MEDICAL DEVICES- INNOVATIVE MODELS TO ACCESS THE MARKET LEVERAGING ON SHARED INFRASTRUCTURE AMONG PAYERS AND PHARMACEUTICAL COMPANIES

Author(s)

Ortali M, Roncadori A, Covezzoli A, De Rosa M
CINECA Interuniversity Consortium, Casalecchio di Reno, Italy

OBJECTIVES: To provide on-line shared infrastructures among Payers and Companies, used by health personnel, regulatory bodies and Sponsors, in order to allow the management of medical devices delivery process, from prescription until direct reimbursement from National Health System. METHODS: Based on a long history in collecting and analyzing real-world data, CINECA Interuniversity Consortium has developed an innovative Cloud-based IT infrastructure for the entire management of the service arrangements among Pharmaceutical Companies and Payers. The solution is designed to ensure proper data collection aimed to evaluate appropriateness, assess device performance and estimate efficacy in a real-world context, according to highest quality and security industry standards. The system may foresee the direct distribution of device and materials to the patient, in order to speed up the process and increase compliance. RESULTS: In innovative therapies setting, the web-based system has been used in Italy for more than 75.000 patients with type 2 diabetes treated with antidiabetic drugs. Access to therapy was allowed through 3.741 diabetes specialists belonging to 1.278 dedicated centers. The system is being extended to manage and allow market access for innovative devices. The system can manage the entire process of device management (prescription, eligibility, order, delivery and invoicing) in an integrated manner in order to easily activate new market opportunities from the perspective of Companies, Payers and Patients. By defining appropriate minimum datasets, it is possible to involve all stakeholders obtaining systematic, homogeneous and high-quality real-world data on the use and appropriateness of such devices. CONCLUSIONS: The introduction of online integrated and shared infrastructures allows to activate common processes among Payers and Companies in the challenge of introducing innovative therapies and devices in a strained macroeconomic scenario, with the aim to simplify market access, facilitate transparency,  monitor related costs, while enabling the collection of Healthcare Big Data for scientific purposes.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PMD127

Topic

Health Policy & Regulatory, Study Approaches

Topic Subcategory

Pricing Policy & Schemes, Registries, Reimbursement & Access Policy, Risk-sharing Approaches

Disease

Diabetes/Endocrine/Metabolic Disorders, Multiple Diseases

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