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Amgen’s Repatha Unclogs Arteries in Good Sign for Future Sales

  • Repatha reversed plaque buildup in 64 percent of patients
  • Data bodes well before large-studies results in coming months

Amgen Inc.’s Repatha was shown to strip plaque out of patients’ arteries in an imaging study, providing evidence that the injected medication helps reverse the progression of heart disease that is the leading cause of death worldwide.

The results, presented at the American Heart Association’s annual meeting, are an important step as doctors, patients and investors await definitive trials on whether Repatha and a rival medicine from Sanofi and Regeneron Pharmaceuticals Inc. can prevent heart attacks and deaths. Insurers, too, want evidence that the drugs lower cardiovascular events, not just cholesterol levels, to potentially extend coverage of the expensive drugs.

Plaque buildup in the artery can trigger a heart attack when it ruptures. The degree of plaque reduction in Amgen’s study, dubbed Glagov, is well within the range of other heart medicines that found health benefits, according to Steven Nissen, the senior author of the paper that was also published in the Journal of the American Medical Association.

“This is the first time anyone has shown these drugs do anything other than lower cholesterol,” said Nissen, chair of cardiovascular medicine at the Cleveland Clinic in Ohio.

The benefit continued to increase as cholesterol levels fell, Nissen said. Fewer patients getting Repatha suffered cardiac complications such as heart attacks and needed artery-clearing surgery, though the study was too small to determine if the differences were meaningful. Still, it bodes well for the large outcome studies that are expected to have results in the coming months.

Key results from Glagov:

Repatha + statinsPlacebo + statins
Plaque volume- 0.95 percent+ 0.05 percent
Plaque regression64 percent of patients47 percent of patients
Death0.6 percent0.8 percent
Heart attack2.1 percent2.9 percent
First major heart event12.2 percent15.3 percent
Muscle pain7.0 percent5.8 percent

Sales of Repatha and Praluent, made by Regeneron and Sanofi, have been slow to ramp up because insurers have restricted their coverage, seeing the list price of about $14,000 a year as too expensive if the treatments only lower cholesterol. Repatha sales were $83 million in the first nine months of the year, lower than the $97.8 million average analysts anticipated in total for the three quarters.

“I love these drugs -- they are definitely life-saving for the right people,” said Eliot Brinton, president of the Utah Lipid Center. “But the problem is that they are priced in a way that I think we can only justify their use in a small number of patients.”

Many payers have instituted prior authorization forms, requiring physicians to prove that patients either have a genetic condition called familial hypercholesterolemia or that they’ve tried multiple statins, like Pfizer Inc.’s Lipitor, and still aren’t able to keep cholesterol under control.

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“It’s hours of work, and then what happens is uniformly you get denied, so then you do the appeal,” said Seth Baum, president of the American Society for Preventive Cardiology. He’s prescribed Praluent or Repatha to about 50 patients, and only about half of them actually got the medication.

Out of about 100,000 prescriptions written for Repatha in its first year on the market, only one-third of patients have been able to get the drug, according to Amgen’s Joshua Ofman, senior vice president of global value, access and policy. On average, it took them five appeals. For Praluent, the percentage of prescriptions that have been dispensed is about 25 percent, according to Regeneron spokeswoman Arleen Goldenberg.

Amgen’s Ofman says the drugmaker is committed to working with payers through value-based contracts that protect payers from unexpected cost increases, or give discounts if patients don’t respond as expected. Both Amgen and Regeneron have signed contracts with insurer Cigna Corp. promising additional discounts based on patients’ LDL level reduction.

Regeneron and Sanofi may announce interim data from their outcomes trial by the end of the month. Amgen, based in Thousand Oaks, California, says it will have final results in the first quarter of 2017.

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