On April 3, 2020, the Association for Value-Based Cancer Care (AVBCC) held a webcast with healthcare experts representing major industry stakeholders to address the impact of the COVID-19 pandemic on oncology delivery systems and the management of patients with cancer. Below are highlights from the AVBCC webcast, representing some of the key presentations. The complete set of articles is available at www.theoncologypharmacist.com/.
- Washington and Public Policy: The COVID-19 Pandemic
- Oncology Pharmacy Making Adjustments
- Pharmaceutical Manufacturers’ Response to COVID-19
Scott Gottlieb, MD, Former FDA Commissioner
Dr Gottlieb provided an assessment of where the pandemic is heading over the next weeks. He started his discussion with an analysis of the epidemic curve in New York City, where the highest number of COVID-19 cases currently are.
Drawing on coronavirus data from Europe and Asia, Dr Gottlieb made an “optimistic” prediction that New York will reach the peak of new diagnoses in 1 or 2 weeks, followed by a week of deceleration and then a leveling off approximately another week later. The New York trajectory is similar to that of Spain and Italy, he said, and will likely follow a similar trend in the time from mitigation implementation to a slowdown in new cases.
Dr Gottlieb cautioned that although the number of new cases of COVID-19 infections will ease in the coming weeks, the number of hospitalizations and deaths will lag diagnoses, sometimes significantly. As data from China show, although the number of new cases peaked 6 weeks after Wuhan implemented its mitigation efforts, the number of new hospitalizations peaked 4 weeks later, and deaths continued to rise. The Chinese data showed an average of 9 to 12 days to hospitalization and an average time to death of 3 to 6 weeks.
Although no aggregated data are available for the United States, data from the United Kingdom showed shorter times to hospitalization and death than in China. Dr Gottlieb said he expects US data to follow the UK experience more closely, which means that the disease here may be more aggressive and briefer than in China, but because hospitalizations and deaths lag the peak in the epidemic, the healthcare system will continue to be overburdened, and hospitalizations and ICU admissions will increase for several weeks.
Thus, he said, it is important for policymakers and the public to understand that “just because you see a region declining in the number of new cases, the healthcare system is going to continue to be significantly pressed.”
Turning to what is happening in the rest of the country, Dr Gottlieb called it a “concerning situation.” Although the number of cases in the Pacific Northwest seems to be slowing, in many northern cities, including Philadelphia, Boston, and Detroit, the number of cases is accelerating, with new diagnoses doubling approximately every 3 to 4 days. However, he added, early mitigation efforts were followed more stringently in these regions and travel plummeted. As a result, he expects to see a leveling off of new cases in the coming weeks, even as they continue to rise in the short-term.
The situation is more troubling in areas outside of the Northeast and in some of the western states, because mitigation efforts did not occur, particularly in the Sun Belt states and in the Southeast.
“These regions look really concerning. We’ve been saying for weeks now that New Orleans looks really bad. I would put Florida in that camp as well, perhaps Georgia. And you have to be very concerned about Texas. These are big populated states that were late to mitigation and still haven’t implemented it with vigor…and have potential to have really large outbreaks,” Dr Gottlieb said.
These states are also undertesting, said Dr Gottlieb, with Texas testing only 0.17% of their population, placing it 45th of 50 states for testing per capita. He referred to the grim predictions in the government modeling delivered by Anthony S. Fauci, MD, and Deborah M. Birx, MD. These models forecast possible deaths in excess of 200,000. Although he concedes that such an outcome is possible, the modeling depends on conditions in the South and southeastern states.
Dr Gottlieb believes that Florida and Texas are poised to have very high rates of infection. “It’s going to be a difficult month,” he said.
Dr Gottlieb predicts reaching the peak of infections in early May, with the possibility of lifting some mitigation steps in June. It is possible that the virus will have a seasonal component and will follow the course of the H1N1 epidemic in 2009, he said, where it was quiescent in July and August and re-emerged in September.
The question is, said Dr Gottlieb, “will we have a different enough toolbox…that allows us to go back to some semblance of our normal lives” come September?
Dr Gottlieb is confident that there will be an effective disease surveillance system in place by Fall, but he noted that it will take a drug to effectively change the contours of the risk profile of this pathogen. He added that although we are still learning about the virus, the statistics have been consistent globally. China may have underreported the severity of COVID-19 cases, but “we have a pretty good handle” on the disease morbidity, he said, with approximately 80% of infected patients having moderate disease, 15% needing hospitalization, 3% needing intensive care, and 1% succumbing to the infection.
“This is a virus that wants to infect 40% of the population,” Dr Gottlieb concluded. However, “the notion that there is a vast pool of people who have been exposed and seroconverted is not true. This is a long way of saying, we’re not going to have herd immunity.”
Michael Reff, RPh, MBA, President, National Community Oncology Dispensing Association (NCODA)
Ray Bailey, BPharm, RPh, Pharmacy Director, Florida Cancer Specialists
Mr Reff and Mr Bailey addressed the modifications that oncology pharmacies are making to keep staff and patients safe during the coronavirus pandemic. Since its virtual Spring Forum, NCODA has been hosting weekly calls that include some of the approximately 700 oncology practice settings it represents, to discuss how best to adjust to the new reality of COVID-19, said Mr Reff.
“The oncology practice settings focus on the importance of the continuation of care, specifically on the provision of oral chemotherapy,” he said. “This oral oncology ecosystem represents several unique business models, which are dependent on the size and scope of the practice they serve.”
For the Florida Cancer Specialists, who are used to hurricane disasters, the pandemic posed new challenges as they launched their crisis response.
“We had never encountered anything like this,” he said. They started with protecting the dispensing staff by sequestering them in an ISO 9 cleanroom with its own entrance. Staff are now wearing masks and gloves, and are subject to temperature checks and questionnaires at the beginning and end of shifts, Mr Bailey noted. In addition, staff were cross-trained to provide backup for the dispensing staff, who are critical to getting medications to patients.
Pharmacy support staff were transitioned to work from home. Because most staff and nurses are accustomed to working in a pharmacy setting, this posed technologic and infrastructural challenges. “It was a heavy lift for us,” Mr Bailey added. It helped that all their systems are cloud-based. Also, Microsoft Teams has proved invaluable for tackling challenges and IT issues, as well as reaching patients, he said.
Pharmacy benefit managers (PBMs) have also adapted to the new paradigm, with some allowing 90-day prescription fills and shipping for some retail contracts. They have suspended audits, and reauthorizations have largely been delayed or suspended. “We appreciate that partnership with the PBMs who are supporting us and our patients,” Mr Bailey added.
With pharmacy pickups suspended, delivery practices have changed as well. The signature requirement on delivery slips was changed; now, FedEx delivery drivers wait for the package to be taken inside and then sign “COVID-19” on the signature pad instead of having the patient sign. Some pharmaceutical companies have made changes to Risk Evaluation and Mitigation Strategy programs for certain drugs that allow flexibility in dispensing pregnancy tests and longer duration of prescription fills, Mr Bailey said.
Patient education about adherence to oral medication, which has always been done via a phone call, has not changed much for Florida Cancer Specialists.
“Maybe one silver lining to this is that all our patients are home, so when we call, we’re not having to leave messages,” noted Mr Bailey.
Julie Gerberding, MD, Chief Patient Officer, Communications, Global Policy, and Population Health, Merck
Brian Morrissey, VP, Strategic Customer Group Oncology, Pfizer
Eric Dozier, VP, Oncology North America, Lilly Oncology
The healthcare supply channel is dependent on drug manufacturers and their innovation and production. Representing 3 of the major biopharmaceutical companies, Dr Gerberding, Mr Morrissey, and Mr Dozier discussed the drug manufacturers’ response to the COVID-19 pandemic, announcing a recent collaboration in the fight against the novel coronavirus.
Through the “first care responders” program, these 3 companies are encouraging their employee clinicians to volunteer on the front lines in hospitals, where their clinical skills can help to care for patients during this crisis. The companies will pay the salaries of their employees who donate time to the effort.
“There is no silver lining to coronavirus, but in some sense, this is a real opportunity for the biopharmaceutical industry to step up to the plate and be the very best we can be,” said Dr Gerberding.
According to Dr Gerberding, the first priorities at Merck are ensuring the safety of its employees, sustaining the supply of medicines and vaccines, and taking care of patients enrolled in clinical trials.
Dr Gerberding noted the unprecedented response to the pandemic crisis, with clinical trials already off the ground, and that there has never been a more rapid mobilization to find treatments and vaccines. She added that Merck’s contribution is not limited to scientific interventions, and that the company has donated items such as 500,000 N95 masks to hard-hit areas in New York and New Jersey.
Mr Morrissey said that Pfizer has not seen a disruption in the supply of medicines they manufacture, and in fact, the company has stepped up its shipping. In addition, Pfizer has undertaken initiatives to relieve pressure on the supply system.
Through its “5 Promises,” Pfizer is also committed to encouraging scientific innovation in the field and vows to help smaller companies with promising therapies or vaccines scale up production to meet demand and get the medications to as many patients as possible.
Mr Dozier said that Lilly also has an effort underway to prevent undue stress on the system. Lilly has paused most of its clinical trials programs, with the exception of some pivotal trials, and pulled its sales force from the field early on.
Mr Dozier said that the goal at Lilly Oncology is to make sure that patients have access to their medicines and that they are affordable.
“The focus at Lilly has been on finding solutions and bringing them to bear quickly,” said Mr Dozier.Read the Whole Webcast series Here