Remdesivir—the experimental COVID19 treatment developed by Gilead Sciences—is having its moment.
The antiviral drug yielded optimistic results in early clinical trials during a federal study, was granted emergency use authorization and has now been fully approved by the FDA.
Out of all potential COVID19 treatments, remdesivir is the most promising and fast-moving. But what will the drug cost healthcare system stakeholders—patients, providers and payers alike?
Enter health technology assessment (HTA).
The concept of HTA was created in the early 1960s. HTA can be considered a comprehensive approach to help develop evidence-based guidelines to explain the significance and possible implications of using any health technology.
One of the major organizations conducting HTAs is the Institute for Clinical and Economic Review (ICER). We sat down with ICER’s Sarah Emond and David Whitrap to tackle the questions of the specific trajectory of the field, particularly about their work evaluating remdesivir.
What is the mission of ICER?
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs, with the goal of establishing fair prices, so patients get fair access, and the life sciences ecosystem has incentives for future innovation. ICER seeks to help create a future in which collaborative efforts to move evidence into action provide the foundation for a more effective, efficient and just health care system.
ICER’s comparative effectiveness reports include a full analysis of how well each new intervention works, the economic value each treatment represents, and other elements of value that are important to patients and their families. The reports use these analyses to establish a “health benefit price benchmark” which represents the highest price a manufacturer should charge for an effective treatment, based on the amount of improvement in health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. To ensure objectivity in its work, all ICER reports are produced with funding exclusively from non-profit foundations and other sources that are free of conflicts of interest from the life science industry or insurers.
Has the current pandemic affected ICERs day-to-day activities and focus?
Beyond the impact that every business is feeling – remote work, increased uncertainty, the new “normal” as it relates to work-life balance – we have released an initial analysis of pricing considerations for the Gilead drug remdesivir.
Our initial analyses are meant to inform the public debate of pricing for remdesivir and other future treatments of COVID-19. Working with external academic partners, ICER developed the ICER-COVID models comprising two alternative pricing paradigms for COVID-19 treatments:
- “Cost recovery” for the manufacturer, representing an estimate based on peer-reviewed methods of calculating the minimum costs of production for a course of therapy ($10 for a course of treatment)
- Traditional cost-effectiveness analyses looking at the incremental health benefits and costs within the health system ($4,500 for a course of treatment). The model will be updated frequently as more data are collected and released.
The Future of Health Technology Evaluation in Pharma
The pharmaceutical industry will continue to expand investments in health economics and pharma economics as a result of the growing need for HTA information. Decision-makers need substantial information in the implementation process to make informed decisions to improve the efficiency in the healthcare system.
For additional intel into the role of HTA in the pharmaceutical industry, download a free overview of our full report, Health Technology Assessment in Pharma: A Review of Major Decisions.