The advent of biosimilar medications has offered the promise of significant cost savings for healthcare systems and patients. Biosimilars are highly similar versions of existing biologic drugs, providing a more affordable alternative once the original biologic patent expires. However, the adoption of biosimilars in the U.S. has been hampered by myriad roadblocks, many of which have placed clinicians in an ethical quandary.
At the heart of this issue is the fundamental clash between the ethical principles that guide a physician’s practice and the economic realities of the healthcare system. Physicians, who have taken an oath to do no harm and act in the best interests of their patients, find themselves navigating a complex landscape in which restrictive formularies and financial considerations clash with their ethical obligations.
Restrictive Formulary Policies, Complex Rebate Structures
One of the primary roadblocks to biosimilar adoption is their placement within formularies created by insurance companies and their associated entities. Pharmaceutical companies have employed a range of tactics to maintain the market dominance of their original biologics, even in the face of biosimilar competition.
Many insurance companies and pharmacy benefit managers (PBMs) have implemented restrictive formulary policies that limit the use of biosimilars, either by requiring patients to try the more expensive original biologic first or by financially incentivizing the use of the original product. These policies are often driven by the complex use of rebate traps and discount structures negotiated between pharmaceutical companies, insurers and PBMs. Physicians, who are tasked with prescribing the most medically appropriate treatments for their patients, find themselves in a challenging position. When the negotiated financial margin for the original biologic is more favorable than that for the biosimilar, payers often mandate that physicians must first attempt treatment with the original product, even if it is not the most cost-effective option for the patient.
The Medical Necessity Dilemma
Adding to this ethical challenge is the issue of medical necessity. Although biosimilars are recognized as an effective treatment, financial dynamics can complicate their adoption. When a payer mandates the use of a biosimilar, but the patient is doing well on the original biologic, it creates a challenging scenario.
Traditionally, physicians have been the primary decision makers regarding the most appropriate treatments for their patients, guided by their clinical judgment and the unique needs of the individual. However, when payers impose step-edits or other utilization management policies that require switching for non-medical reasons, it can hinder physicians’ ability make the best decisions for their patients. In such cases, physicians may feel ethically compelled to keep their patient on a prescribed original biologic, which they believe is the most medically appropriate option, but they are often economically compelled to change to a biosimilar.
A Slippery Slope
When physicians are forced to prioritize financial considerations over patient well-being, it can lead down a slippery slope of compromised care. Patients may be denied access to the most appropriate treatment, either because the physician is financially incentivized to prescribe the most expensive original biologic or because the healthcare system has erected barriers to the use of the biosimilar.
This can have devastating consequences for patients, particularly those with chronic or complex conditions that require ongoing biologic therapy. Patients who are unable to afford the original biologic therapy may be forced to delay treatment or forgo treatment altogether, leading to worsening of their condition, increased hospitalizations and a diminished quality of life.
The Ethical Imperative for Advocacy & Reform
Given the profound ethical implications of the barriers to biosimilar adoption, physicians have a moral obligation to advocate for systemic reforms that align financial incentives with the provision of high-quality, affordable care. This may involve challenging the restrictive formulary policies that discourage the use of biosimilars, pushing for changes to the buy-and-bill reimbursement model, and educating policymakers and the public about the benefits of biosimilars.
Physicians can also collaborate with patient advocacy groups, professional organizations and healthcare policy experts to develop and promote fair, adequate and transparent reimbursement with shared-saving models, and develop and promote policies that enable them to fulfill their ethical obligations without being unduly burdened by financial considerations.
Resolving the medical necessity dilemma requires a collaborative and transparent dialogue between payers, physicians and patients. Payers should be willing to engage with physicians to understand their concerns and consider exceptions or appeals processes when the physician can demonstrate a legitimate medical necessity for an original biologic over a biosimilar. Physicians, in turn, should be prepared to provide clear, evidence-based justifications for their treatment recommendations and work to educate payers on the nuances of individual patient needs. This includes using transparent and fair reimbursement models and explaining how biosimilars can enhance patient access to essential treatments while also reducing overall healthcare costs.
Ultimately, the goal must be to create a healthcare environment that empowers physicians to make decisions based on the best interests of their patients, rather than being constrained by the economic realities of the system. By advocating for reforms that prioritize patient well-being and the responsible use of healthcare resources, physicians can help ensure the promise of biosimilars is realized and that all patients have access to the most affordable and effective treatments available.
Biological treatments represent enormous progress in the management of patients with rheumatic diseases. Nonetheless, the cost issues are significant. There is no bottomless pit of financial resources for healthcare in the context of competing societal needs, such as public safety, education, national defense, maintenance of infrastructure, environmental protection and other social goods. Unless a claim can be made and defended that healthcare expenditures should have priority status over all other social goods, choices must be made.
The availability of biosimilars should represent a partial strategy to improve access and to contain costs. That outcome is contingent on a level playing field and pricing transparency in what should be improved access to less costly products with comparable safety and efficacy profiles. This is a timely matter of distributive justice—the ethical choice of how to fairly allocate finite social resources.
Karen Ferguson, MS, is a seasoned healthcare executive with more than 20 years of leadership experience, including her role as past practice administrator at Arthritis Northwest PLLC. Currently, she is the founder and president of Our Stories Rx, a 501(c)(4) organization dedicated to using interactive storytelling to advocate for policy improvements that enhance the health and well-being of vulnerable patient populations and their care teams.
Richard L. Allman, MD, MS, FACP, FACR, was the associate program director of the Internal Medicine Residency Program, Einstein Medical Center in Philadelphia from 2002–2017, and the interim chair of rheumatology at Einstein Medical Center from 2017–2020. He is an associate professor of medicine at Sidney Kimmel School of Medicine of Thomas Jefferson University, the clinic preceptor for internal medicine residents and the lead ethics consultant at Jefferson Einstein Medical Center.
