Drug Price Trends for AFREZZA (REGULAR INSULIN)

Average Pharmacy Cost for AFREZZA (REGULAR INSULIN)

These are average pharmacy acquisition costs (net of discounts) from a US national survey

Drug Name	NDC	Price/Unit ($)	Unit	Date
AFREZZA (REGULAR INSULIN) 90-4 UNIT / 90-8 UNIT	47918-0880-18	7.58948	EACH	2024-12-16
AFREZZA (REGULAR INSULIN) 4 UNIT CARTRIDGE	47918-0874-90	5.05828	EACH	2024-12-16
AFREZZA (REGULAR INSULIN) 90-8 UNIT / 90-12 UNIT	47918-0898-18	12.60966	EACH	2024-12-16
AFREZZA (REGULAR INSULIN) 60-4 UNIT/60-8 UNIT/60-12 UNIT	47918-0902-18	10.13516	EACH	2024-12-16
AFREZZA (REGULAR INSULIN) 12 UNIT CARTRIDGE	47918-0891-90	15.18477	EACH	2024-12-16
AFREZZA (REGULAR INSULIN) 4 UNIT CARTRIDGE	47918-0874-90	4.81741	EACH	2024-11-20

AFREZZA (REGULAR INSULIN) Market Analysis and Financial Projection

Market Analysis and Price Projections for Afrezza (Inhaled Insulin)

Introduction to Afrezza

Afrezza, developed by MannKind Corporation, is a rapid-acting inhaled insulin indicated for the improvement of glycemic control in adult patients with type 1 and type 2 diabetes mellitus. It is administered via a breath-powered inhaler and is the only FDA-approved inhaled rapid-acting mealtime insulin in the United States[2].

Market Context

Diabetes Prevalence and Insulin Demand

The demand for insulin is significant and growing. Approximately 8.3 million people in the United States require insulin to manage their diabetes, and global insulin use is projected to increase by 20% by 2030[4].

Competition in the Insulin Market

The insulin market is characterized by limited competition, primarily due to the dominance of three major manufacturers (Eli Lilly, Novo Nordisk, and Sanofi) and the lack of a regulatory pathway for biosimilar insulins until recently. However, with the expiration of patents for many insulin products by the end of 2020, the market is expected to see increased competition from biosimilars, which could lead to downward price pressure[4].

Unique Selling Points of Afrezza

Rapid Action Profile

Afrezza has a unique time-action profile that closely mimics physiological insulin. It begins to reduce blood sugar levels within about 12 minutes of administration and returns serum insulin levels to baseline sooner than injected insulins. This profile reduces the risk of hypoglycemia, a significant concern for diabetic patients[5].

Patient Compliance

The fear of hypoglycemia is a major reason why many diabetic patients skip mealtime insulin, leading to insufficient glucose control. Afrezza's rapid action and shorter duration of effect address this issue, potentially improving patient compliance and overall glycemic control[5].

Pricing and Affordability

Current Pricing

Afrezza is available in various cartridge strengths (4-unit, 8-unit, and 12-unit) and can be purchased through a direct purchase program that offers the medication for as low as $4 a day for eligible patients. This program aims to make Afrezza more accessible to those who pay cash for their insulin[2].

Historical Price Trends

The prices of insulin products, including traditional injectable insulins, have increased significantly over the past few decades. For example, the adjusted average wholesale price (AWP) for human insulins has seen a compounded annual growth rate (CAGR) ranging from 4.89% to 8.89% between 1983 and 2019. However, biosimilar and follow-on insulins have shown negative CAGRs, indicating potential price reductions in the future[3].

Market Analysis

Target Market

Afrezza is targeted at adult patients with type 1 and type 2 diabetes who require mealtime insulin. Given its unique delivery method and rapid action profile, it is particularly appealing to patients who struggle with the traditional injectable insulin regimen or fear hypoglycemia[2].

Market Penetration

Despite its advantages, Afrezza faces challenges in market penetration due to the established dominance of injectable insulins and the need for healthcare providers to become familiar with the new delivery method. However, the direct purchase program and educational efforts by MannKind Corporation are aimed at increasing adoption[2].

Price Projections

Impact of Biosimilars

The introduction of biosimilar insulins is expected to increase competition in the market, which could lead to downward price pressure. However, Afrezza's unique delivery method and clinical benefits may allow it to maintain a premium pricing strategy compared to traditional and biosimilar insulins[4].

Regulatory and Market Dynamics

As the regulatory environment evolves to support biosimilars, Afrezza's pricing strategy will need to adapt. The company may need to balance the premium pricing with competitive pressures to maintain market share. The direct purchase program is a strategic move to keep prices affordable for patients while navigating these market dynamics[2].

Financial Considerations

Revenue Potential

Given the growing demand for insulin and the unique benefits of Afrezza, the revenue potential is significant. However, the actual revenue will depend on market penetration, pricing strategies, and the competitive landscape.

Cost Savings

For patients, Afrezza's direct purchase program offers significant cost savings, especially for those who pay cash for their insulin. This program can help reduce the financial burden associated with diabetes management[2].

Key Takeaways

• Unique Delivery Method: Afrezza's inhaled delivery method offers a rapid action profile that closely mimics physiological insulin, reducing the risk of hypoglycemia.
• Market Competition: The insulin market is evolving with the introduction of biosimilars, which may lead to downward price pressure.
• Pricing Strategy: Afrezza's pricing is competitive, with a direct purchase program offering the medication at an affordable rate.
• Market Penetration: Despite challenges, Afrezza's unique benefits and educational efforts are aimed at increasing adoption.
• Financial Impact: The revenue potential is significant, but will depend on market dynamics and pricing strategies.

FAQs

Q: What is Afrezza and how is it administered? A: Afrezza is a rapid-acting inhaled insulin administered via a breath-powered inhaler. It is used to improve glycemic control in adult patients with type 1 and type 2 diabetes mellitus[2].

Q: How does Afrezza compare to traditional injectable insulins? A: Afrezza has a faster onset of action and returns serum insulin levels to baseline sooner than injected insulins, reducing the risk of hypoglycemia[5].

Q: What is the current pricing for Afrezza? A: Afrezza is available through a direct purchase program that offers the medication for as low as $4 a day for eligible patients[2].

Q: How will the introduction of biosimilar insulins affect Afrezza's pricing? A: The introduction of biosimilars is expected to increase competition, potentially leading to downward price pressure. However, Afrezza's unique benefits may allow it to maintain a premium pricing strategy[4].

Q: What are the key benefits of Afrezza for diabetic patients? A: Afrezza offers a rapid action profile, reduces the risk of hypoglycemia, and improves patient compliance due to its more physiological insulin curve[5].

Sources

1. FDA Clinical Pharmacology Review: Afrezza NDA 022472 Orig1s000 ClinPharmR.
2. MannKind Corporation: MannKind Announces Direct Purchase Insulin Program Providing Afrezza for as low as $4 a Day.
3. Chapman University: Trends in Prices of Insulin Marketed in the US.
4. American Action Forum: Understanding the Insulin Market.
5. Zacks Small-Cap Research: Afrezza, a rapid-acting dry powder inhaled insulin.