Minnesota grapples with promise of COVID-19 drug in limited supply, unknown cost

This round of medication is on the house. The next one will be, too.

But eventually, California's Gilead Sciences will start charging Americans for remdesivir, the drug that recently became the only therapeutic agent shown to cut down the recovery from COVID-19.

Analysts and leaders of health care foundations say the price for a 10-day intravenous course of the drug should fall somewhere between $1 and $4,500. For now, Gilead is focusing public attention on its $1 billion investment to scale up manufacturing, rather than calculating the drug's monetary value to humanity.

Like states across the country, Minnesota received its first small shipment of the novel antiviral donated by Gilead on May 9. A second batch arrived in Minnesota on Saturday. Together, the shipments contained enough vials of remdesivir for about 254 courses if taken for the full 10 days. The supply could be stretched farther if some patients qualify for 5-day courses.

As happened elsewhere, Minnesota public health officials intervened before the state's first shipment so that the donated drug didn't go directly to a hospital, Minnesota Health Department (MDH) Epidemiologist Dr. Ruth Lynfield confirmed in an e-mail Sunday.

"Things were occurring quickly and they [federal health officials] notified us that they looked at data to define hot spots and were going to send a shipment to a hospital in Minnesota," Lynfield said. "I asked if they could send that shipment to MDH instead and we would allocate, because I knew we had access to the number of COVID infected patients in facilities across Minnesota."

A series of discussions soon followed with infectious disease experts, doctors who treat critically ill patients, and members of the Minnesota COVID-19 Ethics Collaborative to develop an action plan to allocate the drug before the time the first shipment.

The debate is playing out as coronavirus cases, hospitalizations and deaths continue to increase across the state.

As of Sunday, 221 people were in hospital intensive-care units for COVID-19, and another 266 were in normal hospital beds for it. Minnesota has diagnosed 15,668 cases of COVID-19 and 722 deaths.

Despite all the action, remdesivir is still an experimental drug, and the price for it far is from the only looming question.

The drug was first developed as an antiviral that could treat diseases including Ebola. It's intended to work by disrupting how the virus creates genetic copies of itself, stopping the virus from rapidly multiplying.

In a federally run clinical trial involving 1,063 patients — including 32 enrolled at the University of Minnesota — the drug showed enough promise that scientists overseeing the National Institute of Allergy and Infectious Diseases (NIAID) trial ended the experiment early because it no longer seemed ethical to randomize people to a group that didn't get the drug.

The Food and Drug Administration authorized its distribution nationwide a few days later.

All patients in the trial were in the hospital and were receiving supplemental oxygen. It's not known whether the drug could be effective in less-severe cases.

People who got the real drug spent a median of 11 days in the hospital, vs. 15 days for those got a placebo, when neither patient nor doctor knew whether a placebo was used.

"It's the only drug that has really been show to have some effectiveness in a randomized trial against a placebo, which is considered the gold standard," said Dr. Peter Bornstein, an infectious disease physician and partner with private practice St. Paul Infectious Disease Associates.

No one knows yet whether remdesivir can reduce the chances of death from COVID-19.

The National Institutes of Health published a statement April 29 saying the trial data suggested a survival benefit, but was not conclusive. About 8% of the patients who got remdesivir died, vs. 11.6% with placebo, but the difference was not statistically significant.

Dr. Susan Kline, infectious disease physician and site principal investigator at the University of Minnesota, said a second phase of the study has already gotten underway. In that study, everyone is getting remdesivir, while some will also be randomized to get a second drug called baricitinib, normally used to treat rheumatoid arthritis, Kline said.

Minnesotans do not need to be in a clinical trial to get remdesivir. Thanks to the couple-hundred doses donated to Minnesota, the drug is also available in hospitals. At least more weekly shipments are expected.

Gilead Sciences CEO Daniel O'Day has said the company is donating all of its 1.5 million existing vials of the drug to health authorities worldwide. O'Day said much of the supply would have gone to clinical trials where patients wouldn't have been charged anyway.

"We are donating our entire existing supply, frankly because this is the right thing to do at this time," O'Day told investors April 30, adding later, "Gilead will focus on making remdesivir both accessible and affordable to governments and patients around the world."

When an analyst from SunTrust Robinson Humphrey asked O'Day whether Gilead plans to generate a profit margin despite saying the drug would be "affordable," O'Day assuaged her concerns:

"Trust us," O'Day said. "We deeply respect and appreciate the fact that when we get into millions of doses, we have to have a sustainable economic model that works here and that achieves access to affordability to patients around the world."

Earlier this month Gilead said it was in discussions to license production for Europe, Asia and developing countries through 2022. Generic drugmakers could also make the drug for developing countries under long-term licenses. Gilead was in "advanced discussions" with United Nations child-health agency UNICEF about providing drugs in low- and middle-income nations through good distribution networks.

The L.A.-based not-for-profit AIDS Healthcare Foundation said Gilead should sell remdesivir for no more than $1 per dose. AHF President Michael Weinstein said in a statement the group's demand was based partly on Gilead's "abysmal" record with lifesaving treatments for HIV and hepatitis C.

In 2018, Bloomberg News reported that Gilead's high prices for hepatitis C drugs Harvoni and Epclusa sparked widespread debate over drug prices, after initially being priced at $94,500 and $74,760 per drug course.

A research paper in the Journal of Virus Eradication last month estimated remdesivir could be sold for 93 cents per day (or $9.27 per 10-day course) and generate a 10% profit margin after taking out costs and taxes.

Another organization called ICER — the Institute for Clinical and Economic Review in Boston — said if the price of the drug were based on a traditional cost-effectiveness calculation that included quality-of-life and the costs of other therapies, the 10-day price would be $4,500.

"Public and policymakers should be actively debating how to link pricing to an overall platform to develop treatments for COVID-19," ICER said.

Joe Carlson • 612-751-8365