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Last Updated: December 19, 2025

Drug Price Trends for NDC 68180-0828


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Market Analysis and Price Projections for NDC 68180-0828

Last updated: July 29, 2025

Introduction

NDC 68180-0828 corresponds to Repatha (evolocumab), a monoclonal antibody indicated for hyperlipidemia and familial hypercholesterolemia. As a PCSK9 inhibitor, Repatha represents a significant advancement in lipid management, addressing unmet needs in both primary and secondary prevention of cardiovascular disease. The drug's market trajectory, pricing landscape, and competitive positioning are influenced by evolving clinical guidelines, payer dynamics, and pipeline developments. This report provides an in-depth market analysis and price projection estimates for Repatha, considering current data and future trends.


Market Overview

Therapeutic Landscape

Repatha operates within the lipid-lowering agent market, competing against statins, ezetimibe, PCSK9 inhibitors, and emerging therapeutics such as inclisiran and bempedoic acid. Statins remain first-line therapy, but PCSK9 inhibitors like Repatha address gaps for high-risk patients who are intolerant or inadequately controlled on existing therapies.

Market Size and Growth Potential

The global hyperlipidemia market was valued at approximately $6.5 billion in 2021 and is projected to reach over $10 billion by 2027, with a compound annual growth rate (CAGR) of approximately 7%[1]. Repatha contributes a significant fraction, particularly in secondary prevention in high-risk populations.

The US market dominates, driven by broad payer coverage and high prevalence of cardiovascular disease (CVD). In 2020, approximately 95 million adults in the US had elevated LDL cholesterol levels, with only a subset currently on PCSK9 inhibitors due to cost and access barriers[2].

Regulatory Status and Market Penetration

Repatha received FDA approval in 2015 for specific indications, including familial hypercholesterolemia and atherosclerotic CVD. Market penetration expanded through incorporation into clinical guidelines, such as the 2018 ACC/AHA guidelines endorsing PCSK9 inhibitors for very high-risk patients.

Despite initial slow uptake, market share increased with greater awareness and wider insurance coverage, especially following the approval of more convenient dosing options and price negotiations.


Pricing Analysis

Current Price Structure

Repatha’s list price is approximately $585 per syringe (as of 2023), with dosing typically ranging from $6,200 to $7,800 annually per patient, depending on dosing frequency. Payer discounts and rebates significantly influence net prices, often reducing costs to the healthcare system.

Pricing Trends and Industry Benchmarks

Compared to peer biologics, Repatha’s pricing is competitive but remains high relative to traditional lipid-lowering agents. The average wholesale price (AWP) has seen minimal reductions since launch but is subject to ongoing negotiations and value-based agreements.

Recent price adjustments are driven by:

  • Market Pressure: Payers aim to contain costs amid rising drug budgets.
  • Value-based Pricing: Initiatives focus on aligning reimbursement with clinical outcomes.
  • Pipeline Competition: Emergence of alternatives like inclisiran (approved in 2023) potentially exert downward pressure on list prices.

Future Market Dynamics and Price Projections

Impact of Pipeline and Competitive Landscape

  • Inclisiran (Leqvio): Approved in 2023, offers twice-yearly dosing, targeting adherence issues associated with biweekly injections for Repatha.
  • Bempedoic Acid (Nexletol): Oral agent providing a cost-effective alternative, especially for patients with statin intolerance.
  • Gene Therapies: Emerging research could disrupt the market, though clinical translation remains nascent.

Healthcare Policy and Reimbursement Trends

With increasing emphasis on value-based care, payers are likely to negotiate steeper discounts and favor therapeutics demonstrating cost-effectiveness. The ICER (Institute for Clinical and Economic Review) has recommended pricing for PCSK9 inhibitors ranging from $5,000 to $8,000 annually to optimize payer adoption.

Price Trajectory Predictions

Based on current market dynamics and competitive factors, the following projections are made:

  • 2023-2025: Stable list prices with modest rebates (~10%), net prices estimated at ~$5,000–$6,000 annually per patient. Increased utilization expected as guidelines and insurance coverage evolve.
  • 2026-2028: Potential downward adjustments of 10-15% driven by increased competition from inclisiran and biosimilar developments, with net prices possibly falling to ~$4,200–$5,200.
  • Long-Term Outlook (2029 onward): Prices may stabilize or decline further (~10-20%) due to biosimilar entry, value-based agreements, and policy reforms targeting high-cost biologics.

Market Access and Reimbursement Considerations

The success of Repatha’s market relies heavily on clearing reimbursement hurdles. Payer policies are increasingly favoring high-value therapies, pushing for:

  • Prior authorization criteria verifying high-risk status.
  • Outcomes-based contracts linking reimbursement to LDL cholesterol reduction and cardiovascular event reduction.
  • Formularies that favor alternative agents under certain circumstances, especially oral Bempedoic acid.

The adoption rate will also be influenced by educational efforts to demonstrate clinical benefits, such as reductions in major adverse cardiovascular events (MACE).


Conclusion

Repatha remains a pivotal player amid a competitive and evolving lipid management market. Its high price point is justified by clinical efficacy but faces pressure from pipeline innovations, policy reforms, and cost-containment strategies. Short to medium-term projections suggest stable prices with slight downward trends, driven by increasing competition and value-based reimbursement models. For stakeholders, remaining attentive to pipeline developments, payor dynamics, and guideline updates will be critical to optimizing market opportunities.


Key Takeaways

  • Market Size & Growth: The hyperlipidemia market, particularly high-risk populations, offers substantial growth opportunities, with Repatha positioned as a premium solution.
  • Pricing Trends: Current list prices are high; discounts and rebates lower net prices. Future reductions (~10-20%) are anticipated due to market competition.
  • Competitive Landscape: Inclisiran's approval and biosimilar considerations pose significant threats, potentially leading to price erosion.
  • Reimbursement Strategies: Success hinges on outcomes-based contracts, strict payer access criteria, and demonstrating cost-effectiveness.
  • Strategic Implication: Companies should focus on innovating dosing, expanding indications, and engaging in value-based pricing to sustain profitability.

FAQs

1. How does the pricing of Repatha compare to other PCSK9 inhibitors?
Repatha’s list prices are comparable to similar agents like Praluent (alirocumab). Both have similar annual costs (~$6,000–$7,000), though actual net prices differ due to rebates and discounts.

2. What are the main factors affecting Repatha's market penetration?
Efficacy, payer reimbursement policies, clinical guidelines, patient adherence, and competition from oral agents like Bempedoic acid and pipeline alternatives.

3. Will biosimilars or generics significantly lower Repatha's price?
Biosimilar versions could reduce costs, but as of 2023, none are FDA-approved. Congressional and FDA pathways for biosimilar entry may eventually impact pricing.

4. How does the emergence of inclisiran influence Repatha's market?
Inclisiran’s twice-yearly dosing may improve adherence and patient convenience, potentially cannibalizing Repatha’s market share, especially if priced competitively.

5. What role do healthcare policies play in future pricing?
Policies favoring value-based care and cost-effectiveness assessments could lead to stricter reimbursement criteria and sustained price reductions for biologics like Repatha.


References

[1] Grand View Research. "Hyperlipidemia Market Size, Share & Trends Analysis Report." 2022.
[2] CDC. "High LDL Cholesterol in Adults." 2020.

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