Results from a prospective study for CMS coverage presented at the 57th Annual Meeting of the American Society of Hematology compared patients older and younger than age 65
MINNEAPOLIS - December 6, 2015
Results from a prospective study of 1,280 patients with myelodysplastic syndrome (MDS) showed that survival at 100 days and at two years following hematopoietic cell transplant (HCT) for patients aged 65 and older is comparable to patients aged 55 to 64. The study demonstrates that age alone should not be a determinant when considering HCT for patients with MDS. The study results were presented in an oral session at the 57th Annual Meeting of the American Society of Hematology on Sunday, Dec. 6.
The study was undertaken to demonstrate efficacy for HCT in older patients with MDS with the goal of securing coverage for HCT for Medicare beneficiaries. Previously, Medicare did not have a clear coverage policy for beneficiaries, which created an access barrier for those patients. This multi-center study - conducted by CIBMTR® (Center for International Blood and Marrow Transplant Research®) - was approved after the Centers for Medicare and Medicaid Services (CMS) established coverage for HCT for MDS through Coverage with Evidence Development (CED) in 2010. The study compared the outcomes of 688 patients aged 65 years and older and 592 patients aged 55-64 years who underwent allogeneic HCT for MDS from 2010 to 2014.
No significant differences were found in the two-year overall survival (42 percent compared to 46 percent, p=0.1) and 100-day mortality (p=0.16) after allogeneic HCT for patients in the 65 and older age group (median age 68 years) compared to patients in the 55-64 age group (median age 61 years), respectively. While age was not found to be prognostic of HCT outcomes, multivariate analysis showed that marrow blasts prior to transplantation, cytogenetics, and Sorror co-morbidity scores were independently associated with outcomes.
"This study confirms that age alone should not be a determining factor in the decision to refer older patients for transplant consultation to determine patient eligibility for transplant," said Ehab Atallah, M.D., lead study author and associate professor of medicine at the Medical College of Wisconsin's Division of Hematology/Oncology. "Based on our observations, transplant should be considered as a treatment option with payment coverage for older patients who are eligible for HCT."
"Results of the study represent an important development for older patients and their physicians seeking access to transplant as a potential cure for MDS," said Michael Boo, J.D., study author and chief strategy officer at the National Marrow Donor Program ® (NMDP)/Be The Match ® . "The study acknowledges HCT as an important and effective treatment for MDS patients regardless of age."
Results of this study will be shared with CMS to determine future coverage for Medicare-eligible HCT recipients.
Visit https://ash.confex.com/ash/2015/webprogram/Paper78833.html to access the abstract and visit http://www.cibmtr.org/Studies/ClinicalTrials/HCT-MDS/Pages/index.aspx for more information about the study.
About CIBMTR (Center for International Blood and Marrow Transplant Research)
A research collaboration between the National Marrow Donor Program (NMDP)/Be The Match and the Medical College of Wisconsin, CIBMTR facilitates critical, cutting-edge research that has led to increased survival and an enriched quality of life for thousands of patients. CIBMTR collaborates with the global scientific community to advance hematopoietic cell transplantation and cellular therapy research worldwide. The prospective and observational research is accomplished through scientific and statistical expertise, a large network of transplant centers and clinical database of more than 415,000 transplant recipients.