CVS Strikes Deal for Repatha Only; 18,000 Enroll in Long-term Praluent CV Outcomes Trial

CVS Health Corp. announced Monday that it will add Amgen’s evolocumab, being marketed as Repatha, to its formulary, opting to cover just 1 and not both of the recently approved cholesterol-fighting PCSK9 inhibitors to its formulary. Terms of the deal were not announced.

The move comes about 6 weeks after Express Scripts, the nation’s largest pharmacy benefits manager, announced it would cover both evolocumab and alirocumab, being marketed as Praluent by Sanofi and Regeneron. Terms of those deals were not disclosed. FDA approved the 2 injectable therapies were approved this summer after clinical trials showed they could reduce low-density lipoprotein (LDL) cholesterol levels by 60%.

Both drugs were introduced at wholesale prices above $14,000 a year, well above analysts’ estimates, and there has been considerable outcry about the price. A draft report from the Institute for Clinical and Economic Review found that the drugs should cost 85% less than their list prices.

Britain’s cost watchdog agency NICE last week refused to recommend evolocumab for the nation’s National Health Service because it did not see enough value in the therapy, and it said long-term cardiovascular (CV) data were not yet available.

CVS said its review found that Repatha and Praluent were “therapeutically equivalent.” Thus, the decision to go with 1 drug came down to cost. “CVS Health is committed to providing high-quality medications for our clients and their members at the lowest possible cost,” said Troyen Brennan, MD, MPH, CVS Health executive vice president and chief medical officer in a statement.

“We have determined that choosing a single PCSK9 inhibitor for our commercial formularies allows us to get the best price possible for clients and preserves our commitment to deliver the best are possible.”

Both drugs are monoclonal antibodies that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme that when blocked results in dramatically lower levels of LDL cholesterol. PCSK9 stymies the liver from effectively eliminating LDL cholesterol on its own. When it was found that people who naturally lacked this enzyme had abnormally low cholesterol levels, the race was on to look for ways to block PCSK9.

While there has been considerable excitement from some cardiologists over the potential to treat patients who have been unable to attain cholesterol goals, even on the most powerful statins, there have also been concerns that researchers do not yet have long-term data about CV effects. For that reason FDA limited the labels on both drugs to the highest-risk patients and those with a genetic conditions that cause abnormally high cholesterol levels. In Europe, patients who simply can’t tolerate statins also can get access to the drug.

To gain that long-term data, Sanofi and Regeneron announced nearly a year ago they would embark on the ODYSSEY OUTCOME trial, which will find out whether adding Praluent to statin therapy among patients who have already had a cardiac event, such as a heart attack, increases risk of another event.

Today, the 2 companies announced they have enrolled 18,000 patients in the trial, whose primary endpoint is the time to the first occurrence of a coronary heart disease death, acute myocardial infarction, hospitalization for unstable angina, or a stroke.