Introduction
XTAMPZA ER, with the National Drug Code (NDC) 24510-110, is an extended-release oral capsule containing oxycodone, a full opioid agonist. It is marketed by Collegium Pharmaceutical, Inc. and was approved by the FDA on May 10, 2016. Here, we will delve into the market analysis and price projections for this medication.
Market Overview
The opioid market, while controversial due to the opioid crisis, remains significant due to the ongoing need for pain management. XTAMPZA ER is positioned as a treatment for severe pain that requires long-term opioid therapy.
Competitive Landscape
The opioid market is highly competitive, with several other extended-release formulations available. However, XTAMPZA ER has a unique formulation designed to deter abuse by making it more difficult to crush or dissolve, which can be a competitive advantage[1].
Pricing and Reimbursement
Current Pricing
As of the latest data, the pricing for XTAMPZA ER is not explicitly mentioned in the sources provided. However, it is known that opioid medications, especially extended-release formulations, can be costly.
Medicare Drug Price Negotiation Program
The Medicare Drug Price Negotiation Program, part of the Inflation Reduction Act, aims to reduce prescription drug costs for Medicare beneficiaries. While XTAMPZA ER is not listed among the initial drugs selected for negotiation, future cycles of negotiations could potentially impact its pricing if it is selected[2].
Price Transparency and Reporting
State-Level Transparency
State-level initiatives, such as Oregon's Prescription Drug Price Transparency Act, require pharmaceutical manufacturers to report on new drugs costing more than $670 per month and annual price increases exceeding 10%. This transparency can help in understanding the pricing dynamics and potential future adjustments[3].
Factors Influencing Pricing
Regulatory Changes
The FDA's potential changes to the National Drug Code (NDC) system, such as transitioning from 5-digit to 6-digit labeler codes, could have broad implications for the pharmaceutical industry, including costs associated with updating systems. However, this is more of a structural change rather than a direct price influencer[4].
Market Forces
- Demand and Supply: The demand for opioid medications, particularly those with abuse-deterrent properties, can influence pricing.
- Competition: The presence of other extended-release opioid formulations affects the pricing strategy for XTAMPZA ER.
- Regulatory Environment: Stricter regulations and transparency requirements can impact pricing strategies.
Price Projections
Short-Term Projections
In the short term, prices for XTAMPZA ER are likely to remain stable unless it is selected for the Medicare Drug Price Negotiation Program or other significant regulatory changes occur. The current pricing will be influenced by the existing market dynamics and competition.
Long-Term Projections
Long-term price projections are more uncertain and will depend on several factors:
- Regulatory Changes: Future negotiations under the Medicare Drug Price Negotiation Program could significantly reduce prices if XTAMPZA ER is selected.
- Market Competition: New entrants into the market with similar or better formulations could drive prices down.
- Economic Factors: General economic conditions, such as inflation and healthcare spending trends, will also play a role.
Impact of Medicare Negotiations
If XTAMPZA ER were to be selected for the Medicare Drug Price Negotiation Program, the prices could be significantly reduced, similar to the savings seen with other drugs in the program. For example, drugs like Januvia and Farxiga saw price reductions of 79% and 68%, respectively, from their 2023 list prices[2].
Consumer and Payer Impact
Savings for Medicare Beneficiaries
If prices are negotiated under the Medicare program, beneficiaries can expect significant savings, similar to the estimated $1.5 billion in savings projected for the first cycle of negotiations[2].
Health Insurance and Pharmacy Impact
Health insurance companies and pharmacies will need to adjust their formularies and pricing structures to reflect any negotiated prices. This could lead to lower out-of-pocket costs for patients and reduced overall healthcare spending.
Key Takeaways
- Market Position: XTAMPZA ER holds a unique position in the opioid market with its abuse-deterrent formulation.
- Pricing Stability: Short-term prices are likely to remain stable unless significant regulatory changes occur.
- Regulatory Impact: Future inclusion in the Medicare Drug Price Negotiation Program could lead to substantial price reductions.
- Market Dynamics: Competition and demand will continue to influence pricing strategies.
FAQs
-
What is XTAMPZA ER used for?
XTAMPZA ER is used for the management of severe pain that requires long-term opioid therapy.
-
Who manufactures XTAMPZA ER?
XTAMPZA ER is manufactured and marketed by Collegium Pharmaceutical, Inc.[1].
-
How does the Medicare Drug Price Negotiation Program affect XTAMPZA ER?
If selected, the program could significantly reduce the price of XTAMPZA ER, similar to other drugs in the program[2].
-
What are the potential long-term price projections for XTAMPZA ER?
Long-term prices will depend on regulatory changes, market competition, and economic factors. Significant reductions are possible if the drug is selected for Medicare negotiations.
-
How does state-level price transparency affect XTAMPZA ER pricing?
State-level transparency initiatives help in understanding pricing dynamics but do not directly set prices. They can influence future pricing adjustments by providing more visibility into cost factors[3].
Sources
- FDA Report: NDC 24510-110 Oral Capsule, Extended Release XTAMPZA ER...
- CMS Fact Sheet: Medicare Drug Price Negotiation Program
- Oregon Drug Price Transparency Report: Prescription Drug Price Transparency Results and Recommendations
- Wolters Kluwer Insight: Are You Prepared for a Major Industry Change to the National Drug Code (NDC) Number?
