by Seth J. Baum, MD

A recent article by Caroline Humer and Ransdell Pierson for Reuters reported on the unexpectedly paltry number of prescriptions for PCSK9 inhibitors, the revolutionary cholesterol lowering drugs that were FDA approved in the summer of 2015. Insurance providers had viewed these costly medications as a potentially grave threat to their bottom line, as they were certain that many physicians would rapidly adopt their use. Steve Miller, CMO of Express Scripts, asserted that his company grossly overestimated how many cardiologists would prescribe these medications, now postulating that physicians are awaiting “outcomes data” before embracing the powerhouse LDL-lowering drugs. An explanation offered by one medical source is that doctors are worried about the cost of the medicines, and they also want proof that these drugs will decrease heart attacks. Another physician cited insurance barriers as the cause. I have extensive real word experience in this arena: I am a preventive cardiologist and clinical lipidologist directing one of a handful of lipid clinics in America that treats extraordinarily high-risk patients who are optimal candidates for such medications. I have sat on various scientific advisory boards for pharmaceutical companies and also spoken on behalf of some of these corporations. Additionally, I am proud to be the President Elect of the American Society for Preventive Cardiology, whose mission is to prevent heart attacks, stroke, and vascular death. I am also honored to serve as a board member for the FH Foundation, the preeminent patient-centric, scientifically rooted organization for familial hypercholesterolemia. This editorial however is entirely my own; it is independent of these aforementioned entities and in no way reflects their views or positions. I am writing from my own clinical experience, which has taught me much about the question raised by Humer and Pierson. I also firmly believe that patients have a right to know the truth.

Great advances were made in 2015 – two new heart failure drugs, a cardiovascular-disease-reducing diabetes medicine, and the revolutionary lipid lowering drugs – the now famed PCSK9 inhibitors – all became available to better treat our patients’ ailments. Doctors were overjoyed with this panoply of novel and potentially life-saving additions to our armamentarium. And so we began to prescribe. That is what doctors do, identify and utilize what they consider to be beneficial therapies for their patients. Financial remuneration is never gained from this; it is solely the gratification of helping our patients that fuels physicians’ interest in novel treatments.

Many of us have spent decades endeavoring to understand the nuances of diseases and their remedies. So when we enthusiastically prescribed these therapies and found our prescriptions repeatedly denied by clerks, nurses, and less well-informed physicians, we were shocked. Across the nation, doctors have universally shared this distasteful experience. Everywhere, insurance providers are demanding that we alter our treatments to suit their arbitrary and monetarily motivated formularies. Their requirements not only place enormous burdens upon physicians and their staff, but they also necessitate numerous prolonged medication trials that patients must endure before they can hope to receive the optimal care their physicians initially prescribed. This is senseless. Medical education is demanding, long (10+ years after college), and extraordinarily complex. Additionally, no one can appreciate a patient’s medical condition better than his/her physician. Someone who has never seen you, never had the opportunity to speak with you or lay his or her hands on you, someone who lacks the skillset of your doctor, and an individual with an irrefutably vested financial interest in denying the prescriptions of your doctor now enjoys the power to countermand your doctor’s orders. This is precisely what takes place every day in every doctor’s office in America. Insurance providers deny doctors’ prescriptions. And this is the cause of the purported “under-prescribing” of the PCSK9 inhibitors.

The reason for doctors’ reluctance to continue to prescribe PCSK9 inhibitors stems from the extraordinary barriers erected by insurance providers and prescription benefit managers (PBMs). Witness two real life examples. One patient suffers from severe familial hypercholesterolemia and coronary artery disease, and requires every-other week 3-hour blood cleansing procedures (apheresis) through two large intravenous lines; yet, she was recently denied a PCSK9 inhibitor. Unequivocally this young woman satisfies FDA criteria for the medication, yet my staff and I have had to complete reams of paperwork – and I was even forced to demand and then endure a “peer-to-peer” interview – in order to get her the medicine she needs. Another patient, who is also a physician, has required apheresis for 20 years because of familial hypercholesterolemia. He has suffered a heart attack, stroke, and required several stents. Curiously, he too was denied. Sadly, after months of struggling, I have not yet succeeded in getting him the medication he requires. I forge forward however, daily inveighing new threats and charges against his insurance provider. And he waits. He anxiously wonders when he will have his next cardiac event, or worse, when he might follow his family’s legacy and succumb to a cardiac event. Though I assiduously fight with these insurance providers, many doctors lack the time and office infrastructure to support their patients in a similar fashion. And so they surrender. They also learn another lesson: Do not prescribe the PCSK9 inhibitors lest you drain your resources and those of your office. Yes; that’s the pragmatic truth. The insurance providers are winning by attrition. They are beating down the very people who have sworn oaths to protect their patients.

So when Steve Miller wonders why Express Scripts so badly miscalculated the number of prescriptions that would be written for the PCSK9 inhibitors, there is really no mystery to be solved. The answer is clear. Insurance companies have built a veritable army who through sheer volume and perseverance are winning medical battles in order to defend the coffers of their masters. This is why the wonder drugs Repatha and Praluent are being under-prescribed. Not for medical reasons, but rather because doctors lack a formidable fighting force.