CMS announces delay of CAR T-cell national coverage determination

Kite CAR-T manufacturing
Kite Pharma, a subsidiary of Gilead Sciences, develops cancer immunotherapy products with a primary focus on genetically engineered autologous T cell therapy with chimeric antigen receptors, or CAR-T therapy. (Kite Pharma)

While the Centers for Medicare & Medicaid Services has said it plans to cover what's best known as CAR T-cell therapy for cancer patients, that determination is going to take a little longer than planned.

On Friday, CMS announced a delay in its final national coverage determination for chimeric antigen receptor (CAR) T-cell therapy, in which oncologists use a patient’s own immune system to attack a tumor. 

CMS did not give a reason for the delay, simply saying in a statement: "CMS will not be issuing a final National Coverage Determination on CAR T-cell therapy for cancer today, but a decision is forthcoming."

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CMS first initiated a national coverage analysis for CAR T-cell therapy for cancers last May and began considering public comments. In February, CMS posted a proposed decision memo saying it intends to allow Medicare to pay for CAR T.

RELATED: CMS looks to expand Medicare coverage to CAR-T therapy

CMS had been seeking comment on the plans for coverage with evidence development (CED).

The plan includes several data requirements. Hospitals and clinicians looking to offer the treatments must join a registry that tracks outcomes data for comparison with clinical trials. Clinical studies must follow similar guidelines, including tracking data for two years after the treatment. 

In CAR T-cell therapy, a patient’s white blood cells are extracted and modified with a receptor that drives the cells to seek out the cancer and attack it. The ultimate goal of the therapy is to not only kill existing tumors but provide an internal line of defense against future cancers. 

Groups like the the American Society for Transplantation and Cellular Therapy (ASTCT) said making a national coverage determination was "premature."

"ASTCT opposed the establishment of a National Coverage Determination (NCD) due to concerns that it would cause significant and ongoing barriers to providing current and future CAR-T therapies to beneficiaries in need of these breakthrough treatments," the group wrote in a comment submitted to CMS. "Patients who receive CAR-T have typically exhausted all other available therapies. The Society still believes that it is premature to implement a NCD because this is a rapidly evolving area of medicine. A coverage policy should not be developed until the field matures."

RELATED: How Sean Parker is working to build 'a clone army of cancer-killing assassins' for patients 

America's Health Insurance Plans (AHIP) also weighed in, encouraging caution from CMS. "We agree with CMS that there is currently limited evidence for CAR-T Therapies. To date, studies have consisted of single-arm trials performed in specialty-trained hospitals with small sample sizes; we agree that a CED will allow CMS to collect additional evidence," wrote Kate Berry, AHIP's senior vice president for strategic planning. 

They asked CMS to consider evaluating collecting long-term efficacy and safety data to ensure quality care and improved health outcomes through the CED, evaluating nonmedical costs associated with CAR-T and offering more clarity around who will be administering patient registries required for patients who will receive CAR-T. 

However, manufacturers wrote in with support for the a coverage determination, pointing out the growing evidence supporting CAR T-cell therapy.

Among them was Kite Pharma, which manufacturers Yescarta, the first FDA-approved CAR T-cell therapy for adults with relapsed or refractory large B-cell lymphoma, which questioned whether CED was necessary.

RELATED: CMS proposes updates to hospital wage index, payments for emerging therapies

"We believe that the existing and growing body of evidence strongly supports that CAR T-cell therapy is reasonable and necessary for Medicare beneficiaries," wrote Michael Amoroso, senior vice president and head of worldwide commercial cell therapy at Kite Pharma. Kite was calling for CMS to remove the CED coverage limit that restricts treatment to patients who have relapsed or refractory cancer to allow coverage for all patients with cancer who receive CAR T therapy for any FDA approved indications or indications recommended by the National Comprehensive Cancer Network.

Celgene, which got its own CAR T-cell therapy with its $9 billion Juno Therapeutics acquisition last year, also called for expanded coverage of the immunotherapy

"Medicare beneficiaries are disproportionately impacted by several of the cancer types currently under study for treatment with CAR T cell therapy. Therefore, CMS’s final National Coverage Determination (NCD) will be critical to ensure patient access to current and future treatment options as CAR T cell therapy continues to rapidly evolve and progress," wrote Richard Bagger, executive vice president of corporate affairs and market access for Celgene. "We are concerned that the [proposed decision memo], as currently structured, would limit CMS’s flexibility to cover future CAR T therapies that could receive FDA approval within the next two years for unique patient populations or that have different characteristics (e.g., safety, dosing) than the two products currently available to patients."

The company made recommendations to increase flexibility such as aligning patient eligibility criteria for CAR T-cell therapies with FDA-approved labeling or medically accepted indications recognized in Medicare-approved compendia and covering the therapy under the CED framework when administered at an appropriately qualified site regardless of the site’s status as a hospital.

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