New cholesterol drugs will lead to huge healthcare cost increases but few benefits

The U.S. healthcare system has had a hard time digesting the recent debut of Sovaldi and Harvoni, two drugs that have proven effective in curing hepatitis C but cost close to $100,000 for a regimen. They've put a strain on the budgets of state Medicaid programs and commercial insurers trying to determine who should receive coverage for those medications, The Wall Street Journal reports.

But despite their stupefying cost, in the long run such drugs could actually save money along with lives. The only effective cure for hepatitis C prior to the introduction of those medications was a liver transplant, one of the most complicated and expensive surgeries to perform--it's a procedure that starts at about $500,000 and moves on from there, according to Sutter Health. At retail prices, five hepatitis C patients are cured for every one that undergoes a liver transplant. And Sovaldi and Harvoni are offered to a lot of safety-net providers and bulk purchasers at about 10 to 15 percent below retail, making the cure ratio closer to 6:1 for every liver transplant.

That brings me to a drug that is also extraordinarily expensive--more so than Sovaldi and Harvoni over the long run--but its benefits are questionable at best. That would be the new cholesterol drugs Praluent and Repatha. Both were recently approved by the U.S. Food and Drug Administration and will cost more than $14,000 a year.

Sanofi Regeneron and Amgen, which will manufacture and distribute Praluent and Repatha, will position the drugs as a potential replacement for statins. They also lower LDL cholesterol but do so at a vastly lower cost--around $145 a year for a generic version of the drug, according to the Pharmacy Checker Blog.  Using that same equation for every patient that will take Praluent or Repatha, 100 others can have their cholesterol lowered by using statins.

But as the New York Times reported the other day, statins cause muscle aches in about a quarter of patients who take them, making them potential candidates for Praluent or Repatha. Peter J. Neumann, a health economist at Tufts Medical Center, told the Times that the availability of the two new drugs "raises questions about how much we are willing to pay for effective innovation in the face of uncertainty about long-term effects and questions of affordability."

Statins can lower LDL cholesterol levels by as much as 63 percent when taken in its highest dosages. Altogether, they lower the risk of a heart attack by about 20 percent, according to Harvard Medical School.

Repatha cuts the risk of major coronary or vascular incidents even further--about 50 percent--according to a study published earlier this year in the New England Journal of Medicine.

Although the data suggest a drug like Repatha is more effective in cutting such risks, a 2.5 multiplier of effectiveness versus statins still does not come close to penciling out the extra 100 multiplier of cost.

Of course, many would say curbing the risk of heart attacks is worthwhile, saving pain and lives. Heart attacks are no doubt deadly, but their effects on the heart can be all but reversed if an angioplasty is performed in a timely manner. The total fair price for such a procedure is $23,991, according to the Healthcare Bluebook.

The math is pretty straightforward over the course of a decade. The cost of the statins is under $1,500. If the patient has one heart attack during that decade treated via angioplasty, the cost is about $25,500. The cost for treating the same patient with Repatha or Praluent for that same time period is more than $140,000.

Let's say I'm underestimating all of the costs associated with an angioplasty, and I throw in another $15,000. That increases the cost of a (failed) statin regimen over the course of a decade to around $40,500. Let's say the patient needs a more serious procedure, such as a coronary bypass artery graft. That's another $46,912, according to the Healthcare Blue Book. That puts the failed statin regimen at around $87,000. Or let's say the same patient is at risk for a stroke. The price for a carotid endarterectomy: $14,975.

Even if the statin patient has all three procedures during the course of a decade, their care would still cost tens of thousands of dollars less than if they took Praluent or Repatha without a single mishap. And the fact is, two out of those 10 statin patients will avoid many of these procedures anyway simply because of the therapeutic value of those particular kind of drugs.

The same could be said of more patients taking Repatha or Praluent, but their vastly higher cost wipes out their prophylactic benefits.

Nevertheless, I suspect many Americans will clamor for these drugs. There are a variety of reasons for this, including the hundreds of millions of dollars Sanofi Regeneron and Amgen will spend to market them and amp up our collective desire to try something that's the "latest" or "new" (if you observe the lines outside an Apple store the day a new iPhone comes out, such a phenomenon is obvious). The avoidance of muscle cramps many say they experience when they take the old-line statins will be another reason.

But another phenomenon also comes into play: We almost always want to take a pill as be-all or end-all curative. Despite the fact that regular physical activity would put a dent into the rate of heart attacks that would top the effect of statins, most Americans don't want to put in the effort.

"Unfortunately, most Americans prefer prescription of pills to proscription of harmful lifestyles such as physical inactivity," said Charles H. Hennekens, M.D., a professor at Florida Atlantic University's College of Medicine.

That's primarily why Praluent and Repatha have good shots at being blockbusters--and our healthcare costs will continue to spiral upward. - Ron (@FierceHealth)