The LDL drug wars: A new hope
Thursday, February 02, 2017
"It is a period of civil war. Rebel spaceships, striking from a hidden base, have won their first victory against the evil ..."
No, I'm not talking a galaxy far, far away. I'm talking about the current battle involving Repatha (evolocumab) and Praluent (alirocumab). These two injectable drugs, both belonging to a class known as PCSK-9 inhibitors, are used to help lower very high LDL cholesterol levels in patients.
To me, the drug class (PCSK-9) sounds like a name for a new Star Wars droid. And maybe the Star Wars series is an appropriate association, since they seem to have been involved in some battles of galactic significance.
First, there was the battle to even gain physician interest in considering anything beyond statin therapy for cholesterol reduction. Statins have been the gold standard for years, and they are extremely effective for many patients.
However, for pharmacists like myself involved in counseling patients who have started on statin therapy, we know this approach isn't always successful. Some patients fail to achieve the LDL reduction needed to reduce the risk of cardiovascular disease, and others experience side effects such as muscle pain, weakness and tenderness requiring discontinuation of the drug.
But the most recent study data seems to be helping ease the mind of clinicians about the benefit of using this new class of drugs for the appropriate patient.
Two months ago, the results of a study conducted by Amgen (makers of Repatha), published in the Journal of the American Medical Association, were discussed at the conference of the American Heart Association. The LDL reductions achieved were dramatic, and there was even a modest regression in actual plaque formation as well.
"You know we used to say you can’t be too rich or too thin, we now say, you can’t be too rich, too thin, or have too low of a cholesterol level," said Dr. Steven Nissen, chairman of cardiovascular medicine at Cleveland Clinic in Ohio.
Next, there was (and still is) the battle for payer acceptance of these new drugs. At $14,000 per year, they are a steep hike up from the modest costs of the mostly generic statin therapy currently available. In early 2016, it seemed like most payers were still in denial, refusing to cover either of these new products for almost everyone. But I'm finding the wind to be changing a bit in the last few months.
All health plans will still require prior authorization for either of these medications. And in some cases, I have seen rather intimidating prior authorization forms stretching to 10 or 12 pages in length.
But most of the time they are looking for evidence of a genetic type of hypercholesterolemia or clinical atherosclerotic cardiovascular disease for which statin therapy has been unsuccessful. Be prepared to have well-documented statin trials, including the high-intensity statins such as atorvastatin and rosuvastatin, along with ezetimibe.
Once approved, sometimes patients will be left with large and unaffordable copays, which presents a whole new challenge as well.
And the battle for patient acceptance has not been easy either. The very idea of treating high cholesterol with an injection, even if it is only once or twice monthly, is a concept that many patients are reluctant to consider.
Just the other day, I was talking with a potential candidate for one of these new drugs. As soon as I mentioned they were injected, I could almost see the walls go up. "No way," she said. "I'm not going to use anything I have to inject. The doctor will have to find another way."
Nevertheless, many of my patients are adjusting to the idea and have found the process to be easier than they thought.
Finally, and most recently, has been the battle between the makers of Repatha and Praluent themselves. There appears to be something of a legal case in which Amgen (makers of Repatha) claims Sanofi/Regeneron (makers of Praluent) infringed upon their patent. If Amgen wins, they could end up receiving royalties on the sales of their competitor's drug.
Well, maybe the battle involving these PCSK-9's is somewhat less enthralling than the swinging light sabers and asteroid-dodging drama of the Star Wars series. But pharma has its own version of the Force, and right now it seems to be gaining ground against the Dark Side of LDL cholesterol.
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