GlaxoSmithKline’s controversial type 2 diabetes drug Avandia is back in the headlines following the news that two major pharmacy benefit managers in the USA are pulling the treatment from their formularies.
First of all, Prime Therapeutics, which acts as a PBM to “approximately 12.5 million covered lives”, said it had removed Avandia (rosiglitazone) “after careful examination of clinical literature regarding the safety and efficacy” of the drug. It has been looking at the drug since May following the meta-analysis in the New England Journal of Medicine which raised concerns about cardiovascular risk.
Prime said that its own “in-depth analysis” of medical and pharmacy claims revealed that over 25% of patients on Avandia had a history of coronary artery disease or heart failure. It also noted that since the meta-analysis, the PBM has seen a 58% decline in Avandia utilisation.
The label on Avandia has been expanded, although the US Food and Drug Administration still says that the drug’s risk/benefit ratio is still favourable. Nevertheless, Prime’s senior director of drug technology assessment and formulary development Craig Mattson still has his doubts and the PBM “takes drug safety warnings very seriously and our primary concern is the safety of our members”.
This view was echoed by another PBM, HealthTrans, which will remove Avandia from the beginning of next year. Chief executive Jack Haynes said that HealthTrans’ Pharmacy and Therapeutics Committee, which is comprised of independent physicians, pharmacists, and nurses, “have to make some tough decisions about discontinuing drugs that they have determined present significant risks”. This has also led to a recommendation that Takeda’s thiazolidinedione Actos (pioglitazone) should be moved to the third tier of the formulary.
The changes proposed by Prime and HealthTrans are likely to further hurt sales of Avandia which fell 38% globally in the third quarter to £225 million, and crashed 48% in the USA. It could get worse if other PBMs follow their example and GSK said it was disappointed by the moves, saying that limiting options for treatment could be detrimental for patients.
