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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #20.14

News on Coronavirus Treatments

Within the last days the US FDA has granted an emergency approval for two agents linked with the COVID-19 diagnostic and treatment.

On Sunday May 3^rd, Roche received a green light for its Elecsys diagnostic kit, an anti -SARS-COV-2 antibody test for gauging people’s exposure and immune response to COVID-19. “Thanks to the enormous effort of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVI619 health crisis” Roche CEO Severin Schwan said.  According to a statement made by Roche, Eclecsys is designed to run on Roche cobas hardware providing a single result in about 18 minutes and running up to 300 tests per hour. In addition, when the test is used at least two weeks after a COVID-19 infection, the test can be highly accurate with 100% sensitivity and a specificity higher than 99.8%, with no false-positive results when checked against four other human coronavirus, such as strains that cause the common cold. The test will be produced at Roche’s manufacturing site in Penzberg (Germany) where the company plans to invest $459 million.

Eclesys is also available in Europe under a CE mark.

On Friday May 2^nd, President Trump and Gilead CEO Daniel O’Day made the announcement that remdesivir had received an emergency authorization from the US FDA with the fact sheet stating that the drug “may benefit certain people in the hospital”.  “Based on the totality of scientific evidence available to the FDA, it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the know and potential benefits of remdesivir when used to treat COVID-19 outweigh the known potential risks of such products” US FDA chief scientist Denise Hinton wrote.

The question, which is now on everybody’s mind, is how much will Gilead Sciences charge for a remdesivir treatment. The company has already announced that it will donate the first 1.5 million doses of remdesivir to US government for allocation which could treat 140,000 patients on a 10-day regimens. When specifically asked about the topic of pricing Daniel O’Day said he was “very thoughtful’” about providing fast access and later on “we just don’t have the answers yet”.

On May 3rd, in an unexpected move, ICER (the Institute for Clinical and Economic Review) an influential pricing watchdog, issued two possible pricing models.

On the low end, the pricing could be $10 for a 10-day course. This cost recovery model incorporates one single input, namely the marginal cost to produce a 10-day treatment with remdesivir, estimated according to a study published in the Journal of Virus Eradication. That 1$/day would cover the cost of the active pharmaceutical ingredients (API), formulation, packaging, transportation cost and a 10% profit margin.

On the high end ICER says that a 10-day remsedivir therapy would be cost-effective at $4,460 per course of treatment. This cost-effectiveness threshold was based on $50,000 per incremental QALY (quality-adjusted life-year) gained with a remsedivir use, although the more commonly used standards are $100, 000/QUALY and even $150 000/QUALY when applied to immuno-oncology drugs.

In a note issued by Michael Yee, an analyst at Jefferies, he stated that a $1,000 tag is “pretty reasonable” given the global context of modern drug pricing. “The fact that ICER is typically conservative in all their analyses, and yet they can justify up to $4,500, seems pretty interesting.”

Like many other observers, we will be watching closely the remsedivir commercial plans Gilead should reveal within the next days, as it will set a benchmark for other developers of COVID-19 therapies in the US.

Paris, May 5, 2020

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