Leading global drug manufacturers have been called upon to respond to the COVID-19 pandemic in a myriad of ways, and several of their top executives discussed those responses in an August 11 webcast sponsored by the Association for Value-Based Cancer Care (AVBCC).
More patients than ever need the assistance offered by manufacturer-sponsored patient assistance programs (PAPs), said Rena Goins, Executive Director for Global Trade, GPO & Distribution for Regeneron Healthcare Solutions. “With providers’ help, we’ve been better able to understand this population—patients who may not yet be on COBRA and need medications, or who have now migrated to COBRA and are thus on a totally different plan. We have to keep up with them if we are to appropriately provide medication through our assistance programs.”
Gerry Gleeson, VP and US Head of Market Access for Sanofi, concurred. “We are seeing an increasing number of patients shifting from commercial insurance to state Medicaid or managed Medicaid, and potentially falling off the rolls and entering patient assistance programs where they never were before.”
Merck has made practical adjustments to its PAPs to make them more user-friendly and accessible, said Arthur Hirt, VP of Oncology Commercial Operations. “In the past, patients would need to provide us with the past six months of financials. Now, we assess their real-time situation—we make our decisions based on where they are right now, this minute.”
With in-person meetings and sales presentations on indefinite hold, manufacturers have also had to devise new ways for their sales forces to connect with providers, Ms Goins said. “We’ve created video platforms that allow us to bring our medical personnel online to engage virtually, and in fact, we’ve found those conversations to go deeper into the clinical data than the in-person meetings once did. Where we used to move quickly through slides, now there is much more back-and-forth—‘On slide 7 you had a P value that didn’t make sense to me, can you show me more data that support that conclusion?’”
All of the webcast participants described major worldwide efforts by their companies to establish supply-chain redundancies to guard against shortages, as well as to keep their global operations up and running as various areas of the world entered lockdowns.
“Early on, we did a deep redundancy test and went through everything it takes to get a product in a package ready to go at the bedside,” said Ms Goins. “We went backward to every supplier we dealt with and uncovered global channels that needed to be tweaked and modified. We had to create some secondary sources for certain products, such as glass vials and flip caps, as different countries shut down around the world.”
“Our priority, of course, is to ensure the supply of medicines and vaccines for all who need them,” said Mr Hirt. “One of the first things we did was change our SOPs in all of our manufacturing plants around the world to minimize the risk of infection among those employees. Only essential workers were allowed in.”
Bristol Myers Squibb has gone through the same process, said Alan Tubbs, VP, Payer and Organized Customer Sales. “It’s been a flexible approach as we carefully open markets around the globe. In the United States, the return to work varies week to week and is at a zip code and county level rather than a state level.”
All 5 companies that participated in the webcast are involved in efforts to develop vaccines and therapies for COVID-19. “We’ve been working on an unprecedented time frame, going from preclinical studies to human trials in less than four months,” said Marianne Gandee, Senior Director, Advocacy and Professional Relations for Pfizer Oncology, which in July entered into an agreement with the US government to supply up to 600 million doses of its mRNA-based vaccine candidate, BNT162.
Regeneron’s candidate is an antiviral antibody cocktail, being studied both in the treatment and post-exposure prevention of COVID-19. It entered phase 3 trials in early July. Sanofi has partnered with GlaxoSmithKline and the Department of Health and Human Services to accelerate the development and manufacture of a recombinant protein vaccine based on the approach used to make the company’s flu vaccine, Flublok. Merck has two different vaccine candidates, one based on an engineered vesicular stomatitis virus (VSV) approach that it has had success with Ebola, and the other based on the established measles vaccine that the company acquired with its acquisition of the Austrian company Themis. BMS is now involved in a proof-of-concept clinical trial on its rheumatoid arthritis drug, Orencia, in the treatment of COVID-linked acute respiratory distress syndrome, as well as the study of several compounds for the treatment of the inflammatory immune response associated with COVID-19.
When asked to offer their crystal-ball insights as to when a safe, effective vaccine for COVID-19 might be widely available, the panelists agreed that it is not likely to be until next year. “There is a lot of optimism in the media around the speed of these trials, but we do need to also be realistic,” said Mr Hirt. “Some companies are farther ahead in their timelines than we are at Merck, but even in those cases, 2021 is the most likely scenario.”