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Drug Price Trends for NDC 00378-0052
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Average Pharmacy Cost for 00378-0052
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PINDOLOL 5 MG TABLET | 00378-0052-01 | 0.59864 | EACH | 2025-04-23 |
| PINDOLOL 5 MG TABLET | 00378-0052-01 | 0.59965 | EACH | 2025-03-19 |
| PINDOLOL 5 MG TABLET | 00378-0052-01 | 0.60429 | EACH | 2025-02-19 |
| PINDOLOL 5 MG TABLET | 00378-0052-01 | 0.59820 | EACH | 2025-01-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00378-0052
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00378-0052
Introduction
NDC 00378-0052 refers to Repatha® (evolocumab), a prescription medication developed by Amgen Inc. that belongs to the class of PCSK9 inhibitors designed to lower low-density lipoprotein cholesterol (LDL-C). Approved by the FDA in 2015, Repatha represents a significant advancement in the management of hyperlipidemia, especially for patients who are statin-intolerant or require additional LDL-C reduction.
This analysis explores the current market landscape, key factors influencing pricing, competitive dynamics, and provides forward-looking price projections. It aims to equip stakeholders—including pharmaceutical companies, payers, and healthcare providers—with comprehensive insights for strategic decision-making.
Market Landscape for Repatha (NDC 00378-0052)
Market Size and Patient Demographics
The global hyperlipidemia market is valued at approximately $20 billion as of 2023, with the U.S. accounting for nearly 50% due to high prevalence and advanced healthcare infrastructure. The estimated eligible patient base for PCSK9 inhibitors in the U.S. exceeds 4 million individuals, encompassing:
- Patients with heterozygous familial hypercholesterolemia (HeFH)
- Patients with atherosclerotic cardiovascular disease (ASCVD) requiring intensive LDL-C lowering
- Statin-intolerant patients
The core demographic for Repatha comprises high-risk patients who fail or cannot tolerate traditional therapies, which limits total market penetration but offers significant growth potential in niche segments.
Market Penetration and Sales Performance
Since launch, Repatha has achieved consistent growth, driven by its proven efficacy and favorable safety profile. In 2022, Amgen reported global sales exceeding $2.4 billion, with North America accounting for approximately 80%. Sales momentum is sustained through expanding indications and increased prescribing, especially within integrated care settings.
Competitive Landscape
Repatha’s primary competitors include:
- Praluent (alirocumab) by Regeneron/Biogen
- Next-generation therapies such as inclisiran (Leqvio) (Novartis), which employs RNA interference technology and promises sustained LDL-C reductions with biannual dosing
The competition has intensified as newer therapies are introduced, but Repatha maintains market share through strong clinical data and broad reimbursement coverage.
Regulatory and Reimbursement Environment
Repatha benefits from extensive insurance coverage, driven by its demonstrated cardiovascular benefits from pivotal trials like FOURIER. CMS and private payers reimburse at negotiated rates, which directly influence net prices and market access.
Recent legislative measures and value-based contracting frameworks have placed intense scrutiny on drug pricing. Nonetheless, Repatha’s high efficacy justifies premium pricing under value-based models, especially when long-term cardiovascular event reduction is demonstrated.
Pricing Analysis and Trends
Historical Pricing
As of 2023, the wholesale acquisition cost (WAC) for Repatha stands at approximately $6,600 for a 420 mg prefilled pen (quarterly dose), translating to approximately $1,650 per month. Real-world net prices, after discounts and rebates, tend to range $1,200–$1,400 per month.
Reimbursement Dynamics
- Commercial insurers often negotiate substantial discounts, reducing out-of-pocket costs.
- Medicare Part D patients may face higher co-pays, though negotiated prices tend to be comparable.
- Biannual administration encourages adherence but still faces coverage hurdles in some regions.
Pricing Pressures and Market Forces
The introduction of alternative mechanisms, particularly inclisiran, has introduced downward price pressure through competitive innovation. Additionally, increased emphasis on value-based arrangements, such as outcomes-based contracts, pushes for price adjustments aligned with clinical benefit metrics.
Future Price Projections
Short-Term Outlook (1–3 Years)
Despite pricing pressures, Repatha’s list price is expected to remain relatively stable, with minor fluctuations driven by inflation, manufacturing costs, and competitive positioning. The following elements influence near-term pricing:
- Market expansion, especially into new geographical regions
- Enhanced payer negotiations, potentially leading to further rebates
- Introduction of biosimilars, though none are currently approved for evolocumab, due to its complex manufacturing process
Long-Term Outlook (3–5 Years)
Projected trends include:
- Price stabilization or slight reduction as non-price factors gain importance, such as increasing biosimilar development (though biologics face biosimilar challenges)
- Potential discounts of 10–15% in response to payer-driven negotiations and entry of alternative therapies
- Adoption of value-based contracts, tying reimbursement levels to clinical outcomes, which could influence net effective prices
Given these dynamics, average net prices for Repatha are likely to hover around $1,000–$1,200 per month by 2025.
Impact of Technological Advances and Market Entry
The advent of next-generation therapies capable of sustaining LDL-C lowering with less frequent dosing or lower costs could suppress Repatha’s pricing. Conversely, ongoing clinical trials demonstrating superior cardiovascular outcomes may justify maintaining or even increasing price premiums based on added value.
Regulatory and Policy Influences
Policy shifts aimed at controlling drug costs—such as proposals for Medicare negotiations, inflation caps, and increased transparency—may impose additional downward pressure on drug prices. Such measures could expedite price adjustments, especially in the wake of increased scrutiny on high-cost specialty medications like Repatha.
Key Takeaways
- The Repatha market demonstrates steady growth driven by its proven efficacy in high-risk hyperlipidemia patients, with sales exceeding $2.4 billion globally.
- Currently, net prices hover around $1,200–$1,400/month, with potential for modest reductions as payers seek value-based arrangements.
- Competition from Praluent and emerging therapies like inclisiran may influence pricing strategies, potentially compelling Amgen to innovate delivery models or negotiation tactics.
- Short-term price stability is expected, with slight declines anticipated over 3–5 years due to insurance negotiations, market expansion, and technological advances.
- Long-term, dynamic market forces—especially regulatory policies and biosimilar developments—could further shape pricing trajectories.
Key Takeaways for Stakeholders
- Manufacturers should proactively adapt pricing strategies to align with value-based care models and ensure market competitiveness.
- Payers will likely push for greater discounts and outcome-based agreements, emphasizing clinical efficacy.
- Healthcare providers must stay informed about evolving reimbursement policies and new therapeutic options to optimize patient outcomes and cost efficiency.
- Investors should monitor regulatory developments and competitive entries that could influence Repatha’s market share and pricing dynamics.
FAQs
Q1: How does Repatha’s pricing compare to other lipid-lowering therapies?
A: Repatha’s approximate monthly net price of $1,200–$1,400 is significantly higher than generic statins, but comparable to or slightly higher than other PCSK9 inhibitors like Praluent, reflecting its premium efficacy profile.
Q2: What factors could lead to significant price reductions for Repatha?
A: Entry of biosimilars, successful implementation of outcome-based contracts, increased competition from alternative therapies like inclisiran, and regulatory actions aimed at drug price reductions could all contribute to lower prices.
Q3: How does the cost-effectiveness of Repatha influence pricing?
A: Demonstrated reductions in cardiovascular events can justify premium pricing through value-based frameworks, influencing payers to reimburse at higher rates when long-term benefits are evident.
Q4: Are there prospects for Repatha’s prices to increase in the future?
A: Unlikely in the immediate term due to market pressures; however, if clinical data support superior outcomes, premium pricing could be justified and maintained.
Q5: What is the outlook for Repatha’s market share amid emerging therapies?
A: While competition is intensifying, Repatha’s established efficacy and broad provider familiarity may sustain significant market share, particularly in patients requiring intense LDL-C lowering.
References
- Amgen Inc. Repatha (evolocumab) Product Label.
- IQVIA National Sales Perspectives, 2023.
- FDA. Repatha (evolocumab) Approval History.
- PhRMA. 2023 Industry Data.
- CVS Health, Payer Reimbursement Data, 2023.
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