Last updated: February 15, 2026
What is the current market status of drug NDC 24478-0102?
The drug identified by NDC 24478-0102 is Evolocumab, marketed under the brand name Repatha. It is a monoclonal antibody used to lower LDL cholesterol levels. Approved by the FDA in 2015, it targets PCSK9 to reduce cardiovascular risk in patients with hyperlipidemia.
The drug is typically prescribed for patients with familial hypercholesterolemia or established cardiovascular disease who require aggressive LDL lowering despite maximized statin therapy. It has positioned itself as an alternative or adjunct to statins for lipid management.
Evolocumab’s market has expanded since approval, driven by its position as a secondary or adjunct therapy. It is available in multiple formulations, including prefilled syringes and auto-injectors.
What is the current price range for NDC 24478-0102?
Pricing varies by payer, distribution channel, and geographic location. As of the latest data:
- Average Wholesale Price (AWP): Approximately $1,200 to $1,400 per month (assuming monthly dosing of 140 mg via subcutaneous injections).
- Medicaid and Medicare reimbursements: Slightly lower, in the range of $1,020 to $1,250 per month.
- Patient out-of-pocket costs: Can range from $10 to $75 per administration, depending on insurance coverage and assistance programs.
The wholesale and pharmacy acquisition prices remain relatively stable, but rebates and discounts influence net prices significantly.
How has the market for evolocumab evolved?
The market has experienced growth driven by increased recognition of PCSK9 inhibitors' efficacy in high-risk populations. The launch of PCSK9 inhibitors, including alirocumab (Praluent) alongside evolocumab, created a competitive landscape.
In 2021, total US sales for evolocumab approached $1.5 billion, according to IQVIA data, reflecting steady growth from initial launch. Sales are influenced by:
- Expanded indications
- Evolving treatment guidelines
- Payer coverage policies
The drug faces competition from other lipid-lowering agents, notably statins and bempedoic acid. Recent advancements include the approval of new formulations, such as pen injectors, to improve adherence.
What are the market projections for evolocumab over the next five years?
Analysts project a compound annual growth rate (CAGR) of 4% to 6% from 2023 to 2028, reaching approximately $2 billion in annual sales by 2028. Growth drivers include:
- Broadened patient access through improved payer coverage
- Expanded clinical data supporting use in diverse populations (e.g., familial hypercholesterolemia)
- Additional indications such as newer lipid-modulating therapies gaining market share
However, growth may slow as biosimilar and alternative treatments emerge, and if pricing pressures increase from payers seeking cost containment.
How might pricing trends impact market dynamics?
Pricing pressures are likely to influence future contracting strategies. Repatha's list price has remained relatively stable, but payer negotiations, rebates, and discounting are expected to increase.
Key factors include:
- Potential biosimilar entry, which could lower list prices by 20-40%
- Continued policy focus on drug cost regulation
- Value-based agreements linking reimbursement levels to clinical outcomes
Rising biosimilar competition may reduce net prices for evolocumab, leading to a possible decline in per-unit revenue but encouraging increased volume sales.
What are the regulatory and policy influences?
Regulatory policies targeted at drug pricing could shape future market and pricing strategies. The U.S. Inflation Reduction Act (IRP) enacted in 2022 emphasizes drug price negotiation, potentially impacting high-cost biologics like evolocumab.
Additionally, expanding indications and updated clinical guidelines—including the American College of Cardiology (ACC)—support broader use, which can sustain or expand utilization.
Summary of competitive landscape
| Drug |
Class |
Price (monthly) |
Year of FDA approval |
Main indications |
Market share (2022) |
| Evolocumab (Repatha) |
PCSK9 inhibitor |
$1,200–$1,400 |
2015 |
Hyperlipidemia, atherosclerosis |
~65% |
| Alirocumab (Praluent) |
PCSK9 inhibitor |
$1,200–$1,400 |
2015 |
Same as Repatha |
~35% |
Pricing remains competitive due to shared manufacturing costs and similar efficacy profiles.
Key takeaways
- Evolocumab is a leading PCSK9 inhibitor with stable pricing around $1,200–$1,400/month.
- Its market has grown to approximately $1.5 billion in US sales (2021), with projections reaching $2 billion by 2028.
- Pricing pressures, potential biosimilar entry, and policy reforms will influence future revenue streams and market share.
- Payer coverage is expanding, but rebates and discounts significantly impact net prices.
- The drug maintains a critical role in lipid management, especially in high-risk populations.
FAQs
1. What factors influence evolocumab pricing?
Rebate agreements, insurance coverage policies, manufacturing costs, and competition from biosimilars or alternative drugs.
2. Are biosimilars available for evolocumab?
As of 2023, biosimilars are under development, but none have received FDA approval. Market entry could impact prices significantly.
3. How does evolocumab compare to other lipid-lowering therapies in efficacy?
Evolocumab reduces LDL cholesterol by approximately 60% when added to statins. It provides superior LDL lowering compared to many oral agents.
4. What indications are approved for evolocumab?
Familial hypercholesterolemia, established cardiovascular disease, and heterozygous familial hypercholesterolemia with statins.
5. How might policy changes affect future prices?
Legislation aimed at controlling drug costs could lead to price negotiations or reimbursement adjustments, reducing list prices and affecting market dynamics.
Sources
[1] IQVIA, 2022 data reports.
[2] FDA, Evolocumab approval documents.
[3] American College of Cardiology guidelines, 2022.
[4] CMS, drug pricing and coverage policies.
[5] Pharma intelligence databases, 2023 projections.
