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.
