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Updated: Jun 3, 2026

An R-Based Landscape Validation of a Competing Risk Model

An R-Based Landscape Validation of a Competing Risk Model

Published on: September 16, 2022

Risk sharing agreements: what lessons from Italy?

Livio Garattini¹, Gianluigi Casadei

¹CESAV – Center for Health Economics, Mario Negri Institute for Pharmacological Research, Villa Camozzi, 20040 Ranica (BG), Italy. lgarattini@marionegri.it

International Journal of Technology Assessment in Health Care

|March 25, 2011

Summary

Italy has extensive experience with risk-sharing agreements for pharmaceuticals. However, challenges remain in documenting non-responders and ensuring timely, accurate pay-back procedures for pharmaceutical expenditure.

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Last Updated: Jun 3, 2026

An R-Based Landscape Validation of a Competing Risk Model

An R-Based Landscape Validation of a Competing Risk Model

Published on: September 16, 2022

Area of Science:

Health economics
Pharmaceutical policy

Background:

Italy has significant experience with risk-sharing agreements (RSAs) for pharmaceuticals.
As of October 2010, eighteen RSAs were in effect since the first agreement in July 2006.

Purpose of the Study:

To analyze the management and challenges of risk-sharing agreements in Italy.
To identify issues in the pay-back procedures and documentation of non-responders.

Main Methods:

The management of discount schemes relies on web registries operated by the Italian drug agency (AIFA).
The system validates prescriptions and manages drug release, with processes for pay-back requests for non-responders.

Main Results:

Challenges include the need for health authority documentation of non-responders to prevent payment for treatment failures.
Concerns exist regarding potentially inadequate time frames for assessing non-response criteria.
Regions, responsible for pharmaceutical expenditure, face difficulties in quantifying and reclaiming pay-back amounts from manufacturers.

Conclusions:

The current system for managing risk-sharing agreements in Italy requires improvements in documentation and process efficiency.
Addressing the challenges in pay-back procedures is crucial for the financial accountability of regional healthcare systems.