Last updated: July 28, 2025
Overview of NDC 72603-0171
The National Drug Code (NDC) 72603-0171 corresponds to Evolocumab, marketed under the brand name Repatha. It is a monoclonal antibody designed to lower low-density lipoprotein (LDL) cholesterol levels by inhibiting PCSK9. Approved by the FDA in 2015, Evolocumab provides an alternative for patients with hypercholesterolemia who are statin-intolerant or require additional LDL reduction.
Market Landscape
Therapeutic Rationale and Market Need
Hypercholesterolemia remains a leading risk factor for cardiovascular diseases globally. Statins constitute the first-line therapy, but a significant subset of patients experience inadequate LDL reduction or statin-associated side effects. PCSK9 inhibitors like Evolocumab address these unmet needs, offering potent LDL lowering with a favorable safety profile.
Market Penetration and Growth Drivers
Evolocumab’s market penetration is driven by:
- Growing prevalence of cardiovascular diseases (CVD), projected to reach over 600 million globally by 2030 [1].
- Increasing adoption of PCSK9 inhibitors as adjunct therapy in high-risk populations.
- Expanding indications, including familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease (ASCVD).
The global PCSK9 inhibitors market was valued at approximately USD 0.9 billion in 2021 and is projected to expand at a compound annual growth rate (CAGR) of 24% through 2028 [2].
Competitive Landscape
Evolocumab competes primarily with Alirocumab (Praluent). Both drugs exhibit similar efficacy profiles but differ in dosing regimens and pricing strategies. Biogen’s FDA-approved inclisiran (Leqvio) also enters this space, leveraging RNA interference technology for sustained LDL reduction, potentially reshaping market dynamics.
Pricing Landscape
Historical Pricing Trends
When launched, Evolocumab was priced at approximately USD 14,100 annually per patient [3]. Post-launch, prices have experienced slight reductions due to payer negotiations and increased market competition. Notably:
- 2018-2019: List price hovered around USD 14,000-16,000 annually.
- 2020-2022: Negotiated net prices declined approximately 20-30%, influenced by payer discounts and value-based contracts.
Current Pricing Environment
As of 2023, the average wholesale price (AWP) for Evolocumab remains in the USD 14,000-15,500 range annually. Payers often secure net prices significantly below the list price through rebates and access agreements, effectively reducing patient billing and insurer expenditures.
Reimbursement and Access Trends
Reimbursement policies increasingly favor value-based access models. The American College of Cardiology emphasizes the importance of LDL reduction metrics, influencing formulary inclusion and reimbursement levels. Market access remains tied to demonstration of cost-effectiveness, with ICER reports citing incremental cost-effectiveness ratios (ICERs) ranging from USD 100,000 to USD 150,000 per quality-adjusted life year (QALY) gained, depending on the patient cohort [4].
Future Price Projections
Factors Influencing Price Trends
- Competition from Inclisiran: As a novel RNA-based therapy with less frequent dosing, inclisiran's advent may exert downward pricing pressure on existing PCSK9 inhibitors.
- Market Expansion: Broader indications, such as familial hypercholesterolemia, and increased patient access expand volume, potentially enhancing revenue even at reduced prices.
- Cost-Effectiveness Evaluations: Payers’ increasing emphasis on cost per QALY may incentivize further price cuts to improve formulary positioning and patient access.
Projection Scenarios (2023-2030)
-
Moderate Price Reduction Scenario:
Continued negotiations and payer discounts could reduce the net annual price of Evolocumab by approximately 25% by 2025, reaching USD 11,000-12,000. Competition and biosimilar considerations are unlikely in the immediate future, but payers may implement more aggressive formulary restrictions.
-
Aggressive Price Decrease Scenario:
Introduction of alternative therapies and value-based contracting could drive a 40-50% reduction by 2030, with net prices falling below USD 8,500 annually. Such a shift aligns with trends observed in other biologics, where market pressures necessitate substantial price adjustments.
-
Upward Price Stability Scenario:
Limited price erosion due to high clinical efficacy and therapeutic exclusivity might maintain current or slightly reduced pricing levels through 2030, especially if new indications or combination therapies elevate drug utilization.
Summary Table of Price Projections:
| Year |
Price Scenario 1 |
Price Scenario 2 |
Price Scenario 3 |
| 2023 |
USD 13,500 |
USD 13,500 |
USD 13,500 |
| 2025 |
USD 11,000-12,000 |
USD 9,000-10,000 |
USD 13,500 |
| 2030 |
USD 8,000-10,000 |
USD 6,000-8,500 |
USD 13,500-15,000 |
(Note: These projections are illustrative, based on current market and policy trends.)
Implications for Stakeholders
- Pharmaceutical Companies: Strategic negotiations, differential pricing, and value-based contracts will be critical to maintain market share amid downward pricing pressures.
- Payers and Providers: Emphasis on cost-effectiveness and access management will influence formulary decisions and reimbursement policies.
- Patients: Expanded access contingent on affordability and coverage policies, with potential benefits from reduced drug costs over time.
Key Takeaways
- Evolocumab remains a vital agent within hypercholesterolemia management but faces increasing pricing pressures due to competition and evolving reimbursement landscapes.
- Market projections indicate a likely significant reduction in net prices by 2025-2030, with potential variations based on competition, policy changes, and innovation.
- Strategic pricing and value demonstration will be essential for sustained market viability, especially as novel therapies like inclisiran and biosimilar biologics emerge.
- The growing prevalence of CVD and expanding indications sustain demand, but cost containment efforts will influence pricing trajectories.
FAQs
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What is the current list price of Evolocumab (NDC 72603-0171)?
The current list price hovers around USD 14,000 to USD 15,500 annually, though net prices after discounts are usually lower.
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How does the entry of inclisiran impact Evolocumab’s market and pricing?
Inclisiran offers less frequent dosing and potentially lower costs, which may lead to increased price competition and market share shifts, pressuring Evolocumab to reduce its prices.
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Are payers moving toward value-based agreements for PCSK9 inhibitors?
Yes. Payers increasingly favor value-based contracts that tie reimbursement to LDL reduction targets and patient outcomes, influencing net pricing and access.
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What are the main factors affecting future price decisions?
Competition, regulatory changes, cost-effectiveness evaluations, and the development of alternative therapies like inclisiran and biosimilars are key influences.
-
Will Evolocumab’s price increase in response to higher demand?
Unlikely. Market pressures and reimbursement policies favor price stabilization or reduction, even amid rising demand, to ensure affordability and statutory compliance.
References
[1] World Health Organization. Cardiovascular Diseases (CVDs) Fact Sheet. 2022.
[2] Grand View Research. PCSK9 inhibitors Market Size, Share & Trends Analysis Report. 2022.
[3] Bloomberg Intelligence. Pharmaceutical Pricing Trends. 2021.
[4] Institute for Clinical and Economic Review (ICER). Lipid-Lowering Therapies Summary. 2022.
