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.jhoponline.com.
- Washington and Public Policy: The COVID-19 Pandemic
- Comprehensive Cancer Care Systems
- Pharmaceutical Manufacturers’ Response to COVID-19
- Oncology Pharmacy Making Adjustments
- Unintended Consequences of COVID-19 on Oncology
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.”
Robert Carlson, MD, CEO, National Comprehensive Cancer Network (NCCN)
Pat Basu, MD, MBA, President & CEO, Cancer Treatment Centers of America
Christian Downs, MHA, JD, Executive Director, Association of Community Cancer Centers
According to the NCCN, an alliance of 30 leading academic cancer centers in the United States, the data suggest that although patients with cancer are not more susceptible to infection from the new coronavirus than other people, they do have much worse outcomes. “Prevention is thus the key for oncology patients,” Dr Carlson said.
“COVID-19 changed cancer care almost overnight,” he said. The care delivery centers in the NCCN are together taking an aggressive approach to screening for the virus and are sharing approaches and best practices. Comprehensive evaluation of patients and visitors to the cancer centers includes temperature monitoring, symptom screening, contact screening, and triage to an evaluation unit. Some facilities are not allowing patients to have accompanying visitors and are requiring masks for everyone entering treatment centers.
The NCCN centers have also implemented changes in the care delivery paradigm, including delaying appointments, using telehealth for follow-up and surveillance appointments, prioritization of care, and the separation of coronavirus-positive patients to specialized units.
The workforce and workplace are also having to adapt to the new circumstances, said Dr Carlson. In addition to shortages of equipment, the workforce is being depleted by infection or quarantine, and the physical and emotional stress of the pandemic is taking a toll.
Dr Basu said that providers are seeing a tremendous amount of confusion by patients about the messaging during this crisis. As a result, providers are fielding hundreds and thousands of phone calls on a broad range of questions about what patients have seen in the news.
Another area of concern is the shortage of provider protective equipment (PPE); consequently, we’re seeing price gouging for PPE that is so crucial to the protection of healthcare providers. Dr Basu said that in some cases, there has been an 800% markup on critical items, such as N95 masks.
Finally, he said that some large community oncology centers are engaged in debates as they confront new situations, including how to handle patients who have crossed state lines for care and whether to treat patients from neighboring hot spots.
“This is really a time for providers to band together to show the nation how we take care of patients,” he said.
Mr Downs discussed the concerns of smaller healthcare systems and hospitals, and the impact the virus is having on their operations.
Smaller systems have different needs and challenges than larger systems, he said. Many small healthcare systems are already overextended and are having difficulty maintaining operating margins and staying fully staffed. Some are struggling with new challenges in understanding telehealth or adapting to new testing procedures and care coordination across departments.
Many systems have large populations of patients who require social services and patients experiencing difficulties with insurance coverage or clinical matters, all of which further strain limited resources. This will become a crisis if the predictions in the acceleration of cases bear out.
“We want to keep the big picture in view,” Mr Downs said.
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.
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.
Don McDaniel, MBA, CEO, Canton & Company
Michael Consuelos, MD, MBA, FAAP, Principal, MJC Solutions; former CMO,
Hospital Association of Pennsylvania
Mr McDaniel and Dr Consuelos discussed the likely long-term impact of and lessons for the healthcare industry from the COVID-19 pandemic.
“I’m intrigued and compelled by what I think of as this dynamic duopoly, that we’re dealing with what we call the ‘culture of &’—the culture of doing 2 things well simultaneously: the need to focus on the virus and on the economy, the need to focus on the now and to prepare for the future, and in all of those contexts, be really focused on high reliability,” Mr McDaniel said.
Defining reliability as the interdependency between business achievement and service, he said that despite discussing the business of care, he has a firsthand understanding of the human pain of COVID-19 and cancer; his son was diagnosed with lung cancer at age 28.
Regarding the United States’ overdependence on global supply chains, Mr McDaniel said the inevitable future push to buy American is more than a nationalist mantra.
“This really gets at the heart of ensuring that we are bulletproof for the future,” he noted, adding that deregulating manufacturing and allowing for innovation will also help.
With many medical practices being small businesses, it is important to consider their future viability. Mr McDaniel cited the Centers for Medicare & Medicaid Services’ CARES Act, which allows for advance payments and the expanded coverage of telehealth under the recently passed coronavirus relief bill.
“On the technology front, telehealth has become table stakes, and we all talk about payment as a regulatory force, but the lack of payment shouldn’t be a limiting factor in terms of access or innovation,” he said.
Going forward, the oncology community must become less reliant on institutions and more reliant on a holistic ecosystem.
Ask yourself, “If we can so easily deregulate to solve these critical patient problems, why do we need the regulations in the first place, and how much of the regulatory infrastructure that is in place today hampered our ability to respond to this?” Mr McDaniel concluded.
Dr Consuelos is a cancer survivor who has worked in pandemic and emergency response for 20 years. He focused his talk on recovery, emphasizing that it is critical to learn from the pandemic and transform cancer care rather than simply return to how things were in the past.
“If we don’t change cancer care for the future, we may never recover to its former state,” he said, adding, “We do have a history of not learning from past events.”
Dr Consuelos cited the first coronavirus epidemic of SARS in 2003 and H1N1 in 2009, when shortages of personal protective equipment (PPE) arose. Although hospitals and corporations have since stockpiled PPE, it’s questionable whether the lesson was amply learned from those shortages in light of the current situation, he said. It is also important to realize that the virus does not observe boundaries.
“Many of our patients…are crossing state lines, yet our data, our response, our resourcing is continuing to observe those state lines,” Dr Consuelos said, citing the regional response called for by the Office of the Assistant Secretary for Preparedness and Response. In terms of the long-term implications of the virus, he said that the birth of Generation P (pandemic) is occurring.
“Like every generation after a major event, the world will be changed forever,” Dr Consuelos noted.
He challenged attendees to consider identifying their role in improving readiness and recovery, as well as their next steps. Dr Consuelos encouraged healthcare experts to record in a journal lessons learned to take the necessary steps toward recovery in the future.