BOSTON – Biosimilar versions of disease-modifying antirheumatic drugs have arrived in the United States, but even the best, most efficacious drugs are worthless if patients don’t want to take them.
“The science is important, the medicine is important, but at the end of the day, acceptance and use is what’s going to measure success,” said Seth D. Ginsberg, at a biosimilars symposium sponsored by Corrona, a business that provides registry data and consulting services to biopharmaceutical companies.
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He illustrated the value of biologic agents with this anecdote: “When we got started long, long ago, we used to hold patient events,” he said “and we usually set up for 100. The instructions to meeting planners were right before the event that it was protocol to pull the front 25, the front-right quarter of chairs. Why? To make room for those who can’t walk, to make room for the wheelchairs,” he said.
“Today, if we have one wheelchair at an event, it’s an outlier, and I can’t think of a better way to summarize the impact that biologics have had on our lives,” he said.
Biosimilar confidence
His group has launched “Operation: Biosimilar Confidence” which is designed to educate patients and physicians about the clinical value and scientific underpinnings of biosimilars, as well as the thorough development, review, and regulatory processes involved.
The goal of the project is to instill confidence in patients by helping them to understand the manufacturer’s safety track record, reliability of the biosimilar supply chain, and the availability to them of support services, if they make the switch to a biosimilar.
“Generics don’t have equivalent patient-support programs, and the projection is theoretically that [biosimilar] manufacturers won’t either. We will not accept that. We are going to do everything we can for those patients, to advocate for the continuation of the support programs that we rely on as patients,” he said.
Patient concerns
Surveys of patient concerns about biosimilars have highlighted four key areas:
- What is the manufacturer’s overall safety record in both biologic agents and small-molecule therapies?
- Supply-chain logistic – Will the manufacturer commit to consistent production and supply?
- Will biosimilar manufacturers provide patient support at levels equal to those offered by innovator biologic makers, and what kind of support will be available – phone, websites, social media, copays, etc.?
- Payer ethics – Will payers offer lower copays, deductibles, or premiums, and are payers as concerned as patients about product safety, supply chain, and support?
The implementation strategy for the campaign will focus on speaking directly to patients through CreakyJoints.org, partner Global Healthy Living Foundation, patient and physician organizations, social and conventional media, advertising, and one-on-one encounters.
“We have to talk directly and indirectly to employers and employee-advocacy groups. We have to let these big self-insured employers understand what the perspective of the patient is and what life is like thanks to these medicine, and why biosimilars are a critical component to the success of living with these conditions,” he said.
Advocates also have to work with the media to create “a surround-sound message that reaches all audiences with additional frequency.”
“We cannot allow Wall Street Journal business analysts to dictate the conversations about biosimilars. Why? They’re looking at one thing, and only one thing, and they’re ignoring the patient perspective,” Ginsberg said.
Lastly, patient groups need to work closely with payers, physician groups, and manufacturers to ensure that biosimilars can be smoothly integrated into the healthcare system, he emphasized.
“I want to be crystal clear here: We can’t wait for biosimilars. Bring it on! We want them,” he said.