Medicare Aims to Expand Coverage of Cancer Care. But Is It Enough?

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WASHINGTON — In a major test case, Medicare is poised to cover a promising but expensive new type of cancer treatment, with significant restrictions meant to hold down the cost.

Cancer patients, doctors and drug companies are urging the Trump administration to remove the restrictions and broaden coverage so more patients can benefit from the treatment, known as CAR T cell therapy, or CAR-T. But insurance companies are pushing for the restrictions.

The treatment is manufactured specifically for each patient, and many more such “personalized medicines” are in the pipeline. Medicare’s final decision, expected in the next few weeks, will influence commercial insurers and state Medicaid programs, which often follow its lead.

Medicare and other insurers typically pay for drugs as they are used, from month to month and year to year. By contrast, the CAR-T treatments generate high costs up front, but the benefits could last for years.

The Food and Drug Administration has approved two CAR-T products to treat certain blood cancers: Kymriah, made by Novartis, with a list price of $373,000 or $475,000, depending on the type of cancer, and Yescarta, made by Gilead Sciences, with a list price of $373,000.

The treatments have been remarkably effective in some patients who had a dismal prognosis after exhausting other options. Researchers around the country are conducting more than 450 clinical trials to explore other uses of CAR-T medicines that work in similar ways.

The Trump administration has proposed covering CAR-T therapy when it is prescribed by a cancer specialist and given in a hospital to Medicare patients whose cancer has not responded to other treatments like chemotherapy and radiation. Medicare would also cover the treatment for patients whose cancer returns, causing a relapse after a period of improvement.

Seema Verma, the administrator of the Centers for Medicare and Medicaid Services, has described CAR-T as “an entirely new approach to treating serious and even life-threatening diseases.”

Dr. Francis S. Collins, the director of the National Institutes of Health, said that harnessing the power of a patient’s immune system in this way was a “marvel of modern medicine.” But “because of the need to personalize the preparation of cells for every patient,” he said, “costs are quite high, and it could be truly challenging to scale up use of the technology.”

Officials will increasingly confront such challenges as they try to ensure that Medicare beneficiaries have access to the latest treatments at an affordable cost.

CAR-T therapy sounds like science fiction. Immune cells — T cells — are removed from a patient’s blood, sent to a laboratory where they are genetically engineered to recognize and attack cancer cells, and then sent back to the hospital for infusion into the patient.

The total cost of treatment, including the CAR-T infusion, doctors’ services and hospital stays, can easily exceed $750,000.

“This looks like a big price tag,” said Dr. Caron A. Jacobson, director of a cell therapy program at the Dana-Farber Cancer Institute in Boston. “But when you actually consider what you are paying for over the course of someone’s lifetime, and you think about the cost of other therapies that this is replacing, it actually is not astronomical.”

There is no national Medicare policy for covering CAR T cell therapy. The request for a Medicare coverage decision came from one of the nation’s largest insurers, UnitedHealth Group, which expressed concern that “CAR-T therapies could create significant financial risks” for the government and for private Medicare Advantage plans.

UnitedHealth is the largest provider of Medicare Advantage plans, with about five million people enrolled in its plans. The private plans receive a fixed monthly payment from the government to provide the full range of services covered by Medicare.

America’s Health Insurance Plans, a trade group for insurers, also urged caution, saying, “There is currently limited evidence for CAR-T therapies.”

But Bonnie Falbo of Charlottesville, Va., a caregiver for her 70-year-old husband, who has multiple myeloma, said: “This treatment is one that could save his life one day. Immunotherapy is the future of cancer care. Approving payment for this therapy right now will save the lives of patients who have run out of other options.”

Advocates for patients and physician groups said the coverage policy proposed by the Trump administration was too limited and could delay lifesaving treatment for cancer patients who were very ill.

“We have a new therapy, a result of years of research, and it has been approved by the F.D.A.,” said Kirsten A. Sloan, a vice president of the American Cancer Society Cancer Action Network. “Let’s make sure people have access to it. Let the doctor decide which patients should be eligible. A patient’s health care provider is in the best position to determine when and whether a patient will benefit from CAR T cell therapy and should not be limited by a narrow coverage policy.”

Ted Okon, the executive director of the Community Oncology Alliance, an advocacy group for cancer doctors and patients, said the coverage criteria proposed by the Trump administration were “much more restrictive” than the uses of CAR-T therapy permitted in the F.D.A.-approved label.

Moreover, Mr. Okon said, coverage should not be limited to patients treated at a hospital, as the government proposed. “CAR-T treatment has been slowly moving to the outpatient setting,” he said. “Many community oncology practices have the experience and capabilities to administer CAR-T treatment, saving money for patients and Medicare.”

Hospitals providing CAR-T therapy said they were trying to figure out how to pay for it.

Charles N. Kahn III, the president and chief executive of the Federation of American Hospitals, which represents investor-owned hospitals, said they faced large financial losses in providing the treatment to Medicare patients.

“This is a brave new world,” Mr. Kahn said. “No one anticipated such an extraordinary expense when Medicare’s hospital payment formulas were adopted.”

Under the Trump administration proposal, Medicare would pay for CAR-T therapy in patients who have “relapsed or refractory cancer” that has resisted other treatments.

“CAR T cell therapy shows promise,” the administration said in a 39,000-word decision memo, but “the evidence is inadequate to confidently conclude” that it will improve health outcomes for Medicare beneficiaries.

To date, it said, “few clinical trials on CAR T cell therapy have been performed, and those data available have limited participation by Medicare beneficiaries.” More study is needed, it said.

So Medicare would cover the procedure only if hospitals agreed to monitor patients, enroll them in a study or “registry” and report detailed data on their medical condition and quality of life for at least two years after treatment.

Doctors and scientific researchers raised several concerns.

The eligibility requirements “may exclude some patients who could benefit from treatment,” said Cynthia A. Bens, a senior vice president of the Personalized Medicine Coalition, an education and advocacy group.

Dr. Roy L. Silverstein, the president of the American Society of Hematology, said it was “shortsighted to limit coverage to those patients who have not responded to chemotherapy or have relapsed after chemotherapy.”

“I can predict with pretty good certainty that there will be indications not too far in the future for using these treatments as part of the initial therapeutic plan for patients with certain kinds of cancers,” Dr. Silverstein said.

This article is from NYT – go to source

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