Mark this case a clear FAIL. Health Canada and related agencies abdicated their responsibility to properly inform the public and allowed industry to manipulate and poison the biosimilar conversation. Physicians were pressured to stamp all of their biologic prescriptions with a Do Not Substitute order. Prestigious physicians wrote opinion articles disguised as evidence-based reporting that were published in medical journals advocating against substitution. And patient organizations, whether knowingly or not were parties to delivering mixed messages to patients by disseminating material and webinars produced and paid for by drug companies.
Worse still, its been reported that coercive marketing tactics by originators took advantage of many patients’ vulnerability while they were in hospital that directly interfered in and biased their treatment, resulting in the loss of their biologically naïve status and their right to choose a therapy most appropriate for them.
However, the Holy Grail of scientific evidence, such as The NOR-SWITCH Study, is now proving that biosimilars are equally effective in patients who switch.
So at this late stage of the conversation should regulators step in with a communications plan? It’s clear that fighting a rear guard action as a knee-jerk reaction would be costly and risky, both of which these bodies typically avoid like the plague.
As a warning against such an action, when the US Preventive Services Task Force (USPSTF) released its recommendations against routine prostate screening for healthy men, celebrity patients had already been lined up to challenge the population based recommendations. The result – millions of healthy men anxious that they’d lose access to screening stampeded into doctors’ offices demanding a PSA test.
It will be very easy to hijack government messaging. Tackling a well funded and subversive action, with a very restrictive communication model that government uses will only cause more problems. There is too much at stake here – we’re talking about BILLIONS of dollars and the impact on patient experience and health outcomes.
The answer: don’t wait until the sky is falling to engage with patients. We need a different approach from the get-go. Drug and treatment policy decisions can’t be made in the absence of the patient voice. All agencies involved in these decisions, and our policy leadership up to and including our federal Minister of Health, need to seriously re-evaluate and overhaul how patients and the public are being involved in health care decision-making. While intentions are well meaning, its clear from this example that current engagement practice isn’t effective in understanding the BILLION+ dollar impact of this issue.