- Under a proposal released Friday, Medicare would cover CAR-T cell therapies through a Centers for Medicare and Medicaid Services (CMS) pathway known as Coverage with Evidence Development.
- The proposal holds a mix of provisions, including that patients must be monitored for at least two years post-treatment. Hospitals administering CAR-T therapy, whether through inpatient or outpatient care, must participate in a CMS-approved registry that collects data on patient outcomes and characteristics and then compares that data to what's been seen in pivotal clinical trials of the therapy or standard of care treatment.
- CMS-approved clinical trials would face the same data requirements. Hospitals and clinicians would track certain clinical data elements at baseline, at treatment, and then at three-month, six-month, one-year and two-year follow ups following administration.
Two CAR-T therapies — Novartis' Kymriah (tisagenlecleucel) and Gilead Sciences' Yescarta (axicabtagene ciloleucel) — are already on the market, yet their high price tags and potentially one-time administration has put pressure on CMS to figure out a way to cover these kinds of treatments.
The agency took a few steps toward that goal over the last year. In April, it agreed to reimburse hospitals about $400,000 for Yescarta and $500,000 for Kymriah through Medicare Part B, which covers outpatient medical needs for people who have certain disabilities, end-stage renal cancer or are at least 65 years old. A month later, CMS said it would conduct National Coverage Analysis for CAR-T therapies to be completed by May 17, 2019.
Still, some worry not enough is being done to tackle the reimbursement challenges these complex treatments present.
Food and Drug Administrator Commissioner Scott Gottlieb said at a health summit in October that the drug reimbursement model needs reform to better address new technologies like CAR-T cell therapy.
And at the most recent American Society of Hematology conference, hospital doctors noted there are still cost concerns with CMS-insured patients despite the Medicare Part B reimbursement. One of the biggest is in the inpatient setting, where hospitals can face a loss of roughly $200,000 per patient.
With no formal Medicare policy covering CAR-T therapies, discretion over whether to pay for the treatments has thus far been left to local Medicare Administrative Contractors, according to a Feb. 15 statement from CMS. But that could change under Friday's proposed National Coverage Determination.
"Today's proposed coverage decision would improve access to this therapy while deepening CMS's understanding of how patients in Medicare respond to it, so the agency can ensure that it is paying for CAR-T cell therapy for cases in which the benefits outweigh the risks," CMS Administrator Seema Verma said in the statement.
The agency is seeking comments on its proposal until March 17. A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period.
"Given that the draft National Coverage Determination ... has just been released, we are still in the process of reviewing the document," a spokesperson for Gilead wrote in an emailed statement to BioPharma Dive.
"Novartis is pleased to work with stakeholders across the healthcare spectrum to ensure patients have access to innovative therapies like Kymriah," the Swiss pharma wrote in an emailed statement to BioPharma Dive. "Novartis plans to provide comments to today's CMS proposed decision for the agency’s consideration during this 30-day open comment period."