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Medicare will cover allogeneic hematopoietic stem cell transplantation (HSCT) for beneficiaries with multiple myeloma, myelofibrosis, or sickle cell disease in the context of approved, prospective clinical trials, the Centers for Medicare & Medicaid Services announced in a final decision memo Jan. 27.
Approvable studies must examine whether Medicare beneficiaries who receive allogeneic HSCT have improved outcomes, compared with patients who do not receive allogeneic HSCT as measured by graft vs. host disease, other transplant-related adverse events, overall survival, and, optionally, quality of life measures.
In multiple myeloma, allogeneic HSCT will be covered only for Medicare beneficiaries who have Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma, and are participating in an approved prospective clinical study. Such studies must control for selection bias and potential confounding by age, duration of diagnosis, disease classification, International Myeloma Working Group (IMWG) classification, ISS staging, Durie-Salmon staging, comorbid conditions, type of preparative/conditioning regimen, graft vs. host disease (GVHD) prophylaxis, donor type, and cell source, the CMS said in its memo.
In myelofibrosis, allogeneic HSCT will be covered by Medicare in an approved prospective study only for beneficiaries with Dynamic International Prognostic Scoring System (DIPSS plus) intermediate-2 or high primary or secondary myelofibrosis. Studies must be controlled for selection bias and potential confounding by age, duration of diagnosis, disease classification, DIPSS plus score, comorbid conditions, type of preparative/conditioning regimen, GVHD prophylaxis, donor type, and cell source.
In sickle cell disease, allogeneic HSCT will be covered by Medicare only for beneficiaries who have severe, symptomatic disease. Approvable studies must control for selection bias and potential confounding by age, duration of diagnosis, comorbid conditions, type of preparative/conditioning regimen, GVHD prophylaxis, donor type, and cell source.
On Twitter @maryjodales
Dr. Navneet Majhail comments: I welcome the decision by CMS [the Centers for Medicare & Medicaid Services] to cover allogeneic hematopoietic stem cell transplantation (HSCT) for multiple myeloma, myelofibrosis, and sickle cell disease under the coverage with evidence development (CED) mechanism. This action will allow us to provide transplant as a treatment option for older patients with myeloma and myelofibrosis and for Medicare beneficiaries with sickle cell disease: Lack of coverage is a real challenge at present for this population and prevents us from offering a potentially curative treatment option to these high-risk patients.
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Dr. Navneet Majhail |
The decision is the result of collective advocacy efforts of our transplant community, patients, and patient advocacy organizations, Be the Match, and the American Society for Blood and Marrow Transplantation.
The CED asks for a prospective clinical trial that mandates the presence of a control arm of comparable patients who do not receive allogeneic transplantation. I completely support provision of transplantation on a clinical trial for CED purposes; however, I believe it would have been better to allow hematology and transplant experts to determine the appropriate study design in consultation with CMS to fulfill the CED requirements. For example, on the basis of available evidence, it will be challenging to enroll patients with high-risk myelofibrosis to a nontransplant arm. Irrespective, this is a big win for patients with these life-threatening diseases and for physicians who treat them.
Dr. Navneet Majhail is the director of the Cleveland Clinic’s Blood & Marrow Transplant Program. He serves as a staff physician at the Taussig Cancer Institute and is a professor of medicine with the Cleveland Clinic Lerner College of Medicine.
Dr. Navneet Majhail comments: I welcome the decision by CMS [the Centers for Medicare & Medicaid Services] to cover allogeneic hematopoietic stem cell transplantation (HSCT) for multiple myeloma, myelofibrosis, and sickle cell disease under the coverage with evidence development (CED) mechanism. This action will allow us to provide transplant as a treatment option for older patients with myeloma and myelofibrosis and for Medicare beneficiaries with sickle cell disease: Lack of coverage is a real challenge at present for this population and prevents us from offering a potentially curative treatment option to these high-risk patients.
|
Dr. Navneet Majhail |
The decision is the result of collective advocacy efforts of our transplant community, patients, and patient advocacy organizations, Be the Match, and the American Society for Blood and Marrow Transplantation.
The CED asks for a prospective clinical trial that mandates the presence of a control arm of comparable patients who do not receive allogeneic transplantation. I completely support provision of transplantation on a clinical trial for CED purposes; however, I believe it would have been better to allow hematology and transplant experts to determine the appropriate study design in consultation with CMS to fulfill the CED requirements. For example, on the basis of available evidence, it will be challenging to enroll patients with high-risk myelofibrosis to a nontransplant arm. Irrespective, this is a big win for patients with these life-threatening diseases and for physicians who treat them.
Dr. Navneet Majhail is the director of the Cleveland Clinic’s Blood & Marrow Transplant Program. He serves as a staff physician at the Taussig Cancer Institute and is a professor of medicine with the Cleveland Clinic Lerner College of Medicine.
Dr. Navneet Majhail comments: I welcome the decision by CMS [the Centers for Medicare & Medicaid Services] to cover allogeneic hematopoietic stem cell transplantation (HSCT) for multiple myeloma, myelofibrosis, and sickle cell disease under the coverage with evidence development (CED) mechanism. This action will allow us to provide transplant as a treatment option for older patients with myeloma and myelofibrosis and for Medicare beneficiaries with sickle cell disease: Lack of coverage is a real challenge at present for this population and prevents us from offering a potentially curative treatment option to these high-risk patients.
|
Dr. Navneet Majhail |
The decision is the result of collective advocacy efforts of our transplant community, patients, and patient advocacy organizations, Be the Match, and the American Society for Blood and Marrow Transplantation.
The CED asks for a prospective clinical trial that mandates the presence of a control arm of comparable patients who do not receive allogeneic transplantation. I completely support provision of transplantation on a clinical trial for CED purposes; however, I believe it would have been better to allow hematology and transplant experts to determine the appropriate study design in consultation with CMS to fulfill the CED requirements. For example, on the basis of available evidence, it will be challenging to enroll patients with high-risk myelofibrosis to a nontransplant arm. Irrespective, this is a big win for patients with these life-threatening diseases and for physicians who treat them.
Dr. Navneet Majhail is the director of the Cleveland Clinic’s Blood & Marrow Transplant Program. He serves as a staff physician at the Taussig Cancer Institute and is a professor of medicine with the Cleveland Clinic Lerner College of Medicine.
Medicare will cover allogeneic hematopoietic stem cell transplantation (HSCT) for beneficiaries with multiple myeloma, myelofibrosis, or sickle cell disease in the context of approved, prospective clinical trials, the Centers for Medicare & Medicaid Services announced in a final decision memo Jan. 27.
Approvable studies must examine whether Medicare beneficiaries who receive allogeneic HSCT have improved outcomes, compared with patients who do not receive allogeneic HSCT as measured by graft vs. host disease, other transplant-related adverse events, overall survival, and, optionally, quality of life measures.
In multiple myeloma, allogeneic HSCT will be covered only for Medicare beneficiaries who have Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma, and are participating in an approved prospective clinical study. Such studies must control for selection bias and potential confounding by age, duration of diagnosis, disease classification, International Myeloma Working Group (IMWG) classification, ISS staging, Durie-Salmon staging, comorbid conditions, type of preparative/conditioning regimen, graft vs. host disease (GVHD) prophylaxis, donor type, and cell source, the CMS said in its memo.
In myelofibrosis, allogeneic HSCT will be covered by Medicare in an approved prospective study only for beneficiaries with Dynamic International Prognostic Scoring System (DIPSS plus) intermediate-2 or high primary or secondary myelofibrosis. Studies must be controlled for selection bias and potential confounding by age, duration of diagnosis, disease classification, DIPSS plus score, comorbid conditions, type of preparative/conditioning regimen, GVHD prophylaxis, donor type, and cell source.
In sickle cell disease, allogeneic HSCT will be covered by Medicare only for beneficiaries who have severe, symptomatic disease. Approvable studies must control for selection bias and potential confounding by age, duration of diagnosis, comorbid conditions, type of preparative/conditioning regimen, GVHD prophylaxis, donor type, and cell source.
On Twitter @maryjodales
Medicare will cover allogeneic hematopoietic stem cell transplantation (HSCT) for beneficiaries with multiple myeloma, myelofibrosis, or sickle cell disease in the context of approved, prospective clinical trials, the Centers for Medicare & Medicaid Services announced in a final decision memo Jan. 27.
Approvable studies must examine whether Medicare beneficiaries who receive allogeneic HSCT have improved outcomes, compared with patients who do not receive allogeneic HSCT as measured by graft vs. host disease, other transplant-related adverse events, overall survival, and, optionally, quality of life measures.
In multiple myeloma, allogeneic HSCT will be covered only for Medicare beneficiaries who have Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma, and are participating in an approved prospective clinical study. Such studies must control for selection bias and potential confounding by age, duration of diagnosis, disease classification, International Myeloma Working Group (IMWG) classification, ISS staging, Durie-Salmon staging, comorbid conditions, type of preparative/conditioning regimen, graft vs. host disease (GVHD) prophylaxis, donor type, and cell source, the CMS said in its memo.
In myelofibrosis, allogeneic HSCT will be covered by Medicare in an approved prospective study only for beneficiaries with Dynamic International Prognostic Scoring System (DIPSS plus) intermediate-2 or high primary or secondary myelofibrosis. Studies must be controlled for selection bias and potential confounding by age, duration of diagnosis, disease classification, DIPSS plus score, comorbid conditions, type of preparative/conditioning regimen, GVHD prophylaxis, donor type, and cell source.
In sickle cell disease, allogeneic HSCT will be covered by Medicare only for beneficiaries who have severe, symptomatic disease. Approvable studies must control for selection bias and potential confounding by age, duration of diagnosis, comorbid conditions, type of preparative/conditioning regimen, GVHD prophylaxis, donor type, and cell source.
On Twitter @maryjodales
