Necitumumab - Biologic Drug Details

Summary for necitumumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for necitumumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for necitumumab

Recent Clinical Trials for necitumumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Genentech, Inc.	Phase 1/Phase 2
Jonsson Comprehensive Cancer Center	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 1/Phase 2

See all necitumumab clinical trials

Pharmacology for necitumumab

Mechanism of Action	HER1 Antagonists
Established Pharmacologic Class	Epidermal Growth Factor Receptor Antagonist

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for necitumumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for necitumumab Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for necitumumab Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Necitumumab

Introduction

Necitumumab, a recombinant human IgG1 monoclonal antibody, was approved by the FDA for the first-line treatment of metastatic squamous non-small cell lung cancer (msqNSCLC) in combination with gemcitabine and cisplatin. This article delves into the market dynamics and financial trajectory of necitumumab, highlighting its impact on healthcare budgets, market share, and overall financial performance.

Clinical Efficacy and Approval

Necitumumab has demonstrated significant clinical efficacy in improving overall survival for patients with msqNSCLC. The Phase III SQUIRE trial showed that patients treated with necitumumab in combination with gemcitabine and cisplatin had a median overall survival of 11.5 months, compared to 9.9 months for those treated with chemotherapy alone[4].

Market Share and Adoption

The adoption of necitumumab into treatment regimens has been gradual. In a hypothetical U.S. commercial health plan, the initial market share of necitumumab plus gemcitabine and cisplatin (Neci + GCis) was estimated at approximately 5% in the first year, increasing to 11.8% and 14.7% in the second and third years, respectively. This increase in market share corresponds to a decrease in the market share of other treatment options[1].

Budget Impact on Health Plans

The introduction of necitumumab into health plan formularies has a modest impact on overall healthcare budgets. For a hypothetical 1,000,000-member commercial health plan, the year 1 incremental budget impact was estimated at $88,394, representing a 2.9% cost increase. By the third year, this increased to $304,079, or a 7.4% cost increase, primarily due to the higher drug costs and longer treatment duration associated with necitumumab[1].

Commercial Health Plans

• The per-member-per-month (PMPM) budgetary impact was less than $0.01 in the first year, rising to $0.025 by the third year[1].

Medicare

• From the Medicare perspective, the overall year 1 incremental budget impact was $438,056, with a PMPM impact of $0.037, increasing over time as the market share of necitumumab grows[1].

Cost Components

The increased costs associated with necitumumab are primarily driven by the drug itself and the longer survival and treatment duration of patients.

• Drug Costs: The majority of the increased costs are attributable to the high cost of necitumumab.
• Disease Costs: There was a slight increase in disease costs, but this was minimal compared to the drug costs.
• Adverse Event Costs: Interestingly, the costs associated with adverse events decreased slightly, likely due to the overall improved health outcomes of patients treated with necitumumab[1].

Financial Performance and Market Sales

Necitumumab, as part of the oncology drug cohort, benefits from a market that rewards drugs with high comparative clinical benefit. Oncology drugs tend to have significantly higher early market sales compared to other drug categories.

• Sales Performance: Oncology drugs, including necitumumab, have average cumulative sales of $1,041 million over the first nine quarters post-launch, far exceeding the sales of antimicrobial and non-AM comparator drugs[3].

Regulatory and Development Costs

The development and approval of necitumumab, like other biologic drugs, involve substantial costs. However, compared to other drug categories, oncology drugs have higher development costs but also higher potential returns.

• Development Costs: The average capitalized development and approval costs for oncology drugs are estimated at $6,293 million, which is higher than for antimicrobial and non-AM comparator drugs[3].

Safety and Efficacy

The safety profile of necitumumab, while generally favorable, includes higher rates of certain adverse events such as hypomagnesemia and rash compared to chemotherapy alone[4].

Market Dynamics and Competition

The market for msqNSCLC treatments is competitive, with several chemotherapy regimens available. However, necitumumab's unique mechanism of action and clinical benefits position it as a valuable addition to treatment options.

• Competitive Landscape: The introduction of necitumumab has led to a shift in market share among various chemotherapy regimens, with necitumumab gaining ground over time[1].

Future Outlook

The future of necitumumab is tied to its continued adoption and the outcomes of real-world studies. As more data becomes available, policymakers and healthcare providers will be better equipped to make informed decisions about its use.

• Real-World Studies: The real-world effect of necitumumab needs to be evaluated to validate the budget impact analysis and ensure its continued value in clinical practice[1].

Key Takeaways

• Clinical Efficacy: Necitumumab improves overall survival in patients with msqNSCLC.
• Market Share: Gradual adoption with increasing market share over the first three years.
• Budget Impact: Modest increase in healthcare budgets, primarily due to drug costs.
• Cost Components: Higher drug costs and longer treatment duration drive increased costs.
• Financial Performance: High potential returns due to its classification as an oncology drug.
• Regulatory and Development Costs: Substantial development costs but high potential returns.

FAQs

Q: What is necitumumab used for?

Necitumumab is used in combination with gemcitabine and cisplatin as a first-line treatment for metastatic squamous non-small cell lung cancer (msqNSCLC).

Q: How does necitumumab impact overall survival in msqNSCLC patients?

Necitumumab has been shown to improve overall survival, with a median survival of 11.5 months compared to 9.9 months for chemotherapy alone[4].

Q: What is the estimated budget impact of introducing necitumumab into a commercial health plan?

The estimated budget impact is modest, with an initial year 1 incremental budget impact of $88,394, representing a 2.9% cost increase, rising to $304,079 or a 7.4% cost increase by the third year[1].

Q: How does the market share of necitumumab change over time?

The market share of necitumumab is estimated to increase from approximately 5% in the first year to 14.7% by the third year[1].

Q: What are the main drivers of the increased costs associated with necitumumab?

The main drivers are the high cost of the drug itself and the longer survival and treatment duration of patients treated with necitumumab[1].

Sources

1. The Budget Impact of Including Necitumumab on the Formulary for Metastatic Squamous Non-Small Cell Lung Cancer - PMC.
2. Necitumumab in Metastatic Squamous NSCLC: Establishing a Value-Based Cost - Value Based Cancer.
3. Antimicrobial Drugs Market Returns Analysis - ASPE.
4. Lilly's Necitumumab Improves Overall Survival In Largest Ever Phase III Study In First-Line Treatment Of Stage IV Squamous Non-Small Cell Lung Cancer - Lilly Investor.

Last updated: 2024-12-18