Medicare will begin nationwide coverage of CAR T-cell therapy

[The_Eagle]

Medicare will begin nationwide coverage of CAR T-cell therapy, a complicated treatment for some cancer patients who have run out of other treatment options, the Centers for Medicare and Medicaid Services (CMS) announced on Wednesday.

The Food and Drug Administration has approved chimeric antigen receptor T-cell, or CAR T-cell, therapy to treat some specific cancers, including certain types of non-Hodgkin’s lymphoma. The treatment involves removing some of the patient’s own CAR T-cells, genetically modifying them, and then putting them back into the patient so they can attack a protein on the surface of cancer cells. The treatment — which is applied once — is estimated to cost between $375,000 and $475,000.

“Today’s coverage decision provides consistent and predictable patient access nationwide,” CMS Administrator Seema Verma said in a statement. “CMS will work closely with our sister agencies to monitor outcomes for Medicare patients receiving this innovative therapy going forward.”

Medicare said it will cover CAR T-cell therapy when it is performed in facilities enrolled in an FDA safety program that includes training in handling side effects of such treatments.

“We’ve recently seen dramatic progress in the development of CAR T-cell therapies and other treatments that harness patients’ own immune cells to treat their cancers, and we continue to learn more in clinical studies,” says Douglas R. Lowy, acting director of the National Cancer Institute, where the first successful cancer treatment with CAR T-cells was developed. “By partnering with CMS and FDA, we have an opportunity to increase our understanding of how different patients’ cancers respond to these treatments through the collection of this data, ultimately allowing us to better understand who will benefit from these therapies.

[Ptown]

Hello Eagle, thanks for sharing this good news that will positively impact many members of our community and give a sense of relief . Great news! Carolyn

[Smakwater]

Eagle,

Can you provide a source publication please?

Thank You,

JM

[bhayes84]

Wow, I didn’t expect this to happen so soon. Nice to know this treatment is available if all other treatments fail. The $375k cost sounds expensive until you realize that costs less than three years of Ibrutinib or Acalabrutinib.

Here’s the link to the press release from CMS.gov.

cms.gov/newsroom/press-rele...

Bill

[Jonquiljo in reply to bhayes84]

I’m not surprised. Car-t has many possible uses. I think the big rock in the road is to prevent physicians from treating people with Car-t unless the FDA can be sure that they are qualified to do so.

Since Car-t is a process rather than a drug, it isn’t easy to simply approve it. The process has to have approval - and be monitored. This milestone is likely the first of many with car-t that will improve and increase its use with time. As people have said, $375-$475K is minor relative to the cost of novel agent monotherapy - let alone multiple therapies.

I also gather that the concern among hospitals (at least in the US) is that reimbursement from programs like Medicare will be too small to cover the real cost of Car-t. While many hospitals overcharge, they really squirm at the thought of losing money. The first step in overcoming this is for CMS (Medicare) to approve the procedure which means reimbursement amounts will be forthcoming.

[The_Eagle]

I was offered CAR-T this year for free at University of Texas but you need to have someone with you all the time (I live alone) and the first 30 day I was told I could be in ICU because of the side effects the first few weeks and you might have to spend 90 days in the hospital total. I turned it down but now I am getting a clinical trial (will know soon) if accepted. This will be my 3 treatment in last 14 years.