug price inflation rate for 2025 is projected to be 3.81%. This increase is driven by several factors, including the expanding indications of previously approved medications and the introduction of high-cost cell and gene therapies[2].
High-Cost Therapies
Gene and cell therapies are becoming increasingly significant, with prices ranging from $250,000 to $4.25 million per treatment. These therapies are transforming the treatment landscape for conditions such as sickle cell anemia, beta-thalassemia, and various neurological disorders. The high costs associated with these treatments pose significant budgetary and operational challenges for healthcare providers[2].
Impact of GLP-1 Agents
GLP-1 agents, such as semaglutide and tirzepatide, are seeing increased usage due to their expanded indications. Semaglutide, in particular, has experienced a 77% increase in spend compared to the previous year, making it a critical factor in pharmacy spend management[2].
Specific Analysis for NDC 75788-0115
To analyze the market and price projections for a specific NDC like 75788-0115, several steps are necessary:
Identifying the Drug Product
First, it is essential to identify the drug product associated with the NDC 75788-0115. This can be done by referencing the FDA's NDC Directory or other reliable sources such as the CDC's vaccine and drug databases[3][4].
Market Demand and Usage
Understanding the market demand and usage patterns of the drug is crucial. This involves analyzing prescription data, patient demographics, and the prevalence of the condition the drug treats.
Price History and Projections
Historical price data and current market trends can help in projecting future prices. For instance, if the drug falls under a category experiencing significant price inflation, such as gene therapies or GLP-1 agents, this would need to be factored into the projections.
Regulatory and Market Factors
Regulatory changes, new approvals, and changes in reimbursement policies can all impact the price and availability of a drug. For example, if a drug receives a new indication or faces competition from a generic or biosimilar, this could affect its pricing[4].
Case Study: Impact of Expanding Indications
The case of semaglutide (NDCs associated with Ozempic® and Wegovy®) illustrates how expanding indications can significantly impact drug prices and usage. With its recent approvals for reducing the risk of major adverse cardiovascular events, semaglutide has seen a substantial increase in spend, up 77% from the previous year. This trend highlights the importance of monitoring regulatory approvals and their impact on market dynamics[2].
Operational and Budgetary Considerations
Healthcare providers must prepare for the financial and operational implications of high-cost therapies. As Carina Dolan from Vizient noted, "Gene and cell therapies present budgetary, operational and revenue obstacles that require health systems' multidisciplinary teams and processes to quickly identify qualified patients, access treatments and synchronize logistics for drug administration"[2].
Key Takeaways
- Drug Price Inflation: The overall drug price inflation rate for 2025 is projected at 3.81%, driven by high-cost therapies and expanding indications.
- High-Cost Therapies: Gene and cell therapies are increasingly costly, ranging from $250,000 to $4.25 million per treatment.
- GLP-1 Agents: Drugs like semaglutide are experiencing significant increases in spend due to expanded indications.
- Regulatory Impact: New approvals and changes in regulatory policies can significantly affect drug prices and availability.
- Operational Preparedness: Healthcare providers need to be prepared for the operational and budgetary challenges posed by high-cost therapies.
FAQs
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What is the projected overall drug price inflation rate for 2025?
- The projected overall drug price inflation rate for 2025 is 3.81% according to Vizient's summer 2024 Pharmacy Market Outlook[2].
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How are gene and cell therapies impacting healthcare costs?
- Gene and cell therapies are significantly increasing healthcare costs, with prices ranging from $250,000 to $4.25 million per treatment, and are expected to continue impacting provider budgets and operational processes[2].
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What is the significance of GLP-1 agents in current pharmacy spend?
- GLP-1 agents, such as semaglutide, are seeing increased usage and spend due to their expanded indications, including the reduction of major adverse cardiovascular events in overweight or obese adults with established cardiovascular disease[2].
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How does the FDA's NDC Directory help in tracking drug products?
- The FDA's NDC Directory contains detailed information on all finished, unfinished, and compounded drug products, including their marketing start and end dates, which helps in tracking their commercial distribution[4].
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What operational challenges do high-cost therapies pose for healthcare providers?
- High-cost therapies require healthcare providers to have multidisciplinary teams and processes in place to quickly identify qualified patients, access treatments, and synchronize logistics for drug administration[2].
Sources
- Drug Name and National Drug Code (NDC) Reference Data Instructions - CMS
- Vizient projects drug price inflation at 3.81% - Vizient Inc.
- IIS | Code Sets | NDC | Vaccines - CDC
- National Drug Code Directory - FDA
- Pharmacy Market Outlook Summer 2024 - Vizient Inc.
