Introduction
Piperacillin and Tazobactam, a combination antibiotic consisting of a penicillin-class antibacterial and a β-lactamase inhibitor, is widely used for treating various infections, including intra-abdominal, nosocomial pneumonia, skin and skin structure infections, and more. This analysis will delve into the market dynamics, current pricing, and potential price projections for this drug, specifically focusing on the NDC 00409-3385.
Market Demand and Usage
Piperacillin and Tazobactam is a critical antibiotic in the treatment of gram-negative infections. The demand for this drug is consistent due to its broad spectrum of activity and the increasing prevalence of antibiotic-resistant bacteria. According to the FDA, the drug is indicated for several infections, including intra-abdominal infections, nosocomial pneumonia, and skin and skin structure infections[3].
Current Pricing and Availability
The NDC 00409-3385 corresponds to a package of 10 vials, each containing 3.375 grams of Piperacillin and Tazobactam, manufactured by Pfizer. The current pricing for this drug can vary based on several factors, including the supplier, distribution channel, and geographical location.
As of recent reports, the pricing for generic and brand-name versions of Piperacillin and Tazobactam has seen fluctuations. For instance, the median price increase for generic drugs in 2022 was 19.9%, while brand-name drugs saw a median increase of 13.4%[2].
Supply Chain and Manufacturers
The market for Piperacillin and Tazobactam is supplied by multiple manufacturers, including Pfizer, Athenex, Fresenius Kabi, Sagent, Sandoz, and others. This diversity in suppliers helps maintain a relatively stable supply chain, although shortages can occur due to various reasons such as manufacturing issues or increased demand[1].
Regulatory Environment
The pricing and availability of Piperacillin and Tazobactam are influenced by regulatory environments. For example, Oregon’s Prescription Drug Price Transparency Act requires pharmaceutical manufacturers to report price increases and new high-cost drugs. This transparency helps in understanding the factors influencing drug prices and can lead to policy changes aimed at making drugs more affordable[2].
Price Transparency and Affordability
The issue of drug affordability is a significant concern. A substantial portion of Americans report not taking their medications as prescribed due to cost, with 29% of Americans skipping doses or using alternative medications[2].
Breakpoints and Clinical Efficacy
Recent revisions by the Clinical and Laboratory Standards Institute (CLSI) and approved by the FDA have updated the breakpoints for Piperacillin and Tazobactam, particularly for Enterobacterales. These updates are based on pharmacokinetic-pharmacodynamic (PK-PD) data and clinical outcomes, ensuring that the drug is used effectively and safely[3].
Price Projections
Given the current market trends and regulatory environment, here are some key points to consider for price projections:
Inflation and Market Trends
- The median price increase for generic drugs was 19.9% in 2022, and for brand-name drugs, it was 13.4%. This trend may continue, leading to potential price increases for Piperacillin and Tazobactam[2].
Regulatory Impact
- Efforts to enhance price transparency and implement measures like upper payment limits could stabilize or reduce prices. However, the effectiveness of these measures is yet to be fully tested[2].
Supply Chain Stability
- With multiple manufacturers supplying the market, the risk of significant price spikes due to supply chain disruptions is mitigated. However, any major disruption could lead to temporary price increases[1].
Clinical Demand
- The consistent demand for this antibiotic due to its clinical efficacy and the need to combat antibiotic-resistant bacteria will likely maintain or increase its market value.
Key Takeaways
- Market Demand: Consistent demand due to the drug's broad spectrum of activity.
- Current Pricing: Varies based on supplier and distribution channel, with recent median price increases of 19.9% for generics and 13.4% for brand-name drugs.
- Regulatory Environment: Price transparency acts and potential upper payment limits could impact pricing.
- Supply Chain: Multiple manufacturers help maintain supply stability.
- Clinical Efficacy: Updated breakpoints ensure effective and safe use.
FAQs
-
What is the current NDC for Piperacillin and Tazobactam manufactured by Pfizer?
- The NDC is 00409-3385, corresponding to a package of 10 vials, each containing 3.375 grams of Piperacillin and Tazobactam[4].
-
Why are there price fluctuations for Piperacillin and Tazobactam?
- Price fluctuations can be due to various factors including inflation, regulatory changes, supply chain issues, and market demand[2].
-
What are the updated breakpoints for Piperacillin and Tazobactam?
- The updated breakpoints include a susceptible breakpoint of ≤ 8 mcg/mL and a resistant breakpoint, with specific dosing regimens to ensure optimal efficacy[3].
-
How does the regulatory environment impact the pricing of Piperacillin and Tazobactam?
- Regulatory measures such as price transparency acts and potential upper payment limits can influence pricing by providing more transparency and potentially stabilizing or reducing prices[2].
-
What is the impact of supply chain stability on the pricing of Piperacillin and Tazobactam?
- A stable supply chain, maintained by multiple manufacturers, helps in preventing significant price spikes due to supply disruptions[1].
Sources
- ASHP: Drug Shortage Detail: Piperacillin and Tazobactam Injection.
- Oregon Drug Price Transparency Program: Prescription Drug Price Transparency Results and Recommendations - Annual Report 2022.
- FDA: Piperacillin-Tazobactam Breakpoints for Enterobacterales.
- NDC List: NDC Package 0409-3385-13 Piperacillin And Tazobactam.
