Last updated: February 24, 2026
What is the drug with NDC 78206-0168?
NDC 78206-0168 refers to Caplacizumab (Cablivi), a biotherapeutic drug approved by the FDA in February 2019. It is indicated for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). Caplacizumab is a monoclonal antibody targeting von Willebrand factor (vWF), used to prevent platelet aggregation in aTTP.
Current Market Landscape
Regulatory Status and Adoption
- FDA approval: February 2019.
- EUA status: Not authorized under emergency use.
- Reimbursement: Covered by most commercial insurers; Medicaid and Medicare cover varies.
- Adoption: Limited adopters due to high cost, with early use primarily in specialized centers.
Market Size
- Prevalence of aTTP: Estimated at 3-4 cases per million annually in the U.S.
- Target population: Approx. 1,100 to 1,500 patients in the U.S. annually.
- Potential market value: Small in overall volume; however, high pricing yields significant revenue potential.
Competitive Landscape
- Current treatments: Plasma exchange, corticosteroids, rituximab.
- Market entrant: Caplacizumab offers a targeted, adjunctive approach, reducing the need for plasma exchange duration.
- Alternatives: Limited; no direct biosimilars, with off-label use of other monoclonal antibodies or supportive care.
Pricing Overview
List Price
- Average wholesale price (AWP): Approx. $2,800 per dose.
- Dosing regimen: Initial IV dose followed by daily subcutaneous injections for 30 days.
- Cost per treatment course: Estimated at $300,000 - $350,000, depending on dosing adjustments.
Patient and Payer Burden
- Reimbursement rates: Vary by insurer; commercial plans reimburse most of the cost.
- Patient out-of-pocket: Can reach $20,000 - $50,000, depending on coverage.
Cost Comparisons
| Treatment |
Cost per course |
Duration |
Notes |
| Caplacizumab (Cablivi) |
$300,000 - $350,000 |
30 days plus monitoring |
Higher than plasma exchange alone |
| Plasma exchange |
$25,000 - $40,000 |
5-14 days |
Standard of care, less expensive |
| Rituximab |
$7,000 - $15,000 |
1 time or multiple doses |
Adjunct, not standalone |
Market Projections
Revenue Estimates
- 2022: Estimated sales of $60 million in the U.S.
- 2023–2027 growth: CAGR of 15-20%, driven by increasing awareness and expanded indications.
Key Drivers
- Increased recognition of caplacizumab's efficacy in reducing treatment time.
- Expanded indications: Potential approvals for other thrombotic disorders.
- Pricing negotiations: Improved reimbursement agreements positively impact revenue.
Challenges
- High cost: Limits access; payers may restrict use.
- Small patient population: Caps total market size.
- Delivery complexity: IV and subcutaneous administration require specialized resources.
Global Perspective
- European markets: Approved since 2018, impactful in similar populations.
- Emerging markets: Limited penetration due to high price and infrastructure.
Strategic Considerations
- Market Expansion: Seek approval for related indications to increase addressable volume.
- Pricing Strategies: Implement tiered pricing aligned with payer negotiations.
- Partnerships: Collaborate with specialty centers to increase uptake.
- Cost Management: Explore biosimilar development to reduce prices or similar novel agents.
Key Takeaways
- NDC 78206-0168 corresponds to caplacizumab, used for aTTP.
- The drug commands a high per-treatment price (~$300,000), balanced against a small patient population.
- Revenue prospects depend on widening payer acceptance and indication expansion.
- Market challenges include high cost, limited patient pool, and administrative barriers.
- Future growth hinges on continued clinical validation, reimbursement negotiations, and pipeline expansion.
FAQs
1. What is the primary indication for NDC 78206-0168?
Treating acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood disorder.
2. How does caplacizumab's price compare to treatments like plasma exchange?
It is significantly more expensive, with a course costing around $300,000 to $350,000 versus $25,000 to $40,000 for plasma exchange.
3. What are the barriers to wider adoption?
High costs, limited awareness, and logistical challenges of administration restrict broader use.
4. Is there potential for expanding the drug’s use to other conditions?
Yes, early-stage research explores applications in other thrombotic microangiopathies, but regulatory approvals are pending.
5. How might pricing strategies evolve?
Negotiations with payers and biosimilar development could lower costs, facilitating broader access.
References
[1] Food and Drug Administration. (2019). Cablivi (caplacizumab-yfvk) Approval Letter.
[2] IQVIA. (2022). Market Trends in Thrombotic Disorders.
[3] Medpanel. (2023). Biologic Pricing Analysis.
[4] EvaluatePharma. (2022). Global Biologic Market Forecast.
[5] FDA. (2018). Approval Summary: Caplacizumab.
