The news about the pharmacovigilance is that there is ‘no news,’ or nothing [untoward] has happened.
More transparency in how health care money is spent could improve utilization and efficiency, panelists said at the Medicines for Europe event.
More education about the value of biosimilars for doctors, nurses, and especially patients could help significantly with getting more of these agents into circulation and achieving savings that, in turn, could be plowed into health care system improvements. This observation came from a recent Medicines for Europe expert panel discussion on biosimilar use in Europe.
“Whenever I speak about biosimilars, the prior knowledge of patients makes them believe that I’m giving them something cheaper that is not the same quality, and they will look at me in a way that says, ‘Are you certain you really want to give me that stuff?’” said Matti Aapro, MD, president of the European Cancer Organization. “I think education is extremely important.”
The news about the pharmacovigilance is that there is ‘no news,’ or nothing [untoward] has happened.
Biosimilar Basic Training
The panelists suggested moving education about biosimilars into early training for health care professionals, such as doctors and nurses, many of whom can influence how patients perceive biosimilars.
“As we know in biosimilars, the switching process is very important for patients to take biosimilars up, because we sometimes see the nocebo effect with patients and they go back to the innovator product, and this could be prevented if you educate your patients the right way, and it’s not just the nurse’s job. It’s about aligning every health care professional to make this happen,” said Johan De Munter, president of the European Oncology Nursing Society and assistant nurse manager in the University Hospital Ghent Cancer Center, Belgium.
Digestive Cancers Europe (DiCE) has done extensive project work to promote the use of biosimilars in colorectal and gastric cancers, and these efforts have involved participation from pharmacy, clinical, industry, and nursing, said Zorana Maravic, acting DiCE CEO. She’s observed that patients become more supportive of biosimilar use if you let them know that the savings from these often lower-cost agents can be spent to broaden and improve their care and care facilities.
There should be a setting of health care system priorities that says if the drugs are equivalent, you use the cheapest one.
“If you say to a patient a biosimilar saves money for the health care system, this doesn’t mean anything to them; but if you say biosimilars save money and, in turn, facilities can be improved or patients will have an additional nurse or support from a nutritionist or psychologist, this is something tangible for them,” Maravic said.
She recalled an educational meeting with a group of patients that transformed their attitudes toward these agents. “That was really a magical experience, because we were in a room together with 8 or 9 patients, and we organized the session during an afternoon where, I have to say, patients in the beginning were skeptical about biosimilars because, you know, ‘They’re similar but not equal.’
“That was their perception, and then the experts presented the science and the safety and the role of the European Medicines Agency [in approving biosimilars]. And all that information really changed their perspective, and those 8 or 9 patients are now really advocates for biosimilars,” she said.
Leveraging the Pharmacology
Europe is ahead of the United States in biosimilar use and has closely studied the pharmacologic effects of biosimilars. European regulators have made good use of this growing body of evidence to help convince a skeptical public that biosimilars as safe and efficacious as their reference products, said Maja Sercic, policy and science manager for Medicines for Europe.
“The news about the pharmacovigilance is that there is ‘no news,’ or nothing [untoward] has happened. So, I think this is such an important piece of information, that biosimilars are actually safe and there were no complications in the last 15 years. So, regulators share this clinical experience. I think that is really the key, and I think it can really comfort the whole community,” Sercic said.
A big theme with the panel was the existing inefficiencies in health care, which they said are quite large in some instances and in serious need of attention. “We think it’s really important to look at the health care budgets overall. Too often—for us and for everybody—it’s difficult to find the data. We don’t know how the money is invested in every hospital, according to the outcomes that happen, so there are a lot of inefficiencies, and it’s important to stop wasting the money,” Maravic said. “I think that biosimilars can contribute to, if not making some surpluses, definitely in decreasing the budget deficit.”
Waste may involve inefficiencies at the practice level, such as preparing drug for patients who do not show up for their appointments, Aapro said.
The savings from biosimilars can be deployed strategically to cut down on overall requirements for care, Maravic said. “Currently we have a budget for prevention, we have a budget for treatment, and we can use the savings from biosimilars and deploy this into screening. We could save money because a lot of cancers would be detected at an earlier stage.”
It costs $4881 on average to treat a patient with stage I colorectal cancer, whereas stage IV disease requires treatment that costs $48,800. Currently just 14% of the population in the European Union has access to screening, and this just shows the value of earlier screening, Maravic said.
Adding to this, Sercic said that optimal use of biosimilars for just 3 molecules routinely used in cancer could save up to $2.9 billion in Europe. “I think that’s a huge value. And I’m not sure if my perception personally is that not everyone is aware how great the potential actually is.”
Panel Suggestions
The panelists suggested a range of core objectives that, if implemented, would get biosimilars used more often and foster trickle-down savings and health care quality improvements:
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Stable Patient Satisfaction Found After Switching From the Humira or Biosimilar CT-P17
December 14th 2024A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.
Review Confirms Clinical Safety of Sandoz Denosumab Biosimilar vs Originator
December 11th 2024Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.