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John Bujnoski is Managing Director of Pangea Advisory and Consulting, LLC, a strategic marketing consulting firm focused on the specialty biopharmaceutical and biosimilar market segments. John has extensive global biopharmaceutical industry expertise including extensive knowledge and understanding of the global market environment including pricing, market access, and reimbursement systems.

John Bujnoski

Safaraz Niazi, PhD, is an adjunct professor of biopharmaceutical Sciences at the College of Pharmacy at the University of Illinois at Chicago. 

Sarfarzaz K. Niazi

George C. Yu, JD, is a partner in the Intellectual Property group of Schiff Hardin LLP. He is an experienced patent attorney who focuses his practice focuses on patent infringement litigation and counseling and has worked in private practice and in-house positions. George has litigated patents relating to recombinant proteins, monoclonal antibodies, microarray technology, and small molecule therapeutics. George has advised companies developing novel biologics as well as biosimilars on patent strategy.

George C. Yu, JD

Coronavirus disease 2019 (COVID-19) altered the workflow in all areas of the health care and life sciences industries. The FDA was not exempt from pandemic-induced upheaval. Meetings of advisory committees, which provide the FDA with expert advice on scientific, technical, and policy matters, were often postponed, and although drugs were still reviewed and approved, significant delays occurred.

From the start of the United States’ response to the COVID-19 pandemic in March 2020 until late summer, 2 biosimilars were 

: Hulio (adalimumab) and Nyvepria (pegfilgrastim). This represented not only an improvement in patient access and affordability of life-changing medications, but also a slowdown in biosimilar approvals.

In previous years, biosimilar approvals had steadily increased. As shown in the figure, the projected trend suggested approximately 12 biosimilar approvals for 2020 and 14 for 2021.

The trend line for biosimilar approvals suggested 2020 would be another strong year for the emergence of these lower-cost therapies; however, just 2 had been approved by the midyear point.

Although other factors came into play, such as patent expirations and product development, it appeared unlikely that the total of 12 biosimilar approvals would be achieved in the final quarter of 2020, and there was even potential for this slower pace to extend into 2021.

There were other reasons why patient access did not improve as expected. Typically, once manufacturers receive biosimilar approval, many face 

 that delay products from reaching the market promptly. These court cases often are purposely filed to interfere with market access to a new product. In some cases, “

” agreements postpone market entry of a biosimilar for many 

The COVID-19 crisis extended these delays because court systems temporarily closed to prevent spread of the virus and reopenings were late or occurred only in stages. Well into 2020, virus hot spots 

 to stall judiciary system operations, adding to the time needed to achieve market access for these new therapy options.

In addition to regulatory and judicial barriers, the overwhelming workflow within health systems also played a role in limiting access to new therapies. When health care facilities are in crisis mode, many components of the reimbursement and education processes, each of which is vital for biosimilar uptake, are hindered. 

Pharmacy and therapeutics (P&T) committees are necessary for ensuring new therapies will be included in the health care facility formulary. From the start of COVID-19, P&T meetings were often conducted virtually or 

 on evaluating emerging therapies for COVID-19 treatment, leaving little time for consideration of other formulary additions. With so much focus on COVID-19, little time was allocated to much else.

Within hospitals, the same was true regarding in-service education for physicians. With a need to educate physicians on current protocol, diagnostics, and treatment surrounding COVID-19, there was not much time left to educate on biosimilar therapies and novel agents.

“Lunch and learn” programs were likely on hiatus during the pandemic due to social distancing requirements, understaffing, and a strain on funding. Gathering professionals into a conference room could not be prioritized over keeping everyone safe.

Typically, many facilities partner with manufacturers to supply marketing materials and food to lunch and learns, and a clinical staff member presents on the topic at hand. As manufacturer field teams were grounded, less information reached the health care providers. Most nonessential visits were prohibited to prevent unnecessary risk of virus spread. These grounded professionals included sales representatives who provide information about new products, field reimbursement specialists who assist in getting products approved by the health plans, and medical science liaisons who can discuss new products on a higher level. These professionals were not as physically active as the pandemic unfolded and virtual methods of interaction were implemented.

If new therapies, including biosimilars, were not approved by the FDA, litigated promptly in the courts, cleared for formulary placement, or explained to physicians, it is unlikely patients were learning much about them. Especially when it comes to biosimilars, patients need to be aware of their potential options and the associated benefit of cost savings. With COVID-19, the nation entered a time of financial instability and loss of health care coverage, and these new therapy options became even more important for safe and affordable health care.

Coronavirus disease 2019 altered the workflow in all areas of the health care and life sciences industries, and the FDA was not exempt from pandemic-induced upheaval.

The Pandemic's Multilevel Effect on Patient Access

Amanda DeMarzo, PharmD, MBA, PACS, is the associate director of Patient Access with the National Board of Prior Authorization Specialists, an affiliate of the Accreditation Council for Medical Affairs, based in Oradell, New Jersey. She focuses on how to improve the current health care system as a whole through improved training, widespread certification, and advanced technology for better patient outcomes. She developed a passion for patient-centered care and shared decision making during patient-facing roles over the last 8 years.

Amanda DeMarzo, PharmD, MBA, PACS

The House of Representatives has approved the bipartisan 21st Century Cures legislation, which includes funding for innovative research and provisions to speed up the drug approval process.

By a vote of 392-26, the House approved the 21st Century Cures Act. The House had passed an earlier version of the bill in July 2015 but continued to revise and update it, releasing the most recent draft of the bill last week. These updates included provisions for mental health, substance abuse, and child and family services.

Members of both political parties have been vocal in their support of the legislation, often citing its passage as a top priority during the lame-duck Congressional session. Prior to the election, Senate Majority Leader Mitch McConnell, R-Kentucky, had said it “could end up being the most significant piece of legislation we pass in the whole Congress." 

House of Representatives Approves Bipartisan 21st Century Cures Legislation

Christina Mattia

Gregory Schimizzi, MD, is a co-convener of the Biologics Prescribers Collaborative (BPC) and the cofounder of Carolina Arthritis Associates, PA, in Wilmington, NC.  He has been a licensed and board-certified rheumatologist in private practice for 30 years. He co-founded, and previously served as president, of the Coalition for State Rheumatology Organizations (CSRO). He has also previously served as president, and a member of the executive board, at the North Carolina Rheumatology Association. Dr Schimizzi completed his undergraduate and medical school studies at Wayne State University in Detroit and completed his fellowship training at the University of California at Irvine.

Gregory Schimizzi, MD

In a move that may reduce burnout for providers and get needed medications, such as biosimilars, into the hands of patients faster and with less hassle, CMS has established a new 

on prior authorizations and the electronic exchange of health information.

The system sets deadlines for payers to approve or deny urgent requests for health care, requires them to provide reasons for their decisions, and incorporates the use of electronic interface applications that facilitate the communication of health records information between providers and payers.

Seema Verma, administrator of CMS, has described the “new rule” as a 

from “Stone Age” reliance on fax machines; a move that gives patients, payers, and providers ready access to patient data; and an end to “mindless nitpicking and wrangling” over patient entitlements to care.

She described the rule as “the result of numerous listening sessions with plans and providers aimed at crafting a new process that balances the need for greater efficiency and consistency in prior authorization with its important role in preventing fraud, abuse, and unnecessary expenditures.”

The new policy was developed by the Office of Burden Reduction and Health Informatics, which CMS created in June 2020 specifically to increase the efficiency of health information transfers and ease regulatory and administrative burdens faced by providers.

CMS also hopes to see a reduction in repeated requests for prior authorization and an overall reduction in health care costs.

The new CMS Interoperability and Prior Authorization rule affects Medicaid and Children’s Health Insurance Program (CHIP) managed care plans, state Medicaid and CHIP fee-for-service programs, and issuers of individual market Qualified Health Plans on the federally facilitated exchanges. These payers would have to implement software to allow the smooth flow of electronic health information about patients and assist with prior authorization.

The deadlines affecting maximum response time for prior authorization requests go into effect on January 1, 2024. For nonurgent requests, payers will have a full calendar week to respond.

“For patients, there will be no more wrangling with prior providers and locating ancient fax machines to take possession of one’s own data; for providers, there will be no more piecing together patient health histories based on incomplete, half-forgotten snippets of information pried out of the patients themselves; for payers, this is the first step towards building the important data sharing systems we need to move towards value,” Verma said.

last year, prior authorizations were cited as a growing burden on physicians, 91% of whom said they believe prior authorization requirements delayed patients’ access to care and 88% of whom said the burden of these requirements has increased in recent years. 

CMS looks to speed up health information transfer by putting faxes in the past. It also aims to set deadlines for payers to respond to prior authorization requests. 

With New Policy, CMS Promises to Exit "Stone Age" of Health Information 

Tony Hagen is senior managing editor for The Center for Biosimilars

Tony Hagen

Entering 2020, we have the opportunity to take a moment, look back, and reflect on the lessons learned of the previous decade with regard to biosimilars. The road to a successful biosimilars market has been anything but straightforward. With complications including a slow rate of approval, extended delays in product launches due to patent litigation, or the small and incremental degree of economic impact, it’s easy to become frustrated and question whether or not biosimilars represent an economically prudent investment in the new decade. 

While I would not argue with anyone that we should expect more from the biosimilars opportunity, simply throwing the baby out with the bathwater at this point would be a monumental mistake that fails to see the growing opportunity the space provides us. Essentially, these hurdles are not as insurmountable as they appear and can be managed if we focus our approach at the appropriate obstacles and recognize the benefits to continued biosimilar development beyond simply the primary goal of lowering the price of biologic drugs. 

The Elephant in the Room: What is a Fair Price?

While the question of pricing is critically important, we must also acknowledge the other structural and economic realities of drug prices. One prominently articulated alternative to biosimilars is the implementation of pricing regulation for biologics after they reach the end of their exclusivity period. This approach would attempt to establish a “fair price” at which an originator biologic will be sold that is intended to include all of the expenses associated with biologic development and the ongoing supply of that product. However, there are several issues with this concept that should be addressed:

Given the current political landscape, it appears rather remote that agreement on a price setting process for biologics or any other pharmaceuticals could be established within the near future.

The creation of this “fair price” would require a degree of transparency from the pharmaceutical industry far beyond anything that presently exists. Currently, there are little if any details concerning the true cost of drug development, high quality manufacturing, and consistent supply. 

The most challenging aspect of this endeavor would be establishing an agreed upon definition of a “fair price.” Given the number of stakeholders involved in and impacted by the pricing of pharmaceuticals, it appears highly unlikely that these participants would agree to a threshold for profit generation.

Realigning our Understanding of Biologics, Generics, and the Concept of Cost

Much of the recent frustration with biosimilars stems from our previous experience with generics. Over the last 35 years, generics have demonstrated that competition can drive dramatic savings with the value being recognized almost immediately. The simplicity of the molecules and the well-established mechanism of declaring products interchangeable, creates a clear pathway for competition. However, the US healthcare market is now closing in on the second decade of a drug shortage crisis that has primarily centered on the persistent and extended interruptions in the supply of hundreds of generic medications.

As a result, we must re-examine our traditional perspective that it is always easy to create generic drugs and always hard to create biosimilars. We have learned that all pharmaceuticals require a great degree of due diligence and commitment to quality. Perhaps the modest barriers to generic entry have been too low to ensure a long-term and consistent availability of high-quality small molecule drugs. Rather than stopping biosimilar development, we should use this ongoing experience to improve our understanding of safe, effective, and sustainable manufacturing for all medications.

A Holistic Approach to Enter the New Year

We are still early in the biosimilars experience and are continuing to make strides in addressing many of the challenges that have slowed and diluted the extent of financial impact. Even with these challenges, the future of biosimilars looks exceedingly bright. According to a report by Global Market Insights, by 2025 the global biosimilars industry is poised to surpass a valuation of $69 billion. However, that will be merely a dream if we are unable to address those hurdles. So what are our next steps? 

Physicians and other clinicians need to understand the concepts of risk management to avoid unnecessary apprehension. If clinicians become more comfortable with the analytical characterization methods to monitor changes in biologics, we move closer to a day when redundant clinical studies are no longer required.

The manufacturing of biosimilars must be monitored closely to avoid any negative impact on product quality. An increased degree of scrutiny of small molecule drugs, including generics, is also important.

We must continue to leverage our advocacy capabilities to remove additional barriers such as the use of excessive patenting to delay the introduction of competition.

Long-term resolution to our challenge of lowering the cost of medications must at some point address the way in which providers are reimbursed. As long as physicians and other providers are reimbursed in a way that higher acquisition costs lead to larger reimbursement opportunities, acceptance of competing products, biosimilars or other, will continue to be limited.

Hurdles to a vibrant biosimilar market are not as insurmountable as they appear.

Understanding the Risks, Opportunities, and Prospects of Biosimilars in 2020 and Beyond

Steven Lucio, PharmD, BCPS

Mauricio Rubio is a pharmacist with advanced studies in administration, and he is currently a master of business administration candidate. He has 13 years of experience in sales, marketing, and business development in Latin America for pharmaceutical and consultancy companies. He has participated as a speaker in the Jack Leckerman Biosimilars Forum in 2018 and 2019.

Authors