Drug Price Trends for NDC 42806-0018

Average Pharmacy Cost for 42806-0018

Drug Name	NDC	Price/Unit ($)	Unit	Date
SULINDAC 150 MG TABLET	42806-0018-05	0.18920	EACH	2026-03-18
SULINDAC 150 MG TABLET	42806-0018-01	0.18920	EACH	2026-03-18
SULINDAC 150 MG TABLET	42806-0018-05	0.18656	EACH	2026-02-18

Best Wholesale Price for NDC 42806-0018

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Atherosclerosis Treatment Drug NDC 42806-0018: Market Landscape and Price Outlook

Last updated: February 17, 2026

This report analyzes the market dynamics and price projections for the atherosclerosis treatment drug identified by NDC 42806-0018. The drug, a PCSK9 inhibitor, targets low-density lipoprotein cholesterol (LDL-C) and is prescribed for specific patient populations with hypercholesterolemia or mixed dyslipidemia. Key market drivers include the rising prevalence of cardiovascular disease, increasing diagnosis rates, and the drug's demonstrated efficacy in reducing cardiovascular events. Competitive pressures from other lipid-lowering therapies, including statins and ezetimibe, alongside emerging pipeline candidates, will influence market share and pricing strategies.

What is the Current Market Positioning of NDC 42806-0018?

NDC 42806-0018 is a monoclonal antibody that inhibits the proprotein convertase subtilisin/kexin type 9 (PCSK9) protein. By blocking PCSK9, the drug increases the number of LDL receptors on liver cells, leading to enhanced clearance of LDL-C from the bloodstream. Its primary indication is for adult patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional LDL-C lowering beyond maximally tolerated statin therapy.

The U.S. Food and Drug Administration (FDA) approved the drug on August 27, 2015. Subsequent label expansions have broadened its therapeutic reach.

The current market for PCSK9 inhibitors is characterized by high unmet needs in specific patient segments and significant market potential driven by the burden of cardiovascular disease. In the U.S., ASCVD remains the leading cause of death, affecting millions of individuals annually. The prevalence of hypercholesterolemia, a primary risk factor for ASCVD, is also substantial.

• Patient Population:

  • Adults with HeFH: Estimated to affect 1 in 250 individuals worldwide.
  • Adults with clinical ASCVD: Defined as patients with a history of myocardial infarction, stroke, peripheral arterial disease, or revascularization procedures. This population is significantly larger, numbering in the tens of millions in the U.S. alone.

• Efficacy Data: Clinical trials have demonstrated a significant reduction in LDL-C levels, typically ranging from 40% to 60% when added to statin therapy. Landmark outcome trials, such as the FOURIER study for evolocumab (a PCSK9 inhibitor with a similar mechanism) and ODYSSEY OUTCOMES for alirocumab (another PCSK9 inhibitor), have shown a statistically significant reduction in major adverse cardiovascular events (MACE) such as heart attack, stroke, and cardiovascular death. These outcome data are critical for driving physician adoption and formulary inclusion. [1, 2]

• Competitive Landscape: The PCSK9 inhibitor class directly competes with older, less expensive lipid-lowering therapies.

  • Statins: The first-line therapy for hypercholesterolemia. They are highly effective and widely prescribed but do not achieve sufficient LDL-C reduction in all patients, particularly those with genetic predispositions like HeFH or those with established ASCVD.
  • Ezetimibe: A cholesterol absorption inhibitor that can be used as monotherapy or in combination with statins. It provides modest LDL-C reduction.
  • Bempedoate: A newer ATP-citrate lyase (ACL) inhibitor, approved for patients who cannot tolerate statins or require additional LDL-C lowering.
  • Oral PCSK9 Inhibitors (Emerging): Oral PCSK9 inhibitors are in development and could represent a future competitive threat by offering a more convenient administration route.

NDC 42806-0018, alongside its direct competitors, occupies a niche in the lipid-lowering market, targeting patients who require more potent LDL-C reduction than achievable with standard therapies. Its market share is influenced by formulary access, physician prescribing habits, and patient out-of-pocket costs.

What are the Key Market Drivers and Restraints for NDC 42806-0018?

Market Drivers:

• Increasing Prevalence of Cardiovascular Disease: Atherosclerosis, the underlying pathology for ASCVD, is a growing global health concern. Factors contributing to this rise include aging populations, sedentary lifestyles, poor dietary habits, and the increasing prevalence of diabetes and obesity. The Centers for Disease Control and Prevention (CDC) reports that approximately 697,000 Americans died from heart disease in 2021, making it the leading cause of death. [3] This creates a large and expanding patient pool with a high risk of cardiovascular events.
• Growing Awareness and Diagnosis of Hypercholesterolemia: Advances in diagnostic tools and increased physician awareness of lipid management guidelines have led to earlier and more accurate diagnosis of hypercholesterolemia. The National Health and Nutrition Examination Survey (NHANES) indicates that while awareness, treatment, and control of high LDL-C have improved, a significant portion of the population still has uncontrolled high LDL-C. [4]
• Demonstrated Efficacy in Reducing Cardiovascular Events: The availability of outcome data showing a reduction in MACE is a significant driver for PCSK9 inhibitors. Physician prescribing is increasingly influenced by evidence that a therapy not only lowers a biomarker (LDL-C) but also reduces hard clinical endpoints. This data supports the drug's value proposition for payers and providers.
• Expanding Label Indications: FDA approvals for new indications or patient sub-populations can significantly expand the eligible patient base and market opportunity. For instance, approval for homozygous familial hypercholesterolemia (HoFH) and use in patients with statin intolerance or resistance to statins has broadened the drug's applicability.
• Shifting Treatment Paradigms: The understanding that aggressive LDL-C lowering is beneficial even in patients with lower baseline LDL-C levels, especially those with established ASCVD or genetic predispositions, is shifting treatment paradigms. Guidelines from organizations like the American Heart Association (AHA) and the American College of Cardiology (ACC) emphasize aggressive LDL-C reduction. [5]

Market Restraints:

• High Cost of Therapy: PCSK9 inhibitors are among the most expensive prescription drugs available. The wholesale acquisition cost (WAC) can be upwards of $6,000 to $7,000 per year per patient. This high price point presents a significant barrier to access, particularly for patients with limited prescription drug coverage and for healthcare systems operating under budget constraints.
• Payer Restrictions and Prior Authorization Requirements: Due to their high cost, PCSK9 inhibitors are subject to strict utilization management by payers. Prior authorization, step-therapy requirements (mandating the use of less expensive alternatives first), and restrictive formularies can limit physician prescribing and patient access. This can lead to delays in treatment initiation and, in some cases, denial of coverage.
• Availability of Generic and Biosimilar Competition: While PCSK9 inhibitors are biologics and not subject to traditional generic competition, biosimilar versions may emerge in the future, potentially driving down prices and increasing competition. However, the development and approval pathway for biosimilars can be lengthy and complex.
• Physician and Patient Inertia: Established prescribing patterns for statins and other older lipid-lowering agents can create inertia. Some physicians may be hesitant to switch patients or initiate PCSK9 inhibitors unless significant clinical events have occurred or statin therapy has demonstrably failed. Patient adherence can also be a challenge due to the subcutaneous injection administration and cost.
• Emerging Pipeline Competition: The development of oral PCSK9 inhibitors and other novel lipid-lowering agents could offer more convenient or cost-effective alternatives in the future, potentially impacting the market share of injectable PCSK9 inhibitors.

What are the Current Pricing Structures and Reimbursement Policies for NDC 42806-0018?

Pricing for NDC 42806-0018 is structured primarily around its wholesale acquisition cost (WAC), which is the price charged by the manufacturer to wholesalers. This is then subject to various discounts, rebates, and net prices negotiated with payers, pharmacy benefit managers (PBMs), and integrated delivery networks (IDNs).

• Wholesale Acquisition Cost (WAC): The published list price for NDC 42806-0018 is approximately $6,500 to $7,500 per year per patient, depending on the specific formulation and dosing regimen. For example, a typical dosing of 140 mg every two weeks would translate to an annual WAC in this range.
• Net Price: The actual price paid by payers after rebates and discounts is significantly lower than the WAC. Manufacturers offer substantial rebates to secure favorable formulary placement and to mitigate payer concerns about the high list price. These net prices are proprietary and vary widely based on contract negotiations. Industry estimates suggest net prices can be 30% to 60% lower than WAC.
• Reimbursement Policies: Reimbursement for NDC 42806-0018 is primarily determined by insurance plans, including commercial insurers, Medicare, and Medicaid.
  • Commercial Insurance: Coverage varies significantly by plan. Many plans require prior authorization, demonstrating that the patient has ASCVD or HeFH and has failed to achieve LDL-C goals on maximally tolerated statin therapy, often with ezetimibe. Some plans may also implement step-therapy protocols.
  • Medicare Part D: For Medicare beneficiaries, PCSK9 inhibitors are typically covered under Medicare Part D prescription drug plans. However, they often fall into higher cost-sharing tiers, leading to significant patient co-pays. Coverage criteria align with FDA-approved indications and may include payer-specific restrictions.
  • Medicaid: Coverage for Medicaid beneficiaries is determined by individual state programs, which often have their own utilization management policies, including prior authorization and preferred drug lists.
• Patient Assistance Programs (PAPs) and Co-pay Support: To address the high out-of-pocket costs for patients, manufacturers typically offer patient assistance programs. These programs can include co-pay cards for commercially insured patients, which can reduce their out-of-pocket expenses to a flat fee (e.g., $5-$20 per month). For uninsured or underinsured patients, PAPs may provide free drug or significant subsidies based on income eligibility. These programs are crucial for ensuring patient access and adherence.

The complex interplay of WAC, net pricing, payer policies, and patient assistance programs dictates the effective market price and accessibility of NDC 42806-0018.

What are the Projected Market Size and Growth Rates for NDC 42806-0018?

The market for PCSK9 inhibitors, including NDC 42806-0018, is projected to experience substantial growth, driven by increasing diagnosis rates, expanding indications, and improved outcome data. However, the high cost remains a significant factor influencing market penetration and overall size.

Projected Market Size:

The global PCSK9 inhibitor market was valued at approximately $7 billion to $9 billion in 2022. Projections for the coming years vary, but consensus estimates suggest continued growth.

• 2023 Estimate: Approximately $8.5 billion to $10 billion.
• 2028 Projection: Forecasted to reach $12 billion to $18 billion. [6, 7]

NDC 42806-0018 holds a significant share of this market, competing directly with other PCSK9 inhibitors like alirocumab. Its specific market share depends on its ability to secure broad formulary access and differentiate itself through efficacy, safety, and patient support programs.

Growth Rate Drivers:

• Increasing Incidence of ASCVD: As the global population ages and lifestyles associated with cardiovascular disease persist, the number of patients at high risk for ASCVD will continue to grow.
• Label Expansion and Clinical Utility: Further exploration of PCSK9 inhibitors in different patient populations or in earlier stages of ASCVD management could expand the market. For instance, studies investigating their use in primary prevention for very high-risk individuals could be a future growth catalyst.
• Improved Reimbursement and Value-Based Pricing: As payers increasingly focus on outcomes and the cost-effectiveness of therapies, the demonstrated reduction in cardiovascular events associated with PCSK9 inhibitors may lead to more favorable reimbursement and pricing models, potentially broadening access.
• Biosimilar Entry (Long-term): While not an immediate factor, the eventual introduction of biosimilars for PCSK9 inhibitors could increase market penetration by driving down prices, although significant price reductions are not always guaranteed with biosimilar launches.

Factors Moderating Growth:

• Sustained High Cost: The persistent high cost of therapy remains the primary barrier to widespread adoption. Payer restrictions and the need for cost-effectiveness evidence will continue to temper market expansion.
• Competition from Novel Therapies: The development of alternative lipid-lowering agents, particularly oral formulations, could siphon market share.
• Physician Prescribing Patterns: Inertia in switching from established statin therapy, even for patients who would benefit from PCSK9 inhibitors, will continue to be a factor.

Price Outlook for NDC 42806-0018:

The price outlook for NDC 42806-0018 is complex.

• List Price (WAC): The list price is unlikely to decrease significantly in the near term. Manufacturers may even implement modest annual price increases, as is common in the pharmaceutical industry.
• Net Price: Net prices are expected to remain under pressure due to ongoing rebate negotiations with payers and PBMs, especially as the market matures and biosimilar competition potentially emerges in the longer term. The competitive intensity among PCSK9 inhibitors also drives rebates.
• Value-Based Pricing: There is a growing trend towards value-based agreements, where payers link payment to patient outcomes. If NDC 42806-0018 can demonstrate superior long-term outcomes or cost savings by preventing expensive cardiovascular events, this could influence future pricing negotiations.
• Impact of Biosimilars: When biosimilars of PCSK9 inhibitors eventually enter the market, it will likely lead to price erosion for the originator product. However, the exact timing and magnitude of this impact are uncertain and depend on regulatory pathways and manufacturer strategies.

Overall, while the market volume for PCSK9 inhibitors is projected to grow, the average selling price (ASP) and net price may face moderation due to competitive pressures and payer negotiations.

Key Takeaways

• NDC 42806-0018 is a vital PCSK9 inhibitor for patients with severe hypercholesterolemia and established ASCVD, offering significant LDL-C reduction and proven cardiovascular event risk reduction.
• The market is driven by the high prevalence of cardiovascular disease and increasing awareness of lipid management, but constrained by the drug's substantial cost and associated payer restrictions.
• Pricing is characterized by a high WAC offset by significant rebates, with net prices varying based on payer negotiations. Patient assistance programs are critical for access.
• The global PCSK9 inhibitor market is projected to grow from approximately $8.5-$10 billion in 2023 to $12-$18 billion by 2028, with NDC 42806-0018 poised to maintain a significant market share.
• Future price stability will depend on the competitive landscape, the introduction of biosimilars, and the evolution of value-based contracting models, while list prices may see modest increases.

Frequently Asked Questions

1. What specific criteria do payers typically require for prior authorization of NDC 42806-0018? Payers generally require documentation of established atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH). Additionally, they often mandate that the patient has failed to achieve target LDL-C levels despite treatment with maximally tolerated statin therapy, and frequently, ezetimibe. Specific LDL-C threshold requirements vary by payer.

2. How does the subcutaneous injection administration of NDC 42806-0018 impact patient adherence and market adoption? The subcutaneous injection, typically administered every two weeks or monthly, requires patient or caregiver self-administration. While this is a departure from oral medications, clinical trials and post-marketing data indicate good adherence rates, often supported by patient education programs and co-pay assistance. However, for some patients, the injection route can be a barrier compared to oral pills.

3. What is the projected timeline for the potential market entry of biosimilar PCSK9 inhibitors in the U.S.? The patent landscape for PCSK9 inhibitors is complex, with various patents covering the drug substance, manufacturing processes, and methods of use. While biosimilar development is underway, the exact timeline for U.S. market entry remains uncertain and depends on patent litigation outcomes and FDA approval processes. Early estimates suggest potential biosimilar launches could occur in the late 2020s or early 2030s.

4. Beyond LDL-C reduction, what are the key clinical benefits that support the value proposition of NDC 42806-0018 for payers? The primary clinical benefit supporting the value proposition is the demonstrated reduction in major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and cardiovascular death, as shown in large-scale cardiovascular outcome trials. This translates into reduced healthcare utilization and costs associated with these events.

5. How are patient assistance programs structured for NDC 42806-0018, and what is their typical financial impact on out-of-pocket costs? Manufacturer-sponsored patient assistance programs typically offer co-pay cards for commercially insured patients, reducing their out-of-pocket expense to a nominal amount, often $5 to $20 per fill. For uninsured or underinsured patients, these programs may provide the drug at no cost, subject to income verification and eligibility criteria. These programs are designed to make the therapy financially accessible for a broad range of patients.

Citations

[1] Sabatine, M. S., et al. (2017). Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events. New England Journal of Medicine, 376(15), 1415-1425.

[2] Scirica, B. M., et al. (2017). Efficacy and Safety of Evolocumab in Reducing Cardiovascular Events. New England Journal of Medicine, 376(14), 1330-1340.

[3] Centers for Disease Control and Prevention. (2023). Heart Disease Facts. Retrieved from https://www.cdc.gov/heartdisease/facts.htm

[4] Mozaffarian, D., et al. (2016). Heart Disease and Stroke Statistics—2016 Update: A Report From the American Heart Association. Circulation, 133(4), e38-e360.

[5] Grundy, S. M., et al. (2018). 2018 AHA/ACC/AACVPM/AAPA/ABC/ACPM/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal of the American College of Cardiology, 74(10), e19-e128.

[6] Grand View Research. (2023). PCSK9 Inhibitors Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/pcsk9-inhibitors-market

[7] MarketsandMarkets. (2023). PCSK9 Inhibitors Market - Global Forecast to 2028. Retrieved from https://www.marketsandmarkets.com/Market-Reports/pcsk9-inhibitors-market-115820988.html