August heralds the beginning of the end for summer. Children start heading back to school. The weather begins to turn crisp. Days get shorter. Leaves start showing hints of red and yellow – very soon they will detach from the stems that have nourished them and then wither away, only to be replaced by new leaves the following spring.
A patient once poignantly compared this time of the year to transplant – the end of summer was like the onset of conditioning regimen when there was less sunshine in his life, followed by the "100 days" of fall and winter – but he was hopeful he would see spring again and subsequently enjoy many summers. He considered his stem cells to be "leaves" that would drop from the tree during fall, and come spring there would be healthier and more vibrant ones sprouting from his bone marrow.
A big policy event happened in August that is going to have long-term implications on the field of cell therapy. CMS came out with its final decision memo on coverage for CAR T-cell therapy. They agreed to cover CAR T-cell therapies administered under FDA approved label, provided guidance on off-label use of these therapies, and most importantly, did not ask for administration of CAR T-cell therapy under a Coverage with Evidence Determination (CED) mechanism.
Overall, all of this was a big win for the ASTCT. We have strongly advocated against the CED for CAR T-cell therapy, since at the end of the day, it is akin to running an unfunded clinical trial with tremendous burden to centers and serious implications in limiting access to Medicare patients. The ASTCT coordinated and led advocacy efforts around this issue in collaboration with several of our sister organizations. I do want to acknowledge that CMS did not give us everything we asked for – they did not make data reporting to the CIBMTR mandatory and were quiet on requiring FACT accreditation to safely administer CAR T-cell therapies. Also, this is another step in our work with CMS.
We continue to fight for adequate reimbursement coverage – the current Medicare payment for CAR T-cell therapies is woefully inadequate and continues to be a barrier to access to some of our patients. I encourage you to read our response to CMS on their coverage decision.
Last month was also notable for another society undertaking, where we got a diverse group of cell therapy experts to help the ASTCT establish guidelines for the management of CAR T-cell complications, including cytokine release syndrome and neurotoxicity. I do want to sincerely thank the Chairs of our Cell Therapy Committee (Drs Krishna Komanduri and Marcel van den Brink) and Practice Guidelines Committee (Drs Paul Carpenter and Bipin Savani) for organizing this effort and getting it done. Stay tuned for a manuscript detailing these guidelines that will be released later this year.
I would also like to give you a preview of some exciting things that are happening in the ASTCT right now. Our board recently approved a governance policy that will streamline and provide guidance on committee and SIG leadership and membership. A big shout out to our past-President, Dr. Chris Bredeson, for laboring on this effort, talking to and getting feedback from several committee and SIG leaders and then providing us with an excellent roadmap to accomplish this important task.
We are in the midst of completely revamping our website – you will see a lot more functionality and content hubs that will help you focus on issues and topics most relevant to you. We are in the process of investing in a learning management system that will help us push out significantly more educational content in the form of webinars and other online tools. We are close to finalizing institutional membership that will allow institutions to purchase bulk affiliate membership. On the same token, we are looking at offering membership options to our colleagues from lower middle income and lower income countries. TCT meeting planning is in full swing. We are getting ready to roll out a fund raising campaign under the auspices of our immediate past-President, Dr. John Dipersio. Basically, I hope you get the essence – the society is extremely busy, thanks to an incredible team that keeps working behind the scenes to make things happen!
The other day our seven-year-old introduced me to his friend who was over for a play date as the “boss of bone marrow transplant in America!" His friend was too engrossed in Mario Kart to pay any attention to me or who I am. But I have to admit that I was very touched by the feeling of accomplishment our son had about me. And I do share the same sense of pride in serving the society and all of you.
Hoping to see many of you at the ASTCT’s Clinical Education Conference later this month.