Abemaciclib early access - an Italian experience.

Area of Science:

• Oncology
• Pharmacoeconomics
• Clinical Pharmacology

Background:

• Italian legislation permits pre-negotiation drug marketing under the C(nn) classification.
• Verzenios (Abemaciclib) was made available for high-risk breast cancer adjuvant treatment under this C(nn) status since April 2022.
• This facilitated early patient access to a novel therapy.

Purpose of the Study:

• To evaluate the real-world impact of early Verzenios (Abemaciclib) access in Italy.
• To assess the clinical efficacy and tolerability of Verzenios plus endocrine therapy (ET) in high-risk breast cancer.
• To analyze the economic implications for the Italian National Health System.

Main Methods:

• The MonarchE study results were analyzed for efficacy and safety outcomes.
• Real-world data on patient numbers and treatment duration were considered.
• Economic modeling was used to calculate cost savings related to avoided metastatic disease.

Main Results:

• Verzenios plus ET reduced recurrence and distant metastasis risk by 35% in high-risk patients.
• Long-term benefits (IDFS, DRFS) were sustained up to 48 months.
• The C(nn) approach with nominal pricing resulted in significant cost savings for the Italian National Health System, avoiding costs associated with metastatic recurrence.

Conclusions:

• Early access to Verzenios via the C(nn) category provided substantial clinical benefits for high-risk breast cancer patients.
• This strategy proved economically advantageous, generating significant savings by preventing costly metastatic disease.
• The Italian C(nn) model demonstrates a viable pathway for early access to innovative cancer therapies with fiscal responsibility.