Therapeutic innovation in the European Union: analysis of the drugs approved by the EMEA between 1995 and 2003

Abstract

Since January 1995, all European Union applications for marketing approval for medicinal products derived from biotechnology and other drugs considered potentially innovative follow the EMEA centralized procedure. In order to assess the overall degree of therapeutic innovation of these drugs, we considered, for each approved agent, its target, the availability of previous treatments and the extent of its therapeutic effect. The following scores for therapeutic innovation were assigned through a consensus process: 'A' (important), 'B' (moderate) and 'C' (modest). The overall degree of important/moderate therapeutic innovation was 47% of all therapeutic agents (32% important; 15% moderate). Most (80%) of the EMEA-approved therapeutic agents were for serious diseases. The remaining ones were for risk factors (7%) or nonserious diseases (13%).

Análise de medicamentos novos registrados no Brasil na perspectiva do Sistema Único de Saúde e da carga de doença

“…Some of these measures are already incorporated by the SUS for the medicinal products of the specialized component, the HIV/ AIDS program and others from the strategic component 46 . The classification of Motola et al 31 , adopted in the present study to determine the therapeutic value of drugs, considers the interrelationship between treatment availability and the therapeutic effect, addressing three areas of pharmaceutical innovation 4,47 : use context (including alternative therapies), drug novelty (chemical, pharmacological and pharmaceutical) and impact (efficacy, safety). However, like other concepts available in the literature, the Motola algorithm does not consider the impact on public health and health services (disease severity, affected population size and possibility of introduction).…”

“…The analysis was conducted by two researchers independently and disagreements were resolved by consensus. To assess the level of therapeutic innovation of new drugs the algorithm of Motola et al 31 was used. The algorithm graded the drugs as: important, moderate, modest, pharmacological, or technological innovations.…”

The Italian Horizon Scanning Project

“…It assigns a priority to emerging drugs according to their possible M.A. date and their potential grade of innovation [11,12], therapeutic and economic impact, possible price, and NHS sustainability. Other tasks include the revision of all assessments produced, decisions on their dissemination, identification of possible therapeutic needs and priority research areas for the Italian NHS, and the development of links with other NHS institutions, scientific associations, and international groups.…”

The Urgent Need of New Mood-Stabilizers: The Promising Results of Memantine

“…No important therapeutic innovations (i.e., a drug with major clinical benefit compared with existing drugs, according to the definition of Motola [2] have been introduced in the last 60 years.Some anticonvulsant medications and atypical antipsychotics are currently approved or used off-label as lithium alternative mood stabilizers. Anticonvulsants have been shown to be of limited efficacy both as a monotherapy and in combination with lithium [1,[3][4][5][6][7] and the mood stabilizing effect of atypical antipsychotics has been severely questioned [8,9].…”

“…No important therapeutic innovations (i.e., a drug with major clinical benefit compared with existing drugs, according to the definition of Motola [2] have been introduced in the last 60 years.…”