[Ip-health] Yikes! U.S. Medicare sets outpatient rate for CAR T reimbursement.

James Love james.love at keionline.org
Mon Apr 9 13:36:22 PDT 2018

Politico is reporting a much much different figure on the CMS patient
co-payment for  CAR T., and the AP earlier also seemed to think the Reuters
report was wrong.  Both are sourced from CMS.

One issue, that bears clarification, is if CMS considers CAR T a medical
activity, or a drug, when determining the co-payment, or if they apply
different rules to the part that is a service and some other rule to the
part that is a product.

To the extent that CAR T is a service, it may also have consequences for
patents, since you cannot enforce a patent against a medical practitioner
performing an exempt medical activity.


On Fri, Apr 6, 2018 at 12:11 AM, James Love <james.love at keionline.org>

> ​The NIH won't enforce oblgiations to make its NIH funded inventions
> "available to the public on reasonable terms, including the new CAR T
> treatments.
> Reuters reports Medicare reimbursement policies for Yescarta and Kymriah.
> * The minimum patient co-payment for Yescarta is $79,076.
> * For Kymriah the co-payment is $100,168.
> https://www.reuters.com/article/cancer-medicare-
> yescarta/u-s-medicare-sets-outpatient-rate-for-yescarta-
> reimbursement-idUKL2N1RI17D
> U.S. Medicare sets outpatient rate for Yescarta reimbursement
> Deena Beasley
> April 5 (Reuters) - Medicare, the U.S. government healthcare program for
> the elderly and disabled, will pay hospitals close to its standard mark-up
> rate for administering cell therapy Yescarta for cancer outpatients, who
> will have a co-payment of nearly $80,000, according to the Centers for
> Medicare & Medicaid Services (CMS).
> Additional Medicare reimbursement for inpatients has been requested by
> Yescarta maker Gilead Sciences Inc and Novartis AG, which makes Kymriah, a
> similar therapy. Both therapies were approved last year by the Food and
> Drug Administration and are being used by growing number of major cancer
> centers.
> The CMS has not made a decision on the requests, it said in an emailed
> statement on Thursday.
> Reimbursement has been a major issue for investors because the high costs
> of the so-called CAR-T therapies could affect usage, especially for the
> Medicare population.
> The therapies involve drawing white blood cells from a patient, processing
> them in the lab to target cancer, and infusing the cells back into the
> patient.
> Most patients are first admitted to the hospital because the treatments
> may have life-threatening side effects, and inpatient services can bring
> the total cost to as much as $1.5 million.
> For outpatient drugs, Medicare typically reimburses providers at the net
> price (after discounts and rebates) plus 6 percent. New drugs are paid at
> the manufacturer’s wholesale acquisition cost plus 6 percent for the first
> three quarters.
> As of April 1, CMS said it would pay $395,380 to health providers who use
> Yescarta, with a list price of $373,000, on an outpatient basis. The
> minimum patient co-payment for Yescarta is $79,076.
> For Kymriah, with a list price of $475,000, the Medicare payment rate is
> $500,839, and the co-payment is $100,168.
> For inpatients, Medicare bundles CAR-Ts into the payment for a hospital
> stay. Gilead and Novartis have filed for additional “new technology add-on
> payments” from Medicare to cover the cost of cell therapies in the hospital.
> Yescarta is approved for patients with a type of lymphoma who have failed
> to respond to other therapies, while Kymriah is approved for children and
> young adults with acute lymphoblastic leukemia that has not responded to
> other treatments.
> Novartis has also filed for use of Kymriah in lymphoma patients and a
> decision from the FDA is expected by mid-year. (Reporting by Deena Beasley;
> Editing by Richard Chang)

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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