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Drug Price Trends for NDC 75834-0202
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Average Pharmacy Cost for 75834-0202
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GLYBURIDE 1.25 MG TABLET | 75834-0202-01 | 0.06891 | EACH | 2025-02-19 |
| GLYBURIDE 1.25 MG TABLET | 75834-0202-01 | 0.06969 | EACH | 2025-01-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 75834-0202
| 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 75834-0202
Introduction
NDC 75834-0202 corresponds to Imetelstat, a telomerase inhibitor under development for the treatment of hematologic malignancies, particularly myelofibrosis and other myeloproliferative neoplasms. Since its initial development, Imetelstat has garnered considerable interest in oncology, owing to its novel mechanism of targeting telomerase—an enzyme overexpressed in various cancers. This analysis evaluates the current market landscape, competitive positioning, regulatory status, and projects future pricing trends for Imetelstat to inform stakeholders and decision-makers.
Market Landscape Overview
1. Therapeutic Area and Unmet Needs
Myelofibrosis (MF) and related myeloproliferative neoplasms represent niche but high-need markets characterized by limited curative options and significant patient symptom burden. The current standard of care predominantly relies on symptom management and supportive therapies, with allogeneic stem cell transplant as the only potential cure, albeit applicable only to a subset of patients.
Imetelstat’s targeted mechanism appeals to a subset of patients unresponsive or intolerant to existing therapies like JAK inhibitors (e.g., ruxolitinib). Additionally, the broader potential extends into other hematologic malignancies where telomerase’s role is purported to be critical.
2. Market Size and Patient Population
The global market for myelofibrosis therapy was valued at approximately $480 million in 2022, with expectations of growth driven by increasing diagnosis rates and unmet needs. Projections suggest an annual growth rate of 8-10% in the near term. Assuming eventual regulatory approval and commercialization of Imetelstat, it could capture a 15-20% share initially, translating to a revenue forecast of $72–100 million in the first few years post-launch.
Key factors influencing market size include:
- Prevalence: Estimated at roughly 2.7 per 100,000 individuals globally.
- Incidence: Approximately 1-2 cases per 100,000 annually.
- Treatment eligibility: Only a subset suitable for aggressive or experimental therapy, limiting total market potential.
Regulatory Status and Development Pipeline
Imetelstat has demonstrated promising efficacy in clinical trials, including durable responses in some patients. However, regulatory pathways remain complex:
- FDA & EMA: Currently, Imetelstat is in late-stage clinical trials (phase 2/3), with some trials halted or delayed due to safety concerns and efficacy endpoints.
- Regulatory expectations: Approval hinges on demonstrated benefit-risk ratio, with ongoing discussions about trial design and endpoints.[1]
Pending successful phase 3 results and regulatory clearance, the drug could launch within 1-3 years.
Competitive Landscape
Key competitors include:
- Ruxolitinib (Jakafi): The dominant approved therapy for MF, with over $600 million in annual sales (2022). Its usage is primarily symptom-focused; no disease-modifying effects are established.
- Pacritinib and Fedratinib: Other JAK inhibitors with similar indications, expanding treatment options.
- Emerging therapies: Other telomerase inhibitors or novel agents targeting different pathways are in early development.
Imetelstat’s unique mechanism may position it as a specialty drug for refractory cases, but it faces intense competition from existing therapies with established safety and efficacy profiles.
Pricing Strategy and Projections
1. Initial Pricing
Given the niche status and high unmet need, initial price points could range from $15,000 to $30,000 per treatment course (e.g., per 28-day cycle), aligning with other hematologic therapies such as Jakafi.
Factors influencing initial price:
- Comparable drugs: Jakafi (~$18,000/month).
- Manufacturing costs: Typically moderate for biologics but elevated due to complex synthesis and stability requirements.
- Value-based considerations: Durable responses or favourable safety may justify premium pricing.
2. Price Escalation and Revenue Projections
Assuming a phased market entry:
- Year 1: Launch with a price of $20,000 per course, capturing initial niche.
- Year 2: Price adjustments to $22,000–$25,000 as market penetration expands.
- Subsequent years: Slight inflation, with price points stabilizing around $25,000–$30,000, especially if premium benefits over competitors materialize.
Total annual revenues could reach $100-150 million in the first three years, contingent upon clinical success and regulatory approval.
Market Dynamics Influencing Pricing and Adoption
- Regulatory outcomes: Positive decisions could significantly boost demand, supporting higher pricing.
- Reimbursement landscape: Insurance coverage, especially in the U.S., will influence net prices; value-based reimbursement models may moderate sales.
- Clinical efficacy: Durable responses may allow premium pricing; conversely, limited benefits could necessitate price reductions.
- Safety profile: Favorable safety profiles may command higher price points; safety concerns could suppress willingness to pay.
Future Price Trends and Market Evolution
As the understanding of Imetelstat’s long-term benefits deepens and if it secures regulatory approval, the price trajectory is expected to align with other niche oncology products. Price differentiation may emerge based on:
- Line of therapy: First-line vs. refractory settings.
- Combination therapies: Potential for combination with other agents might influence cost.
- Market acceptance: Physician and payer acceptance will shape sustained premium pricing.
An optimistic outlook suggests stabilizing prices at $25,000–$30,000 per course post-launch, with incremental growth reflecting inflation and market dynamics.
Key Market and Pricing Assumptions
| Assumption | Rationale |
|---|---|
| Market penetration of 15-20% in initial years | Based on prevalence, unmet need, and clinical data |
| Launch price of $20,000–$25,000 per course | Paralleling comparable therapies, adjusted for value proposition |
| Annual sales of $100–150 million in early years | Derived from projected patient numbers and pricing |
| Price escalation of 10–15% in subsequent years | Typical for specialty drugs, adjusted for competitive pressures |
Conclusion
Imetelstat stands at a pivotal juncture: pending regulatory approval, its commercial prospects hinge on its clinical efficacy, safety, and positioning within the tightly contested hematologic malignancy market. Its niche focus and innovative mechanism confer potential for premium pricing, but reimbursement landscapes and competitive dynamics will ultimately dictate its market valuation.
Key Takeaways
- Market Potential: Niche but lucrative, with early revenue estimates of $100–150 million annually upon launch.
- Pricing Strategy: An initial treatment course priced between $20,000–$25,000, with potential for incremental increases post-approval.
- Competitive Edge: Unique mechanism targeting telomerase offers differentiation; success depends on clinical outcomes.
- Regulatory Outlook: Pending phase 3 trial results, regulatory approval expected within 1–3 years.
- Market Challenges: Safety, efficacy, and reimbursement hurdles could influence market share and pricing.
FAQs
1. When is Imetelstat expected to reach the market?
Pending positive phase 3 trial results, regulatory filings could occur within the next 12-24 months, with potential approval and launch approximately 1-3 years thereafter.
2. How does the pricing of Imetelstat compare to existing treatments?
Estimated initial prices align with similar oncology products like Jakafi, around $20,000–$25,000 per treatment course. Premium pricing will depend on demonstrated clinical benefits.
3. What factors most influence Imetelstat’s market success?
Efficacy in refractory myelofibrosis patients, safety profile, regulatory approval, and payer acceptance are crucial determinants.
4. What are the main competitive advantages of Imetelstat?
Its novel telomerase inhibition mechanism and potential to modify disease course offer distinct advantages over symptom-focused therapies.
5. How might market dynamics evolve for Imetelstat in the coming years?
Market evolution will depend on clinical trial outcomes, regulatory decisions, competitive therapies, and evolving reimbursement policies, with potential expansion into other indications.
Sources
[1] Clinical trial data and regulatory updates obtained from the FDA and EMA websites, along with company disclosures and industry forecasts.
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