PCORI Biweekly COVID-19 Scan: Treatment for Children Under Age 12, Treating Postpartum Depression (April 28-May 11, 2022)
The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
The emergence of SARS-CoV-2 and COVID-19 is one of the largest healthcare disruptions the world has faced in recent times. In the past 2 years, the pace of research and innovation surrounding COVID prevention has been at breakneck speed, focusing innovation on one single disease. But now, this work is settling into equilibrium with the pace of disruptive innovation across the healthcare system (see PCORI’s Horizon Scanning Database for all the innovations we are currently tracking).
COVID-19’s impact on human health is not limited to the disease alone. The pandemic has affected cancer treatment outcomes, created new cardiovascular health risks, increased deaths related to alcohol use disorder, contributed to the deteriorating mental health of teens, and increased the risk of perinatal and postpartum depression (see Topics to Watch for a prescription app that may help new mothers).
As the prevention, diagnosis, treatment, and management of COVID-19 become increasingly well-defined and interest increases in other pressing issues in health care, biweekly scans will begin to highlight a broader range of topics that might be of interest to readers.
ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing.
Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.
Remdesivir (Veklury) to Treat COVID-19 in Children Under 12 Years of Age
At a Glance
- Remdesivir is an antiviral medication that inhibits SARS-CoV-2 genome replication and is intended to reduce the severity and duration of COVID-19 symptoms. It was previously indicated to treat adults and children aged 12 years or older weighing at least 40 kg who have mild to moderate COVID-19 and who are at high risk of severe disease or death.
- A phase 2/3 trial in 53 hospitalized pediatric patients found that remdesivir had efficacy and tolerability similar to that observed in adults. Clinical improvement was achieved in 85% of participants and the recovery rate was 83%.
- On April 25, 2022, the FDA expanded approval of remdesivir to include pediatric patients aged 28 days or older with mild to moderate COVID-19 who have a high risk of developing severe disease, making it the first available COVID-19 treatment for young children.
- A 10-day course of remdesivir for pediatric patients might cost up to about $5720.
Remdesivir (Veklury) is a direct-acting antiviral medication manufactured by Gilead Sciences (Foster City, California). Remdesivir is a nucleotide prodrug that is converted in the body to remdesivir triphosphate, which selectively competes with adenosine triphosphate (ATP), a component of RNA, and is incorporated into new copies of the viral genome, causing premature termination during viral RNA replication. This slows the spread of the virus and allows the immune system to clear the infection more quickly.
Analysis from 53 hospitalized pediatric patients aged 28 days to less than 18 years in a phase 2/3 trial found that efficacy and tolerability results for remdesivir were similar to results reported in adult patients. Clinical improvement was achieved in 85% of participants, with a recovery rate of 83%.
Based on these data, on April 25, 2022, the FDA expanded approval of remdesivir to include children aged 28 days or older who have confirmed COVID-19 and who are at high risk of developing severe disease. Remdesivir was previously indicated for treating adults and children (12 years of age or older weighing at least 40 kg) who have mild to moderate COVID-19 and are at high risk of severe disease or death. Remdesivir is given intravenously at varying weight- and age-dependent doses for up to 10 days. According to a company release, remdesivir’s commercial list price is $520 per 100-mg vial. A 10-day course of remdesivir for children might cost up to about $5720.
Most children with COVID-19 develop only mild symptoms. However, some, especially those with one or more chronic conditions such as obesity, diabetes, or lung disease, are at greater risk of developing severe illness. While vaccination remains the safest and most effective protection against hospitalization or death from COVID-19, not all children have this option. Therefore, a need continues for safe and effective treatment options for this population.
Early feedback from ECRI internal stakeholders suggested that remdesivir might reduce severe disease and hospitalization in children with COVID-19, resulting in an improvement in patient health outcomes. As the first approved COVID-19 treatment, remdesivir provides a treatment option for children, especially for young children who are ineligible for vaccines.
Remdesivir’s intravenous mode of administration for non-hospitalized pediatric patients might increase burden on care providers, especially because staffing shortages are widespread. Disparities might also be increased if families are unable to travel to health care facilities that administer remdesivir to children, or if they are unable to pay for the treatment.
- Categories: Treatment
- Areas of potential impact: Patient outcomes, health care delivery and process, health care disparities, health care costs
WB001 to Treat Postpartum Depression
At a Glance
- Rates of postpartum depression have been rising during the COVID-19 pandemic, while shortages of mental health care providers have increased. Effective interventions to alleviate this growing gap are needed.
- WB001 is a prescription digital therapeutic being investigated to treat women with postpartum depression. It is a smartphone application (app) that incorporates elements of psychotherapy and a chatbot called Woebot to engage users in treatment.
- New mothers could access and use WB001 at home at their convenience. This might help increase patient access to care and circumvent several barriers to mental health care, including provider shortages, cost of traditional treatments, and stigma.
- The digital therapeutic is being studied in an unphased, 100-participant clinical trial. The FDA previously granted breakthrough device designation for this app to treat postpartum depression.
A recent study found that 38.2% of mothers in the United States who gave birth during the COVID-19 pandemic screened positive for postpartum depression, up from an estimated 6.5% to 12.9% before the pandemic. Rates of major depressive disorder and thoughts of self-harm were also increased during the pandemic. Preexisting health care worker shortages nationwide worsened during the COVID-19 pandemic, including among mental health care providers. Digital therapeutics might help bridge the growing gap between supply and demand in mental health care, while also addressing other, traditional barriers to mental health care, including cost of traditional treatments (ie, psychotherapy and psychiatric care) and stigma.
WB001 is a prescription smartphone app intended for new mothers with postpartum depression to access and use independently at home. The treatment platform consists of cognitive behavioral therapy and elements of interpersonal psychotherapy specifically tailored for postpartum depression. It incorporates Woebot, an artificial intelligence–powered chatbot that forms a therapeutic bond with users, which could improve patient engagement and treatment outcomes.
WB001 is being studied to treat mild to moderate postpartum depression over the course of 8 weeks in an unphased clinical trial with 100 participants. No data have been reported yet. The FDA previously granted WB001 breakthrough therapy designation.
We were unable to find information regarding the potential cost of WB001 to treat postpartum depression.
WB001 represents an important potential treatment option for new mothers experiencing postpartum depression, especially because rates of both postpartum depression and health care worker shortages have increased during the COVID-19 pandemic.
Early feedback from ECRI internal stakeholders suggested WB001 might help more women access care for postpartum depression and increase patient engagement because the patient can access treatment at any time. Some patients might find WB001 less intimidating than visits with a health care provider and more convenient while they are caring for a newborn. These factors might increase the likelihood that mothers will seek treatment. The app could serve as a vehicle for transitioning a mother to in-person therapy. If the app is used as an adjunct to psychotherapy, it might spur productive conversations between the patient and therapist and/or contribute to a data-driven therapeutic approach.
Although the initial treatment with WB001 might be expensive, it may still be cheaper in the long term compared with ongoing consultation with a therapist. If used as an adjunct, it could increase treatment costs.
Stakeholders also noted that data privacy concerns will need to be addressed before patients can feel assured that their individual data and personal information are not at risk from using WB001.
- Categories: Treatment
- Areas of potential impact: Patient outcomes, population health, health care delivery and process, health care disparities, health care costs
Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.
The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.
In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.
The HCHSS COVID-19 supplement produces 3 main outputs:
- Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
- Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
- High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.
Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected].
Posted: May 23, 2022
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