Health technology assessment (HTA) criteria in the light of current R&D trends - Mauro Patroncini

Roche Template Health technology assessment (HTA) criteria in the light of current R&D trends Mauro Patroncini Pipeline Product Strategy Leader Roche Italy HTA and R&D • Meeting HTA requirements from the very beginning of the development process of a new product • Challenges of early products from an HTA perspective • Product value and Market access: experiences in outcome based managed entry agre. [...] 232 - Budget Law 2017) and inclusion into the Regional Therapeutic Formulary within the terms of the current legislation (Chapter III, Article 10, paragraph 2, Law No 189 of 8 November 2012) 2) The recognition of conditional (or potential) innovation status only results in the inclusion into the Regional Therapeutic Formulary within the terms of the current legislation (Chapter III, Article 10, pa. [...] First End of innovation eligibility status (innovation recognition for status for the a specific indication) indication Therapeutic unmet need • Maximum: no therapeutic options for the specific indication • High: There are therapeutic alternatives for the specific indication, but do not produce any impact on clinically relevant and validated outcomes for the disease • Moderate: presence of therape. [...] The drug modifies the natural history of the disease in a subpopulation of patients, or there is a clinically relevant benefit (for example in terms of quality of life and disease-free interval compared to the available therapeutic alternatives) • Moderate: moderate efficacy improvement in some subpopulations of patients or surrogate outcomes, with limited effects on the quality of life. [...] Clinical data robustness and power Proper evaluation of the innovative potential of a drug depends on the quality of the scientific evidence brought to support the request.