Laura is the editorial director of The American Journal of Managed Care

) and all its brands, including The American Journal of Accountable Care

, Evidence-Based Oncology™, and The Center for Biosimilars

, since 2011. She has an MA in business and economic reporting from New York University.

Laura Joszt

Biosimilars offer a “big shot” at addressing the high cost burdens patients face for drugs, but they still face a number of barriers in the United States, explained Robert M. Rifkin, MD, FACP, medical director of biosimilars at McKesson Specialty Health, The US Oncology Network, during a session at the 2018 Community Oncology Conference, hosted by the Community Oncology Alliance April 12-13 in National Harbor, Maryland.

Rifkin highlighted the current high prices patients have to pay for treatments and that the monthly cost of a new cancer drug is $10,000, and that biosimilars offer an opportunity to address those rising costs with lower-cost competitors.

Despite the promise of reducing costs and increasing access, biosimilars have faced big challenges as the manufacturer of the reference product has fiercely defended the originator, prices haven’t been as low as initially expected, and education among providers and payers remains an issue.

“We’ve been hearing about biosimilars for a number of years, but until now, it has been vaporware,” Rifkin said. With another 2 biosimilars expected to be approved by the end of 2018, the challenges facing biosimilars will need to be addressed.

There is going to be a greater need for payer, patient, and provider education to ensure that biosimilars successfully come to market and are used in place of the more expensive reference product. Rifkin noted that after Zarxio had come to market, 1 payer considered it investigational, despite its having FDA approval. Another payer had decided that patients could only get Zarxio if they failed to respond adequately to Neupogen, despite their being the same drug.

Among providers, medical oncologists appear to the be less educated about biosimilars compared with other specialty physicians. The good news, Rifkin joked, is that despite being the least well educated on biosimilars, they were the most willing to accept their lack of knowledge in the area.

“The reason the education lagged behind is because all of us who are busy oncologists don’t want to hear about something that’s coming in 2019, because I’ll pretty much forget that by the end of the day,” Rifkin said.

Rifkin also ran through the major barriers to adoption, which he broke into 3 categories:

Clinical barriers, such as understanding what biosimilars are and whether or not patients can be switched to the biosimilar from the innovator product.

Ease of use barriers, such as whether or not payers will cover the biosimilar, whether the biosimilar is a better deal for patients, and whether using the biosimilar will create more hassle for the clinic and patients.

Economic barriers, such as the cost to patients and the clinic.

Rifkin predicts that 2018 will be important for biosimilars. In 2017, the Supreme Court eliminated the 180-day waiting period after FDA approval to launch a biosimilar, which means that biosimilars can come to market much more quickly once they’re approved, and payers and providers will need to be ready. However, most importantly, biosimilar makers need to ensure a successful product launch.

“Because if you’re product gets approved, and it sits on the shelf at virtually no discount, that really doesn’t help any of us,” Rifkin said. “I think we’re all looking for deep discounts, we’re looking for transparency...to benefit all of our patients, providers, and stakeholders.”

Articles

During a session at the 2018 Community Oncology Conference, hosted by the Community Oncology Alliance April 12-13 in National Harbor, Maryland, Robert M. Rifkin, MD, FACP, medical director of biosimilars at McKesson Specialty Health, The US Oncology Network, highlighted the opportunities biosimilars provide to increase access to drugs while decreasing costs, but also the remaining barriers to adoption.

Session Highlights Barriers to Biosimilar Adoption and Lack of Provider, Payer Education

A new online consultation tool may strengthen the interaction between physicians and their patients with rheumatic diseases, according to new research presented at the 2017 American College of Rheumatology Annual Meeting.

Researchers in China developed the new tool to provide more efficient management of chronic illnesses. The Smart System of Disease Management (SSDM) is a series of applications based on clinical data and a mobile app that allows for online consultation.

In China, patients can seek care in any hospital or with any doctor they want, but those with rheumatic disease tend to seek care in large cities, because that is where the rheumatologists are located. This results in patients traveling long distances and even staying at hotels to see a clinician after a long wait.

“It is not uncommon for most Chinese rheumatologists to have to see up to 60 to 100 patients daily.” Fei Xiao, MD, CEO of Cinkate Corporation and a lead author of the study, 

. “Because of the large volume of patients who go to major hospitals for regular clinical care, physicians may only spend three minutes on average with each patient. This limits the time to do objective disease activity evaluations.”

Patients trained to use SSDM are able to perform self-management for their condition, including disease activity scoring of 28 joints, health assessment evaluations, and medication and lab test data entry. The study aimed to determine the benefits of using SSDM for online consultation.

Rheumatologists educated and trained patients on using SSDM, which includes a doctor/patient interface, a self-assessment, medication management, adverse events management, and laboratory records. After patients submit their data to their doctor, the provider may follow-up in person with patients or consult through text or voice with SSDM. Overall, 66.35% of patients said they found their experience with the online consultation “very satisfying.”

More than one-third (35.3%) of the patients who received online consultations lived in a different city than their rheumatologist. As a result, using SSDM saved a significant amount of money. The total fees collected for SSDM consultations was 477,960 yuan RMB; the total cost for patients seeking care at a hospital, including the cost of registration fees, medical expenses, and the average cost of transportation, accommodations, meals, and lost wages was 3,157,200 yuan RMB. In total, the online consultation created a savings of 84.86% for patients.

According to Xiao, patients and providers will benefit from SSDM, with patients more empowered to input data and follow their disease progression, and physicians able to mine and analyze data for research and publication.

“Access to this online program also helps physicians to mine and analyze data for scientific research and publication,” he said. “Based on the trajectory and real-time data, such as disease activity score, lab results, medication and patient’s symptoms, physicians are able to take proactive interventions, and turn passive practice into outcome-driven care. This model can be replicated into the other disciplines and fields of chronic disease.”

Chinese researchers employed a new online consultation tool to improve disease management for patients with rheumatic diseases who travel long distances for a consultation with their rheumatologist and noted significant savings for the patients.

New Online Consultation Tool Empowers Patients With Rheumatic Diseases, Study Finds

Body mass index (BMI) scores can impact disease activity in patients with rheumatoid arthritis (RA). New research presented at the 2017 American College of Rheumatology's Annual Meeting in San Diego, California, explored associations between BMI and disease remission or low disease activity and functional ability in RA.

Researchers determined that patients with RA and higher BMI have lower rates of remission and higher rates of disability. They suggest that weight screening and management should be a part of RA management.

“Obesity is increasing in prevalence and represents a global health concern. It has been implicated as a risk factor for developing RA, and is an increasingly prevalent comorbidity seen on first presentation of RA,” Elena Nikiphorou, MD, a researcher in the Academic Rheumatology Department at King’s College, London, and a lead author of the study, 

. “There is growing recognition that the inflammatory states mediated by obesity and those by inflammatory rheumatic diseases share common pathways.”

RA causes pain, stiffness, swelling, and limitation in multiple joints and inflammation can develop in other organs. Previous research has linked inflammation, obesity, and joint dysfunction, and the purpose of this study was to more clearly define how these conditions are associated with clinical disease activity and functional disability for patients with RA.

The researchers used data from the Early RA Study (ERAS) and the Early RA Network (ERAN), both of which were multicenter RA inception cohorts in the United Kingdom. There was a total of 1465 patients with a median follow-up of 10 years and a maximum follow-up of 25 years in ERAS, and a total of 1236 patients with a median follow-up of 6 years and a maximum follow-up of 10 years in ERAN.

The study found that 37.2% of RA patients were overweight and 21.3% were obese. BMI increased over 5 years for patients in both the ERAS and ERAN groups. Adjusted for age, sex, and year of recruitment, a higher BMI was associated with a reduced likelihood of patients with RA achieving low disease activity—based on scores of Remission-DAS and Low-DAS&mdash;and increased odds of disability by 63%.

“Our study’s findings demonstrate the increasing prevalence of obesity in RA patients and its negative consequences on disease activity, achieving a treat-to-target low disease activity goal and good functional outcomes,” said Nikiphorou. “Obesity is potentially a reversible comorbidity and successfully treating it can contribute to better disease activity and functional outcomes. Based on our data, there is a strong argument to include obesity screening and management as a central part of all treatment plans for RA patients.”

Research presented at the 2017 American College of Rheumatology Annual Meeting found that patients with rheumatoid arthritis and higher body mass index were less likely to achieve remission and more likely to face higher rates of disability.

Obese Patients With Rheumatoid Arthritis Less Likely to Achieve Remission

Certain factors contribute to the likelihood that patients whose rheumatoid arthritis (RA) is in remission may be more successful in tapering their biologic drugs, according to new research presented at the 2017 American College of Rheumatology’s Annual Meeting, being held November 3 to 8 in San Diego, California.

Researchers from Japan presented their findings at the meeting that patients who are younger, have no concomitant steroid use, and have a low level of serum C-reactive protein (CRP) are better candidates for tapering their dose of biologic disease-modifying antirheumatic drugs (DMARDs). The researchers strove to better understand the process of tapering in the real-world setting, and to identify in which patients tapering would be most successful.

Patients with RA who are in sustained remission may prefer to taper their biologic DMARD dose because, while these treatments are effective in treating RA, they are expensive and are associated with dose-dependent adverse effects, explained Takaaki Komiya, MD, a researcher at Yokohama City University Graduate School of Medicine and a lead author of the study.

 “Biologic DMARD tapering seems to be a feasible approach and it is widely used in clinical practice, but a significant proportion of patients experience relapse,” Komiya 

. “It is important for rheumatologists to know the clinical characteristics of patients who might successfully maintain remission after down-titration.”

The study included 347 patients with RA from 2 university hospitals in Japan. The patients were treated with one of the following biologics for at least 6 months: infliximab, adalimumab, etenercept, golimumab, certolizumab-pegol, tocizilumab, or abatacept. The patients had a mean age of 62.5 years, mean disease duration of 12.3 years, and were mostly female (83.6%).

Of the total number of participants, 255 patients were put into the group on stable treatment and 92 patients were put into the group with tapered treatment. Baseline disease activity was similar for both groups. The researchers noticed that the patients who were successfully tapered were younger at disease onset and at the time when they started using biologics. Patients who were biologic-DMARD naïve were more likely to successfully taper, as were those with no concomitant use of oral corticosteroids and low levels of CRP.

“An important strength is that this study reflects the real-world experience,” said Komiya. “The results of this preliminary study may help rheumatologists to differentiate RA patients who would successfully down-titrate biologics. This management might result in substantial reduction in costs and possible reduction in dose-dependent side effects.”

Researchers identify factors that make certain patients with rheumatoid arthritis good candidates for successfully tapering biologic DMARD dose.

Laura Joszt

Session Highlights Barriers to Biosimilar Adoption and Lack of Provider, Payer Education

New Online Consultation Tool Empowers Patients With Rheumatic Diseases, Study Finds

Obese Patients With Rheumatoid Arthritis Less Likely to Achieve Remission

Study Explores Factors That Predict RA Candidates for Successful DMARD Tapering