And you thought the fight over prices of cancer and hepatitis drugs was hot.
Emerging federal approval of new cholesterol drugs is setting the stage for a battle over the high prices of those specialty medications and the possibility that millions of people will end up using them each year.
The injectable drugs, known as PCSK9 inhibitors, could cost an estimated $7,000 to $12,000 per year for each person using the drug.
That price tag is generating worry that the costs will add to the increasing burden of drug costs borne by government health programs such as Medicare, as well as private insurance plans. Also of concern is the potential out-of-pocket costs to patients from the new drugs. But a leading trade group for the pharmaceutical industry dismissed fears of non-sustainable costs from PCSK9 inhibitor drugs as overblown, arguing that their use will be less widespread than critics' fears, and that their health benefits will more than justify their big price tag.
The Food and Drug Administration on Friday approved the PCSK9 inhibitor known as Praluent, which was developed by Regeneron and Sanofi on Friday. Amgen's version, known as Repatha, is expected to win FDA approval next month.
The FDA limited its approval for the use of Praluent to those with a hereditary form of high cholesterol and to people with heart disease, which could control overall spending on the drug in the short term if doctors adhere to those limitations. Praluent a wholesale price of $14,600 per year, but discounts could lower that for insurers.
The arrival of the drugs and their high prices, have drawn close attention for pharmacy benefit managers, including CVS/caremark, a division of CVS Health, which has 65 million drug plan members.