Biosimilar medications designed to give patients more options may instead become health plans’ newest tool for limiting patient access.
On August 2 CVS Health revealed that it will exclude 35 prescription medication from its 2017 formulary. Two of those are biological treatments for cancer and diabetes – which CVS will now replace, it says, with lower-priced biosimilars.
Company leaders say the move reflects “hyperinflationary” prescription drugs prices, which CVS now intends to monitor and address quarterly. “They have real possibility of helping us control costs,” CVS Chief Medical Officer Troyen Brennan said of biosimilars. The treatments can lower prices by about 10-15 percent.
But some patients and health care providers have a different take.
Intricate and cell-derived biological treatments can impact patients’ immune systems, requiring close monitoring by physicians. Biosimilars, which are similar but not identical to their biologic reference product, offer additional options. They allow physicians to prescribe or change medications based on individual patients’ responses and tolerance for side effects.
Eliminating originator biologics as an option, however, has the reverse effect. Patients have fewer treatment alternatives – and physicians effectively lose control of prescribing decisions.
Non-Medical Switching Concerns
CVS’ move also heightens growing concerns about non-medical switching. If restrictive formularies drive stable patients to switch to a cheaper medication, patients’ health could suffer. So could their ability to manage their condition. But those concerns may not deter cost-conscious health plans.
[Watch: Understanding Non-Medical Switching]
In fact, the potential for non-medical switching could grow, driven by new research from Johns Hopkins Bloomberg School of Public Health and Brigham and Women’s Hospital. Researchers there surveyed 19 studies using biologics and biosimilars to treat rheumatoid arthritis, psoriasis and irritable bowel disease. The researchers announced “very similar safety and effectiveness” for the biologics and biosimilars. They also, however, acknowledged the potential for publication bias and noted the small sample size for the studies they reviewed.
Despite those limitations, the study’s leader announced that the research should “reassure clinicians and patients and, importantly, the folks who pay the bills–insurance companies and government programs like Medicare – that biosimilar TNF-α inhibitors appear comparable to their branded counterparts….”
From a regulatory standpoint, only an interchangeable designation from the Food and Drug Administration can ensure that any given patient will have the same clinical results with the biosimilar as with the biologic. The FDA has not yet issued guidance on interchangeability (but indicates that it will do so this year).
The agency’s delay didn’t seem to deter CVS from assuming biosimilar equivalency – pursuing cost savings at the expense of patient access. The months ahead will show whether other health plans follow suit – and what non-medical switching and cost-driven formulary restrictions may mean for patient health.