Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Imetelstat (Rytelo) may be considered medically necessary when the following criteria are met:
Myelodysplastic Syndrome (MDS) with Transfusion Dependent Anemia
-
Individual is 18 years of age or older;
and
-
Individual has a documented diagnosis of low- to intermediate- risk MDS as defined by
ONE
of the following:
-
Revised International Prognostic Scoring System (IPSS-R); Very low, low, intermediate (defined as a score of 0 to 4.5);
or
-
IPSS: Low/Intermediate-1 (Score 0 to 1);
or
-
WHO-Based Prognostic Scoring System (WPSS): very low, low, intermediate (Score 0 to 2);
and
-
Prescribed by or in consultation with a hematologist, oncologist, or other specialist with expertise in the diagnosis and management of myelodysplastic syndromes;
and
-
Prescriber has ruled out and/or addressed other causes of anemia [e.g., abnormal bleeding (gastrointestinal, uterine, etc.), hemolysis, nutritional deficiency, renal disease];
and
-
Individual has required four (4) or more red blood cell units over an eight (8) week period;
and
-
Individual has had no response to or is ineligible for an erythropoiesis-stimulating agents (ESA);
or
Compendia Sources
Imetelstat (Rytelo) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of imetelstat (Rytelo) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
