Earlier this summer the Food and Drug Administration (FDA) approved the first of a new type of cholesterol-lowering medication, the PCSK9 inhibitors.
The drug companies Sanofi and Regeneron got that honor with their drug Praluent (alirocumab). But not too far behind will be Amgen with Repatha (evolocumab) and Pfizer with borocizumab. (Who names these drugs, anyway?)
Although Praluent is not yet available in pharmacies, its announced price tag has the medical community (and insurers) in an uproar. Pharmaceutical executives are doing their best to rationalize the expense—spend a lot of money up front and maybe save more money down the road. Or something like that.
Unlike statins that are tablets taken by mouth, Praluent and the other PCSK9 inhibitors are an injection that the patient self administers under the skin, like insulin. It only needs to be injected twice a month, but the cost is $560 per dose, or $14,560 per year. And unlike the equally crazy-expensive drugs recently approved to treat hepatitis C and cancer, this drug is taken for the rest of the patient’s life.
By comparison, a brand-name statin costs about $3000 per year; generics are even cheaper.
Related post: The overuse of statins
Of course, Praluent was approved by the FDA to treat only those patients who aren’t helped by statins and/or lifestyle changes. Still, a conservative estimate is that 8 to 10 million patients could be prescribed Praluent or one of its competitors, and there is speculation that it will be much more widely prescribed than that.
Little wonder the insurance companies are not happy, to say the least.
“While the FDA’s focused guidance recognizes the safety and effectiveness of this treatment for certain patients, the exorbitant price raises concerns as to whether consumers and the health system can sustain the long-term cost,” said the interim CEO of America’s Health Insurance Plans, Dan Durham.
And it’s probable insurance companies will ration who gets these medications, by insisting on prior authorizations and laboratory proof that regular statins aren’t working.
Pharmacy benefit managers will attempt to limit that number, based on clinical guidelines and expert opinion. They will likely require laboratory tests to show evidence of muscle inflammation or liver damage before allowing treatment for those with statin intolerance. Patients and their doctors claiming subject symptoms of muscle ache or fatigue will have to re-challenge patients. But it is unclear how much these medical management efforts will limit utilization.
As this is chronic therapy, PCSK9 sales could be expected to persist and grow over time, and will likely be the highest selling class of medications in history. Plus, as a biologic agent, there will not be a simple pathway to cheaper generics in a 10-15 year timeframe. Even in a system that costs $4 trillion per year, a single therapy adding $100-200 billion in costs annually is extraordinary. [my emphasis]
At this time, studies have only shown that Praluent lowers LDL cholesterol levels. Whether this means the drug also decreases the number of heart attacks and/or strokes is not yet known; those studies are underway, but the results won’t be available until 2017.
That information, known as “outcomes data”, wasn’t required by the FDA to get Praluent approved.
Related story: New Drug Sharply Lowers Cholesterol, but It’s Costly
The amount of resources we throw at healthcare in this country is mind boggling. I can only shake my head in wonder and agree with a physician who blogged:
So what we are getting now from the pharmaceutical industry (with occasional exceptions) is wickedly expensive drugs of limited scope, whose safety and effectiveness is never studied adequately. These cost so much that they will likely increase the already unsustainable price of medical care. We all share the burden of those costs. The only non-regulated way to fix this problem is to quit agreeing to pay these high costs for miracle (or not so miracle) drugs. I’m not sure that, in our culture, we are willing to make that choice.
How much more are you willing to pay?