Written by Iro Malekou, Senior Analyst & Srishti Gupta, Senior Consultant Emails: [email protected], [email protected] Over a year ago, the European Commission (EC) set out to
Yescarta, Gilead’s CAR-T cell therapy recently underwent a full HTA assessment in Germany after breaching the annual sales threshold for orphan drugs. Upon reassessment, Germany’s lower HTA body IQWiG recommended downgrading Yescarta’s rating in one indication to ‘no added benefit’, which is likely to negatively impact pricing negotiations.
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).
Written by: Angeliki Meletsi; Analyst Contact: [email protected] The European Commission proposals on the EU pharmaceutical legislation revision, announced in April 2023, have not included any
Written by: Srishti Gupta, PhD; Senior Consultant Contact: [email protected] In March 2023, the Food and Drug Administration (FDA) published, a first of its kind, draft
Written by Priyanka Kiritharan, Analyst Contact: [email protected] Taking effect from January 2025, all advanced therapeutic medicines (ATMPs) and oncology drugs will be mandated to undergo
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
By Chloe Sheppard, Associate Consultant Contact: [email protected] A major milestone in the creation of pan-European joint health technology assessment (HTA) was reached in January this
By Christina Poschen, Consultant Email: [email protected] Background Since 2004, the European Union’s centralised drug approval is in place, allowing manufacturers to submit just one application to
