ICER - Institute for Clinical and Economic Review

[Ryan]

ICER to Evaluate Geron’s Imetelsta for the Treatment of MDS

https://www.navlindaily.com/article/200 ... ent-of-mds

Imetelstat for Anemia in Myelodysplastic Syndrome
Draft Background and Scope
January 3, 2024
https://icer.org/wp-content/uploads/202 ... 032024.pdf

[biopearl123]

Ryan, thanks for posting. Can you give us a primer on who ICER is and would would have commissioned this review (Geron, FDA, Pharmas?). thanks, bp

[Ryan]

From their website:

“ICER provides an independent source of evidence review—free from financial conflicts of interest—to address these fundamental questions. By doing so, we help patients today and in the future by catalyzing a movement toward fair pricing, fair access, and future innovation across the entire US health care system.”

Wikipedia:

https://en.m.wikipedia.org/wiki/Institu ... mic_Review

[biopearl123]

Thanks for the background, pretty impressive advisory board. Will be interesting to see what their analysis reveals. It appears as a non profit, that they could be self appointed watch dogs to reign in or at least shine a spotlight on excessive medical costs. We really don’t know how Imetelstat will be priced per dose and how insurance will approach reimbursement. I do think if there is a substantial impact in AML that this organization will have to look at the cost of bone marrow transplant which is hugely expensive and loaded with morbidities and not just the impact of a major reduction in blood transfusions along with doctor’s visits, iron overload issues etc.in LR patients. The new company presentation states that further articles are yet to come. I think we can anticipate only what time can give that we don’t have yet: PFS, OS, reduction in transformation to high risk and AML. These additional data points could move the needle a bit.

[jayfish101]

I wonder if the FDA pays attention to the ICER findings.

[Ryan]

I wonder if the FDA pays attention to the ICER findings.

I wouldn’t know but I wouldn’t think so. I believe such an independent panel could influence Insurance companies and regulators for the points BP referenced.

It is interesting that there is an open call for input into late January. I’d be interested to find out who sent inputs and what they said, if that becomes public domain.