Introduction
The NDC code 11534-189 refers to a specific formulation of amphetamine-based medications, which are commonly used to treat conditions such as Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. Here, we will delve into the market analysis and price projections for this drug, considering various factors that influence its pricing and market dynamics.
Market Context
Amphetamine-based medications, including those with the NDC code 11534-189, are classified as Human Prescription Drugs and are regulated by the FDA. These drugs are marketed by Sunrise Pharmaceutical, Inc., and fall under the DEA Schedule CII, indicating they have a high potential for abuse but also accepted medical use[4].
Current Pricing Trends
Prescription drug prices in the U.S. have been a subject of significant scrutiny due to their high and often increasing costs. From January 2022 to January 2023, the average price increase for prescription drugs was 15.2%, translating to an average increase of $590 per drug product. This trend is particularly relevant for multi-source drugs, which saw an average price increase of 26.0% during the same period[2].
Comparative Pricing
The pricing of amphetamine-based medications in the U.S. is notably higher compared to other regions. For instance, the average price per unit in the U.S. is 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world. This disparity is not just due to the prices of individual drugs but also because the U.S. market tends to skew towards more expensive drug compounds[3].
Market Size and Growth
The prescription drug market, including amphetamine-based medications, has seen significant growth in recent years. Between 2017 and 2022, the U.S. market experienced an average price increase of 14%, while the rest of the world and OECD (excluding the U.S.) saw decreases in average prices. The U.S. sales revenues for prescription drugs grew substantially, with biologic products showing a 61% growth rate during this period[3].
Regulatory and Policy Impacts
Recent policy changes and regulatory actions are likely to impact the pricing of prescription drugs, including those with NDC code 11534-189. The Biden-Harris Administration's initiatives, such as the Inflation Reduction Act, aim to lower prescription drug costs through Medicare price negotiations. These efforts are expected to save millions of seniors and other Medicare beneficiaries significant amounts in out-of-pocket costs. For example, the new prices announced for the first ten drugs selected for Medicare price negotiation are projected to save $1.5 billion in the first year alone[5].
Price Projections
Given the current trends and regulatory environment, here are some key points to consider for price projections:
Short-Term Projections
- Price Increases: Despite regulatory efforts to curb inflation, the historical trend suggests that prescription drug prices, including those for amphetamine-based medications, may continue to rise, albeit at a potentially slower rate due to ongoing policy changes.
- Average Increase: The average price increase for multi-source drugs, which includes the NDC 11534-189, could remain high, possibly in the range of 10-20% annually, though this may be mitigated by new pricing regulations.
Long-Term Projections
- Regulatory Impact: As more drugs are brought into Medicare price negotiations and other cost-control measures are implemented, the long-term price growth for these medications is likely to be more subdued.
- Market Competition: Increased competition from generic or biosimilar products could also drive prices down over the long term.
Key Takeaways
- High Pricing Disparity: The U.S. market for prescription drugs, including amphetamine-based medications, is characterized by significantly higher prices compared to other regions.
- Regulatory Changes: Ongoing and proposed regulatory changes, such as Medicare price negotiations, are expected to impact pricing trends.
- Market Growth: The prescription drug market continues to grow, with biologic products showing particularly strong growth.
- Price Projections: Short-term price increases are likely, but long-term projections suggest more moderate growth due to regulatory and competitive pressures.
FAQs
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What is the NDC code 11534-189 for?
- The NDC code 11534-189 is for a specific formulation of amphetamine-based medications, used to treat conditions like ADHD and narcolepsy.
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Why are prescription drug prices in the U.S. so high?
- Prescription drug prices in the U.S. are high due to various factors, including a drug mix that skews towards more expensive compounds and lack of price controls compared to other countries.
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How do regulatory changes impact prescription drug prices?
- Regulatory changes, such as Medicare price negotiations and cost-control measures, can significantly lower prescription drug prices by setting negotiated prices and capping out-of-pocket costs.
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What is the expected impact of the Inflation Reduction Act on prescription drug prices?
- The Inflation Reduction Act is expected to lower prescription drug costs through Medicare price negotiations, saving millions of dollars in out-of-pocket costs for beneficiaries.
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How does the U.S. market for prescription drugs compare to other regions?
- The U.S. market for prescription drugs is characterized by prices that are 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world.
Sources
- FDA Report - NDC 11534-190 - FDA.report
- ASPE Issue Brief - Changes in the List Prices of Prescription Drugs, 2017-2023
- ASPE Issue Brief - International Market Size and Prices
- PharmaCompass - NDC Code 11534-189-03 - Amphetamine
- White House Fact Sheet - Biden-Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation
