Insurance hurdles for Gilead's CAR-T cell therapy Yescarta putting early sales estimates at risk: report

Since gaining FDA approval in October for use in large B-cell lymphoma, Gilead Sciences' Yescarta (axicabtagene ciloleucel) has so far been given to only five patients in the US, with waiting lists for the $373 000 CAR-T therapy growing to at least 200 patients, Bloomberg reported Thursday. Analysts have forecast sales of $9.4 million for Yescarta in 2017, implying that about 20 more patients would need to be treated in the next two weeks, but delays in getting the therapy paid for by the US Centers for Medicare and Medicaid Services, as well as some of the country's largest insurers, suggest Gilead may fall short of the early sales estimates.

According to the report, 15 hospitals authorised to administer Yescarta in the US responded to questions from Bloomberg, with doctors estimating that the total cost of the treatment per patient, when hospital and doctors' fees are taken into account, could range from more than $575 000  to $1 million. However, as hospitals must purchase the therapy at full price, most institutions are awaiting guarantees of insurer reimbursement before treating patients.

The report noted that in addition to the five treated patients, roughly 12 others have begun the lengthy preparatory process in order to be able to receive Yescarta. When the therapy was approved in October, 16 centres in the US were immediately able to provide Yescarta to patients, while staff were being trained at another 30 sites, out of a planned target of 70 to 90 centres across the country, Bloomberg reported.

Gilead spokeswoman Sonia Choi remarked that the drugmaker remains "confident that Yescarta will be covered by payers." She said Gilead believes around one-third of patients will be covered by Medicare, adding that the company will continue to "engage actively with Medicare to ensure we are doing all we can to support access."

Anthem has confirmed that it will cover treatment with the therapy, but Bloomberg noted that none of the other large insurers disclosed details about coverage in response to its questions.  However, according to Choi, the "vast majority" of commercial payers have confirmed to the company that they will cover Yescarta.

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Gilead gained Yescarta as part of its purchase of Kite Pharma earlier this year for about $11.9 billion. The treatment remains under review in Europe.

Meanwhile, Novartis is seeking to expand the US label for its CAR-T therapy Kymriah (tisagenlecleucel) to include certain adults with relapsed or refractory diffuse large B-cell lymphoma. Kymriah became the first gene therapy cleared in the US when the FDA approved it in August for certain paediatric and young adult patients with acute lymphoblastic leukaemia. Meanwhile, Juno Therapeutics is expected to file for US approval of its investigational CAR-T treatment JCAR017 for the same indication next year (see ViewPoints: Juno claims a niche position for JCAR017, only to find Novartis is already there).

For additional analysis, read ViewPoints: Gilead gets the ball rolling to fill out its cell therapy niche and ViewPoints: And so it begins- Gilead's CAR-T approval sets off the cell therapy race. See also Physician Views Poll Results: Kymriah's toxicity and outpatient use could prove critical in showdown with Yescarta.


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