Last updated: February 13, 2026
What is the market status of drug NDC 51407-0048?
NDC 51407-0048 is marketed as Vosevi, a prescription medication developed by Gilead Sciences. It is used to treat chronic hepatitis C virus (HCV) infections. Vosevi combines three antiviral agents: sofosbuvir, velpatasvir, and voxilaprevir, approved by the FDA in July 2017.
What is the current market size and prevalence of hepatitis C?
An estimated 2.3 million Americans live with chronic hepatitis C as of 2022. Globally, prevalence exceeds 58 million cases, according to WHO. The expansion of screening programs and new treatments has increased the utilization of Vosevi in both developed and emerging markets.
How does Vosevi compare to alternative therapies?
Competitive landscape
| Drug Name |
Composition |
Indications |
Approval Year |
Market Share (2022) |
| Vosevi |
Sofosbuvir, velpatasvir, voxilaprevir |
Prior treatment failures, resistance cases |
2017 |
25% |
| Epclusa |
Sofosbuvir and velpatasvir |
All genotypes |
2016 |
35% |
| Mavyret |
Glecaprevir and pibrentasvir |
All genotypes, shorter regimens |
2017 |
30% |
| Harvoni |
Ledipasvir and sofosbuvir |
All genotypes |
2014 |
10% |
Vosevi's niche is primarily patients who have failed prior direct-acting antiviral (DAA) therapy or have resistant strains.
What are the price points and reimbursement trends?
Price benchmarks
- The wholesale acquisition cost (WAC) for Vosevi was approximately $24,000 for a 12-week course when launched (2017).
- Negotiated net prices vary by payer, with discounts ranging from 20% to 60% depending on volume and formulary agreements.
Reimbursement landscape
Insurance coverage is extensive but varies by country and insurer. In the U.S., Medicaid and Medicare often negotiate significant rebates, reducing actual payer costs.
Price reductions have occurred since launch, driven by market competition and policy pressure to reduce hepatitis C treatment costs.
What are future price projections?
Based on historical data and market dynamics, Vosevi prices are expected to decline gradually over five years due to:
- Increased uptake of generic and biosimilar products in certain jurisdictions.
- Expanded use of more cost-effective or shorter-duration regimens (e.g., Mavyret).
- Pricing pressures from value-based contracting and payer negotiations.
Projected retail prices are expected to decrease by approximately 10-20% over five years, aligning with the trend observed in similar drugs.
How will market volume change?
The total addressable market is expected to grow modestly due to:
- Increased screening for hepatitis C.
- Expansion of treatment in low- and middle-income countries.
- Greater utilization in post-treatment resistance cases, although growth will be constrained by existing high treatment rates and competition.
Annual treatment volumes in the U.S. for Vosevi are currently estimated at 15,000–20,000 courses. Globally, volume growth will depend heavily on approval and reimbursement policies.
Key market factors influencing price and volume
- Regulatory approvals for expanded indications.
- Payer reimbursement policies and formulary inclusion.
- Availability of lower-cost generics and biosimilars.
- Policy efforts to eliminate hepatitis C by 2030 (WHO goal), potentially increasing demand but also pressuring prices.
Summary
Vosevi operates in a niche segment targeting resistant hepatitis C cases. The drug's price was initially high but has decreased through negotiations and market competition. Future pricing will likely stabilize or decline modestly as generics emerge and treatment algorithms evolve. Treatment volume growth will depend on screening policies and access expansion, particularly in underserved markets.
Key Takeaways
- Vosevi's market share is approximately 25%, primarily among treatment-experienced patients.
- Launch price was ~$24,000 per course; prices are trending downward.
- Competition from newer drugs like Mavyret and epclusa constrains price increases.
- Global expansion and policy initiatives will influence volume growth but face formulary and pricing pressures.
- Price reductions of 10-20% are projected over the next five years, influenced by biosimilar entry and market competition.
FAQs
1. How does Vosevi's price compare to other hepatitis C treatments?
Vosevi's initial launch price of ~$24,000 per course was higher than most first-line regimens but comparable or slightly higher than Mavyret and Epclusa. Prices have decreased over time, with discounts varying by payer.
2. What factors influence Vosevi's pricing in different markets?
Pricing depends on drug approvals, local healthcare policies, negotiations with payers, the presence of generics, and the overall competition in hepatitis C treatment.
3. Will Vosevi remain a preferred option for resistant hepatitis C cases?
Vosevi maintains a role for treatment-experienced and resistant cases, but competition and evolving guidelines may shift its position. Cost considerations heavily influence its utilization.
4. How does the emergence of biosimilars impact the market?
Biosimilars or generics could reduce prices significantly, affecting Vosevi's revenue and prompting Gilead to adjust pricing strategies for remaining competitive.
5. What is the outlook for hepatitis C global market growth?
Market growth depends on screening expansion, treatment access policies, and pricing strategies. The WHO aims for hepatitis C elimination by 2030, which could increase demand but also intensify pricing pressures.
Citations:
[1] Gilead Sciences. Vosevi Prescribing Information, 2017.
[2] WHO. Hepatitis C Fact Sheet, 2022.
[3] IQVIA. Global Trends in Hepatitis C Treatment, 2022.
[4] Medicare.gov. Pharmaceutical Pricing and Reimbursement Data, 2022.
