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Drug Price Trends for NDC 00075-0622
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Average Pharmacy Cost for 00075-0622
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00075-0622
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| LOVENOX INJECTION | Sanofi Aventis U.S. LLC | 00075-0622-80 | 10 | 26.28 | 2.62800 | 2023-06-01 - 2028-05-31 | Big4 |
| LOVENOX INJECTION | Sanofi Aventis U.S. LLC | 00075-0622-80 | 10 | 57.62 | 5.76200 | 2023-06-01 - 2028-05-31 | FSS |
| LOVENOX INJECTION | Sanofi Aventis U.S. LLC | 00075-0622-80 | 10 | 7.99 | 0.79900 | 2024-01-01 - 2028-05-31 | Big4 |
| LOVENOX INJECTION | Sanofi Aventis U.S. LLC | 00075-0622-80 | 10 | 57.62 | 5.76200 | 2024-01-01 - 2028-05-31 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00075-0622
Introduction
The healthcare landscape continually evolves with the development, approval, and commercialization of new pharmacological agents. Understanding market dynamics and price trajectories for specific drugs is essential for stakeholders ranging from pharmaceutical companies to healthcare providers and investors. This report provides an in-depth analysis of the market environment and price projections specifically related to the drug identified by the National Drug Code (NDC) 00075-0622.
Overview of NDC 00075-0622
NDC 00075-0622 corresponds to Ocrevus (Ocrelizumab), a monoclonal antibody biologic developed by Roche for the treatment of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). Ocrevus was approved by the U.S. Food and Drug Administration (FDA) in March 2017 for relapsing forms of MS and later expanded for PPMS.
This drug has become significant in the MS treatment landscape, particularly due to its targeted mechanism and efficacy in slowing disease progression. As a biologic, its manufacturing complexity and therapeutic efficacy underpin its positioning in a high-value, growing niche within neurology.
Market Dynamics
1. Market Size and Growth Potential
Multiple sclerosis affects approximately 2.8 million people worldwide, with an estimated 1 million in the U.S. alone. The global MS market has been expanding, driven by increased diagnosis rates, evolving treatment paradigms, and the introduction of novel therapies. The U.S. MS market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.6% from 2022 to 2027, reaching an estimated $9 billion, according to industry reports (e.g., IQVIA).
Ocrevus commands a significant share of this market given its efficacy profile and first-mover advantage in the PPMS segment. Its sales have topped $3 billion annually, indicating robust demand.
2. Competitive Landscape
Ocrevus faces competition from several MS therapies, including:
- Novartis's Gilenya (Fingolimod)
- Biogen's Tecfidera (Dimethyl fumarate)
- Sanofi's Aubagio (Teriflunomide)
- Aubagio (Teriflunomide)
Biologics like Aventus's Lemtrada and Novartis's Kesimpta are also competing options, especially in progressive forms of MS.
Ocrevus benefits from its dual indication, high efficacy, and favorable safety profile, maintaining a solid market share. However, price competition and biosimilar developments could influence future pricing.
3. Regulatory and Reimbursement Factors
The drug's coverage is generally favorable under U.S. Medicare and private insurers, given its approval status and clinical efficacy. Reimbursement pressures and payor negotiations could impact net prices.
Emerging biosimilar competitors are unlikely to appear imminently due to the complex manufacturing process; however, patent expirations are anticipated in the next 5-10 years, which could introduce price competition.
Pricing Historical Trends
Historically, the wholesale acquisition cost (WAC) for Ocrevus was approximately $65,200 per 300 mg dose, with typical dosing schedules leading to an annual treatment cost of around $66,000–$70,000 per patient (per BlueBook, 2022). Managed care and pharmacy benefit managers (PBMs) negotiate discounts, leading to lower average net prices.
Over the past five years, pricing has remained relatively stable due to the drug’s high-demand status but shows signs of plateauing as market saturation nears and biosimilars threaten pricing margins.
Price Projection: Near to Mid-Term Outlook (2023-2028)
Factors Influencing Future Prices
-
Market Penetration and Competition:
As biosimilars enter the market post-patent expiration—expected around 2028—significant price reductions could ensue. Until then, price increases are likely to remain modest, aligning with inflation-adjusted healthcare costs (estimated 2-3% annually). -
Reimbursement Policies:
Price negotiations with payors and health systems could pressure list prices downward, especially under value-based care initiatives. -
Manufacturing and Supply Chain Dynamics:
Biologic production costs remain high; however, improvements in manufacturing efficiency could counterbalance downward pricing pressures to some extent. -
Development of Orphan Indications or Additional Label Expansions:
Expanded indications could sustain or elevate pricing due to increased market size.
Projected Price Range (2023-2028)
-
Base Case:
The average annual treatment cost remains within the $66,000–$70,000 range, with potential increases of 2% annually, driven primarily by inflation rather than significant price hikes. -
Optimistic Scenario:
Market saturation and competitive pressures could limit price escalation. Prices might stabilize or decrease slightly (~1-2%) by 2028 due to negotiated discounts and payer pressure. -
Pessimistic Scenario:
When biosimilar versions gain market approval, list prices could decline by 20-30%, with net prices experiencing even steeper reductions.
Market Entry and Biosimilar Impact
The expiration of Ocrevus patents, anticipated in 2028, poses a shifting landscape. Biosimilars can significantly disrupt pricing — a trend already observed in other biologic classes. Industry experts project that biosimilar entrants could erode up to 30-50% of the original biologic’s market share within three years of launch, presuming successful regulatory pathways and market acceptance.
Leading biosimilar candidates are in late-stage development, with potential commercialization expected around 2027-2028, aligning with patent expiry timelines.
Strategic Implications for Stakeholders
-
Pharmaceutical Companies:
Continued innovation and lifecycle management, including formulation improvements and expanded indications, will be vital to defend or extend market position. -
Healthcare Providers and Payers:
Cost management strategies, including formulary placement and negotiated discounts, will influence net prices and utilization patterns. -
Investors:
Monitoring patent expiry and biosimilar development timelines is essential for valuation models.
Key Takeaways
-
Market Dynamics:
The MS biologics market remains robust, with Ocrevus maintaining a leading position due to efficacy and label breadth. Competition and biosimilar entry are poised to exert downward pressure over the next 5-10 years. -
Price Trajectory:
Near-term prices are expected to remain stable between $66,000 and $70,000 annually, with room for inflation-based increases. Post-patent expiration, significant price reductions—up to 30-50%—are anticipated. -
Regulatory and Economic Factors:
Price negotiations, reimbursement policies, and biosimilar developments will be primary drivers shaping future prices. -
Investment Implications:
Stakeholders should prepare for increased biosimilar competition by investing in lifecycle management, pipeline expansion, and cost-optimization strategies.
Conclusion
NDC 00075-0622 (Ocrevus) currently holds a dominant position in the MS biologic space with stable pricing. However, the approaching patent cliff and biosimilar licensure will redefine the competitive landscape, ushering in potential price erosion and market sharing shifts. Careful strategic planning, coupled with continuous market monitoring, will be essential for stakeholders aiming to maximize value in this evolving environment.
FAQs
1. When is patent expiration for Ocrevus, and what biosimilar options are in development?
Patent protection for Ocrevus is expected to expire around 2028. Several biosimilar candidates are in advanced stages of development, with regulatory submissions anticipated in the next few years.
2. How will biosimilar entry impact Ocrevus prices?
Biosimilar competition typically reduces list and net prices for biologics by 20-50%, depending on market acceptance and payor negotiations.
3. Are there upcoming label expansions that could influence the market?
Potential future indications in neurological disorders or autoimmune diseases could expand Ocrevus’s market, supporting sustained or increased pricing.
4. What role do healthcare insurers and PBMs play in price setting?
They negotiate discounts, formulary placements, and rebates, significantly impacting net prices, especially as market competition increases.
5. How does the current regulatory environment influence biologic pricing?
Stringent approval pathways and patent protections delay biosimilar entry but also influence pricing strategies and market exclusivity periods.
References
[1] IQVIA. (2022). The Global MS Market Report.
[2] FDA. (2017). Ocrevus (Ocrelizumab) Product Label.
[3] BlueBook. (2022). MS and Biologic Pricing Data.
[4] industry forecasts and patent expiration estimates from IMS Health and industry patent calendars.
This comprehensive analysis aims to empower healthcare professionals, investors, and pharmaceutical strategists with strategic insights into the evolving market environment and pricing outlook for NDC 00075-0622.
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