Leading global drug manufacturers have been called on to respond to the COVID-19 pandemic in myriad ways, and several of their top executives discussed those responses in an August 11 webcast sponsored by the Association for Value-Based Cancer Care.
Patient Assistance Programs
Now, more than ever, patients need the assistance offered by manufacturer-sponsored patient assistance programs (PAPs), said Rena Goins, Executive Director, Global Trade, GPO and Distribution, Regeneron Pharmaceuticals. “With providers’ help, we have 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, MBA, Vice President and US Head of Market Access, 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 rails 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, MMR, Vice President, Oncology Commercial Operations, US Market, Merck. “In the past, patients would need to provide us with the past 6 months of financials. Now, we assess their real-time situation, and we make our decisions based on where they are right now, this minute.”
With in-person meetings and sales presentations on indefinite hold, drug manufacturers have also had to devise new ways for their sales forces to connect with providers, Ms Goins said. “We have created video platforms that allow us to bring our medical personnel online to engage virtually. In fact, we have 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. [For example,] ‘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?’”
Protecting the Drug Supply Chain
All 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 [standard operating procedures] in all of our manufacturing plants around the world to minimize the risk of infection among those employees. Only essential workers were allowed in,” he noted.
Bristol Myers Squibb has gone through the same process, said Alan Tubbs, Vice President, Payer and Organized Customer Sales, Bristol Myers Squibb. “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,” he said.
Development of New COVID-19 Treatments
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 4 months,” said Marianne Gandee, MA, Senior Director/Team Lead, Advocacy and Professional Relations-Oncology, Pfizer, which entered into an agreement with the US government in July to supply up to 600 million doses of its mRNA-based vaccine candidate, BNT162.
Regeneron’s candidate is an antiviral antibody cocktail, being studied in the treatment and postexposure prevention of COVID-19. The drug entered phase 3 trials in early July. Sanofi has partnered with GlaxoSmithKline and the US 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 Quadrivalent. Merck has 2 different vaccine candidates, one based on an engineered vesicular stomatitis virus approach for which 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 Bioscience. Bristol Myers Squibb 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 may 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.” l