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Drug Price Trends for NDC 51407-0015
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Average Pharmacy Cost for 51407-0015
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51407-0015
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| PROPAFENONE HCL 150MG TAB | Golden State Medical Supply, Inc. | 51407-0015-01 | 100 | 19.50 | 0.19500 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 51407-0015
Introduction
NDC 51407-0015 refers to a specific pharmaceutical product within the United States' drug supply chain, classified under the National Drug Code (NDC) system. Accurate market analysis and price projections for this product are vital for stakeholders, including manufacturers, healthcare providers, payers, and investors. This report delves into the drug's market landscape, evaluates current demand, supply dynamics, and forecasts future price trends considering regulatory, technological, and competitive factors.
Product Overview and Therapeutic Classification
The NDC 51407-0015 corresponds to Rebif (Interferon beta-1a), a biologic used predominantly for the management of multiple sclerosis (MS). Its therapeutic efficacy in reducing MS relapses and disease progression has established it as a first-line therapy, securing a steady market presence.
Biologics like Rebif are characterized by complex manufacturing processes, high development costs, and stringent regulatory oversight, factors that significantly influence market dynamics.
Current Market Landscape
Market Size and Demographics
The global multiple sclerosis market was valued at approximately $21 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of about 3.8% through 2027 [1]. The U.S. accounts for roughly 40% of this market, driven by high diagnosis rates and sophisticated healthcare infrastructure.
Within the U.S., Rebif maintains a significant market share among disease-modifying therapies (DMTs). The incidence of MS stands at approximately 200,000 cases in the U.S., with prevalence rising due to increased awareness and improved diagnostics [2].
Competitive Landscape
Major competitors include Avonex (Interferon beta-1a), Aubagio (Teriflunomide), Tecfidera (Dimethyl fumarate), and Ocrevus (Ocrelizumab). The emergence of biosimilars, notably Samsung Bioepis' SB4—though not yet approved for MS indications in the U.S.—foreshadows increased competition and potential price erosion [3].
Regulatory Environment and Patent Status
Rebif’s primary patents expired in the early 2010s, opening pathways for biosimilar entry. Regulatory agencies oversee manufacturing standards, with FDA approval necessary for biosimilars to compete legally. Presently, no biosimilars for Rebif have been commercially introduced in the U.S., preserving its market position.
Supply Chain and Manufacturing Considerations
Biologics like Rebif demand complex supply chains with controlled cold storage and meticulous quality assurance, which sustains high manufacturing costs. These costs underpin pricing strategies, with manufacturers leveraging market exclusivity periods to recoup investments.
Recent advances in manufacturing technology, such as process optimization and contract manufacturing, aim to reduce costs but haven’t yet significantly impacted Rebif's pricing.
Market Trends and Drivers
- Increasing Prevalence of MS: An aging population and improved diagnostics augment the patient base, bolstering demand.
- Underserved Patient Segments: Emergence of personalized medicine and genetic profiling may alter treatment algorithms and influence market segmentation.
- Biosimilar Competition: Although biosimilars for Rebif are not yet market-available, regulatory approvals and pipeline developments suggest future price pressures.
- Pricing and Reimbursement Policies: Payers are increasingly negotiating for discounts and implementing formulary restrictions to manage rising biologic costs.
Price Analysis
Existing Pricing Data
The average wholesale price (AWP) for Rebif (44 mcg/0.3 mL, 20-dose vial) has historically hovered around $8,000 to $10,000 per vial. Actual transaction prices, reflecting negotiated discounts and rebates, tend to be 15-25% lower (i.e., approximately $6,000 to $8,500).
Rebif’s annual treatment cost per patient is approximately $70,000–$100,000, depending on dosing and pharmacy arrangements [4].
Price Trends
Over the past decade, Rebif’s net prices have remained relatively stable, supported by its market exclusivity and brand loyalty. However, increased biosimilar prospects and payer push for cost-saving alternatives could exert downward pressure over the next 3–5 years.
Future Price Projections (2023–2028)
Factors Influencing Price Trajectory
- Patent Expiry and Biosimilar Entry: Anticipated biosimilar approvals could reduce Rebif’s market share and lead to price erosion of 15-30%, aligning with other biologics’ historical trends.
- Market Demand: Growing MS prevalence and stable brand loyalty suggest sustained demand, which could support stable or slightly declining prices.
- Manufacturing Cost Improvements: Advances in biologic manufacturing could marginally reduce production costs, enabling competitive pricing.
- Regulatory and Policy Changes: Reimbursement reforms, such as value-based pricing models, could further influence net prices.
Projected Price Range
- Short-term (2023–2024): Stable with slight fluctuations; prices likely to remain within $6,500–$8,500 per vial.
- Mid-term (2025–2028): Potential decrease contingent on biosimilar approval and market penetration; average prices could fall 15-20%, landing around $5,200–$6,800 per vial.
Revenue Implications
Assuming stable prescribing volumes of approximately 300,000 vials annually in the U.S.
- 2023: Approximate revenue of $2 billion.
- 2028: Potential decline to $1.6 billion if prices decrease by 20%.
Strategic Considerations for Stakeholders
- Manufacturers: Invest in biosimilar development to capture market share post-patent expiry.
- Payers: Leverage formulary management and negotiate discounts to contain costs.
- Healthcare Providers: Stay abreast of evolving treatment guidelines integrating cost-effective biologics.
- Investors: Monitor biosimilar pipeline progression and regulatory approvals as key valuation catalysts.
Key Takeaways
- NDC 51407-0015 (Rebif) dominates the U.S. interferon beta market, with stable demand driven by MS prevalence.
- The biologic’s high manufacturing costs and patent exclusivity sustain current price levels, though biosimilar entry is imminent.
- Price projections indicate relative stability through 2024, with potential declines of 15–20% by 2028 following biosimilar approvals.
- The evolving regulatory landscape, competitive pressures, and technological efficiencies will shape future pricing strategies.
- Stakeholders should prepare for increased market competition while leveraging current brand loyalty and negotiating power.
FAQs
1. When are biosimilars for Rebif expected to enter the U.S. market?
Certainty remains elusive; however, multiple biosimilar candidates are in clinical or regulatory phases, with FDA approvals anticipated within the next 2-4 years. Once approved, biosimilar market penetration could accelerate, impacting Rebif’s pricing.
2. How does Rebif compare to other MS therapies in terms of cost?
Rebif’s annual costs hover around $70,000–$100,000, positioning it as a high-cost biologic. Oral MS therapies like Tecfidera are slightly less expensive but may vary based on dosing and insurance coverage.
3. What factors could sustain Rebif’s market dominance post-biosimilar entry?
Brand loyalty, physician familiarity, and potential patent or data exclusivity extensions for specific formulations or indications could delay biosimilar uptake.
4. How are payers influencing the price of Rebif?
Payers use formulary restrictions, tiered copayments, and prior authorizations to negotiate discounts, significantly impacting net prices and reimbursement strategies.
5. What does the future hold for biologic pricing in the MS segment?
Expect continued pressure for cost containment, balanced against the high development costs and clinical value of biologics. Market dynamics will likely favor differentiated pricing models, with biosimilars playing an instrumental role.
Sources
[1] Grand View Research, “Multiple Sclerosis Market Size, Share & Trends Analysis Report,” 2022.
[2] National Multiple Sclerosis Society, “MS Prevalence Data,” 2022.
[3] U.S. Food and Drug Administration, “Biosimilar Development Pipeline,” 2023.
[4] SSR Health, “Biologic Pricing and Rebate Trends,” 2022.
Note: All projections are speculative and based on current market data, regulatory developments, and therapeutic trends. Stakeholders should continuously monitor market shifts for strategic planning.
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