Calabrese says it is too early to draw any clear conclusions on utilization because patient numbers are currently limited and in turn, data are not of sufficient volume or duration.
In addition, he points out that true outcomes data, such as impact on longer term cardiovascular morbidity and mortality, will not be evident until such studies are completed by manufacturers some time in 2017 or 2018.
Miller agrees that the long-term effects of PCSK9s are not yet known, but anticipates that as more clinical information is available about the drugs and they prove to be better than statins, the population that could benefit should increase in 2017.
Calabrese also says the uptake by doctors prescribing the drugs is low based on a lack of outcomes data, their injectable administration and the availability of much less costly, well-tested generic alternatives, such as high-potency statins with very solid long-term, outcomes data.
Wong agrees with Calabrese that current utilization is very low—probably lower than expected. Cardiologists, he assumes, are being very specific about patients for whom they prescribe PCSK9s, and most of those patients are meeting criteria.
Although he recognizes that the new drugs are as effective as claimed in producing a higher level of cholesterol reduction, the issue is whether every case of high cholesterol will require such a decrease. “Current therapies will provide an adequate reduction if taken properly," he says.