Understanding the National Drug Code (NDC)
To analyze the market and project prices for a specific drug identified by its NDC, it is crucial to understand what the NDC represents. The National Drug Code (NDC) is a unique, three-segment number that identifies a drug product. It includes the labeler code, product code, and package code, each assigned by different entities[1].
Identifying the Drug
The NDC 64380-0880 needs to be broken down to identify the labeler, product, and package size. Here’s a general breakdown:
- Labeler Code: The first segment of the NDC, which identifies the firm that manufactures, repackages, or distributes the drug.
- Product Code: The second segment, which identifies the specific strength, dosage form, and formulation of the drug.
- Package Code: The third segment, which identifies the package size and type.
Market Context
Prescription Drug Prices in the U.S.
Prescription drug prices in the U.S. are significantly higher compared to other countries. Research indicates that prices in the U.S. are 2.78 times as high as in 33 other countries and 5.5 times as high as in the OECD (excluding the U.S.)[3].
Recent Price Negotiations
The Biden-Harris administration has initiated price negotiations for certain drugs under Medicare Part D, aiming to reduce costs for millions of Americans. For example, drugs like Januvia, Farxiga, and Enbrel have seen negotiated price reductions ranging from 38% to 79% compared to their list prices[2][5].
Specific Drug Analysis
To provide a detailed analysis for the drug with NDC 64380-0880, we need to identify the drug and its current market position.
Drug Identification
Assuming the NDC 64380-0880 corresponds to a specific drug, let's hypothetically identify it as a common prescription medication. For the sake of this example, let's say it is a medication for diabetes, such as one of the insulins or oral hypoglycemic agents.
Current Pricing
If the drug is similar to those selected for Medicare price negotiations, it likely has seen significant price increases over the years. For instance, diabetes medications like Januvia and Farxiga have had list price increases ranging from 20% to 55% between 2018 and 2023[5].
Negotiated Prices
If this drug were to be selected for Medicare price negotiations, it could see a substantial reduction in its list price. For example, Januvia's negotiated price resulted in a 79% discount from its list price, reducing the cost from $527 to $113 per unit[2].
Price Projections
Impact of Negotiations
Given the trend of negotiated prices for similar drugs, if the drug with NDC 64380-0880 were to be negotiated under Medicare Part D, it could expect a significant price reduction. Here’s a hypothetical example:
- Current List Price: Let's assume the current list price is around $500 per unit.
- Negotiated Price: Following the trend of discounts seen in other negotiations, a 60% to 70% discount could be expected, reducing the price to around $150 to $200 per unit.
Market Trends
The overall prescription drug market in the U.S. has seen sales revenue growth, particularly in the non-retail sector (hospitals and physician offices). However, the average price per unit has increased significantly, contributing to higher sales revenues despite moderate volume growth[3].
Regulatory and Compliance Aspects
FDA Approval and Listing
The drug must be listed in the FDA's NDC Directory, which includes prescription drugs, OTC drugs, and insulin products. The listing ensures compliance with the Drug Listing Act and regulatory provisions[1].
Compliance with Drug Efficacy Standards
The drug must meet FDA standards for safety and efficacy. If it was approved before 1962, it might be subject to the Drug Efficacy Study Implementation (DESI) program, which evaluates the efficacy of drugs approved on safety grounds alone[1].
Conclusion
The market analysis and price projections for the drug with NDC 64380-0880 depend on several factors, including its identification, current market position, and potential inclusion in Medicare price negotiations. Given the trends in prescription drug pricing and recent negotiations, significant price reductions can be anticipated if the drug is selected for such programs.
Key Takeaways
- NDC Identification: The NDC is crucial for identifying the drug, its labeler, product specifics, and package size.
- Market Pricing: U.S. prescription drug prices are significantly higher than in other countries.
- Negotiated Prices: Medicare price negotiations can result in substantial discounts, up to 79% in some cases.
- Regulatory Compliance: The drug must be listed in the FDA's NDC Directory and comply with safety and efficacy standards.
- Market Trends: The U.S. prescription drug market shows revenue growth driven by price increases rather than volume growth.
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 package size.
How are prescription drug prices in the U.S. compared to other countries?
Prescription drug prices in the U.S. are significantly higher, being 2.78 times as high as in 33 other countries and 5.5 times as high as in the OECD (excluding the U.S.).
What is the impact of Medicare price negotiations on drug prices?
Medicare price negotiations can result in significant discounts, ranging from 38% to 79% compared to list prices.
What are the regulatory requirements for a drug to be listed in the NDC Directory?
The drug must be a prescription drug, OTC drug, or insulin product manufactured by a registered establishment and comply with the Drug Listing Act and FDA regulatory provisions.
How do recent market trends affect the pricing of prescription drugs?
Recent market trends show that the U.S. prescription drug market has seen revenue growth primarily due to price increases rather than volume growth.
Sources
- FDA: National Drug Code Database Background Information - FDA[1]
- White House: FACT SHEET: Biden-Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation[2]
- ASPE: ISSUE BRIEF - International Market Size and Prices[3]
- CDC: IIS | Code Sets | NDC | Vaccines[4]
- ASPE: Medicare Drug Price Negotiation Program: Medicare Prices Negotiated for 2026 Compared to List and U.S. Market Prices[5]
