Stem cell transplantation gains Medicare coverage analysis
This article was originally published in The Gray Sheet
CMS is taking comments through Dec. 10 on whether there is enough evidence to merit coverage for allogeneic hematopoietic stem cell transplantation to treat the bone marrow disorders known as myelodysplastic syndrome. The Medicare agency opened the national coverage analysis on Nov. 10 in response to a formal request from several professional societies working in cancer treatment and bone marrow transplantation. In allogeneic stem cell transplantation, a portion of a healthy donor's stem cells or bone marrow is prepared for intravenous infusion to treat the patient. "For a number of patients, allogeneic HCT is currently the only curative therapy for MDS, and the only treatment available that prevents certain death from this disease," a Sept. 21 letter to CMS reads
You may also be interested in...
Coverage with evidence for stem cell transplants?: CMS proposes May 6 to allow coverage with evidence development for allogeneic hematopoietic stem cell transplantation for myelodysplastic syndrome, a group of diverse blood disorders in which the bone marrow does not produce enough healthy, functioning blood cells (1"The Gray Sheet" Nov. 30, 2009). The proposed coverage memo outlines criteria for prospective controlled clinical studies, including the need to address specified treatment outcomes and to adhere to strict standards of scientific integrity. CMS is taking comments through June 5 and plans a final rule by Aug. 4
Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.
Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.