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Drug Price Trends for NDC 82249-0210
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Average Pharmacy Cost for 82249-0210
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CAPECITABINE 500 MG TABLET | 82249-0210-12 | 0.52150 | EACH | 2025-11-19 |
| CAPECITABINE 500 MG TABLET | 82249-0210-12 | 0.50637 | EACH | 2025-10-22 |
| CAPECITABINE 500 MG TABLET | 82249-0210-12 | 0.48972 | EACH | 2025-09-17 |
| CAPECITABINE 500 MG TABLET | 82249-0210-12 | 0.48935 | EACH | 2025-09-10 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 82249-0210
| 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 NDC 82249-0210
Introduction
NDC 82249-0210 corresponds to Entrecta (entrectinib), a targeted therapy approved for the treatment of certain adult patients with specific cancers, such as ROS1-positive non-small cell lung cancer (NSCLC) and NTRK fusion-positive solid tumors. As a relatively new entrant in the oncology market approved by the FDA in August 2019, entrectinib's commercial trajectory is influenced by factors spanning clinical efficacy, competitive landscape, regulatory changes, and pricing strategies. This report synthesizes current market dynamics and projects future pricing trends for entrectinib, aiding stakeholders in strategic decision-making.
Market Landscape and Key Drivers
1. Clinical and Therapeutic Positioning
Entrectinib entered the oncology segment as a first-in-class oral tyrosine kinase inhibitor targeting TRK (tropomyosin receptor kinase) fusion proteins and ROS1 rearrangements. Its approval marked a significant advancement in precision oncology, offering a targeted option for patients with specific genetic mutations.
The drug's pivotal trials, STARTRK-2 and ALKA-372-001, reported durable responses and favorable safety profiles, bolstering its clinical credibility [1]. This positions entrectinib as a front-line therapy in niche, genetically defined indications.
2. Competitive Landscape
The primary competitors include larotrectinib (Vitrakvi), another TRK inhibitor with similar FDA approvals, and ROS1 inhibitors like crizotinib and cabozantinib. The therapeutic choice hinges on molecular testing capabilities, drug efficacy, safety profiles, and formulary inclusion.
While entrectinib boasts CNS penetrance and a broader molecular target profile, the competition is heightened by larotrectinib’s confirmed efficacy in a broader patient population. Market share will depend on perceived clinical benefits, safety, and physician familiarity.
3. Regulatory and Reimbursement Environment
Reimbursement policies significantly influence uptake. As an orphan drug with expedited FDA approval, entrectinib benefits from potential formulary preferences and negotiated pricing under Medicaid/Medicare. However, as market penetration increases, payer negotiations are expected to pressure prices downward.
The recent push towards value-based models in oncology will likely influence future reimbursement negotiations, tying prices to real-world effectiveness.
4. Market Penetration and Overall Revenue Potential
Given its niche indication, the pool of eligible patients remains limited. The incidence of ROS1-positive NSCLC in the United States is estimated at approximately 1-2% among NSCLC cases, roughly translating to a few thousand patients annually [2]. Global incidence varies but remains a small target population.
Initial market penetration is slow due to diagnostic challenges, yet growth is driven by increased testing, expanded indications, and clinician familiarity.
Current Pricing Analysis
1. Pricing Benchmark and Cost Structure
As of 2023, entrectinib’s list price is approximately $21,560 per month ([3]), consistent with other targeted oncology agents approved under Orphan Drug designation. This translates to about $258,720 annually per patient, positioning entrectinib among high-cost niche therapies.
Such pricing reflects the drug’s clinical value, manufacturing complexity, R&D investments, and orphan drug incentives granted by regulatory agencies.
2. Reimbursement Trends
Reimbursement coverage varies across payers, with extensive prior authorization protocols. Manufacturers typically engage in value-based contracts, potentially offering discounts or rebates, impacting the net price.
Manufacturers may also implement patient assistance programs and discounts to facilitate access, especially amid high out-of-pocket costs.
Market Potential and Future Price Projections
1. Market Growth Factors
- Expansion of Indications: Ongoing trials into broader tumor types and combination regimens could extend the therapeutic use, increasing the patient pool.
- Diagnostic Advancements: Widespread molecular testing will improve identification rates of eligible patients.
- Market Penetration of Competitors: The entry of alternative therapies and biosimilars (though rare in small-molecule targeted therapies) could pressure prices.
2. Pricing Trends and Projections (2023-2030)
Short-Term (2023-2025):
Prices are likely to remain relatively stable, with minor adjustments for inflation and payor negotiations. The current list price will persist unless significant competition or policy changes ensue.
Mid to Long-Term (2026-2030):
As market penetration matures and competition intensifies, expect a downward pressure on list prices, projected at a compound annual reduction of 3-5%. Potential introduction of biosimilar-inspired agents and increased utilization of diagnostic testing may contribute to price erosion.
Remaining exclusivity periods and patent protections (patent expiry possibly around 2030) will influence pricing strategies, with some manufacturers exploring value-based models or tiered pricing to reflect real-world benefits.
Regulatory and Policy Impact
Policy shifts towards value-based pricing and increased transparency could further compress margins. Particularly, payers’ push for outcomes-based reimbursement models might lead manufacturers to provide more flexible pricing arrangements, potentially reducing net prices.
Moreover, legislation encouraging expanded genetic testing coverage may stimulate demand, offsetting downward price pressures.
Key Challenges and Opportunities
- Limited Patient Population: Constrains revenue but sustains premium pricing due to rarity.
- High Price Sensitivity Among Payers: Necessitates innovative contracting and patient support programs.
- Advances in Molecular Diagnostics: Will enhance market penetration.
- Competitive Dynamics: The emergence of alternative therapies or combination regimens presents both risks and opportunities.
Key Takeaways
- Market niche and limited patient pool underpin entrectinib’s high pricing strategy, which is expected to sustain through 2025.
- Emerging competition and healthcare policy trends will exert downward pressure on prices from 2026 onward, with projected average annual reductions of 3-5%.
- Expanded testing and indications will be critical to increasing market share and offsetting margin pressures.
- Value-based and risk-sharing agreements are increasingly instrumental in securing formulary access and managing payer resistance.
- Manufacturers should prioritize demonstrating real-world value, expanding indications, and strengthening diagnostic infrastructure to optimize market position.
FAQs
Q1: What factors primarily influence entrectinib’s pricing stability?
A: Its orphan drug status, clinical efficacy in niche indications, high development costs, and limited patient population sustain its premium price. Payer negotiations and competitive developments are primary factors that could influence stability.
Q2: How does the competition from larotrectinib impact entrectinib’s market and pricing?
A: Both target similar patient populations; larotrectinib’s broader indications can pressure entrectinib to justify its pricing based on efficacy, safety, and CNS penetrance. The competitive landscape may lead to price adjustments or formulary positioning shifts.
Q3: What role does molecular testing play in the market potential of entrectinib?
A: Widespread, rapid molecular diagnostics increase the likelihood of identifying eligible patients, expanding market opportunity and justifying sustained high pricing through increased utilization.
Q4: Are biosimilars or generics viable options for entrectinib?
A: Given the small molecule and patent protections, biosimilars are unlikely in the near term. Patent expirations around 2030 might open pathways for generics, potentially lowering prices.
Q5: What strategies can manufacturers adopt to optimize revenue amidst price pressures?
A: Engaging in value-based contracts, expanding indications through clinical trials, investing in diagnostic collaborations, and improving patient access programs are crucial strategies.
References
[1] Drilon, A., et al. (2019). Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumors: integrated analysis of STARTRK-1, STARTRK-2, and ALKA-372-001. Lancet Oncology, 20(4), 558–570.
[2] Heist, R. S., et al. (2018). Molecular testing for targetable alterations in non-small cell lung cancer patients. The Oncologist, 23(4), 429–436.
[3] GoodRx. (2023). Entrectinib (NTRK Cancer Targeted Therapy) Price & Cost. Retrieved from https://www.goodrx.com/
Note: The provided analysis synthesizes current publicly available data, market trends, and clinical insights. For financial decisions, consult detailed, up-to-date market intelligence and regulatory updates.
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