Last updated: March 13, 2026
What is NDC 23155-0795?
NDC 23155-0795 refers to Repatha (evolocumab), a PCSK9 inhibitor developed by Amgen, approved by the U.S. Food and Drug Administration (FDA) for lowering LDL cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia. Launched in August 2015, Repatha entered an established market of lipid-lowering therapies alongside statins and other biologics.
Market Overview
Market Size and Segmentation
| Segment |
Key Features |
Market Share (2022) |
Notes |
| Primary Prevention |
Patients with high LDL but no prior cardiovascular events |
25% |
Growing due to guidelines |
| Secondary Prevention |
Patients with established cardiovascular disease |
75% |
Largest segment |
| Familial Hypercholesterolemia |
Genetic LDL elevation, requiring aggressive LDL lowering practices |
15% (subset of above) |
Specialized patient group |
Addressable population in the U.S. exceeds 100 million patients with high LDL cholesterol, though eligible patients for biologics represent approximately 2-5 million, dependent on clinical criteria and insurance coverage. The recurrent cost barrier limits widespread utilization.
Competitive Landscape
| Product |
Manufacturer |
Approval Year |
Advantages |
Market Position |
| Repatha (evolocumab) |
Amgen |
2015 |
High efficacy, established safety profile |
Leading biologic, stable market share |
| Praluent (alirocumab) |
Sanofi/Regeneron |
2015 |
Similar efficacy, slightly lower prices |
Competitive alternative |
| Inclisiran (Leqvio) |
Novartis |
2020 |
Less frequent dosing (twice yearly) |
Growing alternative |
Repatha maintains a solid market share due to aggressive marketing, physician familiarity, and broader indication approval.
Pricing Trends and Projections
Current Price Point
In 2023, the average wholesale price (AWP) for Repatha remains approximately:
- $5,850 per year (approx. $487.50/month) for the 140 mg dose, billed per injection.
Insurance negotiations generally reduce patient out-of-pocket costs, but many payers implement prior authorization and formulary restrictions, impacting revenue.
Historical Price Trends
| Year |
Average Wholesale Price (AWP) |
Notes |
| 2015 |
$8,500 |
Launch price, high compared to current levels |
| 2018 |
$6,300 |
Price reductions following competitive pressures |
| 2021 |
$5,850 |
Stabilization with insurer negotiations |
Market Dynamics Affecting Pricing
- Generics and Biosimilars: No biosimilar to Repatha currently available.
- Manufacturing Costs: High R&D and manufacturing costs typical of biologics.
- Negotiations: CMS, private payers, and pharmacy benefit managers (PBMs) continue to negotiate rebates and discounts, impacting net price.
Future Price Projections (Next 3-5 years)
| Year |
Estimated Wholesale Price |
Rationale |
| 2024 |
~$5,500 |
Slight downward pressure due to biosimilar threat, increased competition from Inclisiran |
| 2025 |
~$5,200 |
Payer negotiations and volume-driven discounts |
| 2026-2028 |
~$5,000 |
Market consolidation, further competitive pressures |
Expected price stabilization around $5,000 to $5,500 annually as biosimilar and alternative therapies gain market share.
Revenue and Market Share Outlook
Amgen reported revenues of $1.92 billion in 2022 from Repatha globally, with approximately $1.2 billion in the U.S., representing roughly 16% of Amgen’s total sales.[1]
Revenue Drivers
- Increased adoption in high-risk populations.
- Broader guideline endorsements, such as updated ACC/AHA guidelines.
- Expansion to new indications, including prevention in certain subpopulations.
Market Penetration
| Year |
Estimated U.S. Patients on Repatha |
Market Share of PCSK9 inhibitors |
Comments |
| 2022 |
~600,000 |
30% |
Stable but limited by cost and coverage |
| 2024 |
~800,000 |
35% |
Expected growth driven by reimbursement policies |
Strategic Considerations
- Pricing pressure due to biosimilar emergence could influence gross revenues but may be offset by increased usage.
- Expansion into secondary markets could present upside but faces payer hurdles.
- Cost containment efforts by payers may limit revenue growth and force further discounts.
Key Takeaways
- Repatha is a leading PCSK9 inhibitor with a stable but mature market.
- The 2023 wholesale price remains approximately $5,850 per year, with projections trending downward to ~$5,000–$5,500 by 2028.
- Revenue depends heavily on payer negotiations and market uptake, which are constrained by cost and formulary barriers.
- Competition from biosimilars and newer receptor silencers like Inclisiran will pressure prices and market share.
- Growth prospects include expanded indications and increased penetration in high-risk populations.
FAQs
Q1: How does Repatha's price compare to similar therapies?
A: Its wholesale annual price (~$5,850) exceeds that of Praluent (~$4,600), but both are significantly more expensive than traditional statins. Inclisiran has a lower dosing frequency, which may impact adherence and overall cost.
Q2: What factors influence future pricing?
A: Payer negotiations, biosimilar entry, clinical guideline updates, and competitive innovations like dosing convenience.
Q3: How relevant are biosimilars to Repatha?
A: Currently, no biosimilars are approved for evolocumab, but anticipated biosimilar development could reduce prices and market share.
Q4: What is the main barrier to wider market adoption?
A: High cost, insurance restrictions, and patient eligibility criteria limit broad adoption.
Q5: Are there regulatory or policy changes expected to impact pricing?
A: Potential reductions in drug price negotiations under Medicare and Medicaid could influence prices; Congressional and CMS policies are actively exploring drug pricing reforms.
References
[1] Amgen Inc. (2023). Annual Report 2022. Retrieved from https://investors.amgen.com/2022-annual-report
