"Me Too" Drugs

Today’s Managing Health Care Costs Number is $121

The FDA approved a seventh statin, Pitavastatin (Livalo) – a 
“me-too” drug to lower cholesterol.  Newly approved drugs can increase competition and lower prices, and in some instances they can be downright better than existing drugs. The benefit to society of "me too" drugs tends to be very low in a class where generics are already in place, though.

The Medical Letter,  a non-profit, noncommercial organization that evaluates medicines, says:

Recommended doses of pitavastatin (Livalo) have not been shown to decrease LDL cholesterol more than recommended doses of other statins with longer safety records and, unlike other statins, no data are available on clinical outcomes with pitavastatin. In addition, pitavastatin has a worrisome potential for clinically significant drug interactions. There is no good reason to use it.

This new medication costs $121 per month, while generic statins cost under $30 per month. 

A commentary in JAMA last week suggests that the FDA should only approve “me too” drugs in classes with existing generics if those drugs are frankly superior to existing drugs, rather than non-inferior, which is required by the current regulations.

I think that’s a great idea. This could help us increase the value of pharmaceutical spending, and help the FDA focus its attention on meaningful innovation.     Alas, the likelihood of passing this kind of revision of the FDA’s role is very low.

My colleague Craig Shelley has pointed out that my last post suggesting that the FDA should consider cost-effectiveness when approving medical devices would also require new legislation. This is also very unlikely.