Last updated: March 17, 2026
What is the Drug NDC 00904-7425?
NDC 00904-7425 corresponds to Repatha (evolocumab), a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha is approved for lowering LDL cholesterol in patients with hyperlipidemia or cardiovascular risk factors, including familial hypercholesterolemia and those who require additional LDL reduction despite statin therapy.
Market Landscape
Current Indications and Usage
Repatha's primary use is for adults with:
- Heterozygous familial hypercholesterolemia (HeFH)
- Homozygous familial hypercholesterolemia (HoFH)
- Clinical atherosclerotic cardiovascular disease (ASCVD) at high risk, requiring LDL reduction beyond statins
Market Size
The global hypercholesterolemia treatment market was valued at approximately USD 20 billion in 2022 and is projected to reach USD 28 billion by 2028, expanding at a compound annual growth rate (CAGR) of about 6.1% [1].
Key drivers:
- Rising prevalence of cardiovascular disease
- Increased awareness of cholesterol management
- Expansion of indications to broader patient populations
Competitive Landscape
Repatha competes mainly with:
- Praluent (alirocumab): another PCSK9 inhibitor
- Statins: first-line but often insufficient alone
- Ezetimibe: adjunct therapy
- Inclisiran (Leqvio): siRNA-based PCSK9 inhibitor, more convenient dosing
Market Penetration & Adoption
Repatha has seen slow adoption initially due to high cost, injectable administration, and insurance coverage limitations. Recent policies emphasize its use in high-risk populations, boosting prescriptions.
Price Analysis
Current Pricing Trends
- In the US, the wholesale acquisition cost (WAC) for Repatha is approximately USD 5,850 to USD 6,200 per year (based on a typical 140 mg subcutaneous dose once monthly) [2].
- After negotiations and insurance coverage, patient out-of-pocket expenses vary significantly.
Pricing Compared with Competitors
| Drug |
Price (USD/year) |
Dosing Schedule |
Notes |
| Repatha |
~6,000 |
140 mg once monthly |
Bi-weekly options also available |
| Praluent |
~6,000 |
150 mg every other week |
Similar efficacy; marginally cheaper |
| Inclisiran |
~3,500 |
300 mg initially, then every 3-6 months |
Subcutaneous injections; more convenient |
Cost-Effectiveness
Cost-effectiveness analyses indicate Repatha remains expensive relative to lipid-lowering benefits. Insurance payers scrutinize prescriptions, which influences market penetration.
Price Projections (2023–2028)
Assumptions
- Continual market penetration in high-risk populations
- Increased adoption with expanded indications
- Adoption of biosimilar PCSK9 inhibitors remains limited; no biosimilars for Repatha currently available [3]
- Price reductions driven by pharmacy benefit managers (PBMs) negotiations and value-based contracting
Projected Pricing Trends
| Year |
Estimated Wholesale Price (USD/year) |
Rationale |
| 2023 |
~USD 6,200 |
Current level maintained with minor adjustments |
| 2024 |
~USD 6,000 |
Slight discounts via payer negotiations |
| 2025 |
~USD 5,800 |
Price pressure from increased competition |
| 2026 |
~USD 5,600 |
Strategies to improve market share |
| 2027 |
~USD 5,400 |
Market consolidation and increased use in broader populations |
| 2028 |
~USD 5,200 |
Further discounts, potential policy-driven price caps |
Revenue Projections
Based on adoption rates:
- 2023: USD 1.2 billion (based on estimated 200,000 patients)
- 2028: USD 2.8 billion (renewed approvals, expanded use, increased price competitiveness)
Regulatory and Policy Impact
- Future pricing will depend on Medicare and Medicaid negotiations, with a shift toward value-based agreements.
- US Inflation Reduction Act supports drug price negotiations, potentially capping prices for high-cost drugs like Repatha by 2026 [4].
Key Takeaways
- The global hypercholesterolemia market is growing at around 6% CAGR, with Repatha capturing significant share in the PCSK9 inhibitor segment.
- Current US annual price is about USD 6,000; projections suggest gradual decrease to approximately USD 5,200 by 2028.
- Market penetration remains limited by cost, insurance coverage, and competition, but expansion in indications and policies could alter trends.
FAQs
1. What factors will influence Repatha's future pricing?
Insurance negotiations, competitive market entries, policy reforms, and value-based contracting.
2. How does Repatha compare cost-wise to older therapies?
It costs substantially more than statins and ezetimibe, which are generics, but offers superior LDL reduction in refractory cases.
3. Are biosimilars expected to impact market pricing?
Currently, no biosimilars for Repatha are approved. Their entry could significantly lower prices if approved.
4. What is the potential impact of new PCSK9 inhibitors?
Innovative therapies, including oral agents and longer-acting injectables, could compete on price and convenience.
5. How has policy development affected pricing trends?
Legislation like the Inflation Reduction Act aims to control drug costs, which may lead to further price adjustments for high-cost therapies.
References
[1] MarketResearch.com. (2022). Hyperlipidemia market forecasts.
[2] IQVIA. (2023). National Prescription Data.
[3] U.S. FDA. (2022). Drug approvals and biosimilar guidance.
[4] Congressional Budget Office. (2023). Drug pricing policies and market effects.
