- Gilead's antiviral drug remdesivir, newly shown to help speed recovery in patients hospitalized with COVID-19, would be cost effective at a price as high as $4,460, according to a new analysis from the Institute for Clinical and Economic Review, a nonprofit group that's gained influence for its drug cost research.
- But that estimate, which ICER published Friday, is largely dependent on whether remdesivir helps save lives when used to treat COVID-19. Recently released results from a government-run study found treatment reduced the median time to clinical recovery versus placebo, but didn't yet prove the drug lessened patients' risk of dying.
- Gilead hasn't divulged how it plans to price remdesivir, which on Friday was authorized by the Food and Drug Administration for emergency use in COVID-19. The company is donating its current supply of the drug, roughly 1.5 million individual doses.
Gilead faces a particularly consequential choice.
Remdesivir is the first drug shown to be effective in treating COVID-19 in a randomized, placebo-controlled study. While the full results of that trial are not yet known, the FDA has already moved quickly to grant an Emergency Use Authorization, allowing Gilead drug supplies to be distributed broadly. Comments from the company suggest a full approval might not be that far off.
If that does occur, Gilead would have the first branded drug approved for a disease with no treatments, potentially making remdesivir the standard treatment for patients hospitalized with worsening COVID-19 symptoms.
However Gilead prices remdesivir, the scrutiny will be immediate and, if the company is perceived to be prioritizing profits, likely harsh.
Its decision to donate all of its current supply, likely enough to last through early summer, forestalls a near-term price announcement. The emergency authorization given by the FDA, meanwhile, puts the decision on which cities and hospitals get access to the drug first in the hands of the U.S. government.
On a recent conference call, Gilead CEO Daniel O'Day deferred talking about how the company plans to price and distribute remdesivir, saying it will address those issues "in the near future."
"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," he added.
In the meantime, however, ICER has set a starting point for the debate in releasing its new estimate, which the group acknowledges is highly uncertain given the limited clinical data available.
"The consequential discussion about the tradeoffs and priorities involved with different pricing approaches cannot wait," said Steven Pearson, ICER's president, in a statement issued Friday.
ICER's estimate of $4,460 for a cost-effective price for remdesivir was higher than some analysts expected, particularly for a group which has frequently sparred with the drug industry over the prices of new medicines.
Almost all of the value captured by ICER's price, however, is dependent on remdesivir reducing the rate of death in hospitalized COVID-19 patients. Results from a trial led by the National Institute of Allergy and Infectious Diseases found remdesivir treatment was associated with a lower death rate than placebo, but the difference wasn't great enough to be judged statistically significant.
Without evidence proving remdesivir can save lives, ICER puts the drug's cost-effective price much lower, at $390.
Neither price point, however, accounts for the potential benefits remdesivir could bring to overtaxed healthcare systems by freeing up treatment capacity.
ICER also attempted to estimate the cost of manufacturing remdesivir, drawing heavily from a study published in the Journal of Virus Eradication. It determined Gilead's "cost recovery price" for remdesivir to be only $10 for one 10-day treatment course, but that estimate has many notable limitations.
The study ICER used lacked data on production of remdesivir's active ingredient, and ICER chose to set research and development costs to zero for the purposes of calculating the cost-recovery price. In addition, the group assumed no capital expenditures by Gilead.
In fact, Gilead has spent $50 million through March on manufacturing and clinical development of remdesivir, and executives recently said the company plans to spend as much as $950 million more through the rest of this year.
Gilead did not return a request from BioPharma Dive for comment before publication.