Last updated: February 16, 2026
What is NDC 69292-0588?
NDC 69292-0588 refers to Hemlibra (emicizumab-kxwh), marketed by Genentech. It is a subcutaneous monoclonal antibody used to prevent bleeding episodes in patients with Hemophilia A with inhibitors. The drug received FDA approval in November 2017 and has become a key treatment in hemophilia management.
Market Size and Patient Population
Global Hemophilia A with Inhibitors Prevalence
- Estimated prevalence: 1 in 5,000 male births or approximately 10,000–15,000 patients in the U.S.
- Patients with inhibitors constitute roughly 25% of this population.
Market Penetration
- As of 2022, approximately 4,500 patients in the U.S. use Hemlibra.
- Globally, the number is estimated at 6,000–8,000 patients.
- Growth driven by increased diagnosis, approval in multiple regions, and evolving treatment guidelines.
Competitive Landscape
- Other therapies include bypassing agents (FEIBA, NovoSeven) and immune tolerance induction.
- Hemlibra's advantage: less frequent dosing compared to older therapies, better patient adherence, and fewer adverse events.
Revenue and Price Trends
Historical Revenue
- 2020: ~$1.3 billion globally.
- 2021: ~$2.1 billion.
- 2022: Approximates $2.8 billion.
Pricing Details
- U.S. average wholesale price (AWP): approximately $482,000–$512,000 per year per patient.
- Cost varies based on dosage, administration, and insurance coverage.
Price Comparison with Alternatives
| Drug |
List Price (Annual) |
Dosing Frequency |
Route |
| Hemlibra |
~$480,000 |
Weekly/monthly |
Subcutaneous |
| FEIBA (bypassing agent) |
~$350,000 |
As needed |
Intravenous |
| NovoSeven |
~$600,000 |
Multiple doses daily |
Intravenous |
Market Trends
- Prices stabilize or increase marginally (2–4%) annually, driven by inflation, manufacturing costs, and payer negotiations.
- Maturity of the product in established markets limits rapid price increases but maintain high revenue margins.
Regulatory and Market Access Environment
- Approved in over 70 countries.
- Reimbursement largely driven by health technology assessments (HTA) bodies such as NICE (UK) and ICER (U.S.).
- Payers favor the drug’s convenience, which impacts uptake and persistence.
Future Price Projections
Factors influencing future pricing include:
- Expanded indications, such as prophylaxis in pediatric populations.
- Increased manufacturing efficiencies.
- Competitive biosimilars or follow-on therapies emerging post-2019 patents expiration (e.g., Novartis's LEQVIO, pending biosifics).
Projected Price Range (Next 5 Years)
| Year |
Estimated Annual Cost |
Influencing Factors |
| 2023 |
$480,000–$520,000 |
Inflation, payer negotiations |
| 2024 |
$485,000–$530,000 |
Regulatory changes |
| 2025 |
$490,000–$540,000 |
Biosimilar entries |
| 2026 |
$495,000–$550,000 |
Price stabilization trends |
| 2027 |
$500,000–$560,000 |
Increased competition |
Note: These projections assume continued growth in patient numbers and unchanged pricing strategies but exclude potential discounts or value-based agreements.
Implications for Stakeholders
- Manufacturers aim for volume growth into underserved markets.
- Payers reduce costs through negotiating discounts and value-based contracts.
- Patients benefit from improved adherence, diet flexibility, and reduced bleeding episodes.
Key Takeaways
- Hemlibra (NDC 69292-0588) has a well-established market with consistent revenue growth.
- The drug's high price is justified by the medical benefits, convenience, and reduced hospitalization costs.
- Future pricing will be influenced primarily by biosimilar competition, regulatory changes, and healthcare policy reforms.
- The market remains attractive for continued investment, given the unmet needs in hemophilia care.
FAQs
1. How does Hemlibra’s price compare to other hemophilia treatments?
Hemlibra’s annual cost (~$480,000–$520,000) is comparable to or slightly lower than traditional bypassing agents like NovoSeven (~$600,000), due to less frequent dosing and outpatient administration.
2. What factors could reduce Hemlibra’s price in the future?
Introduction of biosimilars or alternative therapies, reimbursement pressures, and increased competition may lead to negotiated discounts or price reductions.
3. Will expanding indications affect the market size?
Yes. Approvals for pediatric prophylaxis and broader hemophilia populations will increase patient numbers, sustaining revenue growth.
4. Are there regional differences in price and access?
Yes. Prices in Europe and Asia are often negotiated downward and include patient access schemes, unlike the more uniform U.S. list price.
5. What is the likelihood of Hemlibra’s price continuing its upward trend?
Continued moderate increases are expected, with potential stabilization or decreases contingent on market dynamics, regulatory developments, and biosimilar proliferation.
References
- Genentech. Hemlibra (emicizumab-kxwh) Prescribing Information. 2022.
- IQVIA, 2022.
- NICE. Hemlibra Cost-Effectiveness Analysis. 2021.
- CDC. Hemophilia Data Reports. 2022.
- EvaluatePharma. Hemlibra Annual Sales Data. 2022.
