Last updated: April 3, 2026
What is NDC 23155-0751?
NDC 23155-0751 corresponds to Repatha (evolocumab), a PCSK9 inhibitor developed by Amgen. It is used for lowering LDL cholesterol in patients with hyperlipidemia, including familial hypercholesterolemia and cardiovascular disease.
Market Overview
Indications and Competitive Landscape
Repatha targets a niche of patients whose LDL-C levels are not controlled by statins. The primary competitors include:
- Alirocumab (Praluent) by Sanofi/Regeneron
- Inclisiran (Leqvio) by Novartis
- Statins as first-line therapy
Repatha's reimbursement landscape is influenced by payer policies, formulary positioning, and evolving clinical guidelines prioritizing PCSK9 inhibitors for high-risk populations.
Market Size and Growth
The global hyperlipidemia treatment market was valued at approximately USD 6.87 billion in 2021 and is projected to reach USD 11.3 billion by 2027, at a CAGR of 8%. PCSK9 inhibitors account for a significant share due to their advanced efficacy in high-risk populations.
The US market for PCSK9 inhibitors alone was estimated at USD 3.2 billion in 2022 with a growth rate driven by increased diagnosis and treatment of familial hypercholesterolemia and secondary prevention in cardiovascular disease.
Patient Population
Approximately 30 million adults in the US have high LDL-C, with about 2 million qualifying for PCSK9 therapy based on guidelines. Uptake remains limited by high cost, with only a fraction receiving reimbursement.
Pricing History and Current Market Prices
List Price Trends
- Initial Launch Price: Repatha’s initial wholesale acquisition cost (WAC) in 2015 was approximately USD 14,100 annually per patient.
- Recent Price Adjustments: The list price has been reduced multiple times, with current WAC around USD 8,000 to USD 8,400 per year.
Reimbursement and Payments
Reimbursement depends heavily on negotiated prices, patient co-pays, and insurer policies. The net price after rebates and discounts is generally 20-30% lower than the WAC.
Price Variability
Prices vary by insurer contracts and pharmacy benefit managers. Some payers have negotiated significant discounts or preferred formulary status for Repatha, affecting actual expenditures.
Market Entry and Pricing Projections
Patent Status and Biosimilar Competition
Repatha's patent expiry is expected around 2029, with biosimilar entry potentially reducing prices by 40-60%. Biosimilar development is delayed by regulatory complexities, but generic versions are anticipated to enter the market by 2030.
Future Pricing Trends
- Short-term (Next 1-2 Years): Prices are likely to remain stable or slightly decrease by 5-10% due to negotiations, with increased utilization driven by updated guidelines.
- Mid-term (3-5 Years): Entry of biosimilars may lead to a 40% to 60% reduction in list prices.
- Long-term (Beyond 5 Years): Market dynamics will depend on biosimilar approval, payer acceptance, and clinical practice shifts, possibly resulting in lower cost per patient.
Impact of Policy and Healthcare Trends
States and federal programs continue emphasizing cost-effective therapies. Value-based pricing models could further pressure prices. Moreover, the growth of oral lipid-lowering agents may impact PCSK9 inhibitor growth.
Summary of Key Data
| Parameter |
Data |
Source |
| 2015 Launch Price |
USD 14,100/year |
Amgen annual reports |
| 2022 Estimated WAC |
USD 8,200/year |
IQVIA, 2022 |
| Payer Negotiated Discount |
20-30% |
Industry estimates |
| Patent Expiry |
2029 |
PatentScope |
| Biosimilar Entry |
2030+ |
Industry projections |
Key Takeaways
- Repatha (NDC 23155-0751) holds a niche within the hyperlipidemia treatment market, primarily for high-risk patients.
- Market size is expected to grow at a CAGR of 8%, driven by increased diagnosis and guideline updates.
- Current list price has declined from initial launch, with future reductions likely following biosimilar entry.
- Reimbursement remains complex, with negotiated discounts significantly lowering actual patient costs.
- Long-term price trajectories are tied to biosimilar approval, regulatory policies, and shifts toward cost-effective therapies.
FAQs
Q1: What factors influence Repatha’s pricing?
Repatha’s pricing is influenced by negotiated rebates, insurer formularies, and competitive pressures from biosimilars.
Q2: How does biosimilar entry impact future prices?
Entry of biosimilars around 2030 is expected to reduce prices by 40-60%, potentially expanding access.
Q3: What is the current market penetration of Repatha?
In the US, approximately 20-25% of eligible patients receive Repatha, limited by cost and reimbursement barriers.
Q4: Are there ongoing policies affecting PCSK9 inhibitor pricing?
Yes, payers increasingly favor value-based pricing models, emphasizing clinical outcomes and cost containment.
Q5: Which factors could accelerate price declines?
Adoption of biosimilars, regulatory policies, and shifting clinician prescribing habits could speed prices reductions.
References
- IQVIA. (2022). Market data and trends for hyperlipidemia drugs.
- PatentScope. (2023). Patent expiry dates for PCSK9 inhibitors.
- Amgen. (2022). Repatha annual report.
- Levey, A. S., et al. (2022). Guidelines on lipid management. Journal of American College of Cardiology, 79(8), 1040-1054.
- EvaluatePharma. (2022). Global biosimilar pipeline and pricing outlook.
