Last updated: February 28, 2026
What Is the Indication and Market Position of NDC 23155-0840?
NDC 23155-0840 corresponds to Repatha (evolocumab), a PCSK9 inhibitor approved by the FDA in August 2015 for adult patients with familial hypercholesterolemia (FH) and clinical atherosclerotic cardiovascular disease (ASCVD) to lower LDL cholesterol levels. It is positioned as a specialized biologic therapy targeting lipid management.
Current Market Landscape
Key Competitors
| Product |
Class |
Approval Year |
Indications |
Pricing (Annual) |
| Repatha (evolocumab) |
PCSK9 inhibitor |
2015 |
HeFH, ASCVD, HoFH |
$6,300-$7,000 |
| Praluent (alirocumab) |
PCSK9 inhibitor |
2015 |
FH, ASCVD |
$6,000-$6,500 |
| Inclisiran (Leqvio) |
RNA interference therapy |
2020 |
Hypercholesterolemia, ASCVD |
$8,500/year |
Repatha holds a significant market share in the PCSK9 class, with annual revenues exceeding $2 billion in 2022 (EvaluatePharma).
Recent Trends and Innovation
- Biosimilar development: No biosimilars currently available; high barriers to entry due to biologic complexity.
- Pricing pressure: Payers demand discounts or value-based agreements, impacting net prices.
- Expanded indications: Trials for broader lipid disorders are ongoing, potentially influencing market size.
Revenue Drivers and Constraints
- Market penetration in high-risk populations: Patients with recurrent cardiovascular events and familial hypercholesterolemia.
- Physician prescribing patterns: Preference for established biologics over newer options.
- Insurance coverage: Reimbursement remains highly dependent on formulary placement and prior authorization processes.
Price Projection Framework
Assumptions
- Market penetration growth: 3-5% annually over the next five years.
- Net price adjustments: 2-4% annual decrease due to payer pressure.
- Market size expansion: 4% per year, driven by increased diagnosis and eligible patient populations.
5-Year Price and Revenue Forecast
| Year |
Estimated Average Price |
Market Size (Patients) |
Projected Global Revenue |
| 2023 |
$6,500 |
2 million |
$13 billion |
| 2024 |
$6,300 |
2.1 million |
$13.2 billion |
| 2025 |
$6,100 |
2.2 million |
$13.4 billion |
| 2026 |
$5,900 |
2.3 million |
$13.6 billion |
| 2027 |
$5,700 |
2.4 million |
$13.7 billion |
Pricing is projected to decline gradually as competition and payer negotiations intensify, but overall revenues remain stable due to market expansion.
Sensitivity to External Factors
- Patent expiration: Currently not imminent; patent life extends until at least 2030, protecting pricing.
- Regulatory shifts: Policy moves toward value-based pricing may accelerate discounts.
- New entrants: Breakthrough therapies or biosimilars could significantly depress prices in 5-7 years.
Conclusions
Repatha maintains a high price point relative to peers, supported by its biologic nature and specialized indications. Revenue projections suggest stable to slightly declining average prices, with sustained or modest growth in total revenue driven by increased patient access and diagnosis. Price erosion remains a risk but is likely to be offset by market expansion and ongoing innovation.
Key Takeaways
- NDC 23155-0840 (Repatha) remains a top-tier biologic for LDL management.
- Market revenues are projected at approximately $13.7 billion in 2027, with prices declining gradually each year.
- External pressures such as biosimilar competition and policy changes could accelerate price reductions within the next five years.
- High barriers to biosimilar entry support continued pricing stability in the near term.
- Expansion of indications and improved diagnosis rates could sustain growth despite pricing pressures.
FAQs
Q1: What factors most influence Repatha's price?
Repatha's price is primarily influenced by biologic manufacturing costs, patent protection, market demand, payer negotiations, and competition from other PCSK9 inhibitors.
Q2: How will biosimilar entry affect Repatha pricing?
Biosimilar entry could lead to significant price reductions; however, no biosimilars are currently approved, providing a temporary pricing advantage.
Q3: Are there upcoming regulations that could impact Repatha's pricing?
Yes. Policy attempts to implement value-based pricing and increased scrutiny on high-cost biologics could result in negotiated discounts or pricing caps.
Q4: What is the outlook for Repatha's market share?
Market share is expected to stabilize due to clinical efficacy and physician preference, though competition from newer therapies may limit growth.
Q5: How does patient access influence revenue projections?
More extensive insurance coverage and increasing diagnosis rates lead to higher patient volumes, bolstering revenue even if prices decline.
References
[1] EvaluatePharma. (2022). World Preview 2022, Outlook to 2027. Retrieved from https://www.evaluate.com
[2] U.S. Food and Drug Administration. (2015). Repatha (evolocumab) approval. Retrieved from https://www.fda.gov
[3] IQVIA. (2022). Biologics Market Data. Retrieved from https://www.iqvia.com
