Tony Hagen is senior managing editor for The Center for Biosimilars®.
Biosimilars, supply chain adjustments, building trust, and international standardization were discussed as means to deliver innovation when it's needed, not after.
Sifting through the rubble of the pandemic, there are many lessons to be learned in how to make innovation work, said an international panel of government and industry experts convened by Amgen.
Innovation doesn’t always work by itself to put medicine into the hands of those who need it. Government had to step in to get the vaccine development process started, and bureaucratic obstacles had to be cleared away. What has been learned so far will probably be retained to improve the process going forward and lead to a more global approach to solving problems on this scale, the panelists said.
“It’s an interesting health crisis, where the cost of inaction has been so obvious,” said Anne Marie Morris, chair of the All-Party Parliamentary Group on Access to Medicines and Medical Devices in the United Kingdom. “Often with health care, you don’t see any cost of inaction. It’s a person who is ill who dies. Nobody else cares, only their family. Whereas, this time, we saw what happens when systems were slow or rigid. People didn’t get their vaccines, and communities had to stay on lockdown. It turned out to be penny wise, pound foolish.”
To be sure, many positives have emerged during the pandemic. Among them is the digitization trend in health care that has involved patients researching their own health needs and treatment options. This has been accelerated by coronavirus disease 2019 (COVID-19), as evidenced by the momentum gains that biosimilars have achieved in the past year, said panelist Christophe Bourdon, senior vice president and general manager of US Oncology Business for Amgen.
"Innovation Is a Solution"
There are challenges ahead, given recent predictions that deficiencies in screening and testing could lead to more COVID-19–related deaths, but keeping down the cost of medicine can free up capital for investing in solving problems like this, Bourdon said. “Innovation is a solution. The question is going to be how to make sure that we can bring more innovation faster, so we can generate some savings to reinvest to generate additional innovation. That’s going to be one of the critical questions for governments and payers in the years to come.”
Innovation practiced over the past year has taken the form of workarounds that have enabled health care institutions and practices to deliver care despite the challenges of treating patients safely amid the pandemic, said Murray Aitken, executive director of the IQVIA Institute for Human Data Science, another panelist. “That to me speaks to the innovative approaches that have been taken by multiple stakeholders to try to get things back on track as much as possible.”
What was telling about the way vaccines and other treatments for COVID-19 were developed over the past year was that government was involved, said Anthony A. Barruera, senior vice president of government relations for Kaiser Foundation Health Plan, Inc and Hospitals. “The pharmaceutical system has really lavishly funded innovation in the pharmaceutical sector over the past several decades, and there’s a question about whether it’s efficient and whether it’s appropriately broad around the conditions that need to be treated,” Barruera said. “It’s also important to realize that they were not financed through the usual system of pharmaceutical finance. It was largely financed by government direct funding, admittedly on top of a system that exists because of what’s been built up over the past couple decades. But it’s telling what’s possible.”
But when it comes to innovation, especially with biosimilars, it’s important to build physician and patient confidence and trust to support uptake, he said. “You need to have very strong data to make sure that you’ve got the clinical support by the physicians who are using the products, and this is something that our medical groups and our pharmacists have studied intensely. When this level of data has been combined with biosimilar availability, uptake for Kaiser Permanente has soared as high as 95%.”
Vaccines and Trust
Trust is an important matter for vaccinating populations because people tend to be wary of vaccines, the panel noted. “I think the key of government to build that is to be as open and honest as they can be about what’s going on,” Morris said. “That’s not that easy. I think certainly in the United Kingdom, Boris Johnson has taken us through what’s happening step by step.”
The United Kingdom managed to get a vaccine approved before the European Medicines Agency, which led to concerns that there had been shortcuts and compromises on quality. That wasn’t true, Morris said. What really happened was that a lot of inefficient debate that contributed nothing to the development and approval of vaccines was eliminated from the process, and “the consequence was that decisions were able to be made faster.” This, she said, is probably the beginning of a reduction of bureaucracy in how medicines are developed and approved.
The different pace at which international regulatory bodies reach their decisions about vaccines, using basically the same data, is concerning, the panelists agreed. “The timing of their assessments is quite different, and in the context of this pandemic, we now recognize that those differences have real consequences, in terms of lives and in terms of the number of people who can be vaccinated, so I think this is going to trigger a broad rethink about the effective ways to access and look at data and then harness the full value,” Aitken said.
Another disturbing revelation that has emerged from the pandemic is how vulnerable the United States was because of its reliance on a fee-for-service revenue system in the medical industry, Barruera said. “This notion that a massive, immediate economic bailout was necessary to keep the medical system afloat in the short term shocked everyone, and there’s a growing appreciation for the need to be in more of a prepaid, value-based-compensation kind of environment where organizations can take a longer view, have greater stability, and build for the populations that they’re serving. But it’s going to take us a while, I think.”
Medicine for Those Who Need It
One challenge for all stakeholders is getting innovative products to the populations who need them, said Bourdon. “We all see the cracks in the system at the moment.” In some cases, minorities have had less access to COVID-19 vaccines. “I’m a firm believer that innovation will be accepted by society if we are bringing the right innovation to the right patient.” Amgen recently signed a partnership deal with Intermountain Healthcare to develop genetic profiles of a large number of individuals to aid in developing medicines, and this could serve the purpose of individualized medicine, he said.
Other innovation could take the form of corporations building better relationships with their suppliers so that information can be exchanged more openly, Morris said, citing the experience of Ford Motor Company. “They found that what they needed was excellent relationships with their suppliers so that when factories were closed, or whatever, they were able to lend them money, extend credit, help them to get back on their feet, which you wouldn’t do unless you had relationships.” Although this sounds like a one-way relationship with the suppliers gaining all the benefit, Ford was able to obtain data, visibility, and trust, she said. The implication is that better relations between pharmaceutical companies and their suppliers could help avert supply chain breakdowns, which have been an issue during COVID-19.