Medicare Announces Coverage for CAR T-Cell Therapy

Kerry Dooley Young

August 08, 2019

UPDATED August 9, 2019 // Medicare is offering some flexibility in its plan to pay for a costly therapy that involves the re-engingeering of patients' own cells to fight cancer.

The Centers for Medicare & Medicaid Services (CMS) has posted its overdue national coverage decision (NCD) on chimeric antigen receptor T-cell (CAR-T) therapy. This CMS decision was originally expected in May.

The decision allows Medicare coverage when use of CAR-T therapy falls within a framework established by the US Food and Drug Administration (FDA) and, in certain limited cases, for off-label use of these products.

Cost a Major Issue

Cost is a major issue with this emerging class of therapy. So far, two such drugs have been approved in the United States: tisagenlecleucel (Kymriah, Novartis) and axicabtagene ciloleucel (Yescarta, Kite Pharma/Gilead).

The cost of the drug itself is $475,000 for pediatric patients with acute lymphoblastic leukemia and $373,000 for adult patients with diffuse large B-cell lymphoma. There are additional costs for hospital stays while the drug is administered, which can involve intensive care if severe adverse events occur, as previously reported by Medscape Medical News.

CMS has announced that it will cover these CAR-T therapies when administered for FDA-approved indications in hospitals that participate in the FDA's risk evaluation and mitigation strategies (REMS) program.

In addition, Medicare will cover FDA-approved CAR-T therapies for off-label uses that are recommended by a CMS-approved compendia. In the decision memo, CMS said it had been urged to keep its approach to CAR-T payment flexible to accommodate rapid advances in this field.

The agency said it received some objections to its plan to issue an NCD for CAR-T therapy. It was argued that CMS should not issue NCDs for a field poised to undergo rapid change.

"We agree the therapy is evolving and recognize the active ongoing research in the field," CMS said in the memo. "Under the final NCD, all FDA labelled indications and off-label uses recommended by CMS-approved compendia are coverable."

However, CMS did not accept a suggestion regarding the sites of care at which CAR-T therapy will be covered. The agency had received several comments suggesting that CMS should permit clinicians to determine the appropriate care setting for each patient who receives CAR T-cells, but the agency decided not to do so.

"The FDA-approved labelling states that currently CAR T-cell therapy is available only through a restricted REMS program at REMS participating sites. CMS covers all FDA-approved indications for use as well as other uses recommended by CMS-approved compendia," CMS said in the memo. "As of the date of publication, the compendia do not recommend other sites for administration of CAR T-cell therapy."

Analysis of Medicare Recipients

As part of the deliberations leading to the decision to cover CAR-T therapy, the agency performed an analysis of Medicare claims.

This analysis identified approximately 100 Medicare inpatient recipients of CAR-T therapy, CMS said.

"Of the 100 Medicare patients we identified in our claims analysis, 20 of the attributed inpatients did not survive. The 6 month overall survival for those with follow-up available in our claims analysis was approximately 64%. The average survival time of those who died was less than 100 days, and the average length of stay in the hospital for all inpatients was approximately 18 days," the agency reported.

Analyses such as these may support informed decision making by patients and clinicians, it added.

Cancer Societies Applaud the Decision

The American Society of Hematology (ASH) issued a statement saying that it "commends CMS for issuing a broad coverage policy for this innovative, potentially life-saving treatment for Medicare beneficiaries and resolving to move forward in a way that limits additional burden on provider institutions and allows for coverage that can include future indications of CAR-T.

"In particular, the Society is pleased that the final decision does not include a coverage with evidence development requirement, which ASH strongly opposed because it would have put additional burdens on institutions and allowed them to legally opt out of providing CAR-T while still participating in Medicare. Data are already required to be reported to a central repository," the society continued.

However, it pointed out that there are problems with the decision. "Medicare has now put providers in a difficult position. They are required to provide this therapy, but the Administration is providing very little help to cover its high costs. The Administration's final inpatient rule, announced last week, does not do enough to adequately reimburse institutions for the cost of care or the cost of the product."

The American Society of Clinical Oncology (ASCO) also applauded the move, which it says "provides increased access to an innovative cancer treatment to Medicare beneficiaries nationwide.

"ASCO remains concerned, however, that Medicare reimbursement still does not cover the full cost of CAR T-cell therapy," the society said. "As stated in our principles, we believe that Medicare should cover the full cost of CAR T-cell therapy except for any patient or provider cost-sharing that would apply to any other covered drug or therapy under Medicare."

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