Pharmaceutical market access in Italy is the process through which a drug obtains not only regulatory approval, but also the pricing, reimbursement, and accessibility conditions that determine its real impact on the market. View Science supports pharmaceutical and biotech companies in every step of this pathway: from the definition of the access strategy to the negotiation with the competent authorities, with an integrated approach that combines regulatory expertise, pharmacoeconomic analysis and value communication.
Health Technology Assessment (HTA) is the multidimensional health technology assessment process that in Italy, through AIFA, determines the reimbursability conditions and price of drugs. With the new European HTA Regulation 2021/2282, which came into effect on January 12, 2025, the European-wide joint clinical assessment process introduces new requirements and opportunities for companies operating in EU markets.
View Science prepares and manages HTA dossiers according to national and European requirements, ensuring:
Each dossier is constructed with a narrative as well as an analytical approach: the scientific and economic data is presented in a clear, coherent and persuasive manner-a skill that distinguishes View Science from purely technical consulting.
The Italian pharmaceutical market is among the most complex in Europe: regionally fragmented public payers, differentiated local formularies, and evolving HTA criteria require a strategic approach, not just an operational one. View Science integrates pharmaceutical market access activities in Italy with regulatory consulting, medical writing and scientific communication, ensuring consistency of message from AIFA to clinician, payer to patient.
We collaborate with leading international HTA networks and follow the EMA ‘s work on HTA to provide our Clients with constant regulatory updates and access strategies aligned with the latest developments in the European context.
We operate both on innovative first-registration products–oncology drugs, rare diseases, ATMPs–and on established portfolios in need of strategic repositioning, extension of reimbursed indications or defense of position in regional formularies.
Are you preparing Italian market access for a new product or want to strengthen the position of an already licensed drug? Contact us for a free call – Let’s evaluate together the strategy best suited to your product and time horizon.
Alessandro is a professional with over 35 years of experience in the pharmaceutical and biotech industry, gained through roles of increasing responsibility in areas such as marketing, medical affairs, outcomes research, health economics, value access, and HTA. He has worked with major international companies including Merck Sharp & Dohme, Sanofi-Pasteur, Baxter, Baxalta-Shire and Organon. He has strong expertise in pricing and reimbursement processes, with 28 successfully completed procedures in several European countries (UK, Italy, France and Spain). Throughout his career, he has designed and implemented high-impact programs to demonstrate the clinical and economic value, sustainability, and effectiveness of new healthcare solutions. He combines his professional activities with international academic collaboration, particularly with UK university centers, and is currently an external member of the Statistics for Health Economic Evaluation Group at University College London. He also has a wide network of professional contacts that includes key European public decision makers and has contributed numerous publications in scientific and health economics journals.
Giovanni is a leading international expert in the field of advanced therapies, with consolidated experience in regulatory aspects related to the use of cultured cells for clinical applications and in cell and gene therapies. He works as an expert for the Italian Government and the European Medicines Agency (EMA) and was Chair of the CTP group at the European Directorate for the Quality of Medicines (EDQM) from 2010 to 2018. He currently serves as Scientific Director of the TEDDY network (Bari 2026), Regulatory Advisor for the Center for Biological and Pharmacological Evaluations (CVBF, Pavia), and Senior Advisor for the European EATRIS infrastructure. He holds a PhD in Biological Sciences from the University of Naples and has developed his scientific career in the study of mechanisms of stem cell proliferation and differentiation, with research experience in the United States and at the Istituto Superiore di Sanità, contributing more than 200 scientific publications.
Ludovica is a Senior Leader with more than 30 years of experience in the life sciences sector, with a strong results orientation and an established ability to translate scientific research into accessible therapeutic solutions. He has gained significant experience in the area of market access, successfully contributing to processes of drug enhancement and availability for patients. Throughout his career he has built a wide institutional network, actively collaborating with public stakeholders and policy makers. He also has strong expertise in Price and Reimbursement negotiations with Italian regulatory authorities, working in multiple therapeutic areas including chronic non-communicable diseases, oncology, hematology, virology and rare diseases. In parallel, she is active as a business angel in the evaluation and support of innovative startups.
Fabrizio is a professional with scientific background, Founder and currently CEO of ViewScience. His education is developed in the field of biotechnology, with a bachelor’s and a master’s degree in Medical Biotechnology at the University of Rome “Tor Vergata,” followed by a Master’s degree in clinical and preclinical drug development at the Catholic University of the Sacred Heart, with focus on technical-scientific, regulatory and ethical aspects. During his career, he has gained expertise in regulatory affairs and pharmaceutical consulting, working alongside companies in product enhancement from a strategic point of view and in scientific communication.
