Laura Joszt, MA, is the vice president of content for the managed care and pharmacy brands at MJH Life Sciences

. She has been with MJH Life Sciences since 2011.

Laura has an MA in business and economic reporting from New York University.

Laura Joszt, MA

Hospitals and physicians’ offices mark up the cost of certain drugs to the point that they may cost twice the amount as the same drugs being dispensed in specialty pharmacies, according to a new 

. Among the 10 drugs evaluated, 3 have multiple biosimilars available.

The researchers found that the 10 drugs, on average, cost $1400 more when administered in physicians’ offices; the cost per single treatment in hospitals was an average of $7000 more. Notably, the estimates were for a single treatment, but all 10 drugs require multiple treatments.

To identify the 10 drugs on the list, AHIP researchers used the list of top 25 drugs by spending in Medicare Part B for 2019 and consulted with AHIP’s member plans on the drugs commonly delivered through specialty pharmacies. They calculated the 3-year average cost for a single treatment in hospitals, physicians’ offices, and specialty pharmacies using medical and pharmacy claims data from the IBM MarketScan Commercial Database from January 1, 2018, to December 31, 2020.

The 3 drugs with biosimilars that made the list were Herceptin, which has 5 trastuzumab biosimilars approved and on the market; Remicade, which has 4 infliximab biosimilars approved but only 3 on the market; and Rituxan, which has 3 rituximab biosimilars approved and on the market.

“The data are clear, specialty pharmacies lower patient costs by preventing hospitals and physicians from charging patients, families, and employers excessively high prices to buy and store specialty medicines themselves,” Matt Eyles, president and CEO of AHIP, 

. “Secure, direct delivery is a safe and smart competitive alternative that improves affordability and access for everyone.”

Physician offices marked Herceptin up $1875 and hospitals marked up the price $6091. The average markup was 131% in hospitals and 40% in physician offices over specialty pharmacies.

Biosimilars for Herceptin have been on the market in the United States as early as July 2019 when Kanjinti from Amgen/Allergan launched. Kanjinti had been approved in June 2019. The first trastuzumab biosimilar approved was Ogivri from Viatris/Biocon, which was approved December 2017 but did not launch until December 2019.

The other trastuzumab biosimilars are Ontruzant from Organon/Samsung Bioepis, which was approved January 2019 and launched April 2020; Herzuma from Celltrion/Teva, which was approved December 2018 and launched March 2020; and Trazimera from Pfizer, which was approved March 2019 and launched February 2020.

These trastuzumab biosimilars are approved to treat HER2 overexpressed breast cancer.

In physician offices, Remicade, which treats Crohn disease and psoriasis, has been marked up $695 (15%) over pharmacies. Hospitals marked the therapy up $5601 (124%).

There are 4 approved infliximab biosimilars but only 3 launched on the US market. Ixifi was approved in December 2017; however, Pfizer has chosen not to market this product in the United States to avoid competition with another infliximab biosimilar that it manufactures. Inflectra, from Pfizer/Celltrion, was approved in April 2016 and launched in the United States November 2016.

The second infliximab biosimilar approved was Renflexis from Organon/Samsung Bioepis, which was approved May 2017 and launched July 2017. The most recent approval and launch is Avsola from Amgen, which was approved December 2019 and launched July 2020.

On average, the rheumatoid arthritis treatment Rituxan was marked up $625 (7%) in physician offices and $7926 (85%) in hospitals over specialty pharmacies.

Truxima, from Celltrion/Teva, was the first rituximab biosimilar approved in November 2018. It launched November 2019. Ruxience, from Pfizer, was approved July 2019 and launched January 2020. Finally, Riabni, from Amgen, was approved December 2020 and launched January 2021.

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A report from AHIP found 3 drugs that have multiple biosimilars available can be delivered more affordably through specialty pharmacies.

Hospitals, Physician Offices Significantly Mark Up Prices for 3 Drugs With Biosimilars

In 2012, Biogen invested a 15% stake in Samsung Bioepis and then increased ownership up to 50% less 1 share in June 2018. However, it’s now extracting itself from the biosimlar joint venture with Samsung Biologics.

Biogen is selling its stake for up to $2.3 billion.

“We are thankful to Samsung Biologics for a productive collaboration since 2012,” Michel Vounatsos, CEO at Biogen, 

. “We believe biosimilars are essential to help sustain healthcare systems and represent an important value creation opportunity for Biogen.”

Under the agreement, Biogen will receive $1 billion in cash at closing, $812.5 million at the first anniversary of the transaction close, and $437.5 million at the second anniversary of the transaction close. Biogen is also eligible to receive up to $50 million upon achievement of certain commercial milestones.

“The full buyout of Biogen’s stake is expected to accelerate Samsung Bioepis’ biosimilar development capabilities and future performance in novel drug development, with improved autonomy and agility in business operations,” 

, an etancercept biosimilar. At the time, the biosimilar had already been approved in a variety of other markets under the names Benepali and Brenzys.

The FDA approval was for all indications of the reference drug, Enbrel: rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis (PsA), plaque psoriasis, and ankylosing spondylitis (AS).

Eticovo was the second etanercept biosimilar approved after Sandoz’s Erelzi; however, neither have launched in the United States yet.

Renflexis, an infliximab biosimilar to Remicade, was approved in April 2017. The tumor necrosis factor blocker was approved for multiple indications: adult and pediatric Crohn’s disease, ulcerative colitis (UC), RA, AS, PsA, and plaque psoriasis.

It was the second infliximab biosimilar approved after Inflectra from Celltrion/Pfizer. Since then, 2 others have been approved: Avsola and Ixifi. However, Ixifi will not be marketed in the United States since it is also from Pfizer and the company decided to avoid competing with Inflectra.

An adalimumab biosimilar (Hadlima) has been approved since July 2019, although it will not launch until June 2023 as a result of a settlement with AbbVie, the maker of the originator product, Humira. Hadlima is approved for RA, juvenile idiopathic arthritis, PsA, AS, Crohn disease, UC, and plaque psoriasis.

There are a total of 7 adalimumab biosimilars approved in the United States and Amjevita, the first approved in September 2016, will be the first to market with an anticipated launch of January 2023. Cytelzo was approved August 2017 and has an anticipated launch of July 1, 2023, but it has the added advantage of already being 

approved as an interchangeable biosimilar

A trastuzumab biosimilar, Ontruzant, was approved in January 2019 to treat HER2-positive breast cancer and HER2 overexpressing gastric cancer, and it launched in the United States in April 2020. Another 4 trastuzumab biosimilars (reference, Herceptin) are approved and have launched.

Finally, the company has a ranibizumab biosimilar (Byooviz), which was approved September 2021. This is the first ranibizumab biosimilar of reference Lucentis, and it is the first ophthalmology biosimilar to gain approval. It is approved to treat neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Byooviz will not launch until June 2022 due to a licensing agreement between Samsung Bioepis and Biogen and the originator company, Genentech.

Outside of the United States, Samsung Bioepis has a bevacizumab biosimilar, which is sold as Aybintio in Canada and the European Union and as Onbevzi in the European Union and the Republic of Korea.

In addition to the approved biosimilars, Samsung Bioepis has 5 additional products in the pipeline.

SB12 is an eculizumab biosimilar based on Soliris, an immunosuppressive drug that treats paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. SB12 is currently in a phase 3, randomized, double-blind, multicenter, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris (NCT04058158).

The company also has a second ophthalmology candidate with SB15, an aflibercept biosimilar based on the reference product Eylea. This is also in phase 3 with a randomized, double-masked, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of SB15 vs Eylea in patients with neovascular AMD (NCT04450329).

SB16 is a denosumab biosimilar to reference product Prolia in a phase 3, randomized, double-blind, multicenter study evaluating the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of the biosimilar compared with Prolia in postmenopausal women with osteoporosis (NCT04664959).

Finally, SB17 is a ustekinumab biosimilar candidate to reference product Stelara. It is in a phase 3, randomized, double-blind, multicenter study to evaluate the safety, efficacy, tolerability, pharmacokinetics, and immunogenicity of the biosimilar compared with Stelara in patients with moderate to severe plaque psoriasis.

In addition to the biosimilars in the pipeline, Samsung Bioepis also has SB26, a novel biologic. It is an ulinastatin-Fc fusion protein that is intended to treat severe acute pancreatitis, and it is in a phase 1 trial.

In a deal to sell the 50% ownership stake, Biogen would receive up to $2.3 billion.

Biogen to Sell Its Stake in the Biosimilar Venture Samsung Bioepis 

Once the coronavirus disease 2019 (COVID-19) public health emergency ends, telemedicine should continue to be used to increase access and improve care for patients with rheumatic diseases, according to a position statement released by the American College of Rheumatology (ACR). ACR’s position statement also supports continued parity of reimbursement for in-office visits, audio—visual visits, and audio-only visits after the pandemic.

ACR noted that practices have been able to combat the financial strain of reduced in-person visits during the COVID-19 pandemic through the adoption of telemedicine. Policy changes enacted by CMS due to the public health emergency has allowed clinicians to be reimbursed for telemedicine services at the same rate as in-person visits, and ACR supports continued parity reimbursement in order to “preserve the economic viability of rheumatology practices.”

“As providers plan for rheumatology care post-COVID, taking into consideration rheumatology workforce shortages and geographically distant patients, it is apparent that telemedicine could help rheumatology providers improve care models for their patients if the long-term economic and regulatory landscape remains favorable,” Chris Phillips, MD, one of the statement’s lead authors and member of the ACR’s Committee on Rheumatologic Care (CORC), 

ACR noted that telemedicine should be used in conjunction with periodic in-person visits and should not replace essential face-to-face assessments. In addition, ACR stated that reimbursement parity should occur as long the provider—patient relationship includes both in-person and telemedicine services, patients have a choice of provider for telemedicine services, the standard and scope of care provided by telemedicine services is consistent with in-person services, and the provision of telemedicine services is properly documented.

The statement includes another 6 positions, most of which are supporting, as well as 2 opposing positions.

ACR also supports protecting the security and integrity of patient information, proposals that facilitate the interstate practice of telemedicine, outcomes-based research of telemedicine use in rheumatology, and continued access to telemedicine services even after the COVID-19 public health emergency ends. In addition, ACR recommends platforms with a way to obtain informed consent for the delivery of telemedicine services.

In the position statement, ACR opposes geographical restrictions on telemedicine practice and payer policies that would dictate use of specified telemedicine platforms, create restrictive networks, or use telemedicine as a way to divert patients to preferred providers.

“While telemedicine should not replace many of the hands-on skills and in-office assessments rheumatology professionals provide, patients in all areas of the U.S. should have access to telemedicine, regardless of location, and the services should be included in all subscriber benefits and insurance plans,” said Aruni Jayatilleke, MD, one of the statement’s lead authors and member of CORC. “Additionally, rheumatology professionals should be reimbursed equitably for telemedicine services and have access to a streamlined state medical license process.”

The widespread adoption of telemedicine during the coronavirus disease 2019 (COVID-19) pandemic, as well as reimbursement parity that was enacted by CMS, should be continued once the public health emergency passes, according to a new position statement by the American College of Rheumatology (ACR).

ACR Supports Continued Use of Telemedicine and Reimbursement Parity After COVID-19 Crisis

FDA Commissioner Scott Gottlieb, MD, will be stepping down from his post in 1 month. Since taking office, he has encouraged generic drug competition and the growth of biosimilars in the US healthcare system.

In a note to the FDA, Gottlieb explained that he was stepping down because of the time he has spent away from his wife and 3 young children.

"I know that the opportunity to serve in this role was a privelege, and an endeavor that I'll never be able to replicate in my professional life—the impact of our public health work, the camaraderie, and our ability to improve the lives of Americans," he wrote. "There are many important efforts we undertook together, countless new policies we advanced, and laws we enforced with vigor to protect consumers."

He added that in his final weeks as commissioner, he will continue to cement the work he started and secure the 2020 budget.

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” HHS Secretary Alex Azar 

. “He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family.”

President Donald Trump sent out a tweet thanking Gottlieb for his work:

Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month....

released in 2018 the Biosimilar Action Plan

, which was meant to spur biosimilar competition. The plan addressed 4 key areas in order to spur biosimilar competition:

Improving the efficiency of the biosimilar and interchangeable product development and approval process

Maximizing scientific and regulatory clarity for the biosimilar product development community 

Developing effective communications to improve understanding of biosimilars among patients, providers, and payers

Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products 

 for the year at the JP Morgan Healthcare Conference. These goals included bringing down drug prices through increased competition and a robust biosimilars market.

When Gottlieb was nominated to become FDA commissioner, he was 

 over his industry ties and his opposition to many regulations. Ultimately, he was confirmed mostly along party lines in a 57 to 42 vote.

"Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more,” Azar said. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last 2 years.”

FDA Commissioner Scott Gottlieb, MD, will be stepping down from his post in 1 month.

Gottlieb Stepping Down as FDA Commissioner

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.”

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.