Fredrik Schjesvold, Head of Oslo Myeloma Center at Oslo University Hospital, shared a post on LinkedIn:
“There are many who wonder why Carvykti/Cilta-cel (CAR-T for multiple myeloma) has not been brought up again in the Decision Forum. I’ve wondered about that too, and now I’ve figured it out.
New Methods has created a new rule that states that all health regions must approve the company’s (Johnson & Johnson) IT systems for ordering the product. Until this has been approved by all health regions, this cannot be submitted for assessment. Everything else is apparently clear.
It is unclear who or where in New Methods this new rule is determined. It is not found in any meeting minutes. It is therefore also unclear why.
OUS has approved that the IT systems are good enough for OUS in accordance with GDPR, and Central Norway is on its way or has just done the same.
Even though OUS intends to take national responsibility for all regions’ patients, and distribute the patients with the regions that are eventually certified for this CAR-Ten, the situation is that due to this new formality, no one in Norway will receive CAR-T for multiple myeloma until all regions have approved J&J’s IT systems.
It is very difficult to understand why all regions have to do this formal process before assessment, as long as OUS can accept patients from all over the country.
I will add that this is to be considered. Whether it will be yes or no is of course unclear.”
More posts featuring Fredrik Schjesvold on OncoDaily.