Written by Johann Sanseau, Associate Consultant In 2024, the Haute Autorité de Santé (HAS) celebrated 20 years of innovation and rigor, with their 2024 activity
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).
By Fisentzos Stylianou, PhD; Senior Analyst The UK will be the first country to introduce a regulatory framework for innovative medicines manufactured at the point
By Fisentzos Stylianou, PhD; Senior Analyst Contact: Fstylianou@partners4access.com “I can say on behalf of the G-BA that it is possible that we will recognise some
By Fisentzos Stylianou, PhD Contact: Fstylianou@partners4access.com NICE’s launches a real-world evidence framework Closing knowledge gaps and advancing patient access to innovations are major aims of the
By Chloe Sheppard, Senior Analyst & Max Rex, Consultant Email: csheppard@partners4access.com mrex@partners4access.com Cost-effectiveness analyses, as part of Health Technology Assessments (HTAs) for new therapies, appear
Leading specialist market access consultancy Partners4Access (P4A) is to host a free webinar to share insights on key 2021 trends in market access for pharma/biotech
Leading specialist market access consultancy Partners4Access (P4A) has announced it will share insights on gene therapy access for rare diseases at the biotech industry conference
