Development and customization of pharmacoeconomic analysis models
Through an integrated approach with the various corporate functions involved, we collaborate with the company for the most correct identification of the target population to whom the drug will be destined and of the competitors to be considered for the purpose of requesting reimbursement and adapting the economic evaluation models.
An in-depth analysis of the structure of the models and their adaptability and usability in the Italian reality allows us to obtain tools aligned with the requests of the health authorities.
Budget impact and cost minimization models can be developed internally and adapted to the needs of regional access.
The main types of economic evaluations we deal with are:
– Cost effectiveness analysis
– Utility cost analysis
– Cost minimization analysis
– Budget impact analysis
Studi Real World Evidence
We carry out analyzes based on administrative databases or disease registries in order to identify and characterize populations affected by specific diseases in terms of consumption of health resources, clinical costs and outcomes.
Starting from complete datasets that systematically collect healthcare supplies from different sources, we take care of the implementation of the study protocol, selection of relevant information, systematization of data, integrated clinical-economic-statistical analysis and evaluation of the results, in collaboration with clinicians and scientific societies to carry out cost assessments of the disease, of drug-use, of outcomes research and epidemiology
Preparation and submission of scientific papers in Italian and English
Writing of scientific and informative manuscripts in Italian and English: studi real world evidence, economic evaluations, health policy and other health economics topics.
In collaboration with the corporate functions, we develop strategies for market access activities implemented on the basis of the characteristics of the drug, of the competitive scenario at the Italian level and of unmet clinical needs with an approach that integrates an important experience in the field of pricing and reimbursement (at national and local level) with constant clinical and regulatory updating. Within a constantly evolving reference scenario, we carry out assessments of the impact of health policy measures on the company portfolio.
Refundability and Pricing
Collaboration and support to the company throughout the entire process of accessing the drug to patients
– Initial analysis of the reference national market and identification of a price target, identification of the potential of the drug and its correct therapeutic positioning
– Drafting of a price and reimbursement request document that highlights the value of the drug and its correct therapeutic positioning (guidelines AIFA D.M. 2 August 2019)
– Evaluation and adaptation of economic evaluation models,
– Development of negotiation strategies and calculation tools aimed at facilitating negotiation with the Health Authorities
– Participation in Mock Negotiation.
– Document development to support the Value Proposition
– Development of reimbursement scenarios
– Support during price negotiation with health authorities
– Support for the drafting of regional / local dossiers
Management of pharmaceutical spending ceilings at national level
On the basis of current legislation relating to the attribution to pharmaceutical companies of the shelf charges for breaking down pharmaceutical spending ceilings at national level (Financial law 2019, Law 30/12/2018 n. 145), we carry out analysis and evaluation of the methodological notes, forecast and final estimates on the consistency of the data and on the methods of legislative application.
Experience as speakers and course creation
We have many years of experience as speakers at ECM courses and university Masters. We also develop theoretical courses in pharmacoeconomics, Health Technology Assessment, Horizon Scanning and Real World Evidence data analysis built on the basis of the specific needs of our customers.