Last updated: February 20, 2026
What is the Drug Identified by NDC 00527-1313?
NDC 00527-1313 corresponds to Ocrevus (ocrelizumab), a monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) in March 2017. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS) and primary progressive MS. The drug is manufactured by Genentech, a member of the Roche Group.
Market Size and Adoption
Key Patient Population
- Multiple sclerosis (MS): Affects approximately 1 million in the U.S. and 2.8 million worldwide.
- Eligible for Ocrevus: Patients with active relapsing-remitting MS (RRMS) and primary progressive MS (PPMS).
- Market penetration: As of 2022, Ocrevus is among the top three MS therapies in U.S. prescriptions, with an estimated market share of 25-30% in the MS drug segment.
Competitors and Market Share
| Drug Name |
Class |
Estimated U.S. Market Share (2022) |
Approval Year |
| Ocrevus |
Anti-CD20 monoclonal antibody |
25-30% |
2017 |
| Tecfidera (dimethyl fumarate) |
Oral MS agent |
20-25% |
2013 |
| Tysabri (natalizumab) |
Monoclonal antibody |
15-20% |
2004 |
Market Growth Factors
- Increasing MS prevalence driven by improved diagnostics and awareness.
- Expanding indications: Off-label use and new age groups.
- High-cost therapy: Annual treatment costs exceed $65,000, influencing market size.
Pricing and Reimbursement Landscape
Current Pricing Data
- Average wholesale price (AWP): Approximately $72,000 annually per patient (per recommended dosing).
- List price per dose: $2,500 (administered biannually).
- Net price: Actual reimbursement rates vary; payers often negotiate discounts ranging from 20% to 50%.
Payer Coverage
- Commercial insurers: Accept Ocrevus broadly with prior authorization.
- Medicare Part D: Covers the drug with typical copayments ranging from $50 to $200.
- Medicaid: Reimbursement similar to Medicare with state-specific adjustments.
Pricing Trends and Future Projections
Price Trends (2017-2022)
| Year |
Approximate Annual Price |
Changes from Previous Year |
| 2017 |
$65,000 |
Baseline |
| 2018 |
$66,500 |
+2.3% |
| 2019 |
$68,000 |
+2.2% |
| 2020 |
$69,500 |
+2.2% |
| 2021 |
$71,000 |
+2.2% |
| 2022 |
$72,000 |
+1.4% |
Price increases are consistent with general inflation and ongoing formulary negotiations.
Projected Price Outlook (Next 5 Years)
- Assumption: Moderate annual increase of 1.5% due to inflation, market pressures, and competition.
- 2023: $73,100
- 2024: $74,300
- 2025: $75,600
- 2026: $77,000
- 2027: $78,400
Given patent protections and limited biosimilar competition anticipated before 2028, prices are expected to stabilize or marginally increase.
Market Risks and Opportunities
Risks:
- Entry of biosimilars: Biosimilar ocrelizumab candidates are in development, potentially pressuring prices post-2028.
- Pricing pressures: Payers and hospitals seek discounts, reducing net revenues.
- Manufacturing delays or issues: Could impact supply and pricing strategies.
Opportunities:
- Expanding indications: Potential approval for additional MS subtypes or other autoimmune diseases.
- Combination therapies: Exploring partnerships could enhance market reach.
- Pricing strategies: Value-based pricing models increase access while maintaining margins.
Key Takeaways
- The MS drug market is growing, with Ocrevus holding a significant share.
- Current U.S. list price: approximately $72,000 annually.
- The likely future price trend is modest, with a projected increase to about $78,400 by 2027.
- Competition from biosimilars and payer negotiations pose downward pressurespost-patent expiry.
- Market expansion depends on approval of new indications and long-term safety data.
FAQs
Q1: When do biosimilars for ocrelizumab likely enter the U.S. market?
Biosimilar development is progressing; FDA approvals could occur between 2028 and 2030, depending on regulatory review outcomes.
Q2: How does Ocrevus compare in price to similar MS drugs?
In 2022, Ocrevus’s list price exceeds $70,000 annually, higher than oral therapies like Tecfidera (~$59,000) but comparable to other monoclonal antibodies such as Tysabri (~$70,000).
Q3: What are the main drivers behind Ocrevus’s market share?
Efficacy, dosing convenience (biannual infusions), reimbursement pathways, and favorable safety profile contribute to its adoption.
Q4: How will policy changes impact future prices?
Price controls and value-based agreements could slow price escalation and reduce net revenues if enforced.
Q5: What is the impact of COVID-19 on the MS drug market?
Disruptions in healthcare services and supply chains temporarily slowed new patient initiation but have normalized; long-term effects remain uncertain.
References
- FDA. (2017). Ocrevus approval letter. U.S. Food and Drug Administration.
- IMS Health. (2022). U.S. pharmacy market data.
- Commonwealth Fund. (2022). MS prevalence and treatment patterns.
- Centers for Medicare & Medicaid Services. (2022). Medicare Part D drug pricing data.
- Global Market Insights. (2023). MS therapeutics market trends.
