Are we putting the CAR-T before the horse?
There are many things money can’t buy. But FDA-approved CAR-T cell therapies for patients on Medicare? That should be a different story. On Wednesday, the Center for Medicare and Medicaid Services (CMS) finalized rules for covering these potentially curative therapies. Yet, the decision received no applause from providers, pharmaceuticals or patients.
Some of the key points outlined in the CMS national coverage determination include:
- Coverage will be given for the entire CAR-T process. As CMS Administrator Seema Verma outlined, coverage will extend to: “The administration of the drug. The collection of the cells. The manipulation of the cells and then putting it back into the patient. And then any of their outpatient or inpatient care as well."
- Medicare will pay for CAR-Ts that are administered in “healthcare facilities” that adhere to the FDA’s safety rules. Notably, the distinction of “healthcare facilities” (vs. just hospitals) will allow for oncology clinics to also seek coverage.
- The facilities don’t have to collect data on how patients are doing with the treatment, a concept that was present in previous draft rules.
- CMS will only cover 65% of the payment costs, a rate that is 15% higher than previous proposals, but far short of what many hospital and provider groups sought.
This determination confirms the incredible potential of CAR-T therapies, but as we mentioned, not everyone is jumping for joy. Hospitals have serious concerns about whether they can break even by administering these therapies under these rates.
The bigger picture
Figuring out how to pay for CAR-Ts, and other similarly innovative and potentially curative treatments like gene therapies, has been an ongoing pressure point for the healthcare industry. Just days before the final determination, Seema Verma spoke with STAT about the challenges CMS encounters when considering payment for these treatments.
When it comes to pricing, the general consensus is that the current list prices for CAR-Ts are reasonable. ICER’s verdict, that the cost of current CAR-T therapies is aligned to their clinical benefit, has been particularly influential in fostering acceptance of current list prices. CMS even considered ICER’s analysis when developing their coverage rules.
Still, concerns about access and affordability persist, leading many eligible patients to continue to seek access to CAR-Ts through alternate pathways. A recent analysis found that as many as 25% of eligible patients opt for treatment through CAR-T clinical trials instead of approved, available therapies.
What does it mean?
When it comes to CAR-Ts, only time will tell. Many believe more efficacy and long-term data is still needed. Hospitals need to see how they will fare under the newest coverage rates. And, manufacturers need to assess the profitability and potential of CAR-Ts through commercial pathways – and whether deeper discounts are viable.
We’ll be keeping our eye on developments and sharing our perspectives with you along the way.
Who wrote this? The managing editors of TWTW are Dana Davis, who, after 4 years at Syneos, is moving on to her next adventure, and Randi Kahn, who is sad her partner-in-crime is leaving, but simultaneously happy for her. The rest of the team may recover by 2020, but are still in a period of mourning.
Syneos Health Communications' Reputation & Risk Management Practice is a team of healthcare communications consultants, policy-shapers and crisis response specialists. We provide unique solutions to the evolving communications challenges in today’s healthcare industry, using evidence-based approaches to help our clients successfully navigate the most sensitive of situations.
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