Understanding the National Drug Code (NDC)
To analyze the market and price projections for a specific drug identified by its National Drug Code (NDC), it is crucial to understand what the NDC represents. The NDC is a unique, three-segment number that identifies a drug product, including the labeler, product, and trade package size[4].
Identifying the Drug
The NDC 46287-0012 can be broken down into three segments:
- Labeler Code: The first segment identifies the labeler, which could be a manufacturer, repackager, or relabeler.
- Product Code: The second segment specifies the strength, dosage form, and formulation of the drug.
- Package Code: The third segment indicates the package size and type.
Market Context
Drug Price Inflation
The pharmaceutical market is experiencing significant price inflation. According to Vizient's summer Pharmacy Market Outlook, the overall drug price inflation rate for 2025 is projected to be 3.81%[2].
Frequency and Timing of Price Increases
Price increases for prescription drugs are most common in January and July each year. In 2022, for example, the average price increase in January was nearly $150 per drug (10.0% increase), and in July, it was $250 (7.8% increase)[3].
Significant Price Changes
Not all price changes are minor; some drugs experience significant increases. For instance, between January 2022 and January 2023, more than 4,200 drug products had price increases, with 46% of these increases exceeding the rate of inflation. The average price increase during this period was 15.2%, translating to $590 per drug product[5].
Specific Analysis for NDC 46287-0012
Current Pricing and Trends
To analyze the specific drug with NDC 46287-0012, one would need to look at its current pricing and historical trends. Here are some key points to consider:
- Historical Price Changes: Check if the drug has experienced any significant price changes in the past, particularly in January and July, which are the months when most price increases occur[3][5].
- Comparison to Inflation: Determine if the price increases for this drug have exceeded the general inflation rate. For example, between July 2021 and July 2022, the Consumer Price Index (CPI-U) increased by 8.5%, and some drug price increases exceeded this rate[3].
Market Factors Influencing Price
Several market factors can influence the price of a drug:
- Expanding Indications: If the drug has recently received approval for new indications, this could lead to increased demand and potentially higher prices, as seen with drugs like semaglutide[2].
- Competition: The presence of multi-source or generic versions of the drug can impact pricing. Multi-source drugs tend to have higher percentage price increases but lower absolute dollar increases compared to single-source drugs[5].
- Regulatory Changes: Any changes in regulatory requirements or exemptions, such as those related to outsourcing facilities, can also affect pricing and availability[1].
Future Price Projections
Given the current trends and market factors:
- Projected Inflation Rate: With an overall drug price inflation rate projected at 3.81% for 2025, it is likely that the price of the drug with NDC 46287-0012 will increase, though the exact amount will depend on various factors including its current pricing and market position[2].
- Potential for Significant Increases: If the drug is part of a category that has seen significant price increases in the past (e.g., cancer treatments or high-cost therapies), there could be a higher likelihood of substantial price hikes[3][5].
Example of Significant Price Increases
For context, consider the example of a drug approved to treat spinal muscular atrophy, whose price increased from $2.12 million per kit to $2.18 million, a significant dollar increase despite a relatively small percentage change[5].
Impact on Affordability and Healthcare System
High prescription drug prices, including those for the drug with NDC 46287-0012, create affordability challenges for patients, healthcare payers, employers, and taxpayers. Continuous price increases add to these challenges, making it essential for stakeholders to monitor and prepare for these changes[3][5].
Conclusion
The market analysis and price projections for the drug with NDC 46287-0012 depend on various factors, including historical price trends, market conditions, and regulatory changes. Given the projected drug price inflation rate and the common timing of price increases, it is likely that this drug will experience some level of price increase in the future.
Key Takeaways
- NDC Identification: The NDC is a unique identifier for drug products, crucial for tracking and analyzing price changes.
- Price Inflation: The pharmaceutical market is experiencing significant price inflation, with a projected rate of 3.81% for 2025.
- Timing of Price Increases: Most price increases occur in January and July.
- Market Factors: Expanding indications, competition, and regulatory changes can influence drug prices.
- Affordability Challenges: Continuous price increases create significant affordability challenges for various stakeholders.
FAQs
What is the National Drug Code (NDC)?
The National Drug Code (NDC) is a unique, three-segment number that identifies a drug product, including the labeler, product, and trade package size[4].
When do most prescription drug price increases occur?
Most prescription drug price increases occur in January and July each year[3][5].
How does the FDA track drug prices and listings?
The FDA tracks drug prices and listings through the National Drug Code Directory, which is updated daily and includes information on active and certified finished and unfinished drugs[1].
What factors influence the price of a prescription drug?
Factors influencing the price of a prescription drug include expanding indications, competition from multi-source or generic versions, and regulatory changes[2][5].
How do high drug prices impact the healthcare system?
High drug prices create affordability challenges for patients, healthcare payers, employers, and taxpayers, adding to the overall cost of healthcare[3][5].
Sources
- FDA's National Drug Code Directory: Contains information about finished drug products, unfinished drugs, and compounded drug products[1].
- Vizient's Pharmacy Market Outlook: Projects drug price inflation and discusses market trends[2].
- ASPE Issue Brief on Prescription Drug Price Increases: Analyzes price changes for prescription drugs from 2016 to 2022[3].
- FDA's National Drug Code Database Background Information: Provides details on the NDC and its components[4].
- ASPE Issue Brief on Changes in List Prices of Prescription Drugs: Examines price changes from 2017 to 2023[5].
