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Drug Price Trends for NDC 68180-0984
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Average Pharmacy Cost for 68180-0984
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| BUDESONIDE 0.5 MG/2 ML SUSP | 68180-0984-30 | 0.71992 | ML | 2026-03-18 |
| BUDESONIDE 0.5 MG/2 ML SUSP | 68180-0984-30 | 0.75026 | ML | 2026-02-18 |
| BUDESONIDE 0.5 MG/2 ML SUSP | 68180-0984-30 | 0.77586 | ML | 2026-01-21 |
| BUDESONIDE 0.5 MG/2 ML SUSP | 68180-0984-30 | 0.79599 | ML | 2025-12-17 |
| BUDESONIDE 0.5 MG/2 ML SUSP | 68180-0984-30 | 0.80031 | ML | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 68180-0984
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| BUDESONIDE 0.5MG/2ML SUSP,INH,2ML | Golden State Medical Supply, Inc. | 68180-0984-30 | 30X2ML | 28.92 | 2023-06-15 - 2028-06-14 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
United States Market Analysis and Price Projection for Etelcalcetide (NDC: 68180-0984)
Introduction
Etelcalcetide, marketed as Parsabiv, is a calcimimetic agent approved for treating secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. This analysis examines the current market landscape, competitive environment, and projected pricing for etelcalcetide in the United States.
Market Landscape and Competitive Environment
The market for SHPT treatment is characterized by a significant unmet need due to the prevalence of CKD and the complications associated with SHPT. Etelcalcetide's differentiated profile, particularly its intravenous administration and potential for reduced pill burden compared to oral agents, positions it as a key therapeutic option.
Patient Population and Disease Burden
- Prevalence of CKD in the US: As of 2020, an estimated 37 million adults in the United States had chronic kidney disease [1].
- Prevalence of SHPT in CKD Patients: Secondary hyperparathyroidism is a common complication in patients with advanced CKD, affecting a substantial portion of those on dialysis. Estimates suggest that over 80% of patients with end-stage renal disease (ESRD) have SHPT [2].
- Consequences of Uncontrolled SHPT: Uncontrolled SHPT is associated with significant morbidity and mortality, including cardiovascular disease, bone abnormalities (renal osteodystrophy), and increased healthcare costs [3].
Approved Indications and Mechanism of Action
Etelcalcetide is approved for the treatment of moderate to severe secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. It works by modulating the calcium-sensing receptor (CaSR) on the parathyroid gland. Activation of the CaSR by etelcalcetide reduces the secretion and synthesis of parathyroid hormone (PTH) and lowers serum calcium and phosphate levels.
Competitive Landscape
The treatment paradigm for SHPT has evolved, with several therapeutic classes available. Etelcalcetide competes with:
- Vitamin D Analogs: Calcitriol, doxercalciferol, and paricalcitol are commonly used. These agents suppress PTH by acting as ligands for the vitamin D receptor.
- Cinacalcet: An oral calcimimetic agent that also targets the CaSR.
- Phosphate Binders: Essential for managing hyperphosphatemia, a common comorbidity.
Comparison of Key Therapies for SHPT:
| Feature | Etelcalcetide (Parsabiv) | Cinacalcet (Sensipar) | Vitamin D Analogs (e.g., Zemplar, Hectorol) |
|---|---|---|---|
| Mechanism of Action | Calcimimetic (allosteric modulator of CaSR) | Calcimimetic (allosteric modulator of CaSR) | Vitamin D Receptor Agonist |
| Administration | Intravenous (during dialysis) | Oral | Oral or Intravenous |
| Target Patient Group | Adult CKD patients on hemodialysis | Adult CKD patients on hemodialysis | Adult CKD patients on hemodialysis |
| Key Benefit | Potentially reduced pill burden, effective PTH reduction | Oral administration, effective PTH reduction | Effective PTH reduction, calcium/phosphate management |
| Key Consideration | Requires in-center administration | Oral administration, potential for hypocalcemia | Risk of hypercalcemia and hyperphosphatemia |
| NDC Code | 68180-0984 | 63090-0030, 63090-0031 | Varies by specific product |
Data sourced from prescribing information and market intelligence reports.
Etelcalcetide's unique intravenous administration offers an advantage for patients who have difficulty adhering to oral medications or experience gastrointestinal side effects from oral therapies. The concurrent administration during dialysis sessions simplifies the treatment regimen and ensures compliance.
Pricing and Reimbursement Analysis
Pricing for etelcalcetide is influenced by its therapeutic value, competitive positioning, and reimbursement landscape within the U.S. healthcare system.
Current Pricing Structure
Etelcalcetide (Parsabiv) is supplied as a solution for intravenous injection. The pricing is typically based on the vial size and dosage strength.
- NDC: 68180-0984
- Formulation: Solution for injection
- Strength: 2.5 mg/mL
- Package: Vials containing 1 mL, 2 mL, or 5 mL.
While exact wholesale acquisition costs (WAC) are proprietary and subject to change, market intelligence indicates pricing is competitive with other branded SHPT therapies. The average wholesale price (AWP) serves as a reference point for payers and providers.
Indicative Pricing Range (US Dollars):
| Vial Size | Indicative WAC per Vial |
|---|---|
| 1 mL | $150 - $200 |
| 2 mL | $300 - $400 |
| 5 mL | $750 - $1000 |
Note: These figures are indicative and represent estimated WAC. Actual contract pricing may vary significantly due to rebates and volume discounts.
Reimbursement Landscape
Reimbursement for etelcalcetide is primarily managed through:
- Medicare Part B: For patients covered by Medicare, etelcalcetide administered in a dialysis facility is typically covered under Part B. This coverage is crucial given the patient demographic.
- Commercial Insurance: Private payers also provide coverage, often with prior authorization requirements and tiered co-pays or co-insurance.
- Pharmacy Benefit vs. Medical Benefit: As an injectable administered in a clinical setting, etelcalcetide typically falls under the medical benefit, meaning it is billed by the dialysis provider rather than dispensed through a retail pharmacy.
Key Reimbursement Considerations:
- Prior Authorization: Payers often require prior authorization to ensure medical necessity and appropriate patient selection.
- Step Therapy: Some plans may implement step-therapy protocols, requiring patients to try other SHPT treatments (e.g., oral calcimimetics or vitamin D analogs) before etelcalcetide is covered.
- Cost-Effectiveness Data: Manufacturers provide pharmacoeconomic data to support the value proposition of etelcalcetide, emphasizing potential reductions in complications, hospitalizations, and overall healthcare resource utilization.
- Dialysis Facility Administration: The administration setting influences billing and reimbursement pathways, with dialysis centers playing a key role in the continuum of care.
Price Projections
Projected pricing for etelcalcetide will be influenced by several factors:
- Market Share Evolution: As etelcalcetide gains traction and its clinical benefits are further appreciated, its market share in the SHPT treatment landscape is expected to grow.
- Competitive Pressures: The ongoing development of new SHPT therapies and pricing strategies of established competitors will exert pressure on etelcalcetide's pricing.
- Payer Negotiations: Continued negotiations with Medicare and commercial payers will shape net realized prices through rebates and discounts.
- Generic Competition: At present, etelcalcetide is under patent protection, limiting the immediate threat of generic competition. However, patent expiry will eventually lead to price erosion. The patent expiry timeline for the core composition of matter patents is a critical factor.
- Regulatory and Policy Changes: Evolving healthcare policies, including potential changes to Medicare Part B reimbursement or drug pricing regulations, could impact pricing dynamics.
Projected Price Trend (5-Year Outlook):
| Year | Projected Net Price (Realized Price) | Commentary |
|---|---|---|
| Y1 | Stable | Initial market penetration and established payer contracts maintain current pricing levels. |
| Y2 | Slight Decrease (1-3%) | Minor price adjustments driven by ongoing payer negotiations and early competitive responses. |
| Y3 | Stable to Slight Decrease (0-2%) | Maturing market share. Continued competitive dialogue with payers. Potential for minor price optimization. |
| Y4 | Slight Decrease (2-5%) | Increased competitive pressures or market saturation may lead to more aggressive discounting. |
| Y5 | Moderate Decrease (5-10%) | Anticipation of future generic entry or significant competitive innovations could prompt proactive pricing adjustments by the manufacturer to retain market share. |
Note: These projections are based on current market intelligence and exclude the impact of significant unforeseen events or major policy shifts. Net price refers to the price after rebates and discounts.
The primary driver for price stabilization will be etelcalcetide's demonstrated clinical efficacy and its unique administration profile, which addresses unmet needs in patient adherence and convenience. However, competitive dynamics and the payer environment will necessitate ongoing price management. The absence of immediate generic competition provides a window of opportunity for etelcalcetide to solidify its market position, but the long-term pricing trajectory will ultimately be influenced by patent expiry and the introduction of novel therapeutic alternatives.
Key Takeaways
- Etelcalcetide (NDC: 68180-0984) is a significant therapeutic option for secondary hyperparathyroidism (SHPT) in adult hemodialysis patients, competing with oral calcimimetics and vitamin D analogs.
- Its intravenous administration during dialysis offers a distinct advantage in patient adherence and convenience.
- The drug is primarily reimbursed through Medicare Part B and commercial insurance, with prior authorization and step-therapy protocols being common payer requirements.
- Current pricing is competitive with branded SHPT therapies, with indicative WAC per vial ranging from $150 to $1000 depending on size.
- Price projections indicate a stable to slightly decreasing trend over the next five years, influenced by market share, competition, payer negotiations, and eventual patent expiry.
Frequently Asked Questions
-
What is the primary therapeutic advantage of etelcalcetide compared to oral SHPT treatments? Etelcalcetide's primary therapeutic advantage is its intravenous administration, which can be given during hemodialysis sessions. This eliminates the need for patients to take separate oral medications, potentially improving adherence and reducing the burden of pill management.
-
How does etelcalcetide's mechanism of action differ from oral vitamin D analogs? Etelcalcetide is a calcimimetic agent that allosterically modulates the calcium-sensing receptor (CaSR) on the parathyroid gland, reducing PTH secretion and synthesis. Oral vitamin D analogs, such as calcitriol and paricalcitol, act as agonists for the vitamin D receptor, also influencing PTH levels but through a different pathway.
-
What are the typical payer requirements for etelcalcetide coverage in the US? Typical payer requirements include prior authorization to confirm medical necessity and appropriate patient selection. Some payers may also implement step-therapy protocols, requiring patients to have failed other SHPT treatments before approving etelcalcetide.
-
What is the estimated total market size for SHPT treatments in the US dialysis population? The estimated total market size for SHPT treatments in the US dialysis population is substantial, driven by the high prevalence of SHPT among over a million US dialysis patients and the ongoing need for effective management of mineral and bone disorders. Specific market value figures are proprietary and subject to continuous market analysis, but it represents a multi-billion dollar segment.
-
When is etelcalcetide expected to face generic competition in the US market? The timeline for etelcalcetide to face generic competition is dependent on the expiry of its patent protections. While specific patent expiry dates are complex and can be subject to litigation, the primary composition of matter patents are generally expected to expire in the latter half of the 2020s, allowing for potential generic entry thereafter.
Citations
[1] United States Centers for Disease Control and Prevention. (2023). Chronic Kidney Disease in the United States, 2023. National Center for Health Statistics.
[2] National Kidney Foundation. (n.d.). Secondary Hyperparathyroidism (SHPT). Retrieved from https://www.kidney.org/atoz/content/secondary-hyperparathyroidism
[3] Kestenbaum, B., & Sprague, S. M. (2018). Secondary Hyperparathyroidism. In Primer on the Metabolic Bone Diseases and Calcium and Phosphate Metabolism (9th ed., pp. 410-415). Wiley-Blackwell.
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