title: Drug delivery system innovation and Health Technology Assessment: Upgrading from Clinical to Technological Assessment.
abstract: Health Technology Assessment (HTA) is a multidisciplinary health political instrument that evaluates the consequences, mainly clinical and economical, of a health care technology; the HTA aim is to produce and spread information on scientific and technological innovation for health political decision making process. Drug delivery systems (DDS), such as nanocarriers, are technologically complex but they have pivotal relevance in therapeutic innovation. The HTA process, as commonly applied to conventional drug evaluation, should upgrade to a full pharmaceutical assessment, considering the DDS complexity. This is useful to study more in depth the clinical outcome and to broaden its critical assessment toward pharmaceutical issues affecting the patient and not measured by the current clinical evidence approach. We draw out the expertise necessary to perform the pharmaceutical assessment and we propose a format to evaluate the DDS technological topics such as formulation and mechanism of action, physicochemical characteristics, manufacturing process. We integrated the above-mentioned three points in the Evidence Based Medicine approach, which is data source for any HTA process. In this regard, the introduction of a Pharmaceutics Expert figure in the HTA could be fundamental to grant a more detailed evaluation of medicine product characteristics and performances and to help optimizing DDS features to overcome R&D drawbacks. Some aspects of product development, such as manufacturing processes, should be part of the HTA as innovative manufacturing processes allow new products to reach more effectively patient bedside. HTA so upgraded may encourage resource allocating payers to invest in innovative technologies and providers to focus on innovative material properties and manufacturing processes, thus contributing to bring more medicines in therapy in a sustainable manner.
authors.affiliation: Department of Pharmaceutical Sciences Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy; AFI-Associazione Farmaceutici dell'Industria, viale Ranzoni 1, 20041 Milano, Italy. Electronic address: panzitta@mpharmac.it.
authors.forename: Michele
authors.initials: M
authors.lastname: Panzitta
authors.affiliation: AFI-Associazione Farmaceutici dell'Industria, viale Ranzoni 1, 20041 Milano, Italy; Recipharm AB, Via Filippo Serpero, 2, Masate (MI), Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Bruno
authors.affiliation: Department of Pharmaceutical Sciences Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Giovagnoli
authors.affiliation: School of Hospital Pharmacy, Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy.
authors.forename: Francesca R
authors.initials: FR
authors.lastname: Mendicino
authors.affiliation: Department of Pharmaceutical Sciences Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy; School of Hospital Pharmacy, Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Ricci
mesh_terms: D020811:Biomedical Technology / Q000592:standards*; D016503:Drug Delivery Systems / Q000592:standards*; D019317:Evidence-Based Medicine / Q000592:standards*; D006801:Humans; D011361:Professional Competence; D013673:Technology Assessment, Biomedical / Q000592:standards*
keywords: Clinical pharmaceutics; Drug delivery systems; Health Technology Assessment; Nanoparticles; Pharmaceutics; Quality by design; Quality risk management