Moderna defends its upsized Covid-19 price

Called before a Senate committee to explain why the price of Moderna's Covid-19 vaccine was about to quadruple, CEO Stéphane Bancel stuck to a simple message yesterday: Doing business in 2023 is vastly different than it was in 2020.

As STAT's Rachel Cohrs reports, Bancel maintained that Moderna's vaccine would be cost-effective even at $130 dose, citing the prices of vaccines for influenza and pneumonia.

His more illuminating point involved the specifics of Moderna's business. At the outset of the pandemic, Moderna served a single domestic customer — the U.S. government — which handled its own distribution and covered the cost of unused doses. Once the federal stockpile runs out, Moderna will be dealing with thousands of customers and negotiating with the many middlemen necessary to get doses from the company's plant to the point of care, all while covering the cost of shots that expire before they're used.

"This is not the same product," Bancel said.

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What exactly did we learn from that?

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Somewhere between the combative digression about myocarditis and the third invocation of Jonas Salk, it became clear that yesterday's Senate committee hearing was not going to change the narrative around Moderna's Covid-19 vaccine — much less the cost of medicine in the U.S.

Bancel, unfussy in a blue suit and a wide monochrome tie, was never flustered and rarely baited as he cleared the relatively low bar of not creating any sound bites that might come back to haunt his employer. When senators asked about the vaccine price increase, he got into the weeds. And when they soliloquized about their various grudges and pet issues, he politely thanked them for the commentary and kept his remarks wisely brief.

To the extent those two hours of mid-tier C-SPAN content taught us anything, it's that while there's plainly bipartisan angst about the cost of medicine — whether it's Sen. Bernie Sanders and his allegations of pharmaceutical greed or Sen. Mike Braun, an Indian Republican, castigating pharmacy benefits managers — Bancel was not really the guy to answer for it. Moderna has nothing to do with the cost of Keytruda, the uptake of biosimilars, or the market for insulin, which made yesterday's most pointed remarks about drug prices feel like shadowboxing.

Regulatory

Biogen's ALS drug wins key support

Biogen's treatment for a rare, genetic form of ALS won over a panel of FDA advisers, who voted in favor of its conditional approval despite unanswered questions about its benefit to patients.

The panel voted 9-0 that the "totality of the evidence" was enough to support accelerated approval for Biogen's treatment, called tofersen. The same experts voted 3-5 (with one abstention) that the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval.

In a day-long discussion of Biogen's application, the panelists struggled with how to balance tofersen's uncertain supporting evidence with the devastating and life-threatening effects of its target disease. The drug is meant to treat an inherited form of ALS caused by a mutation in a gene called SOD1, which accounts for just 2% of the overall cases of the disease.

Biotech

89bio's NASH drug hits its mark

An experimental treatment from 89bio improved liver scarring at more than three times the rate of placebo without worsening other symptoms of patients with the fatty liver disease known as NASH, the company said yesterday.

As STAT's Adam Feuerstein reports, 89bio's drug met the main goal of a mid-stage clinical trial, offering the potential for less frequent injections than a similar experimental treatment being developed by Akero Therapeutics, a competing drugmaker.

NASH, short for non-alcoholic steatohepatitis, is a widespread chronic disease in which fat accumulates in the liver. While there are no medicines yet approved for NASH, an increasing number of companies are pressing forward with potential treatments, including Intercept Pharmaceuticals, Novo Nordisk, and Madrigal Pharmaceuticals.

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