— Based on an analysis of four studies evaluating remdesivir’s influence on mortality, ICER has concluded that the totality of evidence no longer supports an assumption of survival benefit from remdesivir; however, new data from US-based ACTT-1 trial does support savings on insurer payment for hospital services —

— Given these new data and remdesivir’s expanded label to include less severely ill patients, ICER now suggests a health-benefit price benchmark of $2,470 for hospitalized patients with moderate-to-severe disease, and $70 for patients hospitalized with milder disease —

— New results, along with scenario analyses retaining survival benefit assumptions, will be shared with international health technology assessment agencies using the ICER-COVID model for policy making —

BOSTON, November 10, 2020 – The Institute for Clinical and Economic Review (ICER) today released updated analyses to inform public debate of pricing for remdesivir (Veklury®, Gilead Sciences) for the treatment of COVID-19.

Adhering to ICER’s adapted methodology for evaluating treatments for a pandemic, the ICER-COVID models comprise two alternative pricing paradigms for COVID-19 treatments: 1) “cost recovery” for the manufacturer, in which the price is adequate to return the costs of production of the drug and may also recoup drug-specific development costs; and 2) traditional cost-effectiveness analyses looking at the incremental health benefits and costs within the health system. ICER previously published an initial iteration of our ICER-COVID models on May 1, as well as our first update on June 24. Today’s updated models incorporate changes based on new data from the ACTT-1, NCT04292730, RECOVERY, and SOLIDARITY trials, as well as public comments and interactions with the manufacturer.

“We have previously noted that, as new treatments emerge for COVID-19, policymakers will need to track the evolution of the maturing data in order to understand the benefits that can be realized for patients and the health system,” said Steven D. Pearson, MD, MSc, ICER’s President. “Remdesivir is an excellent case in point. Given the persuasive results from a new meta-analysis across trials, including SOLIDARITY, ICER’s model no longer assumes that remdesivir provides a significant survival benefit. We acknowledge that SOLIDARITY is an important part of this meta-analysis, that both SOLIDARITY and the meta-analysis still await peer review, and that additional US-based data are needed to fully support or reject a survival benefit. Other new data from a key trial in the US health care system does demonstrate that the clinical impact of treatment shortens hospital stays and reduces the number of patients with moderate-to-severe disease who require higher levels of respiratory support.

“When incorporating all these new data, and in light of remdesivir’s expanded label to treat patients with more mild disease, our model suggests that remdesivir’s current US price is too high to align reasonably with its demonstrated benefits to patients. The current price would meet a key cost-effectiveness threshold only if it were used solely to treat patients hospitalized with moderate-to-severe disease and — importantly — only if one still assumes that remdesivir saves lives. We hope that further evidence does become available on remdesivir and that additional treatments are approved for which the benefits to patients can be demonstrated through well-conducted clinical trials.”

ICER-COVID Model 1: Cost Recovery

There are no updates to ICER’s cost-recovery model for remdesivir. A cost-recovery benchmark price range for a full course of remdesivir is $5-$600 if only considering the marginal cost of producing the treatment, and $1,005-$1,600 if also considering the manufacturer’s forecasted 2020 clinical development expenses related to the treatment.

ICER-COVID Model 2: Traditional Cost-Effectiveness

In ICER’s updated base case analysis, our cost-effectiveness benchmark price for a treatment course of remdesivir is $2,470 for hospitalized patients with moderate-to-severe disease, and $70 for hospitalized individuals only exhibiting mild symptoms. Consistent with updated guidance from the World Health Organization, the base case now assumes that the inexpensive steroid dexamethasone is already part of the standard of care for the moderate-to-severe population. As noted earlier, the updated base case now assumes that remdesivir provides no survival benefit for patients, a factor that drives the price benchmark lower than in our prior reports. However, ICER’s updated price benchmark for patients with moderate-severe disease is influenced in the opposite direction by newly available evidence suggesting that remdesivir reduces costs by lowering the rate of progression to higher levels of respiratory support for patients with moderate-to-severe illness.  The effect of these two major changes to the model inputs produces the price benchmark of $2,470 for this sub-population, a result lower than our previous benchmark that assumed a survival benefit, but higher than our previous price benchmark of only $390 should no survival benefit be assumed.

If a survival benefit for remdesivir is still assumed, our current model suggests that a cost-effectiveness price range would be $3,980-$4,140 for the moderate-to-severe population, and $690-$760 for those requiring less intensive hospitalization care.

Some observers may view the most persuasive evidence as arising from the large, international SOLIDARITY trial. This trial awaits peer review, but if all of its findings are used as the basis of a value assessment, remdesivir would have zero value in either population, given that SOLIDARITY found not only no difference in mortality but also no impact on time to improvement or progression to higher levels of care. We did not select this scenario analysis as our base-case because the trial was not performed within the US, where care patterns within the hospital may differ significantly from those in some foreign health systems.

How the ICER-COVID Models Are Informing Public Policy

Our ICER-COVID model continues to inform how policymakers in the US and around the world consider what may constitute ‘fair’ drug pricing during a pandemic. Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) cited its use of ICER’s model to inform the Institute’s conditional reimbursement recommendation for remdesivir to Quebec’s Minister of Health and Social Services. Within the ICER Interactive Modeler®, INESSS was able to evaluate and adjust key model inputs — e.g., clinical improvement and mortality assumptions — to match the province’s population, cost structure, and approved indication.

In addition, other HTA organizations that have sought and obtained access to the ICER-COVID model include the United Kingdom’s National Institute for Health and Care Excellence (NICE), Australia’s Technical Assessment and Access Division (a division of the Australian Government Department of Health), the Canadian Agency for Drugs and Technologies in Health (CADTH), and MOSAIC, a South African health economic modeling collective.

Public Comment and Future Updates

Additional assumptions, citations, and scenario analyses can be found within the detailed summary of the ICER-COVID models. Following the June 24 publication of our first update to the ICER-COVID models, we received public comments, which we considered when producing this update. We will continue to re-assess each model regularly based on feedback and emerging data, and we will publish frequent updates. Click here for a complete timeline of the history of this assessment.

Any stakeholder interested in providing public comments regarding this updated version of the ICER-COVID models can email that feedback to publiccomments@icer.org. We will be continuing to monitor for new data on remdesivir and other emerging treatments for COVID-19, and we will perform further updates to our model as needed. When we publish that next update, we will also publish any public comments we have received on this version.

About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system. For more information about ICER, please visit ICER’s website