Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Stem cell transplantation gains Medicare coverage analysis

This article was originally published in The Gray Sheet

Executive Summary

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...



CMS In Brief

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

Finance Watch: Silverback, Kinnate, Sigilon Launch December’s First IPOs

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.

BioCryst’s Oral Option To Take On Injectables In HAE Prophylaxis Market

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.

Topics

UsernamePublicRestriction

Register

LL1134940

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel