Market Analysis and Price Projections for Emgality (NDC: 0002-1436)
Introduction to Emgality
Emgality, with the NDC code 0002-1436, is a human prescription drug developed by Eli Lilly and Company. It contains the active ingredient galcanezumab-gnlm and is used to prevent migraine and treat episodic cluster headaches. The drug is administered via a subcutaneous injection using an auto-injector[1][5].
Current Market Position
Emgality was first marketed on September 27, 2018, and has since become a significant player in the migraine prevention market. The drug has been evaluated in several clinical trials, demonstrating its efficacy in reducing the frequency of migraine days and improving quality of life for patients[5].
Pricing and Cost Considerations
Current Pricing
The pricing of Emgality is a critical factor in its market position. As of the latest data, the wholesale price and billing units for Emgality are based on the volume of the solution, typically billed per milliliter[1].
International Price Comparisons
Prescription drug prices in the United States, including those for Emgality, are significantly higher compared to other high-income countries. For example, U.S. prices for brand-name drugs are approximately 422% of prices in other OECD countries, even after adjusting for rebates and discounts[4].
Impact of Medicare Drug Price Negotiation Program
Negotiated Prices
Starting January 1, 2026, the Medicare Drug Price Negotiation Program, as part of the Inflation Reduction Act, will allow Medicare to negotiate prices for certain high-expenditure, single-source drugs, including potentially Emgality if it is selected in future cycles. This could significantly impact the pricing and affordability of Emgality for Medicare beneficiaries. The program is projected to save an estimated $6 billion in net covered prescription drug costs in 2023 if the negotiated prices had been in effect, representing a 22% reduction in net spending[2].
Projected Savings
For people with Medicare Part D coverage, the negotiated prices are expected to save an estimated $1.5 billion in out-of-pocket costs when the program takes effect in 2026. This savings is in addition to other cost-saving provisions, such as the cap on out-of-pocket drug costs for Medicare beneficiaries[2].
Market Trends and Predictions
AI and Health Tech Integration
The pharmaceutical industry, including companies like Eli Lilly, is increasingly adopting artificial intelligence (AI) and health technology. Predictions for 2025 include a doubling of AI adoption in standard clinical development operations and a growing reliance on external data to train internal data science models. This could enhance the development and marketing of drugs like Emgality[3].
Use of Large Language Models (LLMs)
Big pharmaceutical companies are expected to leverage LLMs to retrieve information and produce reports that inform critical decisions. This trend could improve the efficiency and accuracy of market analysis and pricing strategies for Emgality[3].
Price Projections
Short-Term Projections
In the short term, the price of Emgality is likely to remain stable unless it is selected for the Medicare Drug Price Negotiation Program. If selected, the negotiated prices could significantly reduce the cost of the drug for Medicare beneficiaries starting in 2026[2].
Long-Term Projections
Long-term price projections for Emgality will depend on several factors, including the outcome of the Medicare negotiations, changes in market demand, and the introduction of generic or biosimilar competitors. Given the current high prices of brand-name drugs in the U.S., there is a potential for significant price adjustments if international pricing benchmarks or negotiated prices are adopted more widely[4].
Competitive Landscape
Emgality operates in a competitive market for migraine prevention and treatment. Other drugs, such as those from Amgen and Teva, also target this therapeutic area. The competitive landscape will influence pricing strategies, with companies potentially adjusting prices to maintain market share and competitiveness.
Regulatory and Policy Impacts
FDA and Regulatory Approvals
The FDA's approval and ongoing monitoring of Emgality are crucial for its market presence. Any changes in regulatory policies or approvals could impact the drug's pricing and availability[1].
International Reference Pricing
International reference pricing, where drug prices are benchmarked against those in other countries, could also influence Emgality's pricing. If such policies are adopted in the U.S., it could lead to lower prices for the drug[4].
Key Takeaways
- Current Pricing: Emgality is priced based on its volume, with significant costs compared to international benchmarks.
- Medicare Negotiations: Potential inclusion in the Medicare Drug Price Negotiation Program could significantly reduce costs for Medicare beneficiaries starting in 2026.
- Market Trends: Increasing adoption of AI and health tech, and the use of LLMs, could enhance market analysis and pricing strategies.
- Competitive Landscape: Emgality operates in a competitive market, which will influence pricing strategies.
- Regulatory Impacts: FDA approvals and international reference pricing policies could impact the drug's pricing and availability.
FAQs
Q: What is Emgality used for?
A: Emgality is used to prevent migraine and treat episodic cluster headaches.
Q: Who manufactures Emgality?
A: Emgality is manufactured by Eli Lilly and Company.
Q: How is Emgality administered?
A: Emgality is administered via a subcutaneous injection using an auto-injector.
Q: What are the potential savings from the Medicare Drug Price Negotiation Program for Emgality?
A: If included in the program, the negotiated prices could save an estimated $1.5 billion in out-of-pocket costs for Medicare beneficiaries.
Q: How might AI and health tech impact the pricing of Emgality?
A: The adoption of AI and health tech could enhance market analysis and pricing strategies, potentially leading to more efficient and competitive pricing.
Cited Sources
- NDC Package 0002-1436-11 Emgality - NDC List
- Negotiated Prices for Initial Price Applicability Year 2026 - CMS
- 2025 Pharma Predictions: AI, Health Tech, and Data Trends to Watch - Intelligencia AI
- International Prescription Drug Price Comparisons: Estimates Using IQVIA MIDAS Data - ASPE
- EMGALITY- galcanezumab-gnlm injection, solution - DailyMed
