Rytelo (imetelstat) — Medica

Initial criteria

• age ≥ 18 years
• Patient has low- to intermediate-1 risk myelodysplastic syndrome (MDS) as determined by the International Prognostic Scoring System (IPSS)
• Patient has transfusion-dependent anemia, defined as requiring transfusion of ≥ 4 red blood cell units over an 8-week period
• Patient has not responded to, has lost response to, or is ineligible for erythropoiesis-stimulating agents
• Patient does not have deletion 5q [del(5q)] cytogenic abnormality
• Rytelo will not be used in combination with an erythropoiesis-stimulating agent
• Medication is prescribed by or in consultation with an oncologist or hematologist

Reauthorization criteria

• Patient has experienced a clinically meaningful decrease in transfusion burden according to the prescriber

Approval duration

Initial: 6 months; Reauthorization: 1 year