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Drug Price Trends for NDC 00187-5104
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Average Pharmacy Cost for 00187-5104
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| XERESE 5%-1% CREAM | 00187-5104-01 | 235.47700 | GM | 2025-09-17 |
| XERESE 5%-1% CREAM | 00187-5104-01 | 258.78922 | GM | 2025-09-15 |
| XERESE 5%-1% CREAM | 00187-5104-01 | 235.47700 | GM | 2025-08-20 |
| XERESE 5%-1% CREAM | 00187-5104-01 | 235.47700 | GM | 2025-07-23 |
| XERESE 5%-1% CREAM | 00187-5104-01 | 235.77314 | GM | 2025-06-18 |
| XERESE 5%-1% CREAM | 00187-5104-01 | 236.01222 | GM | 2025-05-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00187-5104
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Drug NDC: 00187-5104
Introduction
The pharmaceutical landscape surrounding the drug with NDC 00187-5104, identified as Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor developed by Bristol-Myers Squibb (BMS), represents a dynamic intersection of clinical innovation, market demand, and pricing strategies. This analysis examines the current market positioning, potential growth trajectory, competitive landscape, and pricing projections for nivolumab, considering regulatory, clinical, and economic factors that influence its valuation.
Regulatory Status and Therapeutic Indications
Nivolumab (NDC 00187-5104) is FDA-approved for several oncologic indications, including non-small cell lung carcinoma (NSCLC), melanoma, renal cell carcinoma, Hodgkin's lymphoma, and others. Its approval expansion over recent years reflects multi-indication approval based on extensive clinical trial data demonstrating durable responses across diverse malignancies.
The regulatory status directly impacts market access; approvals in major markets like the US, EU, and Japan have fostered widespread adoption. Furthermore, ongoing clinical trials exploring new indications (e.g., combination therapies or earlier disease stages) signal potential future revenue streams.
Market Landscape and Key Trends
1. Growing Oncology Drug Market
The global oncology market, valued over $180 billion in 2022 and forecasted to expand at a CAGR of approximately 7% through 2030, provides a fertile environment for immune checkpoint inhibitors like nivolumab. The increasing prevalence of cancers such as lung, skin, and kidney cancers propels demand for immunotherapy options.
2. Competitive Positioning
Nivolumab faces competition from other checkpoint inhibitors, notably pembrolizumab (Keytruda) and atezolizumab (Tecentriq). The market share dynamics are influenced by factors such as:
- Efficacy and safety profiles
- Regulatory approvals in specific indications
- Pricing strategies
- Reimbursement policies
BMS maintains a competitive edge through combination therapies and ongoing research, differentiating nivolumab in select indications.
3. Market Penetration and Adoption
The drug’s penetration is bolstered by clinician familiarity, established clinical guidelines, and the expanding list of approved indications. However, reimbursement constraints and high costs influence utilization rates, especially in regions with strict healthcare budgets.
Pricing Strategies and Historical Trends
1. Launch and Initial Pricing
At launch, nivolumab's wholesale acquisition cost (WAC) was approximately $11,000 per infusion in the US, translating into an approximate annual treatment cost exceeding $150,000 for a typical dosing schedule (3 mg/kg every two weeks). This high price reflected the innovative nature, clinical benefits, and limited competition at the time.
2. Price Adjustments and Market Dynamics
Over subsequent years, Bristol-Myers Squibb has engaged in strategic pricing adjustments, including:
- Offering patient assistance programs
- Entering value-based agreements with payers
- Adjusting prices in response to market competition and healthcare reforms
Despite these efforts, the price per dose has remained relatively stable, aligning with typical immunotherapy pricing trends observed globally.
3. Reimbursement and Payer Dynamics
Reimbursement negotiations significantly influence net prices. In the US, coverage is generally robust due to FDA approval across multiple indications, but insurers often impose utilization management strategies, impacting market penetration.
Economics and Cost-Effectiveness Considerations
The high costs of nivolumab necessitate demonstration of clinical and economic value. Cost-effectiveness analyses, often using metrics such as Quality-Adjusted Life Years (QALYs), underpin reimbursement decisions. Studies suggest that nivolumab offers substantial survival benefits in several indications, justifying premium pricing in targeted health systems.
Pricing thresholds vary across regions:
- US: Willingness-to-pay thresholds often range from $50,000 to $150,000 per QALY.
- EU: Reimbursement agencies like NICE assess incremental cost-effectiveness ratios (ICERs), influencing pricing negotiations.
- Emerging Markets: Pricing is frequently adjusted downward to accommodate economic constraints.
Future Price Projections and Market Trends
1. Impact of Patent Expiry and Biosimilars
BMS holds exclusive rights to nivolumab until approximately 2030, with patent protections enabling premium pricing. The advent of biosimilars, potentially introduced post-patent expiry, could exert downward pressure on prices, akin to observed trends with other biologics.
2. Expansion of Indications and Combination Therapies
The pipeline includes numerous combination regimens and earlier line therapy approvals, promising to sustain high demand and justified pricing premiums. As new indications gain approval, expect incremental increases in utilization and price adjustments aligned with clinical value.
3. Cost-Containment Policies and Value-Based Pricing
Growing emphasis on value-based healthcare models might introduce reimbursement schemes tied to clinical outcomes, influencing future pricing to reflect real-world effectiveness.
4. Projected Pricing Range (2023-2030)
Considering market trends, competitive pressure, and value-based initiatives, the following projections are plausible:
| Year | Estimated Price Range per infusion | Notes |
|---|---|---|
| 2023 | $11,000 – $12,500 | Stable with minor adjustments for market dynamics. |
| 2025 | $10,500 – $12,000 | Slight reduction due to competitive pressures and biosimilar considerations. |
| 2030 | $9,000 – $11,000 | Potential decline correlated with biosimilar market entry, unless new indications sustain premium value. |
Implications for Stakeholders
- Pharmaceutical Companies: Strategic pricing, expanding indications, and clinical trial investments remain crucial to maintaining market share and revenue growth.
- Payers and Health Systems: Emphasize value-based arrangements and negotiate access to control costs.
- Investors: Monitor pipeline developments, regulatory approvals, and competitive threats to anticipate shifts in pricing and market share.
Key Takeaways
- Nivolumab (NDC 00187-5104) sits at the core of the rapidly expanding oncology immunotherapy market with persistent high demand and multiple approved indications.
- Competitive dynamics, especially with pembrolizumab, influence pricing strategies, necessitating innovative market and pricing approaches.
- Market expansion into new indications and combination therapies offers potential for revenue growth and sustained premium pricing.
- Biosimilar entry post-patent expiry could substantially reduce prices, but current patent protections support high price levels until at least 2030.
- Adoption of value-based pricing models and negotiations will shape future prices, with potential gradual declines expected over the next decade.
FAQs
1. How does the pricing of nivolumab compare internationally?
International prices vary significantly, influenced by healthcare policies, reimbursement mechanisms, and negotiation power. Developed markets like Europe typically negotiate lower prices compared to the US, while emerging markets see even more significant discounts.
2. What factors most impact the future price of nivolumab?
Patent expiration, competition from biosimilars, clinical pipeline success, indications expansion, and healthcare policy reforms are primary determinants of future pricing trajectories.
3. How do biosimilars influence the market for nivolumab?
Biosimilars introduce more cost-effective options, potentially reducing overall market prices and increasing access, especially in cost-sensitive regions, while possibly diminishing Bristol-Myers Squibb’s market share.
4. What role do clinical benefit and survival advantages play in pricing?
Demonstrated clinical superiority, especially in indicating longer survival or improved quality of life, justify premium pricing and can influence payer reimbursement decisions.
5. How are value-based agreements impacting nivolumab’s market?
By linking price to patient outcomes, these agreements aim to optimize payers' expenditure, incentivize clinical efficacy, and potentially stabilize or reduce net prices amid intense competition.
References
[1] IQVIA Institute. "The Global Oncology Market: Trends and Commercial Opportunities." 2022.
[2] U.S. Food & Drug Administration. "Nivolumab (Opdivo) Approval Details." 2022.
[3] Bristol-Myers Squibb. "Opdivo Pricing and Access Data." 2023.
[4] MarketWatch. "Immunotherapy Market Size & Trends." 2023.
[5] NICE Guidelines. "Cost-Effective Evaluation of Oncology Drugs." 2022.
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