Biosimilars are made to reduce healthcare costs, but a number of factors have kept them from taking off and grabbing the kind of market share that would put a serious dent in the price of biologics and overall healthcare bills. They range from patients and physicians being wary about how similar biosimilars really are to patent tactics by originator manufacturers to an assortment of misaligned incentives that keep less expensive products off the market.
Elizabeth Oyekan, Pharm.D., FCSHP, CPHQ, vice president, access experience team with Precision for Value, notes over the past year, the U.S. is beginning to see long-awaited change to increased prescribing of biosimilars.
Oyekan believes 2020 is shaping up to be a pivotal year for biosimilars based on the following trends.
1. Politics and policies. Despite the tough political climate, Oyekan says Congress recognizes that increasing access to biosimilars is a necessary part of the solution to America’s rising health care costs and is adding provisions in various iterations of drug-cost bills. For example, the final rules for CMS’ 2020 physician fee schedule and outpatient hospital payment system include incentives designed t increase the use of biosimilars, and the FDA updated biosimilar basics for patients to engage and educate patients on the value of biosimilars.
2. Real-world evidence studies are showing efficacy and safety. Study after study shows more U.S. acceptance of the efficacy of biosimilars, and they are destined to become more popular in 2020.
“New studies report on switching, tolerability, and infection risk with biosimilar infliximab,” Oyekan says. “There’s newly presented data on oncology biosimilars showing successful switches, safe use, and little to no evidence of the nocebo effect.” The nocebo effect is the occurrence of negative symptoms and side effects when people have negative expectations about a medication.
3. Tangibly addressing affordability. Oyekan says more healthcare companies are putting their money where their mouths are and acting on the issues of affordability instead of just talking about it.
4. Major players getting on board. With big names like United Healthcare, OneOncology and Kaiser Permanente adding biosimilars as preferred products to formulary, Oyekan expects to see other entities and health systems following suit in 2020.
5. Financial momentum. The 3Q 2019, 4Q 2019, and preliminary 1Q2020 financial numbers show biosimilar momentum for Sandoz, Biogen, Pfizer and Amgen, with some declines in originator products. Precision for Value expects this to continue the rest of this year.
“With continued emphasis on value-based care, new payment models, such as Oncology Care First and Humana and Community Oncology Alliance’ OCM 2.0 may be a viable foundation for biosimilar adoption,” Oyekan says.
6. Employers are seeing the light. Oyekan believes employers will continue to become involved in exploring the availability of biosimilars for their employees especially because of their concerns about health care costs. “They are now being educated on the value of biosimilars to increase the chances of biosimilars added to future PBM contracts as a method of controlling specialty drug spending,” she says.
7. Finding differentiating traits in addition to costs. Precision for Value believes biosimilar manufacturers will continue to find differentiating factors —no matter how small — so the cost advantage won’t be the sole advantage of their products. “Some are focusing on RWE studies, flexibility (multiple size vials), patient support programs, etcetera, for a more holistic picture,” Oyekan says.
8. Operationalizing the biosimilar switching process. Many manufacturers focus on acquisition and access to therapy. However, an area that needs more focus and emphasis is adoption and uptake. For that reason, Oyekan foresees manufacturers developing tools and resources to improve adoption, such as tools that will make it easier for physicians and clinicians to switch patients seamlessly from the originator product to the biosimilar.
9. Continued education of biosimilars and their value. While some biosimilar manufacturers have made some major headway with some large key accounts, awareness and usage of oncology biosimilars are still relatively low. Oyekan expects to see a push to eliminate misunderstandings that patients and providers have about biosimilars and their value.
10. The COVID-19 effect. COVID-19 has definitely put a significant strain on the health systems budgets, so they will be looking for ways to offset COVID-19 financial losses, Oyekan says. Biosimilar prescriptions will part of the 2020 all-hands-on-deck approach to reducing costs.
11. Counterstrategies by originator brands. While biosimilars are gaining traction, originator brands are not sitting idle. “We will see increasing strategies from brands to maintain market share such as new formulations, new studies to shift subpopulations, matching biosimilar pricing to prevent systems from switching patients, to name a few,” Oyekan says. The good news is that with the advent of biosimilars, even originator brands have lowered the costs of their therapies, she notes. So biosimilars are beginning to live up to their raison d’être after all.