The U.S. Department of Health and Human Services’ recent announcement that it was asking states to provide COVID-19 data from hospitals directly through its Teletracking system or the new HHS Protect system rather than going through the CDC is generating criticism. The National Association of County and City Health Officials, for instance, claimed the shift would “fragment COVID-19-related data collection, which can add further complications to our country’s response to COVID-19.” A data reporting structure outside the CDC “can create real disruption for a coordinated response across the entire health system,” the group said, adding that “it also may lead to public distrust over the numbers.” Other concerns revolve around access to HHS Protect, which uses a secure set of capabilities powered by eight commercial technologies for sharing, parsing, housing and accessing COVID-19 data. “No one is taking access or data away from CDC,” CDC Director Robert Redfield said Wednesday in response to the concerns. He clarified that while the information was reported through the CDC in the past, it’s been going to HHS Protect since the system was set up in April. “We have not changed the data ecosystem; we have merely streamlined the data collection mechanism for hospitals on the frontlines,” he said. He added that state and local public health departments, as well as federal agencies, have access to the information in HHS Protect.
The FDA is revoking the biologics license application for Eli Lilly and Co.’s Lartruvo (olaratumab) – nearly 10 months after Lilly asked to withdraw the cancer drug from the market due to its failure in a confirmatory trial. Lartruvo was granted accelerated approval Oct. 19, 2016, to be used in combination with doxorubicin to treat adults with a specific type of soft tissue sarcoma (STS). In January 2019, Lilly reported that the drug failed to meet the confirmatory study’s primary endpoints of overall survival in the full study population in advanced or metastatic STS or in the leiomyosarcoma subpopulation. Despite the withdrawal, Lilly is continuing to evaluate olaratumab in three trials, but none is still recruiting, according to Clinicaltrials.gov. An expanded access study opened last year remains open to provide olaratumab to eligible patients who had been prescribed the drug when it was commercially available. In 2018, Lartruvo generated $305 million in sales, according to Cortellis.
As COVID-19 worsens the opioid overdose crisis in Canada, the Canadian government is trying a new tactic with a $2 million pilot project that will give selected patients at risk of overdose access to hydromorphone tablets from a licensed prescriber. The pilot will be conducted in British Columbia’s Cowichan Valley with people who haven’t responded to other forms of treatment for opioid use disorder. The idea is to give them a pharmaceutical-grade drug as an alternative to toxic illegal opioids, along with wrap-around services, such as peer support, medical care, mental health support and a personal support plan. Data from the four-year pilot will be used in the development of best practices for safer supply programs, according to Health Canada.
The FDA will convene a virtual public meeting Sept. 29, 2020, on the use of patient preference information in regulatory decision-making. The meeting will be jointly sponsored with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and will include presentations on case studies. Interested parties must visit the ISPOR website to register.