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Drug Price Trends for LOKELMA
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Average Pharmacy Cost for LOKELMA
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LOKELMA 5 GRAM POWDER PACKET | 00310-1105-01 | 27.51182 | EACH | 2025-01-01 |
| LOKELMA 10 GRAM POWDER PACKET | 00310-1110-39 | 27.50641 | EACH | 2025-01-01 |
| LOKELMA 5 GRAM POWDER PACKET | 00310-1105-39 | 27.51182 | EACH | 2025-01-01 |
| LOKELMA 10 GRAM POWDER PACKET | 00310-1110-01 | 27.50641 | EACH | 2025-01-01 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Market Analysis and Price Projections for Lokelma
Introduction to Lokelma
Lokelma, also known as sodium zirconium cyclosilicate, is a potassium binder used to treat hyperkalemia, a condition characterized by elevated potassium levels in the blood. Approved by regulatory bodies since 2018, Lokelma has been a significant player in the hyperkalemia treatment market.
Market Growth and Projections
The hyperkalemia treatment market, in which Lokelma is a key player, is expected to grow at a CAGR of 16.79% by 2028. This growth is driven by several factors, including the increasing prevalence of hyperkalemia, particularly among the aging population and those with associated comorbidities like chronic kidney disease (CKD) and heart failure[1].
Regional Market Performance
North America, particularly the United States, is anticipated to hold a significant share of the market. The high burden of hyperkalemia in the U.S., with nearly 800,000 emergency department visits annually, drives the demand for effective treatments like Lokelma. The region's increasing healthcare expenditure and ongoing research and development activities further contribute to market growth[1].
Sales Performance of Lokelma
Lokelma has shown steady sales growth since its approval. In 2022, the drug generated $289 million in revenue, and by the third quarter of 2023, this figure had increased to $300 million for the first nine months of the year. GlobalData predicts that worldwide sales of Lokelma will rise to $799 million by 2029[4].
Pricing and Cost Considerations
The cost of Lokelma is a significant factor in its market dynamics. A supply of 11 packets of 5g oral powder for reconstitution costs around $326.30, which translates to approximately $29.66 per unit. This pricing can be a barrier for some patients, as it is a brand-name drug with no generic version available yet[2].
Pharmacoeconomic Analysis
Pharmacoeconomic studies have highlighted the cost-effectiveness of Lokelma, particularly in certain patient populations. For instance, a cost-utility analysis conducted from the perspective of the Canadian publicly funded healthcare system showed that at a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY), the probability of Lokelma being cost-effective compared to other treatments was 99.6%. However, a significant price reduction would be required for Lokelma to be considered cost-effective at lower willingness-to-pay thresholds[3].
Clinical Trials and Development
AstraZeneca has been conducting various clinical trials to expand the evidence base for Lokelma's use in different cardiorenal conditions. However, two Phase III trials, STABILIZE-CKD and DIALIZE-Outcomes, were discontinued due to slow enrollment and low clinical event rates. Despite this, the company has emphasized that there are no safety concerns and the decision does not impact Lokelma's current approved indication[4].
Patent and Generic Entry Considerations
Lokelma is protected by fourteen U.S. patents, with the earliest potential generic entry date based on patent 9,592,253. However, various factors such as new patent filings, patent extensions, and early generic licensing could influence the actual timing of generic entry. As of now, there is no generic version of Lokelma available, which maintains its market exclusivity[5].
Market Challenges
One of the primary challenges facing Lokelma is its high cost, which can limit patient access. Additionally, the discontinuation of certain clinical trials due to slow enrollment and low event rates may impact the drug's potential to expand its indications and market share[4].
Future Outlook
Despite the challenges, Lokelma is expected to continue its growth trajectory driven by increasing demand and the expanding prevalence of hyperkalemia. The drug's ability to help patients maintain lifesaving RAASi therapy, especially those with CKD or heart failure, is a significant factor in its market success.
"Lokelma has been approved for hyperkalemia—elevated potassium levels in the blood—since 2018. According to the National Kidney Foundation, about 26 million people globally have experienced heart failure and are living with high potassium blood levels."[4]
Key Statistics
- Market Growth Rate: 16.79% CAGR by 2028[1].
- Annual Sales: $289 million in 2022, projected to reach $799 million by 2029[4].
- Cost: Approximately $326.30 for a supply of 11 packets of 5g oral powder for reconstitution[2].
- Generic Entry: Protected by 14 U.S. patents, with the earliest potential generic entry date based on patent 9,592,253[5].
Key Takeaways
- Lokelma is a critical treatment for hyperkalemia, with a growing market driven by increasing prevalence and research.
- The drug faces challenges such as high cost and the discontinuation of certain clinical trials.
- Despite these challenges, Lokelma is projected to achieve significant sales growth by 2029.
- The pharmacoeconomic analysis supports its cost-effectiveness in specific patient populations.
- Patent protection currently maintains its market exclusivity.
FAQs
What is the current market growth rate for the hyperkalemia treatment market?
The hyperkalemia treatment market is expected to grow at a CAGR of 16.79% by 2028[1].
How much does Lokelma cost?
A supply of 11 packets of 5g oral powder for reconstitution of Lokelma costs around $326.30[2].
Why were the STABILIZE-CKD and DIALIZE-Outcomes trials for Lokelma discontinued?
The trials were discontinued due to slow enrollment and low clinical event rates, making it prohibitive to deliver study results within a meaningful timeframe[4].
What is the projected sales figure for Lokelma by 2029?
GlobalData predicts that worldwide sales of Lokelma will rise to $799 million by 2029[4].
Is a generic version of Lokelma available?
No, a generic version of Lokelma is not yet available, as it is protected by several patents[5].
Sources
- Mordor Intelligence: Hyperkalemia Treatment Market - Size, Share & Industry Analysis.
- Drugs.com: Lokelma Prices, Coupons, Copay Cards & Patient Assistance.
- CADTH COMMON DRUG REVIEW: Pharmacoeconomic Review Report for Sodium Zirconium Cyclosilicate (Lokelma).
- Biospace: AstraZeneca Axes Two Phase III Hyperkalemia Trials for Lokelma.
- DrugPatentWatch: When do the LOKELMA patents expire, and when will generic versions be available?
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