Academic medical centers and a group representing community oncology practices have both raised concerns about CMS’ proposed reimbursement plan for chimeric antigen receptor (CAR) T-cell therapy, the individually manufactured gene treatments that are revolutionizing cancer care. The plan will be finalized next month, a year after the federal
government launched a national coverage analysis to determine how to pay for these lifesaving yet expensive cancer treatments.
Academic medical centers and a group representing community oncology practices have both raised concerns about CMS’ proposed reimbursement plan for chimeric antigen receptor (CAR) T-cell therapy,1,2 the individually manufactured gene treatments that are revolutionizing cancer care. The plan will be finalized next month, a year after the federal
government launched a national coverage analysis (NCA) to determine how to pay for these lifesaving yet expensive cancer treatments.
Since February 15, 2019, when CMS issued its proposal,3 cancer centers that have been losing money on CAR T-cell treatments have raised questions about the feasibility of the
plan’s centerpiece: a model called Coverage With Evidence With Development (CED), which critics fear could overburden providers, causing some to opt out of offering CAR T-cell treatment to Medicare patients. Others have asked about requirements to report patient-reported outcomes (PROs) and language they say could squeeze out community practices.
Finally, there are concerns that the plan’s language is tightly crafted based on the first 2 CAR T-cell therapies approved by the FDA, without enough flexibility to reimburse providers
for treatments in the research pipeline. CMS accepted comments on its proposed decision memo through March 17, 2019, and its final national coverage determination (NCD) is
due May 17, 2019.3
Those who support CMS’ approach say it addresses 2 knowledge gaps involving CAR T-cell therapy that are important to Medicare: the lack of data for treatment of those 65 years and older and the need to gather more information about PROs. This is the first year that the National Comprehensive Cancer Network (NCCN) has included a section on CAR T-cell—related toxicities in its guideline on Management of Immunotherapy-Related Toxicities,4 and clinicians continue to fine-tune methods for preventing and treating the significant adverse events associated with CAR T-cell therapy, including cytokine release syndrome.
But providers who spoke with Evidence-Based Oncology™ (EBO) and have filed comments with CMS and appeared in public forums said these good intentions could have consequences if CMS’ proposal isn’t modified. Data gathering requirements include evidence for the CED model and reporting with specified PRO tools. An expert panel that discussed CMS’ CAR T-cell reimbursement plan at the NCCN Annual Conference on March 21, 2019, said the losses cancer centers have already seen from CAR T-cell treatment are not sustainable, and some were unsure who would pay for data collection (see Sidebar). A comment letter sent to CMS from City of Hope in Duarte, California, which infused its first CAR T-cell trial patient in 2000, warned that the requirements “risk exacerbating patient access issues and compounding the financial losses that currently experience while serving Medicare beneficiaries.”1 (A signer of the letter, Joseph Alvarnas, MD, vice president for Government Affairs, is editor-in-chief of EBO.)
Even NCCN, which supports the concept of enrolling patients in registries, urged CMS to be mindful of the current financial burdens on cancer centers. In his comment, NCCN Chief Executive Officer Robert W. Carlson, MD, wrote, “NCCN firmly agrees with the principles of the registry.…We recommend that implementation of registry and data-collection be enacted with considerable focus on reducing administrative burden and supporting patient access to innovation.
“While NCCN recognizes that coverage determinations are made separate and apart from reimbursement determinations, we feel it is important that CMS implement the CED with an appreciation of the current reimbursement environment. Given that most providers of CAR T-cell therapy are currently being undercompensated by several hundreds of thousands of dollars for each Medicare patient treated, and possibly more if complications arise, NCCN has concern that an overly onerous CED process could lead providers to not participate due to the additional administrative cost.”1
The National Coverage Analysis Process
In August 2017, the FDA approved the first CAR T-cell therapy, tisagenlecleucel (Kymriah), and CMS simultaneously announced a value-based agreement with sponsor Novartis that oncologists described as “you’re only charged if you respond in 30 days.”5 The FDA approved the second therapy, axicabtagene ciloleucel (Yescarta), in October 2017. The treatments cost either $373,000 or $495,000, depending on indication.6
Early on, cancer centers focused on getting billing codes and finding out which state Medicaid programs would cover tisagenlecleucel when indicated for pediatric acute lymphoblastic leukemia.6
But UnitedHealthcare brought this to a halt with a request for an NCA; during the recent NCCN conference, UnitedHealthcare Senior Medical Director of Oncology and Genetics
Jennifer Malin, MD, PhD, said the company needed consistency nationwide. That process included an August 2018 meeting of the Medicare Evidence Development & Coverage
Advisory Commission to determine whether CMS would measure PROs as part of reimbursement;7 this led to the inclusion of 2 measurement tools in the February 2019 proposed decision memo despite industry objections.
In the meantime, cancer centers that administer CAR T-cell therapy have been in limbo. With no Medicare national coverage policy in place, they have been using an existing billing code plus an add-on technology payment that does not come close to covering the cost of the manufactured cells; because of the lack of consistency between Medicare Administrative Contractors, oncologists in some states say Medicare basically doesn’t pay for the engineered cells. In parts of the country, Medicaid patients who would benefit from treatment cannot gain access.
Features of the proposed reimbursement plan include3:
Balancing Need for Evidence With Burdens
Ted Okon, MBA, executive director of COA, told EBO in an interview last month that it appears CMS created the proposal to address a lack of data on how CAR T-cell therapy works in the Medicare population. But who should pay to gather these data? During the NCCN panel, Malin suggested the cost should be borne by the pharmaceutical companies. In their letter, City of Hope officials expressed concern that without clarity, the costs will fall on cancer centers.1
Representatives for the Biotechnology Innovation Organization (BIO), a trade group for the biotechnology industry, told EBO in an interview that its members are also concerned
that the proposal is written based on how CAR T-cell therapies are being used at the moment, not how they might be used in the future. City of Hope leaders concurred in their
letter: “There are numerous CAR T-cell products that are in development that are differentiated from the 2 currently FDA-approved products. These emerging therapeutics may employ a different method of action or represent effector cell populations that are targeted against cancer types other than those targeted by Kymriah and Yescarta.”1
In an interview with EBO, Mallory O’Connor, BIO’s director of healthcare policy and federal programs, said the group shares COA’s concern about language that could exclude community practices from reimbursement and seeks additional changes:
Those who administer CAR T-cell therapy noted CMS’ goal is to increase access to treatment, which is what Administrator Seema Verma said in unveiling the February plan. “CAR
T-cell therapy was the first FDA-approved gene therapy, marking the beginning of an entirely new approach to treating serious and even life-threatening diseases,” she said in a statement. The proposed coverage decision “would improve access to this therapy while deepening CMS’ 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.”9REFERENCES: