PHARMACOECONOMICS & MARKET ACCESS

Aims of the Group

The Working Group, built in spring 2009, aims:

  • To promote and make known the pharmacoeconomic culture.
  • To make known and enhance the knowledge on methodology and practice in Clinical and Post-Marketing Pharmaceconomics.
  • To be active representative with the Institutions on Drug Price & Rembuirsment topics.
  • To make a contribution to the enrichment of the discipline, both at National and at European levels, through the rich and versatil multidisciplinary experience which distinguishes the two subgroups and represents the strenght of the Pharmacoeconomics Group.

 

Activities of the Group

The Group pursues its own aim through the following activities:

  • Seminars and in-depth analyses on methodological and factive problems met in the pharmacoeconomic studies during drug development and for the entire life-cycle of the drug.
  • Exchange Forums of professional experiences in Economic, Epidemiological, Medical, Regulatory, Sociological, Statistical areas.
  • Interactions and cooperations with the Institutions and other national/international Societies, all devoted to pharmacoeconomic topics.
  • Contributions from the phamacoeconomic point of view to bimonthly journal SIMeFoggi.

 

Presentation of the Group

Grounds:

  • Each project on Research & Development, Production , Marketing and Distibution of any drug requires essential decisions both from Pharmaceutical Management and from Regulatory and European, National, Local Health Authorities so to achieve best results and optimise the invested resources. Decisions are based on four key points: safety, quality, efficacy, efficiency.
  • The other SIMeF Groups, already actively been committed for several years, deal with the three elements required for drug registration:safety, quality, efficacy.
  • The Pharmacoeconomic Group, focusing on “efficiency” parameter, could contribute to the completion on those aspects which allow to communicate the Value of a Drug to the decision makers, both internal and external ones.
  • Proof of the Value of a certain Drug though Pharmacoeconomics Analyses is more and more required from Health Systems, both from Western and Developing Countries and, as per today, already 35 Countries have drawn up the pharmacoeconomic Guidelines.

“Key” Activities:

  • During Drug Development Phases, as they support “the management flexibility” required by economic-financial decisions in view of a valid allocation of the resoursces in the different steps of R&D; the activities give value to the different info of market potential of “the target drug profile”; they are able to collect key inputs to start and build those price arguments to support for "win-win" with " negotiations payors" throughout the Health Systems of the different Countries.
  • During the Launch Period, in order to analyse deep in details the ways of external communication on the Drug Value - through guidelines together with legislative and regulatory updates-with the aim of the Price and Rembuirsment Dossier which reinforces price negotiation, rembuirsment’s requirements and the integration into “PTN” (National Therapeutic Manual), “PTOR” ( Regional Hospital Therapeutic Manuals) and in “PTO” (Hospital Therapeutic Manuals).
  • During the whole Life-cicle of the Drug once on the market, to implement the value of Studies on drugs utilization, analysing in details the methodologies and benefit of the pharmacoecomic analyses which include and evaluate the Compliance e Persistence Data; finally, to support the decisions to practice the real option of development towards new targets, already identified in the first phases of the development.

Focus of the Group:

  • Clinical Pharmacoeconomics , from point of view of the “Life Sciences” Pharmaceutical Companies, focused on planning, management and implementation of the Pharmacoeonomic studies during clinical trials and from point of view of Health Decision Makers through the detailed study of approach and methods of Horizon Scanning (HS) and algorithm of Innovation
  • Post-Registration Pharmacoeconomics connected to: Market Access strategies, Health Technology Assessment (HTA) and Studies on use of the drug regarding Compliace & Persistence data.

In order to share and disseminate the pharmacoeconomic culture and make an interdisciplinary contribution to the enrichment of the discipline itself on National and European levels.

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