Biosimilars in the United States: Current Status and Future Implications
Biosimilars in the United States: Current Status and Future Implications
May 03, 2018
6 min read

Concerns over nonmedical switching of biologics spur physician guidelines

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Greg Schimizzi
For patients with chronic illnesses, such as rheumatoid arthritis, multiple sclerosis and cancer, the introduction and development of biologic therapies has been a significant boon to their health and quality of life. Still, the process of finding the correct regimen can be painstaking, and involve months, or even years, of trial and error before a physician and their patient find a therapy that works for their individual case.

This is where the practice of nonmedical switching can wreak havoc on not only a patient’s treatment, but their well-being and trust in the health care system. Even if a patient has been stable on a treatment regimen for years, their insurer, based on formularies that potentially change each year, can compel them to abandon their therapy for lower-cost alternatives, for reasons other than their health and well-being. In fact, according to experts, the reasons for nonmedical switching often have more to do with economics and profit margins.

“The problem with nonmedical switching is that it has the potential to undermine and harm patient care,” Greg Schimizzi, MD, cofounder of Carolina Arthritis Associates, in Wilmington, North Carolina, told Healio Rheumatology. “It can also decrease the physician’s and the patients’ ability to have faith in the pharmaceutical supply chain and insurance coverage for patients with chronic illnesses.”

Nonmedical switching can wreak havoc on not only a patient’s treatment, but their well-being and trust in the health care system.
Source: Shutterstock

A rheumatologist in private practice for 30 years, Schimizzi is a member of the Alliance for Patient Access (AfPA), and a leader of that group’s Biologics Prescribers Collaborative, which was created to educate physicians and policy leaders about the safe use of biologics and biosimilars for all patients.

Troubled by the practice of nonmedical switching, the collaborative in March finalized and released a series of principles and guidelines aimed at helping physicians and lawmakers navigate the reality of treatment with biologics, with particular consideration given to the recent availability of biosimilars.

Destabilizing the patient

According to Schimizzi, nonmedical switching can trigger anxiety in a patient and introduce instability in treatment.

“Physicians and their patients, particularly in rheumatology, work very hard to maintain control of their disease, and sometimes it can take four different medication trials before a patient is finally stabilized,” he said. “Once a patient is stabilized, it is important not to discontinue or switch the medicines unless there is sound medical reason to do so.”

Schimizzi added that the practice also forces physicians to struggle with the insurer in an appeals process that can require filling out prior-authorization forms, writing letters of medical necessity, or even contacting the medical director of an insurance company to ask for an exception. All of these actions take time that they could use to see and care for other patients, he said.


Joseph Huffstutter

Joseph Huffstutter , MD, a practicing rheumatologist for the past 33 years, partner at Arthritis Associates in Hixson, Tennessee, and vocal critic of nonmedical switching, said the practice can also introduce health risks for patients.

“Every time you try a drug on a patient, it is an experiment,” Huffstutter, a member of the AfPA’s National Physicians Biologic Working Group, told Healio Rheumatology. “You don’t know what kind of effect it can have on an individual patient. Changing drugs with a patient is not uncommon, but it’s because there was a lack of efficacy, or there was a problem with toxicity, not economics. There is no data to show what happens to people who are stable on drugs when you try these other drugs.”

This is particularly the case with biosimilars, which have the potential to significantly reduce costs for patients but can also complicate treatment when they are substituted for tested biologics, he said.

Dennis R. Cryer

“Often a patient will be stable, and then for whatever reason there will be a hiatus where they do not receive the drug, but then they are re-challenged, and that leads to an injection site reaction, or an infusion reaction,” Huffstutter said. “Something that could have been avoided if they were able to maintain that drug.”

According to Dennis R. Cryer, MD, FAHA, chief medical officer of CryerHealth, in Washington, D.C., and another leader of the Biologics Prescribers Collaborative, the most significant concern regarding biosimilars and nonmedical switching, at least initially, was safety. Particularly, there was a concern that a new biosimilar would have different immunogenicity and adverse effects than, or fail to be as efficacious as their tested and established originators, he said.

“As more data has come out, these concerns have been allayed a bit, by virtue of the fact that studies don’t seem to show a high rate of treatment failure,” Cryer said. “However, much of that research has to be done prior to approval. That is what makes us very nervous. If there isn’t a lot of research, there is a chance you will be missing things.”

Most biosimilar approvals are based on chemical and physical analyses, Cryer noted, and although these tests are exceedingly detailed and sophisticated, they are not primarily based on clinical data.

“For me, that makes me very uncomfortable,” Cryer said. “We encourage the FDA to require tighter pharmaco-vigilance after a drug is approved. We need to watch what goes on after approval very carefully, and we have included that in our guidelines.”


A call for change

The new recommendations released by the collaboration on nonmedical switching include two governing principles: The physician-patient relationship must be protected to ensure the best outcomes; and patients stabilized on a biologic therapy should not be forced to undergo a nonmedical switch.

For Cryer, protecting the patient-physician relationship is critical to the patient’s health and well-being.

“Anything that may work against that really concerns us,” he said.

In addition, there are four guidelines aimed at physicians and policy leaders:

  • To ensure patients can access the right therapy for their condition, streamlined authorization and appeal processes should exist when a patient is faced with a nonmedical switch;
  • Robust scientific and clinical data must inform nonmedical switching;
  • Vigorous pharmaco-vigilance must be in place to track adverse events related to nonmedical switching; and
  • A nonmedical switch should not increase patients’ other medical expenses.

Addressing the first guideline, Schimizzi noted that current prior-authorization forms vary wildly from insurer to insurer and can range from one to 14 pages in length.

“This is the same thing as rationing medication, through inconvenience,” Schimizzi said. “They make it so difficult to keep patients on medication that they need. It makes you want to pull your hair out.”

Cryer added that the principles and guidelines are intended not only for physicians, but to help educate policymakers as well.

“We wanted to be able to do this for our members to use,” he said. “It is also being made available to inform the federal government, including the people in the FDA who are approving biosimilars. We believe it is a good framework for people who do policy, and we are trying to disseminate as wide as we can.”

Looking onward

In terms of future goals, Cryer stressed the importance of developing biosimilars to their “next stage of evolution,” which he said will be interchangeability — or biosimilars that will allow patients to “switch back and forth” between them and the originator for treatment.

“It will give everyone a higher level of confidence and comfort,” Cryer said. “Presumably, there will be a much higher requirement for clinical evaluation of switching, and it will have to be proven that the patient can be switched back and forth between the originator and the biosimilar without any change in efficacy and safety. It will be a very rigorous process.”

Although the guidelines can be an important mission statement and tool for policymakers, the underlying issues at the heart of nonmedical switching remain, particularly the high cost of medical care.


According to Huffstutter, the rising costs of health care is one of the key obstacles that must be cleared in the coming years, coupled with an approach that makes new, lower-cost treatments available to patients without forcefully depriving them of the trusted therapy regimens they have come to rely on.

“The pharmacy benefit managers are right in that certain therapies are incredibly expensive, and we need to bring those costs down — patients understand that,” he said. “However, when it comes to an individual patient, until we have systems to broadly address this issue, we are jeopardizing the health of our patients with the approach we have now. I think it’s going to take a different approach to really try to make sure that these wonderful treatments are available and affordable to the people who need them.”

For Schimizzi, the only way to truly address the issue of nonmedical switching will be to provide a focus on the status quo of the insurance industry, and continue to call for effective laws and regulations.

“We have to shine a light on what insurers and pharmacy benefit managers are doing to all of us — patients and physicians,” Schimizzi said. “To shine a light on this will change the dynamics and help change the conversation with our legislators, who need to get on board and help us address this problem. We need oversight where necessary and regulations regarding these practices, because some of these practices should be outlawed. Nonmedical switching is basically practicing medicine without a license, and they shouldn’t be allowed to do that.” – by Jason Laday

Disclosure: Cryer, Huffstutter and Schimizzi report no relevant financial disclosures.