Written by Marco Sancandi, PhD, Analyst. Email: [email protected] Rare diseases, individually infrequent but collectively prevalent, are in the spotlight as scientists strive to develop safer
From 2024, the Swiss regulatory body (Swissmedic) and health technology assessment (HTA) organization (Federal office of public health; FOPH) are introducing a simultaneous reimbursement and regulatory review process, to promote earlier access of medicines. This approach will enable manufacturers to submit both applications at the same time, making it possible to achieve marketing authorization and reimbursement in situ (1). This has been evidenced under a successful pilot with Roche’s Lunsumio (completed in March 2023).
OD (orphan drug) privilege status under the AMNOG procedure means that ODs are currently exempt from providing comparative data for their assessment. They are assumed to have a positive added benefit (with the lowest rating possible being a positive but unquantifiable added benefit), even when the data is insufficient to support this. If sales over 12 months surpass the €30 million mark, this privilege is revoked, and a full assessment is performed based on comparative data.
Written by Andrea Bernardini, Associate Consultant & Marco Sancandi, Analyst Contacts: abernardini@partners4access; msancandi@partners4access In a significant step forward for healthcare in Italy, the National Rare
By Marco Sancandi, PhD; Analyst On the 31st of January 2023, the 6th joint report from the Orphan Drugs Observatory and the Italian Society of
By Fisentzos Stylianou, PhD; Senior Analyst Contact: [email protected] “I can say on behalf of the G-BA that it is possible that we will recognise some
By Fisentzos Stylianou, PhD Contact: [email protected] NICE’s launches a real-world evidence framework Closing knowledge gaps and advancing patient access to innovations are major aims of the
By Fisentzos Stylianou, PhD Contact: [email protected] One of the main healthcare challenges raised by the European Medicines Agency’s (EMA) network strategy to 2025 is the