What criteria for pharmaceuticals reimbursement?

Abstract

The criteria for the registration of new drugs may differ from the criteria for drug reimbursement. In 2000 the French government entrusted the French Medicines Agency with determining the "medical service rendered" (MSR) for each reimbursable drug. The goal was to determine which drugs could be classified with an "insufficient" MSR and therefore should be taken out of the scope of health insurance. We analyze the concepts and methods used for this evaluation and the kind of results that are obtained. We collected data on the result of MSR classification and the criteria used to perform this classification (efficacy-security, severity of the disease,place in the therapeutic strategy, existence of therapeutic alternative, public health value) for a sample of 1453 drugs belonging to five therapeutic areas. We used statistical analysis to determine what were the most influential criteria. Only two criteria - efficacy and disease severity - suffice to very largely explain the MSR classification. The other criteria contribute little added value. Some of these criteria clearly suffer from a lack of clarification, leading to different interpretations according to therapeutic class or even according to drug or drug family. The evaluation procedure differs between therapeutic classes, at least at intermediate MSR levels. Analysis of the French experience with MSR shows that the evaluation procedure has not succeeded in completely breaking away from the traditional logic of the marketing authorization and registration, as witnessed by the importance of the "efficacy/safety" criterion, the absence of an economic criterion, and the vagueness of the "public health value" criterion, which one would have thought would instead be decisive.

Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries

“…Additional innovation characteristics relating to the nature of the treatment (e.g. differentiating between symptomatic, preventive and curative) are also considered, but as a second line of criteria [ 25 , 56 , 61 , 62 ].…”

“…In terms of socioeconomic parameters, in France ‘expected’ public health benefit acts as another explicit dimension via an indicator known as public health interest (“Intérêt de Santé Publique”, ISP), which is assessed and scored separately by a distinct committee as part of the SMR evaluation but not used often [ 25 , 41 , 62 , 64 ].…”

Patient access to orphan drugs in France

“…On the other hand, the severity of the disease and the lack of satisfactory therapeutic alternatives are elements in favor of orphan drugs. The relative contribution of the drug’s role in the therapeutic strategy within the clinical benefit assessment has evolved: considered as low in 2003 [23], it became a determining factor in 2014 [24]. For the 4 orphan drug-therapeutic indications pair concerned in this study, the HAS justified the insufficient actual benefit by a level of evidence considered as too low [25–28].…”

Identifying Frameworks for Validation and Monitoring of Consensual Behavioral Intervention Technologies: Narrative Review

“…One surprising finding is that the benefit-to-risk ratio is not a main goal. Contrary to drug claims regarding societal recognition and reimbursement for their impact on health outcomes [77], showing evidence of safety and efficacy is paradoxically not a priority for BITs. This fact can explain why researchers have noted that medical mobile phone apps are lightly used by patients in the medium term, have little involvement from health professionals, lack characterization of their content, and have a low integration of behavior change theories [78].…”