The Cautionary Tale of Fenofibrate

Today's Managing Health Care Costs Indicator is $700 million 

Source. Click image to enlarge 

The Archives of Internal Medicine has an illuminating narrative today about how Abbott Pharmaceuticals managed to maintain effective brand name pricing for this questionably-effective lipid medication for over TEN YEARS after its patent expiry.   The authors had an earlier paper showing the striking different use of fenofibrate in Canada compared to the US  - which I linked to in 2011. The annual cost to health care consumers and purchasers: $700 million!

Abbott’s plan, called “a novel and especially clever approach” in the accompanying editorial:

1) Sue potential generic manufacturers for patent infringement. This netted Abbott 30 additional months without generic competition
2) During this 30 month window, Abbott filed for a new formulation – with a slightly different number of milligrams per pill. The drugmaker did no new studies to show clinical efficacy –but rather simply showing that the new formulation was equivalent to the older formulation
3) Before the generic came out – Abbott moved 97% of all patients off the drug that would be substitutable, and to the “new” drug for which a generic had not yet been approved.  

Although the new drug was equivalent to the old one, generics could not be substituted.

4) When a generic was just about to come out for the second formulation – voila – Abbott introduced a third formulation – again showing only equivalency to the old formulation, and again preventing generic substitution.   The company only convinced 96% of patients to switch to the new, equivalent, nonsubstitutable brand name medication this time.

During this time, large studies failed to show survival or cardiac benefit to treatment with fenofibrate, which nonetheless was aggressively marketed.  Rates of use of this medication continued to rise!

The authors suggest a number of solutions to this problem – which could have been addressed by better regulatory efforts, a mandate to allow substitution for equivalent drugs, or prescribing physician unwillingness to go along with this decade-long charade.  

H/T to Marilyn Mann for pointing out this article.