Sophia Z. Humphreys, PharmD, MHA, BCBBS, is the director of system pharmacy formulary management & clinical programs at Sutter Health in Sacramento, California. She has nearly 20 years of specialized experience in the pharmaceutical industry and is an expert in pharmacy regulatory compliance, US Pharmacopeia General Chapter <797>/<800> pharmacy regulations, clinical education, long-term care pharmacy service, and pharmaceutical waste management. She has a strong background in strategic planning and project management. Prior to her current position, she served as the director of system pharmacy clinical services at Providence St. Joseph Health.

Sophia Z. Humphreys, PharmD, MHA

Experts talk about the impact of the launch of adalimumab biosimilar on their clinical practices and pharmacy.

Impact of the Launch of Adalimumab Biosimilars in Different Clinical and Pharmacy Settings

This is a video synopsis/summary of a panel discussion involving Jamie T. Brogan, MSN, APRN, FNP-BC; Kostas Botsoglou, MD; Jordan Axelrad, MD, MPH; Sophia Humphreys, PharmD, MHA; and Peter Lio, MD.

The discussion examines the impact of biosimilar launches in both pharmacy and clinical settings. Initially, the adoption of biosimilars was high in oncology, but more conservative attitudes were observed among gastroenterologists and rheumatologists. However, as more data became available, steady uptake occurred, particularly in rheumatoid arthritis (RA), leading to increased comfort among physicians.

In the pharmacy setting, surveys indicate rising comfort levels with biosimilars among healthcare providers, despite initial challenges in determining coverage by insurance payers. The broader availability of biosimilars is expected to potentially lower costs, although the complexity of navigating different biosimilar options remains a challenge.

In the clinical realm, the learning curve for both patients and providers persists, with a focus on understanding coverage policies to avoid delays in treatment access. Education efforts are crucial to ensure patients receive the appropriate medication. In rheumatology, uptake was initially slow due to the availability of unformulated original products, but increased gradually with payer enforcement of switches to biosimilars.

In dermatology, however, the uptake of biologics and biosimilars lags behind other specialties, presenting an opportunity for expansion of treatment options. Overall, improving comfort levels among healthcare providers and early utilization of biosimilars hold promise for enhancing patient care, particularly in stopping disease progression in conditions like inflammatory bowel diseases.

Video synopsis is AI-generated and reviewed by AJMC editorial staff.

Videos

discuss clinical trials that have shown safety and efficacy of adalimumab biosimilars in inflammatory diseases.

The Safety and Efficacy of Adalimumab Biosimilars in Inflammatory Diseases

The discussion shifts to the safety and efficacy of biosimilars across various inflammatory diseases. The VOLTAIRE-RA trial, featuring an approved interchangeable biosimilar, demonstrates safety, tolerability, and efficacy within predefined primary endpoints, extending to conditions like psoriatic arthritis, ankylosing spondylitis, and uveitis. Biosimilars have also gained approval for psoriasis and hidradenitis suppurativa, indicating their versatility across disease states.

The conversation highlights the reassuring performance of biosimilars across different populations and conditions, underscoring their equivalence to originator drugs. Data from randomized trials show comparable patient outcomes and safety between originator and biosimilar therapies, providing clinical reassurance.

Extrapolating findings from one disease area to another, like from rheumatoid arthritis to inflammatory bowel diseases or psoriasis, enhances clinical accuracy and accessibility. With nearly a decade of biosimilar experience, studies consistently demonstrate no loss of efficacy and robust safety profiles, as evidenced by FDA data encompassing various therapeutic areas, including oncology and immunology.

Overall, the accumulated evidence fosters confidence in biosimilar use in the United States, supporting their integration into clinical practice across a spectrum of inflammatory diseases.

Video synopsis is AI-generated and reviewed by HCPLive editorial staff.

Specialists in rheumatology, dermatology and gastrointestinal disease discuss clinical trials that have shown safety and efficacy of adalimumab biosimilars in inflammatory diseases.

A clinical pharmacist reviews the various pharmacological aspects of the available adalimumab biosimilars.

The Pharmacological Aspects of Adalimumab Biosimilars

The discussion delves into considerations regarding the concentration, citrate-free nature, and volume of adalimumab, particularly in the context of transitioning patients to biosimilars. The speaker emphasizes the importance of minimizing patient discomfort by opting for agents with smaller syringes, no citrate, and lower volume. They highlight the popularity of citrate-free products due to reduced pain and mentions that high concentration with citrate may cause less injection site discomfort. Ideally, biosimilars should offer high concentration, small needles, and be citrate-free, although not all currently meet these criteria. Various delivery mechanisms impact patient experience, necessitating education and informed choices.

The speaker adds insights from a dermatological perspective, noting patient preferences for specific pen devices and potential implications for treatment adherence. He suggests tracking patient feedback to inform future decisions. Concerns about off-label doses and the burden of multiple devices underscore the need for streamlined options to facilitate adherence.

The complexity of managing multiple devices and formulations requires extensive patient and staff education. Providers must navigate diverse product landscapes to ensure optimal treatment experiences. The discussion underscores the need for comprehensive understanding and support to facilitate informed decision-making and improve patient outcomes.

2.	Clinicians and a pharmacist provide an overview of the emerging adalimumab biosimilars in the recent years.

An Overview of Adalimumab Biosimilars

The discussion focuses on adalimumab biosimilars, examining their indications, mechanism of action, interchangeability, and clinical implications. Currently, there are over 40 biosimilars created for a dozen biologic products, with a focus on adalimumab. While most indications of adalimumab have biosimilar alternatives, three orphan drug indications remain unapproved for biosimilars.

The mechanism of action for adalimumab biosimilars mirrors that of the reference product, with rigorous FDA review processes ensuring structural and functional similarity. Biosimilars must demonstrate identical primary and secondary structures to reference products, differing only in tertiary and quaternary folding. Additionally, they share the same administration route and strength.

Interchangeability designation by the FDA streamlines pharmacy-level switches, but specific conditions must be met. Biosimilars must replicate clinical outcomes, maintain safety profiles, and undergo switching studies. Despite potential benefits, providers emphasize the importance of patient education and notification regarding biosimilar switches to maintain therapy continuity.

The discussion highlights the need for proactive patient communication and regulatory compliance to facilitate smooth transitions between reference and biosimilar products. Clinicians express willingness to embrace interchangeable biosimilars to reduce administrative burdens and ensure uninterrupted patient care, underscoring the importance of effective communication and documentation within healthcare systems.

Video synopsis is AI-generated and reviewed by Center for Biosimilars editorial staff.

Clinicians and a pharmacist provide an overview of the emerging adalimumab biosimilars in the recent years.

discuss the need for biosimilars in inflammatory diseases, and clinical pharmacist reviews the regulatory requirements for biosimilar FDA approval. 

The Need for Biosimilars in Inflammatory Diseases and Regulatory Requirements for Approval

Experts discuss the role of biologic agents and biosimilars in managing chronic inflammatory diseases. The advent of biologics has significantly improved patients' lives, and biosimilars offer increased access to these therapies. With a growing array of options, practitioners are identifying and treating patients earlier in the disease progression.

The speaker highlights the importance of biosimilars, which are vital for managing formularies in large healthcare systems like Sutter Health. They emphasize the transformative impact of these therapies in dermatology and underscores the need for cost-effective solutions to broaden access.

The speaker explains the regulatory requirements for biosimilars under the Biologic Price Competition and Innovation Act (BPCIA). While biosimilars are highly similar to reference products, they cannot be substituted at the pharmacy level without physician approval. Formulary decisions within health systems help streamline prescribing practices.

Overall, the exchange emphasizes the significance of biosimilars in expanding access to effective treatments for inflammatory diseases while navigating regulatory complexities and cost considerations.

Drs Lio, Botsoglou, and Alexrad discuss the need for biosimilars in inflammatory diseases, and clinical pharmacist Dr Humphreys reviews the regulatory requirements for biosimilars to receive FDA approval. 

In recent years, specialty medication spending has increased significantly. For the United States, in 2021, specialty medications accounted for 

 Most of these specialty medications are large molecule biologics. In 2019, these large molecule biologic medications represented 43% of all invoice-level medication spending in the United States, reaching 

Thus, control of biologic spending is an important key to reducing drug costs. This can be accomplished through greater utilization of biosimilars. Biosimilars are highly similar to high-cost biologics, with no meaningful clinical differences. They are marketed at a significantly lower price and, therefore, can contribute to significant savings. In 2021, the savings achieved by using biosimilars exceeded $10 Billion in United States.

Biosimilar research and development have been exceedingly active in recent years. As a result, as many as 106 biosimilars are currently under development. Biosimilar development is expanding outside of cancer care medications into 

 such as ophthalmology, bone health and immunosuppressants.

Cancer curative and supportive biosimilars have been very successful. There will be even more competition in these therapeutic classes in the new year. Three biosimilars to cancer supportive care biologics were 

 in 2022, and their US launches are expected in 2023. They are Releuko (filgrastim-ayow), Fylnetra (pegfilgrastim-pbbk), and Stimufend (pegfilgrastim-fpgk). 

More biosimilars to Neupogen (filgrastim) and Neulasta (pegfilgrastim) are in the pipeline from multiple manufacturers in 2023 and beyond. Biosimilars to the 3 curative biologics, Avastin (bevacizumab), Herceptin (trastuzumab), and Rituxan (rituximab) have experienced great success in the past 3 years. They will face more competition from newer biosimilars in the pipeline from multiple manufacturers soon

There are more than 4 biosimilars in the pipeline for all 3 molecules (6 for Avastin, 5 for Herceptin, and 4 for Rituxan).

Autoimmune agents have surpassed oncology medications in spend and growth rate. From 2011 to 2021, the spending on autoimmune medications increased 459%, while spending on oncology medications increased 226%

 Total spend of autoimmune agents exceeded $42 billion dollars in the past 5 years in United States.

 Humira (adalimumab) is the top-selling autoimmune biologic. Humira accounted for $20.7 billion in sales globally in 2021. Thus, the 

 are expected to bring sizable savings to health care systems.2023 marks the first year that biosimilars of Humira are finally reaching the US market.

It has been 6 years since the first biosimilar to Humira was approved by the FDA in 2016. However, litigations and settlement discussions have delayed the product launch until this year. Amgen’s Amjevita (adalimumab-atto) is expected to be available in the United States as early as January 2023. Multiple biosimilars to Humira have been launched in the European Union since 2018, but with 83.7% of the total global purchase of Humira coming from the United States, the 2023 US biosimilar launch will have the 

 As with all other reference products with biosimilars available, we anticipate price competition to 

 for biosimilars and the reference product.

After the December 2022 approval of Idacio (adalimumab-aacf) by Fresenius Kabi, there are now a total of 8 biosimilars to Humira in the United States. They are: Yusimry (adalimumab-aqvh) by Coherus BioSciences, approved in December 2021; Hulio (adalimumab-fkjp) by Viatris/Fujifilm Kyowa Kirin, approved in July 2020; Abrilada (adalimumab-afzb) by Pfizer, approved in November 2019; Hadlima (adalimumab-bwwd) by Organon/Samsung Bioepis, approved in July 2019; Hyrimoz (adalimumab-adaz) by Sandoz, approved in October 2018; Cyltezo (adalimumab-adbm) by Boehringer Ingelheim, approved in August 2017 and Amjevita, approved in September 2016. All are expected to launch in 2023. Five more are in various stages of development. The biosimilar market for Humira is going to be 

Humira biosimilars are unique because they are the first pharmacy benefit non-insulin biosimilars launched in the United States. All non-insulin biosimilars that have been released to the US market thus far are clinic administered and reimbursed under medical benefit. Therefore, large health systems have 

. They can decide which biosimilars to add to their formulary, negotiate with both reference product and biosimilar manufactures for best contract terms, and build system preferred biosimilars in their Electronic Health Recordsystem in ways which encourage the physicians to prescribe the health system preferred biosimilars.

Humira, however, is largely dispensed in the retail pharmacies and reimbursed at the pharmacy level. This presents new challenges to 

. The reference product will almost certainly reduce its price and make Humira more competitive this year. Since each biosimilar is reimbursed based on its own average sales price (ASP), the biosimilar manufacturers have a balancing act to perform. On one hand, they must keep the biosimilars’ ASP high enough for a reasonable reimbursement. On the other hand, they need to offer a price lower than Humira and other biosimilars to satisfy the pharmacies and health systems. Not all payers will cover all 8 biosimilars, so each manufacturer would have to consider 

 to attract the payers and pharmacy benefit managers.

The pipeline of tumor necrosis factor inhibitors’ biosimilar development is also active. Stelara (ustekinumab) is the next autoimmune biologic to lose exclusivity in 2023. There is no FDA-approved biosimilar to Stelara yet, but 9 biosimilars are in various stages of development with 2 pending FDA approval in 2023. Following Stelara, Simponi (golimumab) and Cimzia (certolizumab pegol) will both lose their exclusivity in 2024. The development of biosimilars to both molecules are underway. Potential launches are expected in 2024.

Enbrel’s extended exclusivity pushed biosimilar launch to 2029, even though 2 biosimilars to Enbrel (etanecept) have been approved by the FDA. Erelzi (etanercept-szzs) of Sandoz was approved in 2016, and Eticovo (etanercept-ykro) by Samsung Bioepis was approved in 2019. Lupin and Protheragen are both 

The long awaited biosimilars to Actemra (tocilizumab) are also near launch. Both Fresenius and Bio-Thera/Biogen are expected to seek FDA approval for their biosimilars to Actemra in 2023. Celltrion and Mycenax-Gedeon are expected to seek FDA approval for their biosimilars to Enbrel within the next 3 to 5 years. Xolair (omalizumab) will face biosimilar competition soon after 2024 with both Teva and Celltrion’s biosimilar candidates in phase 3 trials. Tysabri

natalizumab) will not loss exclusivity until 2026, but Sandoz-Polpharma already have a biosimilar pending FDA approval.

Novolog (insulin aspart) will face biosimilar competition from Mylan, Sanofi, and Amphastar in the next few years. All 3 companies have biosimilars to Novolog in development, and all are seeking interchangeability designation. Long-acting insulin, Lantus (insulin glargine) will also face more biosimilar competition in addition to the 2 biosimilar on the US market now: Semglee (insulin glargine-yfgn) and Rezvoglar (insulin glargine-aglr).

Ophthalmology agents saw biosimilar competition for the first time in 2022. There are 2 biosimilars to Lucentis (ranibizumab) available in the United States.Byooviz (ranibizumab-nuna) by Biogen was launched in July 2022. The interchangeable biosimilar by Coherus Biosciences, Cimerli (ranibizumab-eqrn), was launched in October 2022. 

The interchangeable biosimilar to Lucentis is expected to bring more competition, because many states allow automatic pharmacy level switching from reference product to the interchangeable biosimilars without the authorization of the physician who prescribed the reference product.

 Two more biosimilars to Lucentis are in phase 3 trials and expected to seek approval within the next 2 years. As least 9 biosimilars to Elyea (aflibercept) are in various stages of development. The first approval of Elyea biosimilar is expected in 2023.

Amgen’s receptor activator of nuclear factor kappa-B ligand inhibitor Prolia/Xgeva (denosumab) is going to lose its exclusivity by February 2025. Nine biosimilars to reference denosumab are in phase 3 trials.

 Soloris (eculizumab) will also loss exclusivity in 2025, and 2 biosimilars are in development when this report was written in 

Overall, although the acceptance of biosimilars in the United States is relatively slow compared to the European Union, the pace is increasing. This trend is 

 The launch of biosimilars and their utilization in United States health care facilities have reduced biologic medications spend and improved overall health system financial sustainability. The resulting cost savings and the increased access to care are expected to help improve overall population health outcome. 

The financial benefits and treatment accessibility these products offer may play a significant role in optimizing affordable access to critical biologic medications.

 Health system pharmacy leaders should develop and implement innovative, multidisciplinary biosimilar utilization programs to improve the adoption of biosimilars to increase financial sustainability and help to enhance health care industry post COVID-19 financial recovery.

IQVIA. The use of medicines in the U.S. 2022: usage and spending trends and outlook to 2026. April 21, 2022. Accessed December 28, 2022.Retrieved from: 

https://www.iqvia.com/insights/the-iqvia-institute/reports/the-use-ofmedicines-in-the-us-2022

AbbVie. 2021 annual report on Form 10-K and 2022 proxy statement. 2022. Accessed July 31, 2022. Retrieved from: 

https://investors.abbvie.com/static-files/91cf9d6a-8e6f-4059-9575-eda83b7e4623

IDP Analytics.Biosimilar Pipeline Report: Winter 2022/2023. December 2022. Accessed January 20, 2023. 

https://www.ipdanalytics.com/_files/ugd/96c908_3ed999c9b341406f9c1d7dce9e82607d.pdf

Humphreys SZ. Real-world evidence of a successful biosimilar adoption program. 

. 2022;18(16):1997-2006. doi: 10.2217/fon-2021-1584.

FDA. FDA-track: center for drug evaluation & research - pre-approval safety review - biosimilars dashboard. November 18, 2022. Accessed on December 25, 2022. 

https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-center-drug-evaluation-research-pre-approval-safety-review-biosimilars-dashboard

Alexion delays Soliris biosimilar until 2025. GaBI. August 28, 2020.Accessed January 2, 2023. 

https://www.gabionline.net/policies-legislation/Alexion-delays-Soliris-biosimilar-until-2025

IQVIA Institute. Biosimilars in the United States 2020–2024: competition, savings, and sustainability. September 29, 2020. Accessed January 20, 2023. 

www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024

Articles

Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health in Sacramento, California, details the regulatory decisions from 2022, what's to come in 2023, and how the US biosimilars market is expected to shift over the next 5 years.

Contributor: The US Biosimilar Market Outlook for 2023  

COVID-19 caused an overwhelming global health crisis. Worldwide, more than 176 million people were infected, and 38 million deaths were 

 by June 15, 2021. The United States had over 33 million confirmed cases and more than 600,000 deaths.

The pandemic was also devastating to global economic activity. COVID-19 caused an estimated economic loss of more than 

. In the United States, the gross domestic product (GDP) 

. The strain on health care was extraordinary.

COVID-19 caused 2 primary economic setbacks to the health care system in the United States. First, health care entities suffered reduced revenue and declines in volume. These were caused by the cancellation or postponement of elective procedures and outpatient visits, along with lower emergency department (ED) utilization. From January 2020 to January 2021, 

 Operating room utilization was reduced 16.6%. Overall adjusted discharges decreased by 17.6%. 

Second, the cost of care increased significantly due to increased labor, higher use of personal protective equipment, and medication utilization associated with the care of patients with COVID-19. Medication cost was affected more than other elements of the health care spend. For example, the average drug cost for each discharged patient* increased approximately 29%. However, the total expense for each discharged patient increased 19.6% (from February 2020 to February 2021). Clearly, there was a substantial increase in drug spend.

Midsize hospitals (200-299 beds) were hit the hardest. They saw an average increase in drug spend of 44.4%. These changes all negatively affected the health care industry’s financial performance. The March 2021 

 showed a 36% overall reduction of operating margin from February 2020 to February 2021.

Biosimilars Can Reduce Costs and Maintain High Quality Care

American health care systems large and small are actively seeking ways to increase revenue and decrease costs while providing appropriate care for patients with or without COVID-19. Many front-line clinicians have begun exploring new ways to reduce costs while maintaining the quality of patient care.

In recent years, most of the drug cost increases in the United States were due to large- molecule biologic medications. New specialty medications are among the primary drivers of the increase in overall drug costs. Most of these high-cost specialty medications are large-molecule biologic medications. In 2019, approximately $211 billion was spent on biologics, which was about 

There are generic products for small molecule chemical medications, but none for biologic medications, hereafter called reference products. Increasingly, there are biosimilars becoming available. These medications are highly similar in efficacy, safety, and immunogenicity to the reference products, but cost significantly less. This creates more competition in the biologic medication market. The combination of lower cost biosimilars and pressure on originators to reduce the prices of the reference products may help reduce overall costs of biologic medications writ large and 

reduce health care system financial burden

A strategic, comprehensive, and multidisciplinary medication utilization management program can enhance company-wide acceptance of biosimilars, decrease biologic medication costs, simplify workflow, and improve overall financial sustainability.

Since the first biosimilar product approval in 2015, a growing number of biosimilars have been approved by the FDA. In the past 2 years, significantly greater interest in biosimilars has been observed. This is partially driven by the increasing market share of biosimilar medications. According to Fortune Business Insights, the biosimilar market size will increase from $436 million in 2018 to $17 billion in 2026. The FDA strongly supports biosimilar adoption. There are now 29 biosimilar medications approved for use, replacing 9 original reference products (aside from insulin products). IQVIA has estimated savings in excess of 

 associated with the use of biosimilars over the next 10 years.

Challenges to Biosimilar Adoption in the United States

There are multiple challenges for biosimilar adoption in the United States. A pharmacist may not switch from the original reference product to a biosimilar product without the prescribing physician’s authorization. The only exception to this rule would occur if the biosimilar medication were interchangeable with the original reference product. Currently, there are no biosimilars approved by the FDA that are interchangeable with original reference products.

Another challenge to biosimilar adoption is that a biosimilar cannot be approved by the FDA until 12 years after the licensure of the original reference product, to allow the innovator company a fair opportunity for financial return. Sponsors of biosimilars need to do a patent landscape assessment and consider the risks of patent litigation. As a result, many FDA-approved biosimilars have a delayed launch date. Of the 29 noninsulin biosimilars the FDA has approved in the past 5 years, only 

Other factors hindering biosimilar adoption include physician and patient acceptance, third party payer preferences, and creative contracting by the original reference product manufacturers.

Innovative Management Tools Have Spurred Biosimilar Adoption

For decades, formulary decision makers developed different methodologies for medication utilization management. These were designed to reduce drug spend and increase access to care, while maintaining the quality of patient outcomes.

The emergence of biosimilars has created new opportunities to enhance and improve these tools. A strategic, comprehensive, and multidisciplinary medication utilization management program can enhance company-wide acceptance of biosimilars, decrease biologic medication costs, simplify workflow, and improve overall financial sustainability.

A real-world example of such a program is well underway at my health care institution, Providence St Joseph Health, of Renton, Washington. In the beginning of 2019, Providence developed and implemented a new biosimilar utilization management program. This program included clinical research and pharmacoeconomic analysis of available biosimilars.

Thereafter, Providence selected a preferred biosimilar to replace each original reference product for which biosimilars were available. These preferred biosimilars were built into the Providence electronic health record system as the default product for each molecule, which streamlined workflow for physicians and nurses. These initiatives saved Providence more than $27 million in the first 2 years.

New Laws May Help Improve Biosimilar Adoption in the United States

The market share of biosimilars in the United States remains moderate. Biosimilar adoption rates vary depending on launch date, therapeutic class, and indications, among many other factors. In general, the products launched earlier tend to have higher adoption rates. For example, the first filgrastim biosimilar was launched 6 years ago. The biosimilar market share has 

However, early launch does not guarantee favorable adoption rates. The biosimilar adoption rate for infliximab remains below 10% nationwide, 6 years after first launch. This medication is primarily used for maintenance treatment. Thus, biosimilar adoption faces more provider and patient hesitancy.

Some recent launches have done well. The biosimilars for 3 curative cancer biologics, bevacizumab, rituximab, and trastuzumab, were launched in late 2019, right before the COVID-19 pandemics. The adoption rate in the United States for all 3 molecules is expected to exceed 60% in 2021.

On April 23, 2021, President Biden signed The Advancing Education on Biosimilars Act, aimed at promoting biosimilar use and reducing drug cost. The supporters of this bipartisan bill hope to increase biosimilar confidence by educating providers and patients regarding the scientific background of biosimilar efficacy and safety.

The Growing Biosimilar Pipeline Holds Potential for More Savings.

The biosimilar pipeline is growing. Fifty-one percent of all reference biologic medications will face biosimilar competition in the next 5 to 10 years. There are currently more than 100 biosimilars, in various stages of development, seeking to replace 22 expensive, original reference products.These new biosimilars will generate even more savings for the health care industry. With interchangeable biosimilars on the horizon, there is considerable potential for biosimilars to reduce drug costs and enhance a financial recovery for health care. Indeed, IQVIA has estimated that biosimilars may generate over 

The rise in biosimilars is providing an exciting opportunity to improve health care sustainability. Innovative medication utilization management programs, with a biosimilar medication focus, can help health care organizations improve patient access to large molecule biologics, maintain high quality patient outcomes, and accelerate post-COVID-19 financial recovery.

*The figures cited for discharged patients are based on the adjusted discharge, a calculation health care systems use to incorporate both inpatient and outpatient revenue in the evaluation of financial performance to gain an understanding of the productivity of the entire organization.

Sophia Z. Humphreys, PharmD, MHA, explains how biosimilar utilization management can enable health care institutions to put COVID-19–related financial wreckage behind them.

Opinion: Biosimilars Can Aid in Post–COVID-19 Health Care Financial Recovery

American healthcare spending reached $3.65 trillion in 2018. Of that, $344.5 billion was spent on prescription medications, a 30% increase compared with 2013. This was largely due to significant drug price increases over the past 5 years. Notably, the price of brand-name medications increased 60% on average, while the price of generic medications decreased. According to the IQVIA Institute for Human Data Science, new specialty medications are among the primary drivers for this increase in overall drug costs. The majority of these high-cost specialty medications are large-molecule biologic medications. There are generic alternatives for small-molecule chemical medications, but not for biologic medications. However, there are biosimilar medications that compete with these high-cost reference compounds.

Providence St. Joseph Health (PSJH) is the third largest nonprofit healthcare system in the country, with 51 hospitals and over 800 clinics. The PSJH system pharmacy division developed a medication utilization management (MUM) program that promotes biosimilar acceptance, supports contracting negotiation, streamlines physician workflows, simplifies pharmacy operations, and improves performance evaluations. This program saved PSJH nearly $10 million in biologic medication spending in 2019. This article shares the details of PSJH’s real world success in promoting biosimilar uptake.

Since the first biosimilar product was approved by the FDA in 2015, increasing numbers of biosimilars have been approved each year. There were 3 approvals in 2016 and 5 in 2017. In the past 2 years, we observed significantly higher interest in biosimilars, which was accompanied by more FDA approvals: 7 in 2018 and 10 in 2019. Many more agents are in the pipeline. As of the end of 2019, the FDA had approved 26 biosimilars for 9 reference compounds. Sixteen biosimilars are now on the US market.

These biosimilars are highly similar in efficacy, safety, and immunogenicity to the reference compounds. They cost significantly less than the reference compounds. Thus, they create more competition in the biologic medication market and force the reference compound manufacturers to lower prices.

Biosimilars have been widely used in Europe since 2006. In the past 13 years, they have been used for 400 million patient days. The biosimilar products for filgrastim increased patient access in the United Kingdom by 44% between the years 2006 and 2013. IQVIA projected the European Union will see almost US $11 billion in savings on biologic medications between 2016 and 2022, contributing to the utilization of biosimilars.

Unfortunately, the biosimilar uptake in the United States has not been as robust as in Europe. One reason is that United States law regulates biosimilars and interchangeable biosimilars differently. In many states, a pharmacist may not switch a reference compound for its biosimilar product without the prescribing physician’s authorization, unless it is an interchangeable biosimilar. Currently, there are no interchangeable biosimilars approved by the FDA. The FDA finalized its guidance to the industry for interchangeable biosimilars only recently, in May of 2019, which explains why we have not seen any interchangeable biosimilars.

Biosimilars often face patent litigation. Thus, many FDA-approved products have a delayed launch date. Reference compound manufacturers also offer significant financial incentives to third-party payers in the form of a rebate, which slows down payer uptake of biosimilars. Furthermore, healthcare systems often face volume-based tier prices, rebates, and other contracting methodologies utilized by reference compound manufacturers to maintain market share. These can hinder biosimilar adoption. In addition, physicians and patients have limited experience with biosimilars. Their slow acceptance can be another hindering factor for biosimilar uptake.

Healthcare system pharmacy leadership teams should establish various policies, procedures, and MUM programs to reduce cost without sacrificing the quality of patient care. The emergence of biosimilars has introduced new challenges and opportunities. The following discussion outlines strategies for successful utilization management of biosimilars.

Employing Japanese Principles to Increase Savings

The design of the PSJH MUM program was based on Toyota’s kaizen principle. We aimed at reducing variation, increasing efficiency, and standardizing practice. In order to achieve that, we built tools in the electronic health record (EHR) system (PSJH’s EHR system is Epic) to guide the physicians to preferred biosimilars. The EHR-guided prescribing streamlined physician and pharmacist workflow, simplified the biosimilar ordering process, and improved efficiency. However, we used a different EHR model for outpatient infusion centers. This used the PSJH-preferred product as the default biosimilar, but outpatient physicians were still allowed the freedom to prescribe reference compounds or different biosimilars, if the patient’s payer preferred them.

PSJH implemented 4 biosimilar-focused MUM initiatives in 2019. These initiatives reduced spending on high-cost biologic medications that had biosimilars in the US market. Three of the initiatives led to significantly lower outlay for the reference compounds, and the remaining initiative for a single reference compound had a less-meaningful spending reduction (Figures 1-4). All of these results were achieved by using Epic-guided prescribing to lower cost via the use of equally efficacious biosimilars instead of more expensive reference compounds. The following graphs summarize the correlation between the changes of biologic medication spending and the Epic-guided prescribing go-live date, which is marked “Epic” in the figures below. All medication spending is displayed in thousands of dollars. In some cases, declines in the use of reference biologics began prior to the initiation of the Epic system, although pronounced declines generally followed Epic implementation.

Figure 1. Spending Decline for Pegfilgrastim Reference Biologic (Neulasta & Neulasta Onpro)

Figure 2. Spending for Infliximab Reference Biologic (Remicade)

Figure 3. Spending Decline for Epoetin Alfa Reference Biologic (Procrit/Epogen)

Figure 4. Spending Decline for Filgrastim Reference Biologic (Neupogen)

It is important to closely monitor the biologic medication pipeline, evaluate relevant clinical data, and develop an expedited formulary review and approval process. The formulary status of all biosimilar products for the reference compounds should be approved, before products launch. In this way, multiple biosimilars will be on the formulary. This can enhance the negotiation power of contracting teams and improve the ability of healthcare systems to choose biologics on the basis of cost, other things being equal.

Healthcare systems should also build tools in their EHR systems to guide physician prescribing of the preferred biosimilars. EHR-guided prescribing streamlines physician and pharmacist workflow, simplifies the biosimilar ordering process, and improves efficiency.

Pharmacoeconomic analysis is a crucial part of medication utilization management. The pharmacy team must evaluate the full financial benefit of biosimilars in different healthcare settings. Inpatient and outpatient billing and reimbursement methodologies are different; therefore, the financial impact of biosimilars will vary. Inpatient reimbursement is usually based on diagnosis-related group, or DRG, so the lowest-cost biosimilar should be chosen as the preferred product. In contrast, outpatient reimbursement depends on payer preferences. Before switching a patient from the reference compound to a biosimilar, the pharmacy should work closely with the business office and revenue cycle teams to obtain prior authorization and evaluate net profit.

The impact of biosimilars can also vary depending on the account types. Healthcare systems pay one price for a group purchasing organization purchase and a different price for a wholesale acquisition cost purchase. 340B Drug Pricing Program accounts are particularly interesting. Pursuant to the new CMS reimbursement methodology, biosimilar products within the “pass-through period” will be reimbursed at the average sales price (ASP) plus 6%, instead of ASP minus 22.5% for the reference compound. Thus, by selecting a newer biosimilar product (within the pass-through period) for 340B-qualifying patients, a healthcare facility will save money by purchasing a lower-cost product and receiving a greater reimbursement than for the reference compound or older biosimilars (which are no longer in the pass-through period).

This type of program requires collaboration among pharmacists, physicians, data scientists, finance analysts, business office personnel, and healthcare informatics professionals. The resulting cost reductions and the increased access to care will help improve patient clinical outcomes.

In conclusion, this comprehensive, multidisciplinary medication utilization management model can enhance system-wide acceptance of biosimilars, decrease biologic medication cost, simplify physician workflow, and improve overall pharmacy sustainability.

Providence St. Joseph Health used Toyota’s Kaizen system of nonvariance and standardization to build a model that increased use of biosimilars among physicians. The model employed the electronic health record system to guide physicians toward use of biosimilars, thereby increasing savings.