In the lead-up to the likely approval of Geron’s drug to treat certain types of anemia, drug pricing watchdog the Institute for Clinical and Economic Review said Thursday that the drug would not be cost-effective at the potential price of $250,000 per year.
The 112-page draft report also found Geron’s imetelstat to be “slightly less costly but also less effective when compared to” Bristol Myers Squibb’s luspatercept, marketed as Reblozyl, to treat patients with myelodysplastic syndromes (MDS), which affect blood cell development and increase the risk of leukemia. With fewer blood cells to transport oxygen through the body, MDS patients often require blood transfusions, which can be costly, time consuming and lead to fatigue.
The draft report follows the FDA’s Oncologic Drugs Advisory Committee, which earlier this spring voted 12-2 that the benefits of imetelstat outweighed its risks, though committee members had some questions on the drug’s safety.
The FDA is scheduled to make an approval decision on imetelstat by mid-June.
BMS’ Reblozyl has been on the market since 2019 and has nabbed several indications over the past few years, including an approval last summer to treat adult anemia patients with lower-risk MDS.
ICER’s draft report concludes that compared to the best supportive care, the net benefit of imetelstat is “promising, but inconclusive,” and compared to luspatercept, the net benefit was “insufficient.”
The report states that it’s clear that imetelstat is effective at lowering the number of blood transfusions that MDS patients need, but the improvement in fatigue was modest. Further, the results also found that there were substantially more adverse events reported in patients taking imetelstat compared to luspatercept.
“There is no evidence suggesting greater reductions in red blood cell (RBC) transfusions or improvements in quality of life for imetelstat compared with luspatercept and there are many more grade 3 and 4 hematologic adverse events,” the report states.
Still, the authors acknowledge there’s only one head-to-head trial to draw from and only one trial for each medication, lowering the level of certainty of its findings.
“We are aware of and reviewing ICER’s Draft Evidence Report,” Geron said in a statement to Endpoints News. “We remain committed to people with TD LR-MDS whose lives are greatly impacted by the burden of frequent blood transfusions associated with the disease.”
This story has been updated to include comment from Geron.