How Want Became Need With ODYSSEY

Melissa Walton-Shirley, MD


March 11, 2018

After the ODYSSEY presentation by P Gabriel Steg, MD, from the Coronary Care Unit, Hôpital Bichat-Claude Bernard, Paris, France, it dawned on me that what we really need in every physician's office is a full-time hostage negotiator. The trial showed benefit for the PCSK9 inhibitor alirocumab in patients with acute coronary syndrom with a low-density lipoprotein cholesterol level more than 70 mg/dL on optimal statin therapy. The main advantage was seen in the subgroup with a low-density lipoprotein cholesterol level ≥100 mg/dL (2.6 mmol/L) at baseline: they saw a 24% relative risk reduction for cardiovascular events. What's clear, however, is that the vast majority of such patients will never get a chance to benefit. Perhaps only someone skilled in the art of negotiation could win a few more years of good health for these patients.

At the press conference, Mary Norine Walsh, MD, the current American College of Cardiology president, related that she had recently spent a full 22 minutes on the telephone navigating the prior authorization process. Steg indicated that he, too, would have trouble getting this medication for his patient population in France. This proves that whether you're the patient, the prescriber, the designated prior authorization expert, the director of the clinical trial, or the president of the American College of Cardiology, you're more likely to be disappointed than rewarded for your efforts.

I admit I've been slow on the uptake with PCSK9 inhibitors. I've reserved them for the rare patient with familial hypercholesterolemia who comes to my office with extremely high total cholesterol. I've prescribed it to those who have blown through a bypass, past a few stents, and are having recurrent events while receiving statin therapy. I'm guilty of extrapolating the benefit of these molecules to similar patients who are statin intolerant, a population that isn't well studied but is worth the gamble as far as I'm concerned, with a drug whose main adverse effect is a quick sting at the injection site. Most attendees agreed with me at the end of the presentation.

Valentin Fuster, MD, from Mount Sinai in New York City, polled the audience before the ODYSSEY presentation: 6% of respondents prescribed these molecules once a week, and 15% once a month, and 52% had never prescribed them. After they heard the results, 62% agreed that they would change their prescribing habits. "Fantastic. This is the success of your talk," Fuster quipped to Steg. Except it's not really a success if we can't get the drug added to our patients' medication regimen.

The arduous prior authorization process isn't unique to pharmacology: It's also a catfight every time I attempt a prior authorization for a wearable cardioverter defibrillator. I've spent a decade fighting for nuclear stress tests in dyspneic postmenopausal females. Every time I've tried to get a 2-week cardiac monitor to quantitate paroxysmal atrial fibrillation for patients who are covered (or perhaps not really covered) by Cigna Health Spring, I've failed. Denied 100% of the time. A frustrated tweet was quickly answered by that company, inviting me to email them with details last month. To date, I hear only crickets.

In addition to hostage negotiators, the team should also include mediators to haggle over cost, economic advisors to consider the number needed to treat, and ethicists to help us determine who should be treated. Unfortunately, our patients naively rely on us to be all of those things, and we are largely powerless.

As frustrations from the prior authorization process increase, burnout will escalate and practitioners will continue to disappear from the landscape of medicine because we can't get what we need for our patients. Now that ODYSSEY has shown benefit for PCSK9 inhibition in some populations, it matters more than ever that we develop creative ways to fight the system. Until cost comes down, patients will go lacking. Today want became need, and it still didn't matter.


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