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herceptin

At a recent event on the comparative advantages of small molecule vs. biologic drugs, several themes emerged which led me to re-examine the question of whether the practice of medicine is capable of keeping pace with medical innovation.

As mentioned in a previous post, the majority of patients receiving the personalized medicine drug Herceptin had not been previously administered Herceptin’s diagnostic test. This is extremely important, as the diagnostic test can identify those patients most likely to benefit from the drug and exclude those who are likely to see no benefits (and will likely only get sicker as they rotate through an ineffective drug). For all the talk of the promise of personalized medicine, it appears that the gatekeepers — physicians and payers — are unaware of how to effectively prescribe  personalized drugs.

This is not a new phenomenon. Antibiotic drugs have seen their effectiveness drop due to overprescription, which led to the emergence and rapid spread of antibiotic-resistant bacteria.

So, just as mis-prescription of antibiotics took the shine off many lucrative drugs, mis-prescription of personalized medicines stands to likewise diminish their value. What is particularly surprising is that this is not a new trend. For all the advances in drug development over the decades since over-prescription of antibiotics was recognized as a problem, physicians and payers are still hard pressed to prescribe drugs effectively.

When I asked the panel of potential solutions to the problem, I was given a list of emerging technologies such as bioinformatics, e-health, centralized databases, etc. that could solve the problem; adding technology to a problem isn’t necessarily going to solve it, it may just make it a more expensive problem! In reality the solution already exists. All healthcare payers need to do is require prior authorization before prescribing Herceptin, which would require physician consultation, and require a positive result in the diagnostic test prior to reimbursement for the drug.

As with most simple solutions, I’m sure that this one has already been conceived. So why is it not being used? Could it be that healthcare payers are afraid they might end up having to use a litany of diagnostic tests on all cancer patients, thereby offsetting any potential costs savings? I look forward to your thoughts in the comments section below.

In these videos Pfizer’s Vice President and Global Head of Molecular Medicine, Aidan Power, talk about a future where everyone’s genome is sequenced and drug prescriptions are based on your genetic makeup, and argues that personalized medicine will be the defining paradigm for discovering and developing drugs of the future.

To put these videos into context, consider the recent report which found  that a majority of patients receiving Herceptin had not been tested for HER-2 overexpression — Herceptin is a targeted drug intended primarily for patients overexpressing HER-2. The apparently common prescription of Herceptin independent of it’s diagnostic test suggests that the practice of medicine needs to adapt to keep pace with scientific advance.

Vice President and Global Head of Molecular Medicine