BPC's Nonmedical Switching Guidelines Seek to Preserve Physician–Patient Relationship

The Biologics Prescribers Collaborative (BPC), a project of the Alliance for Patient Access that represents member organizations including the American College of Rheumatology, the Endocrine Society, and the American Gastroenterological Association, among others, recently issued a set of principles and guidelines for nonmedical switching of biologic treatments.

Nonmedical switching, or changing a patient’s treatment for reasons (such as cost) other than medical necessity, is increasingly a concern for patients and providers as biosimilars make their way to market and as payers consider transitioning patients to cheaper options.

The 2 principles outlined by BPC are that the physician—patient relationship must be protected in order to ensure the best patient outcomes, and that patients who are stable on a biologic therapy should not be forced to switch treatments.

BPC’s 4 guidelines are that a streamlined authorization and appeal process should exist when a patient is faced with the possibility of a nonmedical switch, robust data must inform nonmedical switching, pharmacovigilance must be in place to track adverse events related to switches, and a nonmedical switch should not increase a patient’s other medical expenses.

In an interview with The Center for Biosimilars^®, Dennis Cryer, MD, physician co-convener of BPC, explained that, while the primary focus of the organization’s guidelines has been on nonmedical switching from a reference biologic to a biosimilar of that same product, the organization also has concerns about switches mandated by payers from a biologic to a different therapy that may even have a different method of action.

“Some of the same problems ensue in switching from one biologic to a different biologic. The bottom line for us is that we really think the physician needs to be involved in that decision.” BPC’s concern is that an insurer might choose to cover one product and not another, potentially forcing a patient to use a therapy to which they might not respond adequately.

In terms of switching from a biologic to a biosimilar of the same molecule, real-world data from Europe are reassuring to providers, says Cryer, and he adds that the FDA “is very serious” about postmarketing safety tracking for biosimilars. However, “We need to look to forces beyond the adverse event reporting system that the FDA has in place…looking at big insurers and big health systems” will help to track safety events that may arise after switching. “Over time, that will make people a lot more confident and a lot more comfortable with [biosimilars].”

BPC is also concerned about the cost of care for patients who switch to a theoretically cost-saving product; Cryer pointed to an August 2017 white paper from the Institute for Patient Access that found, after analyzing 2011 to 2015 data from the Truven MarketScan database and the Medicare supplemental database, that average per member per month nonpharmacy spending actually rose when patients switched to cheaper drugs. In the rheumatoid arthritis setting, a patient who did not switch drugs averaged $1474 per month, while a patient who switched averaged $1894 per month. In Crohn disease, the monthly averages were $2072 and $4499, respectively. These data, the white paper says, suggest that continuity of care for patients may be a preferable way to keep costs down.

Overall, the key factor underlying BPC’s guidelines and principles, says Cryer, is the importance of the physician—patient relationship. “We still feel that much of the effectiveness of therapy is the relationship and the trust that can be developed between the physician and the patient…over time, that can really lead to much better outcomes, as we’ve seen in a number of clinical situations and individually. Anything that gets between that makes everybody nervous.”