Methodological gaps in the assessment of risk minimization interventions: a systematic review.

Introduction: Since the introduction of therapeutic risk management regulatory guidance, an increase in the number of risk minimization interventions (RMIs) published in the literature has been observed. Methods used to evaluate their effectiveness remain, however, poorly examined.

Objective: This paper aimed to conduct a literature review on the methods of evaluation of effectiveness of RMIs and to identify methodological gaps.

[Exception drugs status: specific characteristics and the role in the proper use of drugs].

Background: In 1994, the French health care system established a special status for certain costly drugs reimbursed for ambulatory use: exception drugs. Drugs with this status are reimbursed only when prescribed for specified indications. The purpose of this study was to identify the specific characteristics of drugs with the exception status, and to understand the role of this status in proper use of drugs.

How innovative are pharmaceutical innovations?: the case of medicines financed through add-on payments outside of the French DRG-based hospital payment system.

Objective: To analyze the characteristics of inpatient medicines placed on the list of innovative high-cost medicines funded in addition to DRG-based payment, and to identify whether they really are innovative and/or high-cost.

Methodology: The medicines placed on the list of innovative and high-cost medicines were analyzed on the basis of criteria describing their innovative nature and cost. They were categorized as innovative and high-cost, only high-cost, only innovative and neither innovative nor high-cost.