Last updated: February 27, 2026
What is the Drug Associated with NDC 49348-0543?
NDC 49348-0543 corresponds to Ocrevus (ocrelizumab), a monoclonal antibody approved by the FDA for multiple sclerosis (MS) treatment. It is indicated for relapsing forms of MS and primary progressive MS (PPMS). Approved since March 2017, Ocrevus is administered intravenously.
Market Overview
Commercial Landscape
Ocrevus holds a significant stake in the multiple sclerosis treatment market, competing primarily with interferon-based therapies, glatiramer acetate, and newer agents such as Kesimpta (ofatumumab). Its market share is influenced by:
- Efficacy profile
- Safety concerns, notably infusion reactions and infections
- Competitive pricing and reimbursement strategies
Market Size & Sales Data
- Global sales (2022): Approximately $4.25 billion, with the US accounting for the majority.
- US market share (2022): Estimated at 85%, driven by higher treatment rates and reimbursement coverage.
Market Drivers
- Increasing prevalence of MS: Around 2.8 million people worldwide as of 2022.
- Evolving treatment guidelines favoring high-efficacy therapies.
- Growing diagnosis rates and early intervention practices.
Market Challenges
- High cost of therapy: List prices for Ocrevus are approximately $65,000 per year per patient.
- Reimbursement hurdles, particularly in payers with aggressive cost controls.
- Competition from newer agents with different administration routes or risk profiles.
Price Trends & Projections
Historical Pricing
- List price (2020-2022):
- 2020: $65,200 per-year list price
- 2021: Stable, with slight discounts and rebates
- 2022: Approx. $65,000; rebates reduce net prices for payers
Price Dynamics
- List prices have remained relatively stable over the past three years.
- Payers negotiate substantial rebates, reducing net prices by approximately 20-30%.
- Support programs and discount arrangements are common, affecting final payer cost.
Future Price Trajectory
- Expected to remain stable through 2025 due to market saturation and regulatory stability.
- Slight potential for price increases (2-3% annually) aligned with inflation and administration costs.
- New formulary preferences or biosimilars (not yet available for ocrelizumab) could pressure prices downward post-2025.
Impact of Biosimilars and Competition
- No currently approved biosimilar versions.
- Pending biosimilar development could influence prices post-2028.
- Patent protections extend to 2030, delaying biosimilar entry.
Pricing by Payer and Market Segments
| Segment |
Approximate List Price |
Net Price (after rebates) |
Rebate/Discount Range |
| Commercial insurers |
$65,000 |
$45,500 - $52,000 |
20-30% |
| Medicare Part D |
$65,000 |
$50,000 - $55,000 |
15-23% |
| Medicaid |
Negotiated |
Lower, often under $50,000 |
25-40% |
Opportunities and Risks
Opportunities
- Expansion into earlier MS stages.
- Use as a backbone therapy for combination regimens.
- Potential label expansions, including pediatric MS if approved.
Risks
- Entry of biosimilars reducing price levels.
- Reimbursement access constraints.
- Competitive innovation, especially oral therapies and less immunogenic options.
Key Takeaways
- Ocrevus remains a high-revenue MS therapy with stable list prices but significant rebates.
- Market growth is driven by rising MS prevalence and preference for high-efficacy treatments.
- Pricing projections suggest stability with slight increases, barring biosimilar entry.
- Payer negotiations significantly impact net prices, especially in Medicare and Medicaid segments.
- Patent protections extend until 2030, delaying biosimilar competition.
FAQs
1. How does the price of Ocrevus compare to other MS therapies?
Ocrevus's list price is generally higher than older therapies like interferons but comparable to other high-efficacy monoclonal antibodies such as Kesimpta and Mavenclad.
2. What factors could lead to price reductions for Ocrevus?
Introduction of biosimilars, competitive pressure from alternative treatments, and increased rebate negotiations.
3. Are there plans for biosimilars of ocrelizumab?
While several companies are developing biosimilars, none have received approval as of 2023. Patent protections still limit market entry until around 2030.
4. How do reimbursement policies impact the actual cost to patients?
Rebates and coverage determine out-of-pocket costs. Patients with good insurance may pay significantly less than the list price, potentially below $10,000 annually.
5. What is the outlook for Ocrevus in the next five years?
Market stability with modest growth; potential price pressure from biosimilars around 2028-2030; ongoing clinical trials may expand approved indications, influencing market dynamics.
References
- U.S. Food and Drug Administration. (2017). Ocrevus (ocrelizumab) approval.
- IQVIA. (2023). The Impact of Biosimilars on the US Market.
- PhRMA. (2022). Biopharmaceutical research and development report.
- BloombergNEF. (2023). Special Report on Biotech Pricing Trends.
- CMS. (2022). Medicare Part D Drugs and Rebate Data.
