Saturday, July 13, 2024

ICER Publishes Evidence Report on Anemia Treatment in Myelodysplastic Syndrome

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The Institute for Clinical and Economic Review (ICER) has published a revised Evidence Report assessing the comparative clinical effectiveness and value of imetelstat (Rytelo, Geron Corporation) for the treatment of anemia in myelodysplastic syndrome (MDS). Released on July 2, 2024, this report highlights significant uncertainties regarding the long-term efficacy and safety of imetelstat. The treatment could meet common thresholds for cost-effectiveness if priced between $94,800 and $113,000 per year.

ICER’s report reveals that patients with anemia related to MDS often rely on frequent blood transfusions, significantly impacting their daily lives. Imetelstat, a new treatment option for adults with low-to-intermediate MDS and transfusion-dependent anemia, has shown promise in reducing or eliminating the need for transfusions. However, its effect on the severe fatigue associated with MDS anemia remains unclear. There is no evidence to suggest that imetelstat impacts the progression or trajectory of MDS, and some key side effects are of concern. Consequently, ICER views the evidence as promising but inconclusive, and the current list price of imetelstat is not aligned with the modest benefit observed.

This Evidence Report will be reviewed at a virtual public meeting of the California Technology Assessment Forum (CTAF). The CTAF is one of ICER’s three independent evidence appraisal committees, comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy. The draft version of this report was open for a four-week public comment period, during which feedback was received from patient groups, clinicians, drug manufacturers, and other stakeholders. The updated Evidence Report and voting questions reflect changes made based on these comments. Detailed responses to public comments can be found on ICER’s website.

ICER Finds Imetelstat Promising but Inconclusive for Anemia in MDS

Compared with best supportive care, the net benefit of imetelstat is considered promising but inconclusive. While it offers clear benefits in reducing transfusions, the sustained improvement in fatigue is modest. When compared with luspatercept, ICER rated the evidence for imetelstat as insufficient, finding no evidence of greater reductions in transfusions or improvements in quality of life.

Imetelstat, approved by the FDA, has a list price of approximately $365,000 per year. ICER has calculated a health-benefit price benchmark (HBPB) for imetelstat to be between $94,800 and $113,000 per year. This HBPB is the top price range at which a health system can reward innovation and better health for patients without causing more harm than good by disproportionately increasing healthcare costs.

Anemia

ICER Evaluates Imetelstat’s Effectiveness and Cost-Effectiveness for Anemia in MDS

The Institute for Clinical and Economic Review (ICER) is an independent, non-profit research institute that conducts evidence-based reviews of healthcare interventions, including prescription drugs, other treatments, and diagnostic tests. ICER collaborates with patients, clinical experts, and other key stakeholders to analyze available evidence on the benefits and risks of these interventions, measure their value, and suggest fair prices. ICER also regularly reports on barriers to care for patients and recommends solutions to ensure fair access to prescription drugs.

ICER’s publication of the Evidence Report on imetelstat for anemia in myelodysplastic syndrome provides crucial insights into the treatment’s clinical effectiveness and cost-effectiveness. While imetelstat shows promise in reducing transfusion dependency, uncertainties regarding its long-term efficacy and safety remain. The report emphasizes the need for fair pricing aligned with the modest benefits observed to ensure sustainable healthcare costs and equitable access to innovative treatments.

 

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Resource: Institute for Clinical and Economic Review, July 02, 2024

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