By Brad Klein, M.D.
Philadelphia Business Journal, March 27, 2014
Imagine seeing a patient who was once dependent upon a cane begin to move about unassisted.
I know firsthand how this feels, thanks to the success of one of my neurology patients with a biologic medication. These medications hold particular significance now, as the Pennsylvania legislature debates whether physicians should be notified when their patients receive a substitution, a “biosimilar,” at the pharmacy counter, instead of what the doctor originally prescribed. I urge caution, and encourage broader education, on this nuanced and important issue.
Many Americans may not yet know biologics as such. Derived from the cell lines of living organisms, these are highly complex, highly sensitive drugs. And they offer tremendous potential for patients. Several of my patients suffering from MS, for example, have seen their relapse rate reduced from multiple episodes a year down to a single relapse – with the help of biologics.
But the drugs’ efficacy depends heavily on their make-up. Consider the biologic often used to treat muscle spasticity or dystonia. If replaced by a biosimilar that’s too potent, the agent might move beyond the injection site, risking unintended paralysis, aspiration or unintended immune reactions in the body. Significantly less potent biosimilars can also harm patients if they are not as effective as the original biologic.
Why the dramatic difference in results? Well, notice the “similar” in “biosimilar.” These substitutes are like, but not identical to, the substance they imitate. Unlike traditional medications, easily duplicated by following a standard recipe of chemicals, biologics stem from living cells and assume complex molecular structures. So despite popular misconception, biosimilars are not simply generic variations of biologics. They are separate, different substances altogether.
That’s not to say that biosimilars are inherently problematic. Their efficacy remains to be seen. But, in the meantime, physicians cannot be kept in the dark about which medications their patients consume.
Just consider weeks or months in the course of a biologic treatment that isn’t offering the expected benefits – because, unbeknownst to the doctor, his patient is in fact taking a biosimilar that proves less effective. Treatment goes awry. New symptoms or side effects emerge. The doctor may order more diagnostics, incurring unnecessary cost for the patient. He may even admit the patient to the hospital to treat what is, essentially, a case of misinformation.
This chain of events proves particularly ironic because insurance companies encourage substitution primarily as a cost containment measure. But for patients, the cost of physician ignorance can transcend dollars and cents. Patients, eager for improvement, can miss out on the biologic’s potential for mitigating symptoms or eliminating relapse.
Simply put, quality care cannot proceed when physicians don’t have accurate data. Wellness, remission, progress – none of these stems from physician guesswork. So as my neurology practice’s commitment to providing the best possible care continues into the new year, I hope to see broader recognition for the power of biologics’ potential and the uniqueness of their make-up. I’m interested to see how the Food and Drug Administration and the larger medical community interpret biosimilars. But in the meantime, my colleagues and I are committed to caring for our patients to the best of our ability – and with the full facts on all aspects of their treatment.
Dr. Brad Klein is a neurologist practicing in Abington. Dr. Klein is past president of the Pennsylvania Neurological Society and a member of the National Physician Biologics Working Group.