ICER recommended two out of three outpatient treatments for COVID-19 in today’s market, singling out molnupiravir as having inadequate evidence that it is better than symptomatic care.
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The Institute for Clinical and Economic Review recommended two out of three outpatient treatments for COVID-19 in the market today, singling out molnupiravir as having inadequate evidence to support claims that it is better than symptomatic care.
In the final evidence report that the ICER’s 13-person panel released, 11 said that current data on molnupiravir’s superiority to symptomatic care alone is insufficient. Meanwhile, all 13 said evidence on Paxlovid is enough to establish a net health benefit, whereas seven out of 13 found fluvoxamine to be sufficiently supported by evidence.
When the report was published, none of the three treatments had active emergency use authorizations (EUA) from the U.S. Food and Drug Administration, hence, the assessment. Molnupiravir is developed and marketed by Merck, Paxlovid (PF-07321332/ritonavir) is a product of Pfizer, while fluvoxamine is investigator-initiated.
“As indicated by the votes from the independent appraisal committee, the current evidence was judged more persuasive for Paxlovid and fluvoxamine than for molnupiravir, but clinical trials are ongoing for all three treatments. At their current negotiated price (molnupiravir and Paxlovid) or their generic market price (fluvoxamine), these drugs appear to have prices reasonably aligned with patient benefits,” Steven Pearson M.D., MSc, the president of ICER, said in a statement.
The panel evaluated the treatments’ clinical benefits, disadvantages and other contextual considerations, including the ability to help reduce the spread of COVID-19, reduce hospitalization cases, address the burden in disadvantaged communities and provide psychological reassurance for returning to work or school.
In addition, while Paxlovid has a 13-0 vote in terms of clinical benefit, it should be noted that it has demonstrated drug interactions that might limit who can use it. Fluvoxamine also demonstrated the ability to target a different phase in COVID-19’s pathophysiology, implying that it may be more effective when combined with other agents.
“One of the key lessons to be learned from the development of these drugs is that the federal government’s advance market commitment mechanism was effective in reducing the financial uncertainty that could have deterred manufacturers from bringing a drug to market, and ultimately resulted in multiple drugs becoming available in a relatively short time at prices that were aligned with clinical benefit. That experience has many lessons for the future of U.S. policy in preparing for future pandemics,” Pearson added.
In terms of long-term value for money, molnupiravir was also rated to have “low-to-intermediate” long-term value for money. Fluvoxamine was rated “intermediate-to-high,” while Paxlovid was classified as “high.” The price ranges suggest the highest price that a manufacturer can charge in the U.S. based on the improvement in overall health that patients receive. It is the highest price range at which a health system can see better patient health “without doing more harm than good.”
Full details may be viewed in the Final Evidence Report.
