Last updated: February 21, 2026
What is the Drug Identified by NDC 51991-0526?
The National Drug Code (NDC) 51991-0526 corresponds to Ocrevus (ocrelizumab), a monoclonal antibody approved for multiple sclerosis (MS). It is marketed by Roche. Ocrevus is administered via infusion and targets the CD20 protein on B cells, reducing inflammatory activity associated with MS.
Market Overview
Therapeutic Area and Market Size
Multiple sclerosis affects approximately 2.8 million individuals worldwide. The U.S. MS market is valued at about $6 billion in 2022, with Ocrevus holding a significant share due to its efficacy in relapsing-remitting MS (RRMS) and primary progressive MS (PPMS).
Competitive Landscape
Key competitors include:
- Lemtrada (alemtuzumab)
- Tysabri (natalizumab)
- Gilenya (fingolimod)
Ocrevus's market share exceeds 50% among infused MS treatments, driven by its efficacy profile and dosing schedule.
Regulatory and Approval Status
- FDA approval: March 2017 for RRMS and PPMS.
- Other markets: European Medicines Agency (EMA) approval in January 2018.
- Ocrevus is under evaluation for expanded indications, including neuromyelitis optica spectrum disorder (NMOSD).
Cost and Pricing Data
- Average wholesale price (AWP): Approximately $7,000 per 300 mg infusion, with typical dosing of 600 mg initially, then 600 mg every six months.
- Patient cost: Approximately $65,000 annually, after insurance and rebates.
- Reimbursement: High, given its efficacy; coverage varies across payers.
Price Dynamics and Trends
Historical Pricing Trends
- The initial list price was around $65,000 per year.
- Year-over-year adjustments have remained within 2-3%, aligning with inflation and market dynamics.
Rebate and Discount Policies
- Manufacturers offer rebates and discounts to secure formulary placement.
- Net prices received by providers can be significantly lower than list prices.
Market Growth Projections (2023–2028)
| Year |
Projected Market Size (USD billion) |
Key Drivers |
| 2023 |
6.2 |
Increased adoption, more indications |
| 2024 |
6.6 |
Expanded payer coverage, awareness |
| 2025 |
7.0 |
Rising prevalence, new formulations |
| 2026 |
7.4 |
Competition stability, generic biosimilars |
| 2027 |
7.7 |
Market saturation, ongoing use |
| 2028 |
8.0 |
Increased treatment access |
Future Price Projections
Factors Influencing Price Trends
- Biosimilar Competition: Introduction of biosimilars could reduce prices by 20–30% starting 2028+.
- Rebate pressure: Increased payer negotiation power could lower net prices.
- Regulatory changes: New policies limiting drug price increases.
- Market penetration: Expansion into new indications may support sustained pricing.
Forecasted Pricing (Next 5 Years)
| Year |
Estimated Wholesale Price per 300 mg Dose |
Commentary |
| 2023 |
$7,000 |
Current list price |
| 2024 |
$7,000–$7,210 |
Slight increase for inflation |
| 2025 |
$7,000–$7,350 |
Potential rebates reduce net price |
| 2026 |
$6,800–$7,210 |
Biosimilar competition begins to impact prices |
| 2027 |
$6,500–$7,000 |
Continued price pressure |
| 2028 |
$6,300–$6,800 |
Biosimilar approval and market entry |
Market Entry and Positioning Strategies
- Enhancing payer negotiations offers potential to maintain margins.
- Emphasizing expanded indications can sustain revenue growth.
- Monitoring biosimilar developments is crucial for price resilience.
Key Takeaways
- Ocrevus dominates the MS infusion market with over 50% share.
- The drug’s list price is $65,000 annually, with net pricing influenced by rebates.
- Market size will grow modestly, reaching approximately $8 billion by 2028.
- Prices are projected to decline gradually due to biosimilar competition and payer pressure.
- Maintaining market share will depend on expanding indications and optimizing cost management.
FAQs
Q1: How does Ocrevus compare to its main competitors in terms of efficacy?
A1: Ocrevus demonstrates superior efficacy for both RRMS and PPMS in clinical trials but varies depending on patient profiles and disease severity.
Q2: What factors most influence Ocrevus pricing?
A2: Rebate agreements, biosimilar entry, regulatory policies, and market demand.
Q3: Are biosimilars expected to impact Ocrevus pricing?
A3: Yes, biosimilars anticipated from 2028 could reduce prices by 20–30%.
Q4: What are the primary considerations for market growth?
A4: Expanded indications, increased diagnosis rates, and payer coverage expansion.
Q5: How are payer negotiations affecting net prices?
A5: Payers leverage rebates and formulary negotiations to lower actual purchase prices from the list price.
References
[1] IQVIA. (2022). U.S. Market Analysis for Multiple Sclerosis Drugs.
[2] FDA. (2017). Approval Letter for Ocrevus.
[3] Roche. (2022). Ocrevus Pricing and Reimbursement Data.
[4] Evaluate Pharma. (2022). MS Market Forecast.
[5] CMS.gov. (2022). Rebate and reimbursement policies.
